User login
Aerobic, breathing exercises tied to faster concussion recovery
, preliminary findings from a new study suggest.
Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.
“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.
“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.
The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
Targeting autonomic dysfunction
Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.
Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.
The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.
The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.
All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.
The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.
Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.
The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.
The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.
Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.
A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
Complex problem
Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.
Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.
“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.
Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.
“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.
“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO2 sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.
“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.
The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, preliminary findings from a new study suggest.
Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.
“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.
“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.
The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
Targeting autonomic dysfunction
Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.
Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.
The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.
The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.
All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.
The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.
Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.
The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.
The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.
Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.
A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
Complex problem
Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.
Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.
“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.
Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.
“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.
“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO2 sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.
“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.
The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, preliminary findings from a new study suggest.
Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.
“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.
“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.
The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
Targeting autonomic dysfunction
Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.
Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.
The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.
The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.
All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.
The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.
Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.
The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.
The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.
Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.
A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
Complex problem
Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.
Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.
“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.
Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.
“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.
“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO2 sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.
“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.
The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AAN 2023
At 5 years, TAVI valves perform better than surgical ones
In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.
The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.
The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.
SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
Surgical valve deterioration high at 5 years
On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).
Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).
When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).
However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).
Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).
The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m2 (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
BVD criteria validated for outcome prediction
The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.
“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.
This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.
A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.
“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”
A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.
While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.
Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.
In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.
The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.
The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.
SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
Surgical valve deterioration high at 5 years
On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).
Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).
When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).
However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).
Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).
The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m2 (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
BVD criteria validated for outcome prediction
The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.
“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.
This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.
A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.
“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”
A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.
While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.
Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.
In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.
“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.
The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.
The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.
SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
Surgical valve deterioration high at 5 years
On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).
Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).
When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).
However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).
Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).
The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m2 (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
BVD criteria validated for outcome prediction
The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.
“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.
This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.
A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.
“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”
A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.
While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.
Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.
FROM CRT 2023
Skin reactions from melanoma targeted and immune therapies range from pruritus to SJS
SAN DIEGO – A
“These skin reactions can cause pain, itching, and emotional and social distress that may severely impact activities of daily living,” Aleksandr Itkin, MD, a dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. An estimated 30%-50% of patients on immune checkpoint inhibitors (ICIs) experience cutaneous adverse events, he said, which leads to dose reduction or discontinuation of ICIs in 20% of cases.
Clinicians first observed these side effects in 2011, with the Food and Drug Administration approval of ipilimumab, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody, for metastatic melanoma, followed by the programmed death receptor-1 (PD-1) inhibitors nivolumab and pembrolizumab, which were approved in 2014 for the same indication.
Since then, more ICIs showing similar adverse cutaneous reactions have been approved by the FDA. These include avelumab, atezolizumab in combination with cobimetinib and vemurafenib, and a combination of relatlimab, an anti-LAG-3 antibody, with nivolumab.
Among the targeted therapies, the BRAF inhibitors vemurafenib and dabrafenib alone or in combination with MAPK pathway inhibitors cobimetinib and trametinib, which are a first-line therapy for V600 BRAF mutated metastatic melanoma, are associated with their own set of cutaneous reactions. The oncolytic modified herpes simplex virus T-VEC (talimogene laherparepvec), approved by the FDA in 2015 for the treatment of unresectable stage IIIB-IV metastatic melanoma, also results in cutaneous reactions that have been found useful in assessing the therapeutic outcome of this agent.
According to a 2020 CME article on the dermatologic adverse events that occur after treatment initiation with ICIs, the time of onset of psoriasiform rash is within the first 3 weeks, maculopapular rash and pruritus in the first 4-6 weeks, lichenoid eruption in the first 7-12 weeks, and bullous pemphigoid in weeks 13-15. The most severe reactions – SJS, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) – usually occur after 2-3 months of treatment.
A subsequent retrospective cohort study of patients in the United States treated with ICIs for a variety of systemic malignancies and matched controls found that the ICI-treated group had a significantly higher incidence of pruritus, mucositis, erythroderma, maculopapular eruption, vitiligo, lichen planus, bullous pemphigoid, Grover disease, rash, other nonspecific eruptions, and drug eruption or other nonspecific drug reaction. Patients with melanoma and renal cell carcinoma and those receiving combination therapy were at a higher risk of cutaneous immune-related adverse events.
Another study, a prospective trial of 617 patients with various advanced cancers (including melanoma), found that both severe and mild skin toxicities were significantly associated with improved progression-free and overall survival.
According to Dr. Itkin, erythema multiforme, SJS, and TEN have been reported with anti-PD1, anti-CTLA4, and BRAF inhibitors. In TEN induced by vemurafenib, an in vitro analysis showed cross-activation of lymphocytes with dabrafenib and with sulfamethoxazole. “This means you that may want to avoid sulfonamides in patients with serious hypersensitivity to vemurafenib, and vice versa,” he said at the meeting hosted by Scripps MD Anderson Cancer Center.
Acneiform eruptions
In addition, the use of MAPK inhibitors can trigger acneiform eruptions. In one study, 77% of patients on trametinib developed acneiform eruption, but only 10% of those on trametinib in combination with dabrafenib developed acneiform eruption. “Inhibition of the MAPK pathway leads to decreased proliferative markers, further leading to decreased keratinocyte replication, increased inflammatory cytokine, apoptosis, thinning and abnormal epidermal differentiation, follicular rupture, and papule/pustule formation,” he said. For these cases, “treatment options are similar to what we use for regular acne except for here, use of systemic steroids is sometimes needed, especially in more severe cases. The reaction may be so severe as to lead to dose reduction or discontinuation of antineoplastic treatment.”
Effects on nail, hair
Paronychia and onycholysis are additional potential adverse events of MEK inhibitors and BRAF inhibitors alone or in combination, Dr. Itkin continued. Onycholysis is associated with dabrafenib alone or in combination with trametinib, while vemurafenib has been shown to induce acute paronychia and brittle nails. He said that secondary infections in these cases can be treated with the options familiar to dermatologists in their daily practice: oral doxycycline, azole antifungals, vinegar soaks, topical superpotent corticosteroids under occlusion, nail avulsion, and phenol nail matrix ablation.
Dr. Itkin noted that while PD-1 and PD-L1 inhibitors can cause hair repigmentation, CTLA-4 and PD-1 inhibitors are more likely to cause vitiligo. Appearance of vitiligo is regarded as a good prognostic factor in the treatment of melanoma with various checkpoint inhibitors alone or in combination with each other or with radiation therapy. “About 5% of melanoma patients treated with ipilimumab will develop vitiligo,” he said.
ICI-induced vitiligo differs from conventional vitiligo in that there is no family or personal history of autoimmunity; it presents as a flecked pattern of lesion on photo-exposed skin, and it lacks the Koebner phenomenon. In addition, induction of squamous neoplasms can occur with BRAF inhibitors, especially in patients with a high frequency of RAS mutations.
He said that coadministration of MEK inhibitors such as trametinib and cobimetinib may prevent induction of keratinocytic neoplasms.
Dr. Itkin reported having no relevant financial disclosures.
SAN DIEGO – A
“These skin reactions can cause pain, itching, and emotional and social distress that may severely impact activities of daily living,” Aleksandr Itkin, MD, a dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. An estimated 30%-50% of patients on immune checkpoint inhibitors (ICIs) experience cutaneous adverse events, he said, which leads to dose reduction or discontinuation of ICIs in 20% of cases.
Clinicians first observed these side effects in 2011, with the Food and Drug Administration approval of ipilimumab, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody, for metastatic melanoma, followed by the programmed death receptor-1 (PD-1) inhibitors nivolumab and pembrolizumab, which were approved in 2014 for the same indication.
Since then, more ICIs showing similar adverse cutaneous reactions have been approved by the FDA. These include avelumab, atezolizumab in combination with cobimetinib and vemurafenib, and a combination of relatlimab, an anti-LAG-3 antibody, with nivolumab.
Among the targeted therapies, the BRAF inhibitors vemurafenib and dabrafenib alone or in combination with MAPK pathway inhibitors cobimetinib and trametinib, which are a first-line therapy for V600 BRAF mutated metastatic melanoma, are associated with their own set of cutaneous reactions. The oncolytic modified herpes simplex virus T-VEC (talimogene laherparepvec), approved by the FDA in 2015 for the treatment of unresectable stage IIIB-IV metastatic melanoma, also results in cutaneous reactions that have been found useful in assessing the therapeutic outcome of this agent.
According to a 2020 CME article on the dermatologic adverse events that occur after treatment initiation with ICIs, the time of onset of psoriasiform rash is within the first 3 weeks, maculopapular rash and pruritus in the first 4-6 weeks, lichenoid eruption in the first 7-12 weeks, and bullous pemphigoid in weeks 13-15. The most severe reactions – SJS, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) – usually occur after 2-3 months of treatment.
A subsequent retrospective cohort study of patients in the United States treated with ICIs for a variety of systemic malignancies and matched controls found that the ICI-treated group had a significantly higher incidence of pruritus, mucositis, erythroderma, maculopapular eruption, vitiligo, lichen planus, bullous pemphigoid, Grover disease, rash, other nonspecific eruptions, and drug eruption or other nonspecific drug reaction. Patients with melanoma and renal cell carcinoma and those receiving combination therapy were at a higher risk of cutaneous immune-related adverse events.
Another study, a prospective trial of 617 patients with various advanced cancers (including melanoma), found that both severe and mild skin toxicities were significantly associated with improved progression-free and overall survival.
According to Dr. Itkin, erythema multiforme, SJS, and TEN have been reported with anti-PD1, anti-CTLA4, and BRAF inhibitors. In TEN induced by vemurafenib, an in vitro analysis showed cross-activation of lymphocytes with dabrafenib and with sulfamethoxazole. “This means you that may want to avoid sulfonamides in patients with serious hypersensitivity to vemurafenib, and vice versa,” he said at the meeting hosted by Scripps MD Anderson Cancer Center.
Acneiform eruptions
In addition, the use of MAPK inhibitors can trigger acneiform eruptions. In one study, 77% of patients on trametinib developed acneiform eruption, but only 10% of those on trametinib in combination with dabrafenib developed acneiform eruption. “Inhibition of the MAPK pathway leads to decreased proliferative markers, further leading to decreased keratinocyte replication, increased inflammatory cytokine, apoptosis, thinning and abnormal epidermal differentiation, follicular rupture, and papule/pustule formation,” he said. For these cases, “treatment options are similar to what we use for regular acne except for here, use of systemic steroids is sometimes needed, especially in more severe cases. The reaction may be so severe as to lead to dose reduction or discontinuation of antineoplastic treatment.”
Effects on nail, hair
Paronychia and onycholysis are additional potential adverse events of MEK inhibitors and BRAF inhibitors alone or in combination, Dr. Itkin continued. Onycholysis is associated with dabrafenib alone or in combination with trametinib, while vemurafenib has been shown to induce acute paronychia and brittle nails. He said that secondary infections in these cases can be treated with the options familiar to dermatologists in their daily practice: oral doxycycline, azole antifungals, vinegar soaks, topical superpotent corticosteroids under occlusion, nail avulsion, and phenol nail matrix ablation.
Dr. Itkin noted that while PD-1 and PD-L1 inhibitors can cause hair repigmentation, CTLA-4 and PD-1 inhibitors are more likely to cause vitiligo. Appearance of vitiligo is regarded as a good prognostic factor in the treatment of melanoma with various checkpoint inhibitors alone or in combination with each other or with radiation therapy. “About 5% of melanoma patients treated with ipilimumab will develop vitiligo,” he said.
ICI-induced vitiligo differs from conventional vitiligo in that there is no family or personal history of autoimmunity; it presents as a flecked pattern of lesion on photo-exposed skin, and it lacks the Koebner phenomenon. In addition, induction of squamous neoplasms can occur with BRAF inhibitors, especially in patients with a high frequency of RAS mutations.
He said that coadministration of MEK inhibitors such as trametinib and cobimetinib may prevent induction of keratinocytic neoplasms.
Dr. Itkin reported having no relevant financial disclosures.
SAN DIEGO – A
“These skin reactions can cause pain, itching, and emotional and social distress that may severely impact activities of daily living,” Aleksandr Itkin, MD, a dermatologist at Scripps MD Anderson Cancer Center, San Diego, said at the annual Cutaneous Malignancy Update. An estimated 30%-50% of patients on immune checkpoint inhibitors (ICIs) experience cutaneous adverse events, he said, which leads to dose reduction or discontinuation of ICIs in 20% of cases.
Clinicians first observed these side effects in 2011, with the Food and Drug Administration approval of ipilimumab, a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)–blocking antibody, for metastatic melanoma, followed by the programmed death receptor-1 (PD-1) inhibitors nivolumab and pembrolizumab, which were approved in 2014 for the same indication.
Since then, more ICIs showing similar adverse cutaneous reactions have been approved by the FDA. These include avelumab, atezolizumab in combination with cobimetinib and vemurafenib, and a combination of relatlimab, an anti-LAG-3 antibody, with nivolumab.
Among the targeted therapies, the BRAF inhibitors vemurafenib and dabrafenib alone or in combination with MAPK pathway inhibitors cobimetinib and trametinib, which are a first-line therapy for V600 BRAF mutated metastatic melanoma, are associated with their own set of cutaneous reactions. The oncolytic modified herpes simplex virus T-VEC (talimogene laherparepvec), approved by the FDA in 2015 for the treatment of unresectable stage IIIB-IV metastatic melanoma, also results in cutaneous reactions that have been found useful in assessing the therapeutic outcome of this agent.
According to a 2020 CME article on the dermatologic adverse events that occur after treatment initiation with ICIs, the time of onset of psoriasiform rash is within the first 3 weeks, maculopapular rash and pruritus in the first 4-6 weeks, lichenoid eruption in the first 7-12 weeks, and bullous pemphigoid in weeks 13-15. The most severe reactions – SJS, toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) – usually occur after 2-3 months of treatment.
A subsequent retrospective cohort study of patients in the United States treated with ICIs for a variety of systemic malignancies and matched controls found that the ICI-treated group had a significantly higher incidence of pruritus, mucositis, erythroderma, maculopapular eruption, vitiligo, lichen planus, bullous pemphigoid, Grover disease, rash, other nonspecific eruptions, and drug eruption or other nonspecific drug reaction. Patients with melanoma and renal cell carcinoma and those receiving combination therapy were at a higher risk of cutaneous immune-related adverse events.
Another study, a prospective trial of 617 patients with various advanced cancers (including melanoma), found that both severe and mild skin toxicities were significantly associated with improved progression-free and overall survival.
According to Dr. Itkin, erythema multiforme, SJS, and TEN have been reported with anti-PD1, anti-CTLA4, and BRAF inhibitors. In TEN induced by vemurafenib, an in vitro analysis showed cross-activation of lymphocytes with dabrafenib and with sulfamethoxazole. “This means you that may want to avoid sulfonamides in patients with serious hypersensitivity to vemurafenib, and vice versa,” he said at the meeting hosted by Scripps MD Anderson Cancer Center.
Acneiform eruptions
In addition, the use of MAPK inhibitors can trigger acneiform eruptions. In one study, 77% of patients on trametinib developed acneiform eruption, but only 10% of those on trametinib in combination with dabrafenib developed acneiform eruption. “Inhibition of the MAPK pathway leads to decreased proliferative markers, further leading to decreased keratinocyte replication, increased inflammatory cytokine, apoptosis, thinning and abnormal epidermal differentiation, follicular rupture, and papule/pustule formation,” he said. For these cases, “treatment options are similar to what we use for regular acne except for here, use of systemic steroids is sometimes needed, especially in more severe cases. The reaction may be so severe as to lead to dose reduction or discontinuation of antineoplastic treatment.”
Effects on nail, hair
Paronychia and onycholysis are additional potential adverse events of MEK inhibitors and BRAF inhibitors alone or in combination, Dr. Itkin continued. Onycholysis is associated with dabrafenib alone or in combination with trametinib, while vemurafenib has been shown to induce acute paronychia and brittle nails. He said that secondary infections in these cases can be treated with the options familiar to dermatologists in their daily practice: oral doxycycline, azole antifungals, vinegar soaks, topical superpotent corticosteroids under occlusion, nail avulsion, and phenol nail matrix ablation.
Dr. Itkin noted that while PD-1 and PD-L1 inhibitors can cause hair repigmentation, CTLA-4 and PD-1 inhibitors are more likely to cause vitiligo. Appearance of vitiligo is regarded as a good prognostic factor in the treatment of melanoma with various checkpoint inhibitors alone or in combination with each other or with radiation therapy. “About 5% of melanoma patients treated with ipilimumab will develop vitiligo,” he said.
ICI-induced vitiligo differs from conventional vitiligo in that there is no family or personal history of autoimmunity; it presents as a flecked pattern of lesion on photo-exposed skin, and it lacks the Koebner phenomenon. In addition, induction of squamous neoplasms can occur with BRAF inhibitors, especially in patients with a high frequency of RAS mutations.
He said that coadministration of MEK inhibitors such as trametinib and cobimetinib may prevent induction of keratinocytic neoplasms.
Dr. Itkin reported having no relevant financial disclosures.
AT MELANOMA 2023
Encephalitis linked to psychosis, suicidal thoughts
Investigators assessed 120 patients hospitalized in a neurological center and diagnosed with ANMDARE. Most had psychosis and other severe mental health disturbances. Of these, 13% also had suicidal thoughts and behaviors.
However, after medical treatment that included immunotherapy, neurologic and psychiatric pharmacotherapy, and rehabilitation and psychotherapy, almost all patients with suicidal thoughts and behaviors had sustained remission of their suicidality.
“Most patients [with ANMDARE] suffer with severe mental health problems, and it is not infrequent that suicidal thoughts and behaviors emerge in this context – mainly in patients with clinical features of psychotic depression,” senior author Jesús Ramirez-Bermúdez, MD, PhD, from the neuropsychiatry unit, National Institute of Neurology and Neurosurgery of Mexico, told this news organization.
“The good news is that, in most cases, the suicidal thoughts and behaviors as well as the features of psychotic depression improve significantly with the specific immunological therapy. However, careful psychiatric and psychotherapeutic support are helpful to restore the long-term psychological well-being,” Dr. Ramirez-Bermúdez said.
The findings were published online in the Journal of Neuropsychiatry and Clinical Neurosciences.
Delayed recognition
ANMDARE is a “frequent form of autoimmune encephalitis,” the authors write. It often begins with an “abrupt onset of behavioral and cognitive symptoms, followed by seizures and movement disorders,” they add.
“The clinical care of persons with encephalitis is challenging because these patients suffer from acute and severe mental health disturbances [and] are often misdiagnosed as having a primary psychiatric disorder, for instance, schizophrenia or bipolar disorder; but, they do not improve with the use of psychiatric medication or psychotherapy,” Dr. Ramirez-Bermúdez said.
Rather, the disease requires specific treatments, such as the use of antiviral medication or immunotherapy, he added. Without these, “the mortality rate is high, and many patients have bad outcomes, including disability related to cognitive and affective disturbances,” he said.
Dr. Ramirez-Bermúdez noted that there are “many cultural problems in the conventional approach to mental health problems, including prejudices, fear, myths, stigma, and discrimination.” And these attitudes can contribute to delayed recognition of ANMDARE.
During recent years, Dr. Ramirez-Bermúdez and colleagues observed that some patients with autoimmune encephalitis and, more specifically, patients suffering from ANMDARE had suicidal behavior. A previous study conducted in China suggested that the problem of suicidal behavior is not infrequent in this population.
“We wanted to make a structured, systematic, and prospective approach to this problem to answer some questions related to ANMDARE,” Dr. Ramirez-Bermúdez said. These questions included: What is the frequency of suicidal thoughts and behaviors, what are the neurological and psychiatric features related to suicidal behavior in this population, and what is the outcome after receiving immunological treatment?
The researchers conducted an observational longitudinal study that included patients hospitalized between 2014 and 2021 who had definite ANMDARE (n = 120).
Patients were diagnosed as having encephalitis by means of clinical interviews, neuropsychological studies, brain imaging, EEG, and analysis of cerebrospinal fluid (CSF).
All participants had antibodies against the NMDA glutamate receptor in their CSF and were classified as having ANMDARE based on Graus criteria, “which are considered the best current standard for diagnosis,” Dr. Ramirez-Bermúdez noted.
Clinical measures were obtained both before and after treatment with immunotherapy, and all clinical data were registered prospectively and included a “broad scope of neurological and psychiatric variables seen in patients with ANMDARE.”
Information regarding suicidal thoughts and behaviors was gathered from patients as well as relatives, with assessments occurring at admission and at discharge.
Biological signaling
Results showed that 15 patients presented with suicidal thoughts and/or behaviors. Of this subgroup, the median age was 32 years (range, 19-48 years) and 53.3% were women.
All members of this subgroup had psychotic features, including persecutory, grandiose, nihilistic, or jealousy delusion (n = 14), delirium (n = 13), visual or auditory hallucinations (n = 11), psychotic depression (n = 10), and/or catatonia (n = 8).
Most (n = 12) had suicidal ideation with intent, three had preparatory behaviors, and seven actually engaged in suicidal self-directed violence.
Of these 15 patients, 7 had abnormal CSF findings, 8 had MRI abnormalities involving the medial temporal lobe, and all had abnormal EEG involving generalized slowing.
Fourteen suicidal patients were treated with an antipsychotic, 4 with dexmedetomidine, and 12 with lorazepam. In addition, 10 received plasmapheresis and 7 received immunoglobulin.
Of note, at discharge, self-directed violent thoughts and behaviors completely remitted in 14 of the 15 patients. Long-term follow-up showed that they remained free of suicidality.
Dr. Ramirez-Bermúdez noted that in some patients with neuropsychiatric disturbances, “there are autoantibodies against the NR1 subunit of the NMDA glutamate receptor: the main excitatory neurotransmitter in the human brain.”
The NMDA receptor is “particularly important as part of the biological signaling that is required in several cognitive and affective processes leading to complex behaviors,” he said. NMDA receptor dysfunction “may lead to states in which these cognitive and affective processes are disturbed,” frequently resulting in psychosis.
Study coauthor Ava Easton, MD, chief executive of the Encephalitis Society, told this news organization that mental health issues, self-injurious thoughts, and suicidal behaviors after encephalitis “may occur for a number of reasons and stigma around talking about mental health can be a real barrier to speaking up about symptoms; but it is an important barrier to overcome.”
Dr. Easton, an honorary fellow in the department of clinical infection, microbiology, and immunology, University of Liverpool, England, added that their study “provides a platform on which to break taboo, show tangible links which are based on data between suicide and encephalitis, and call for more awareness of the risk of mental health issues during and after encephalitis.”
‘Neglected symptom’
Commenting on the study, Carsten Finke, MD, Heisenberg Professor for Cognitive Neurology and consultant neurologist, department of neurology at Charité, Berlin, and professor at Berlin School of Mind and Brain, said that the research was on “a very important topic on a so far rather neglected symptom of encephalitis.”
Dr. Finke, a founding member of the scientific council of the German Network for Research on Autoimmune Encephalitis, was not involved in the current study.
He noted that 77% of people don’t know what encephalitis is. “This lack of awareness leads to delays in diagnoses and treatment – and poorer outcomes for patients,” Dr. Finke said.
Also commenting, Michael Eriksen Benros, MD, PhD, professor of immune-psychiatry, department of immunology and microbiology, Health and Medical Sciences, University of Copenhagen, said that the study “underlines the clinical importance of screening individuals with psychotic symptoms for suicidal ideations during acute phases,” as well as those with definite ANMDARE as a likely underlying cause of the psychotic symptoms.
This is important because patients with ANMDARE “might not necessarily be admitted at psychiatric departments where screenings for suicidal ideation are part of the clinical routine,” said Dr. Benros, who was not involved with the research.
Instead, “many patients with ANMDARE are at neurological departments during acute phases,” he added.
The study was supported by the National Council of Science and Technology of Mexico. Dr. Ramirez-Bermúdez, Dr. Easton, Dr. Benros, and Dr. Finke report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators assessed 120 patients hospitalized in a neurological center and diagnosed with ANMDARE. Most had psychosis and other severe mental health disturbances. Of these, 13% also had suicidal thoughts and behaviors.
However, after medical treatment that included immunotherapy, neurologic and psychiatric pharmacotherapy, and rehabilitation and psychotherapy, almost all patients with suicidal thoughts and behaviors had sustained remission of their suicidality.
“Most patients [with ANMDARE] suffer with severe mental health problems, and it is not infrequent that suicidal thoughts and behaviors emerge in this context – mainly in patients with clinical features of psychotic depression,” senior author Jesús Ramirez-Bermúdez, MD, PhD, from the neuropsychiatry unit, National Institute of Neurology and Neurosurgery of Mexico, told this news organization.
“The good news is that, in most cases, the suicidal thoughts and behaviors as well as the features of psychotic depression improve significantly with the specific immunological therapy. However, careful psychiatric and psychotherapeutic support are helpful to restore the long-term psychological well-being,” Dr. Ramirez-Bermúdez said.
The findings were published online in the Journal of Neuropsychiatry and Clinical Neurosciences.
Delayed recognition
ANMDARE is a “frequent form of autoimmune encephalitis,” the authors write. It often begins with an “abrupt onset of behavioral and cognitive symptoms, followed by seizures and movement disorders,” they add.
“The clinical care of persons with encephalitis is challenging because these patients suffer from acute and severe mental health disturbances [and] are often misdiagnosed as having a primary psychiatric disorder, for instance, schizophrenia or bipolar disorder; but, they do not improve with the use of psychiatric medication or psychotherapy,” Dr. Ramirez-Bermúdez said.
Rather, the disease requires specific treatments, such as the use of antiviral medication or immunotherapy, he added. Without these, “the mortality rate is high, and many patients have bad outcomes, including disability related to cognitive and affective disturbances,” he said.
Dr. Ramirez-Bermúdez noted that there are “many cultural problems in the conventional approach to mental health problems, including prejudices, fear, myths, stigma, and discrimination.” And these attitudes can contribute to delayed recognition of ANMDARE.
During recent years, Dr. Ramirez-Bermúdez and colleagues observed that some patients with autoimmune encephalitis and, more specifically, patients suffering from ANMDARE had suicidal behavior. A previous study conducted in China suggested that the problem of suicidal behavior is not infrequent in this population.
“We wanted to make a structured, systematic, and prospective approach to this problem to answer some questions related to ANMDARE,” Dr. Ramirez-Bermúdez said. These questions included: What is the frequency of suicidal thoughts and behaviors, what are the neurological and psychiatric features related to suicidal behavior in this population, and what is the outcome after receiving immunological treatment?
The researchers conducted an observational longitudinal study that included patients hospitalized between 2014 and 2021 who had definite ANMDARE (n = 120).
Patients were diagnosed as having encephalitis by means of clinical interviews, neuropsychological studies, brain imaging, EEG, and analysis of cerebrospinal fluid (CSF).
All participants had antibodies against the NMDA glutamate receptor in their CSF and were classified as having ANMDARE based on Graus criteria, “which are considered the best current standard for diagnosis,” Dr. Ramirez-Bermúdez noted.
Clinical measures were obtained both before and after treatment with immunotherapy, and all clinical data were registered prospectively and included a “broad scope of neurological and psychiatric variables seen in patients with ANMDARE.”
Information regarding suicidal thoughts and behaviors was gathered from patients as well as relatives, with assessments occurring at admission and at discharge.
Biological signaling
Results showed that 15 patients presented with suicidal thoughts and/or behaviors. Of this subgroup, the median age was 32 years (range, 19-48 years) and 53.3% were women.
All members of this subgroup had psychotic features, including persecutory, grandiose, nihilistic, or jealousy delusion (n = 14), delirium (n = 13), visual or auditory hallucinations (n = 11), psychotic depression (n = 10), and/or catatonia (n = 8).
Most (n = 12) had suicidal ideation with intent, three had preparatory behaviors, and seven actually engaged in suicidal self-directed violence.
Of these 15 patients, 7 had abnormal CSF findings, 8 had MRI abnormalities involving the medial temporal lobe, and all had abnormal EEG involving generalized slowing.
Fourteen suicidal patients were treated with an antipsychotic, 4 with dexmedetomidine, and 12 with lorazepam. In addition, 10 received plasmapheresis and 7 received immunoglobulin.
Of note, at discharge, self-directed violent thoughts and behaviors completely remitted in 14 of the 15 patients. Long-term follow-up showed that they remained free of suicidality.
Dr. Ramirez-Bermúdez noted that in some patients with neuropsychiatric disturbances, “there are autoantibodies against the NR1 subunit of the NMDA glutamate receptor: the main excitatory neurotransmitter in the human brain.”
The NMDA receptor is “particularly important as part of the biological signaling that is required in several cognitive and affective processes leading to complex behaviors,” he said. NMDA receptor dysfunction “may lead to states in which these cognitive and affective processes are disturbed,” frequently resulting in psychosis.
Study coauthor Ava Easton, MD, chief executive of the Encephalitis Society, told this news organization that mental health issues, self-injurious thoughts, and suicidal behaviors after encephalitis “may occur for a number of reasons and stigma around talking about mental health can be a real barrier to speaking up about symptoms; but it is an important barrier to overcome.”
Dr. Easton, an honorary fellow in the department of clinical infection, microbiology, and immunology, University of Liverpool, England, added that their study “provides a platform on which to break taboo, show tangible links which are based on data between suicide and encephalitis, and call for more awareness of the risk of mental health issues during and after encephalitis.”
‘Neglected symptom’
Commenting on the study, Carsten Finke, MD, Heisenberg Professor for Cognitive Neurology and consultant neurologist, department of neurology at Charité, Berlin, and professor at Berlin School of Mind and Brain, said that the research was on “a very important topic on a so far rather neglected symptom of encephalitis.”
Dr. Finke, a founding member of the scientific council of the German Network for Research on Autoimmune Encephalitis, was not involved in the current study.
He noted that 77% of people don’t know what encephalitis is. “This lack of awareness leads to delays in diagnoses and treatment – and poorer outcomes for patients,” Dr. Finke said.
Also commenting, Michael Eriksen Benros, MD, PhD, professor of immune-psychiatry, department of immunology and microbiology, Health and Medical Sciences, University of Copenhagen, said that the study “underlines the clinical importance of screening individuals with psychotic symptoms for suicidal ideations during acute phases,” as well as those with definite ANMDARE as a likely underlying cause of the psychotic symptoms.
This is important because patients with ANMDARE “might not necessarily be admitted at psychiatric departments where screenings for suicidal ideation are part of the clinical routine,” said Dr. Benros, who was not involved with the research.
Instead, “many patients with ANMDARE are at neurological departments during acute phases,” he added.
The study was supported by the National Council of Science and Technology of Mexico. Dr. Ramirez-Bermúdez, Dr. Easton, Dr. Benros, and Dr. Finke report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators assessed 120 patients hospitalized in a neurological center and diagnosed with ANMDARE. Most had psychosis and other severe mental health disturbances. Of these, 13% also had suicidal thoughts and behaviors.
However, after medical treatment that included immunotherapy, neurologic and psychiatric pharmacotherapy, and rehabilitation and psychotherapy, almost all patients with suicidal thoughts and behaviors had sustained remission of their suicidality.
“Most patients [with ANMDARE] suffer with severe mental health problems, and it is not infrequent that suicidal thoughts and behaviors emerge in this context – mainly in patients with clinical features of psychotic depression,” senior author Jesús Ramirez-Bermúdez, MD, PhD, from the neuropsychiatry unit, National Institute of Neurology and Neurosurgery of Mexico, told this news organization.
“The good news is that, in most cases, the suicidal thoughts and behaviors as well as the features of psychotic depression improve significantly with the specific immunological therapy. However, careful psychiatric and psychotherapeutic support are helpful to restore the long-term psychological well-being,” Dr. Ramirez-Bermúdez said.
The findings were published online in the Journal of Neuropsychiatry and Clinical Neurosciences.
Delayed recognition
ANMDARE is a “frequent form of autoimmune encephalitis,” the authors write. It often begins with an “abrupt onset of behavioral and cognitive symptoms, followed by seizures and movement disorders,” they add.
“The clinical care of persons with encephalitis is challenging because these patients suffer from acute and severe mental health disturbances [and] are often misdiagnosed as having a primary psychiatric disorder, for instance, schizophrenia or bipolar disorder; but, they do not improve with the use of psychiatric medication or psychotherapy,” Dr. Ramirez-Bermúdez said.
Rather, the disease requires specific treatments, such as the use of antiviral medication or immunotherapy, he added. Without these, “the mortality rate is high, and many patients have bad outcomes, including disability related to cognitive and affective disturbances,” he said.
Dr. Ramirez-Bermúdez noted that there are “many cultural problems in the conventional approach to mental health problems, including prejudices, fear, myths, stigma, and discrimination.” And these attitudes can contribute to delayed recognition of ANMDARE.
During recent years, Dr. Ramirez-Bermúdez and colleagues observed that some patients with autoimmune encephalitis and, more specifically, patients suffering from ANMDARE had suicidal behavior. A previous study conducted in China suggested that the problem of suicidal behavior is not infrequent in this population.
“We wanted to make a structured, systematic, and prospective approach to this problem to answer some questions related to ANMDARE,” Dr. Ramirez-Bermúdez said. These questions included: What is the frequency of suicidal thoughts and behaviors, what are the neurological and psychiatric features related to suicidal behavior in this population, and what is the outcome after receiving immunological treatment?
The researchers conducted an observational longitudinal study that included patients hospitalized between 2014 and 2021 who had definite ANMDARE (n = 120).
Patients were diagnosed as having encephalitis by means of clinical interviews, neuropsychological studies, brain imaging, EEG, and analysis of cerebrospinal fluid (CSF).
All participants had antibodies against the NMDA glutamate receptor in their CSF and were classified as having ANMDARE based on Graus criteria, “which are considered the best current standard for diagnosis,” Dr. Ramirez-Bermúdez noted.
Clinical measures were obtained both before and after treatment with immunotherapy, and all clinical data were registered prospectively and included a “broad scope of neurological and psychiatric variables seen in patients with ANMDARE.”
Information regarding suicidal thoughts and behaviors was gathered from patients as well as relatives, with assessments occurring at admission and at discharge.
Biological signaling
Results showed that 15 patients presented with suicidal thoughts and/or behaviors. Of this subgroup, the median age was 32 years (range, 19-48 years) and 53.3% were women.
All members of this subgroup had psychotic features, including persecutory, grandiose, nihilistic, or jealousy delusion (n = 14), delirium (n = 13), visual or auditory hallucinations (n = 11), psychotic depression (n = 10), and/or catatonia (n = 8).
Most (n = 12) had suicidal ideation with intent, three had preparatory behaviors, and seven actually engaged in suicidal self-directed violence.
Of these 15 patients, 7 had abnormal CSF findings, 8 had MRI abnormalities involving the medial temporal lobe, and all had abnormal EEG involving generalized slowing.
Fourteen suicidal patients were treated with an antipsychotic, 4 with dexmedetomidine, and 12 with lorazepam. In addition, 10 received plasmapheresis and 7 received immunoglobulin.
Of note, at discharge, self-directed violent thoughts and behaviors completely remitted in 14 of the 15 patients. Long-term follow-up showed that they remained free of suicidality.
Dr. Ramirez-Bermúdez noted that in some patients with neuropsychiatric disturbances, “there are autoantibodies against the NR1 subunit of the NMDA glutamate receptor: the main excitatory neurotransmitter in the human brain.”
The NMDA receptor is “particularly important as part of the biological signaling that is required in several cognitive and affective processes leading to complex behaviors,” he said. NMDA receptor dysfunction “may lead to states in which these cognitive and affective processes are disturbed,” frequently resulting in psychosis.
Study coauthor Ava Easton, MD, chief executive of the Encephalitis Society, told this news organization that mental health issues, self-injurious thoughts, and suicidal behaviors after encephalitis “may occur for a number of reasons and stigma around talking about mental health can be a real barrier to speaking up about symptoms; but it is an important barrier to overcome.”
Dr. Easton, an honorary fellow in the department of clinical infection, microbiology, and immunology, University of Liverpool, England, added that their study “provides a platform on which to break taboo, show tangible links which are based on data between suicide and encephalitis, and call for more awareness of the risk of mental health issues during and after encephalitis.”
‘Neglected symptom’
Commenting on the study, Carsten Finke, MD, Heisenberg Professor for Cognitive Neurology and consultant neurologist, department of neurology at Charité, Berlin, and professor at Berlin School of Mind and Brain, said that the research was on “a very important topic on a so far rather neglected symptom of encephalitis.”
Dr. Finke, a founding member of the scientific council of the German Network for Research on Autoimmune Encephalitis, was not involved in the current study.
He noted that 77% of people don’t know what encephalitis is. “This lack of awareness leads to delays in diagnoses and treatment – and poorer outcomes for patients,” Dr. Finke said.
Also commenting, Michael Eriksen Benros, MD, PhD, professor of immune-psychiatry, department of immunology and microbiology, Health and Medical Sciences, University of Copenhagen, said that the study “underlines the clinical importance of screening individuals with psychotic symptoms for suicidal ideations during acute phases,” as well as those with definite ANMDARE as a likely underlying cause of the psychotic symptoms.
This is important because patients with ANMDARE “might not necessarily be admitted at psychiatric departments where screenings for suicidal ideation are part of the clinical routine,” said Dr. Benros, who was not involved with the research.
Instead, “many patients with ANMDARE are at neurological departments during acute phases,” he added.
The study was supported by the National Council of Science and Technology of Mexico. Dr. Ramirez-Bermúdez, Dr. Easton, Dr. Benros, and Dr. Finke report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF NEUROPSYCHIATRY AND CLINICAL NEUROSCIENCES
IBD: More patients on vedolizumab vs. anti-TNFs at 2 years
COPENHAGEN – , according to the first meta-analysis of their real-world effectiveness.
The results mostly applied to bionaive subjects, and the benefit of vedolizumab over both TNFi’s – infliximab (Remicade) and adalimumab (Humira), was more evident in ulcerative colitis, compared with Crohn’s disease, noted the researchers, led by Tsz Hong Yiu, MD, a clinician and researcher at the University of Sydney.
“It appears that patients are more likely to stay on vedolizumab than either infliximab or adalimumab, especially in bionaive patients, which could suggest either a better tolerance to the treatment or a better response,” Dr. Yiu said in an interview at the annual Congress of the European Crohn’s and Colitis Organisation.
The 2-year follow up data were particularly encouraging, noted Dr. Yiu, with more patients persisting on vedolizumab than both anti-TNF alpha drugs overall with respect to both ulcerative colitis and Crohn’s disease.
In a head-to-head comparison, 15% more patients stayed on vedolizumab than anti-TNF alpha drugs overall, at 1-year follow-up for both ulcerative colitis and Crohn’s disease (risk ratio, 1.15). At 2 years of follow-up, 12% more patients remained on vedolizumab in comparison with anti-TNF alpha drugs overall (RR, 1.12), again for both forms of inflammatory bowel disease (IBD).
“This may provide early evidence that supports vedolizumab as a first-line biologic agent for inpatients with inflammatory bowel disease,” said Dr. Yiu, noting that further research was required to validate the correlation of persistence with clinical effectiveness.
Adding comment on the motivation for the study, senior author Rupert Leong, MD, a gastroenterologist at Concord RepatriaKon General Hospital, Sydney, said, “We wanted to identify the drug with the highest effectiveness, which is the real-world benefit of the drug to patients, rather than efficacy, which refers to clinical trial data.”
“Importantly, clinical trial data are usually only 1 year, whereas persistence collects data often for several years. This is relevant in chronic diseases that can affect patients over several decades, because the true benefit of a drug cannot be implied from a short-term clinical trial,” he explained.
Persistence was chosen as the primary end-point because it is a measure that incorporates a drug’s efficacy and side-effect profile but also the patient’s perspective, added Dr. Yiu. “So, a patient may value mild side effects over treatment effectiveness and decide to cease treatment.”
A prior meta-analysis looking at loss of response found that 33% of people taking infliximab and 41% of people taking adalimumab became resistant to the biologics after a median follow up of 1 year. “The most common cause of loss of response to anti-TNF inhibitors is due to immunogenicity,” remarked Dr. Yiu. “These findings suggested that alternative biologics with high effectiveness should be considered.”
Data from the 2019 VARSITY study also informed the researchers’ decision to conduct a real-world study. VARSITY investigators found vedolizumab had increased efficacy over adalimumab in ulcerative colitis, however, data on the real-world effectiveness of vedolizumab, compared with adalimumab and infliximab, in both ulcerative colitis and Crohn’s disease remained unknown.
Dr. Leong pointed out the difficulty in selecting the correct treatment given the increasing numbers of biological agents available. “The paucity of head-to-head studies meant use of cohort studies is considered both relevant and informative, not least because long-term follow-up data can reveal secondary loss of response of these monoclonal antibodies, while pooling data further increases the statistical power and determines consistency.”
As such, the researchers conducted a systematic review and meta-analysis of six observational studies evaluating persistence, as a surrogate marker for clinical response, of vedolizumab versus infliximab and adalimumab among participants aged over 18 years with a diagnosis of either ulcerative colitis or Crohn’s disease from 2017 to July 2022.
Overall, the study found that 1-year persistence of vedolizumab was 71.2% in ulcerative colitis and 76% in Crohn’s disease, which was significantly higher than with infliximab (56.4% in ulcerative colitis, 53.7% in Crohn’s disease), and likewise with adalimumab (53.7% in ulcerative colitis, 55.6% in Crohn’s disease).
Results of 2-year persistence were pooled from four studies and found that vedolizumab had a 2-year persistence of 66% in ulcerative colitis and 61% in Crohn’s disease. By comparison, infliximab had a persistence of 49.7% for ulcerative colitis and 59.1% for Crohn’s disease, and adalimumab had a persistence of 31.4% for ulcerative colitis and 56% for Crohn’s disease).
In ulcerative colitis specifically, vedolizumab performed better than both adalimumab and infliximab with an RR of 1.41 (95% confidence interval, 1.14-1.74) and 1.15 (95% CI, 1.06-1.25) respectively, and an RR of 1.23 (95% CI, 1.14-1.33) was generated when adalimumab and infliximab results were combined after 1 year of follow-up.
In Crohn’s disease specifically, vedolizumab had a slightly higher 1-year persistence over anti-TNF inhibitors combined (RR, 1.10; 95% CI, 1.02-1.19), but there were insufficient data to support individual analysis.
In a subgroup of bionaive patients, vedolizumab had a higher 1-year persistence (RR, 1.14; 95% CI, 1.07-1.22) but did not show a statistically significant advantage in bioexperienced patients (RR, 1.04; 95% CI, 0.80-1.35), compared with anti-TNF inhibitors.
Dr. Yiu remarked that they were unable to identify any randomized controlled trials (RCTs) directly comparing infliximab versus vedolizumab in IBD at the time of their systematic review. However, he drew attention to a recent research article that compared the effectiveness, persistence, and side-effect profile of vedolizumab and infliximab in a small cohort of ulcerative colitis patients. “ In this study, vedolizumab showed overall superiority over infliximab, which is in keeping with our study’s findings.”
Commenting on the study, Viraj Kariyawasam, MD, gastroenterologist and head of IBD at Blacktown and Mount Druitt hospital in Sydney, said the findings were “very important in defining the place of vedolizumab in the treatment of ulcerative colitis, and more so in Crohn’s disease.”
“Despite vedolizumab being considered a lower-efficacy drug, compared to infliximab, in Crohn’s disease by most practicing clinicians, and still favoring anti-TNF in the treatment of Crohn’s disease, the study highlights the superior persistence of vedolizumab,” he said in an interview.
“This is likely associated with efficacy over the two most used anti-TNF agents. With the knowledge we have about reduced efficacy of vedolizumab after the use of anti-TNF, or as a second- or third-line agent, and its superior persistence as a first-line biologic with already published safety data, vedolizumab should be considered and preferred as a first-line agent in the treatment of both ulcerative colitis and Crohn’s disease.”
Dr. Yiu has declared no conflicts of interest. Dr. Leong declares he is an advisory board member of AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, Takeda; research grant recipient of Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer, Joanna Tiddy grant University of Sydney. One coauthor is an advisory board member of AbbVie and has received speaker fees from AbbVie and Takeda. Dr. Kariyawasam has educational grants and/or speaker fees from Janssen, AbbVie, and Takeda.
COPENHAGEN – , according to the first meta-analysis of their real-world effectiveness.
The results mostly applied to bionaive subjects, and the benefit of vedolizumab over both TNFi’s – infliximab (Remicade) and adalimumab (Humira), was more evident in ulcerative colitis, compared with Crohn’s disease, noted the researchers, led by Tsz Hong Yiu, MD, a clinician and researcher at the University of Sydney.
“It appears that patients are more likely to stay on vedolizumab than either infliximab or adalimumab, especially in bionaive patients, which could suggest either a better tolerance to the treatment or a better response,” Dr. Yiu said in an interview at the annual Congress of the European Crohn’s and Colitis Organisation.
The 2-year follow up data were particularly encouraging, noted Dr. Yiu, with more patients persisting on vedolizumab than both anti-TNF alpha drugs overall with respect to both ulcerative colitis and Crohn’s disease.
In a head-to-head comparison, 15% more patients stayed on vedolizumab than anti-TNF alpha drugs overall, at 1-year follow-up for both ulcerative colitis and Crohn’s disease (risk ratio, 1.15). At 2 years of follow-up, 12% more patients remained on vedolizumab in comparison with anti-TNF alpha drugs overall (RR, 1.12), again for both forms of inflammatory bowel disease (IBD).
“This may provide early evidence that supports vedolizumab as a first-line biologic agent for inpatients with inflammatory bowel disease,” said Dr. Yiu, noting that further research was required to validate the correlation of persistence with clinical effectiveness.
Adding comment on the motivation for the study, senior author Rupert Leong, MD, a gastroenterologist at Concord RepatriaKon General Hospital, Sydney, said, “We wanted to identify the drug with the highest effectiveness, which is the real-world benefit of the drug to patients, rather than efficacy, which refers to clinical trial data.”
“Importantly, clinical trial data are usually only 1 year, whereas persistence collects data often for several years. This is relevant in chronic diseases that can affect patients over several decades, because the true benefit of a drug cannot be implied from a short-term clinical trial,” he explained.
Persistence was chosen as the primary end-point because it is a measure that incorporates a drug’s efficacy and side-effect profile but also the patient’s perspective, added Dr. Yiu. “So, a patient may value mild side effects over treatment effectiveness and decide to cease treatment.”
A prior meta-analysis looking at loss of response found that 33% of people taking infliximab and 41% of people taking adalimumab became resistant to the biologics after a median follow up of 1 year. “The most common cause of loss of response to anti-TNF inhibitors is due to immunogenicity,” remarked Dr. Yiu. “These findings suggested that alternative biologics with high effectiveness should be considered.”
Data from the 2019 VARSITY study also informed the researchers’ decision to conduct a real-world study. VARSITY investigators found vedolizumab had increased efficacy over adalimumab in ulcerative colitis, however, data on the real-world effectiveness of vedolizumab, compared with adalimumab and infliximab, in both ulcerative colitis and Crohn’s disease remained unknown.
Dr. Leong pointed out the difficulty in selecting the correct treatment given the increasing numbers of biological agents available. “The paucity of head-to-head studies meant use of cohort studies is considered both relevant and informative, not least because long-term follow-up data can reveal secondary loss of response of these monoclonal antibodies, while pooling data further increases the statistical power and determines consistency.”
As such, the researchers conducted a systematic review and meta-analysis of six observational studies evaluating persistence, as a surrogate marker for clinical response, of vedolizumab versus infliximab and adalimumab among participants aged over 18 years with a diagnosis of either ulcerative colitis or Crohn’s disease from 2017 to July 2022.
Overall, the study found that 1-year persistence of vedolizumab was 71.2% in ulcerative colitis and 76% in Crohn’s disease, which was significantly higher than with infliximab (56.4% in ulcerative colitis, 53.7% in Crohn’s disease), and likewise with adalimumab (53.7% in ulcerative colitis, 55.6% in Crohn’s disease).
Results of 2-year persistence were pooled from four studies and found that vedolizumab had a 2-year persistence of 66% in ulcerative colitis and 61% in Crohn’s disease. By comparison, infliximab had a persistence of 49.7% for ulcerative colitis and 59.1% for Crohn’s disease, and adalimumab had a persistence of 31.4% for ulcerative colitis and 56% for Crohn’s disease).
In ulcerative colitis specifically, vedolizumab performed better than both adalimumab and infliximab with an RR of 1.41 (95% confidence interval, 1.14-1.74) and 1.15 (95% CI, 1.06-1.25) respectively, and an RR of 1.23 (95% CI, 1.14-1.33) was generated when adalimumab and infliximab results were combined after 1 year of follow-up.
In Crohn’s disease specifically, vedolizumab had a slightly higher 1-year persistence over anti-TNF inhibitors combined (RR, 1.10; 95% CI, 1.02-1.19), but there were insufficient data to support individual analysis.
In a subgroup of bionaive patients, vedolizumab had a higher 1-year persistence (RR, 1.14; 95% CI, 1.07-1.22) but did not show a statistically significant advantage in bioexperienced patients (RR, 1.04; 95% CI, 0.80-1.35), compared with anti-TNF inhibitors.
Dr. Yiu remarked that they were unable to identify any randomized controlled trials (RCTs) directly comparing infliximab versus vedolizumab in IBD at the time of their systematic review. However, he drew attention to a recent research article that compared the effectiveness, persistence, and side-effect profile of vedolizumab and infliximab in a small cohort of ulcerative colitis patients. “ In this study, vedolizumab showed overall superiority over infliximab, which is in keeping with our study’s findings.”
Commenting on the study, Viraj Kariyawasam, MD, gastroenterologist and head of IBD at Blacktown and Mount Druitt hospital in Sydney, said the findings were “very important in defining the place of vedolizumab in the treatment of ulcerative colitis, and more so in Crohn’s disease.”
“Despite vedolizumab being considered a lower-efficacy drug, compared to infliximab, in Crohn’s disease by most practicing clinicians, and still favoring anti-TNF in the treatment of Crohn’s disease, the study highlights the superior persistence of vedolizumab,” he said in an interview.
“This is likely associated with efficacy over the two most used anti-TNF agents. With the knowledge we have about reduced efficacy of vedolizumab after the use of anti-TNF, or as a second- or third-line agent, and its superior persistence as a first-line biologic with already published safety data, vedolizumab should be considered and preferred as a first-line agent in the treatment of both ulcerative colitis and Crohn’s disease.”
Dr. Yiu has declared no conflicts of interest. Dr. Leong declares he is an advisory board member of AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, Takeda; research grant recipient of Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer, Joanna Tiddy grant University of Sydney. One coauthor is an advisory board member of AbbVie and has received speaker fees from AbbVie and Takeda. Dr. Kariyawasam has educational grants and/or speaker fees from Janssen, AbbVie, and Takeda.
COPENHAGEN – , according to the first meta-analysis of their real-world effectiveness.
The results mostly applied to bionaive subjects, and the benefit of vedolizumab over both TNFi’s – infliximab (Remicade) and adalimumab (Humira), was more evident in ulcerative colitis, compared with Crohn’s disease, noted the researchers, led by Tsz Hong Yiu, MD, a clinician and researcher at the University of Sydney.
“It appears that patients are more likely to stay on vedolizumab than either infliximab or adalimumab, especially in bionaive patients, which could suggest either a better tolerance to the treatment or a better response,” Dr. Yiu said in an interview at the annual Congress of the European Crohn’s and Colitis Organisation.
The 2-year follow up data were particularly encouraging, noted Dr. Yiu, with more patients persisting on vedolizumab than both anti-TNF alpha drugs overall with respect to both ulcerative colitis and Crohn’s disease.
In a head-to-head comparison, 15% more patients stayed on vedolizumab than anti-TNF alpha drugs overall, at 1-year follow-up for both ulcerative colitis and Crohn’s disease (risk ratio, 1.15). At 2 years of follow-up, 12% more patients remained on vedolizumab in comparison with anti-TNF alpha drugs overall (RR, 1.12), again for both forms of inflammatory bowel disease (IBD).
“This may provide early evidence that supports vedolizumab as a first-line biologic agent for inpatients with inflammatory bowel disease,” said Dr. Yiu, noting that further research was required to validate the correlation of persistence with clinical effectiveness.
Adding comment on the motivation for the study, senior author Rupert Leong, MD, a gastroenterologist at Concord RepatriaKon General Hospital, Sydney, said, “We wanted to identify the drug with the highest effectiveness, which is the real-world benefit of the drug to patients, rather than efficacy, which refers to clinical trial data.”
“Importantly, clinical trial data are usually only 1 year, whereas persistence collects data often for several years. This is relevant in chronic diseases that can affect patients over several decades, because the true benefit of a drug cannot be implied from a short-term clinical trial,” he explained.
Persistence was chosen as the primary end-point because it is a measure that incorporates a drug’s efficacy and side-effect profile but also the patient’s perspective, added Dr. Yiu. “So, a patient may value mild side effects over treatment effectiveness and decide to cease treatment.”
A prior meta-analysis looking at loss of response found that 33% of people taking infliximab and 41% of people taking adalimumab became resistant to the biologics after a median follow up of 1 year. “The most common cause of loss of response to anti-TNF inhibitors is due to immunogenicity,” remarked Dr. Yiu. “These findings suggested that alternative biologics with high effectiveness should be considered.”
Data from the 2019 VARSITY study also informed the researchers’ decision to conduct a real-world study. VARSITY investigators found vedolizumab had increased efficacy over adalimumab in ulcerative colitis, however, data on the real-world effectiveness of vedolizumab, compared with adalimumab and infliximab, in both ulcerative colitis and Crohn’s disease remained unknown.
Dr. Leong pointed out the difficulty in selecting the correct treatment given the increasing numbers of biological agents available. “The paucity of head-to-head studies meant use of cohort studies is considered both relevant and informative, not least because long-term follow-up data can reveal secondary loss of response of these monoclonal antibodies, while pooling data further increases the statistical power and determines consistency.”
As such, the researchers conducted a systematic review and meta-analysis of six observational studies evaluating persistence, as a surrogate marker for clinical response, of vedolizumab versus infliximab and adalimumab among participants aged over 18 years with a diagnosis of either ulcerative colitis or Crohn’s disease from 2017 to July 2022.
Overall, the study found that 1-year persistence of vedolizumab was 71.2% in ulcerative colitis and 76% in Crohn’s disease, which was significantly higher than with infliximab (56.4% in ulcerative colitis, 53.7% in Crohn’s disease), and likewise with adalimumab (53.7% in ulcerative colitis, 55.6% in Crohn’s disease).
Results of 2-year persistence were pooled from four studies and found that vedolizumab had a 2-year persistence of 66% in ulcerative colitis and 61% in Crohn’s disease. By comparison, infliximab had a persistence of 49.7% for ulcerative colitis and 59.1% for Crohn’s disease, and adalimumab had a persistence of 31.4% for ulcerative colitis and 56% for Crohn’s disease).
In ulcerative colitis specifically, vedolizumab performed better than both adalimumab and infliximab with an RR of 1.41 (95% confidence interval, 1.14-1.74) and 1.15 (95% CI, 1.06-1.25) respectively, and an RR of 1.23 (95% CI, 1.14-1.33) was generated when adalimumab and infliximab results were combined after 1 year of follow-up.
In Crohn’s disease specifically, vedolizumab had a slightly higher 1-year persistence over anti-TNF inhibitors combined (RR, 1.10; 95% CI, 1.02-1.19), but there were insufficient data to support individual analysis.
In a subgroup of bionaive patients, vedolizumab had a higher 1-year persistence (RR, 1.14; 95% CI, 1.07-1.22) but did not show a statistically significant advantage in bioexperienced patients (RR, 1.04; 95% CI, 0.80-1.35), compared with anti-TNF inhibitors.
Dr. Yiu remarked that they were unable to identify any randomized controlled trials (RCTs) directly comparing infliximab versus vedolizumab in IBD at the time of their systematic review. However, he drew attention to a recent research article that compared the effectiveness, persistence, and side-effect profile of vedolizumab and infliximab in a small cohort of ulcerative colitis patients. “ In this study, vedolizumab showed overall superiority over infliximab, which is in keeping with our study’s findings.”
Commenting on the study, Viraj Kariyawasam, MD, gastroenterologist and head of IBD at Blacktown and Mount Druitt hospital in Sydney, said the findings were “very important in defining the place of vedolizumab in the treatment of ulcerative colitis, and more so in Crohn’s disease.”
“Despite vedolizumab being considered a lower-efficacy drug, compared to infliximab, in Crohn’s disease by most practicing clinicians, and still favoring anti-TNF in the treatment of Crohn’s disease, the study highlights the superior persistence of vedolizumab,” he said in an interview.
“This is likely associated with efficacy over the two most used anti-TNF agents. With the knowledge we have about reduced efficacy of vedolizumab after the use of anti-TNF, or as a second- or third-line agent, and its superior persistence as a first-line biologic with already published safety data, vedolizumab should be considered and preferred as a first-line agent in the treatment of both ulcerative colitis and Crohn’s disease.”
Dr. Yiu has declared no conflicts of interest. Dr. Leong declares he is an advisory board member of AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, Takeda; research grant recipient of Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer, Joanna Tiddy grant University of Sydney. One coauthor is an advisory board member of AbbVie and has received speaker fees from AbbVie and Takeda. Dr. Kariyawasam has educational grants and/or speaker fees from Janssen, AbbVie, and Takeda.
AT ECCO 2023
Cannabis tied to lower IBD mortality, hospital costs
COPENHAGEN – Mortality rate, length of hospital stay, and cost of hospitalization all drop significantly in patients with inflammatory bowel disease (IBD) concurrently using cannabis, shows a study that supports wider availability of the substance for specified medical use.
Inpatient mortality dropped by more than 70% in those patients concurrently using cannabis for another indication, compared with those not taking the drug, while total cost of hospitalization dropped by more than $11,000.
The findings were presented as a poster by Neethi Dasu, DO, PGY 6 Gastroenterology Fellow, at Jefferson Health Hospital, N.J., at the annual congress of the European Crohn’s and Colitis Organization. Dr. Dasu worked with coinvestigator Brian Blair, DO, FACOI, Gastroenterology Program Director, IBD specialist, at the same hospital.
Dr. Dasu said. “Not only do patients spend less time in hospital, but they also have a decrease in mortality and hospital cost, which can be significant for patients with IBD, a chronic condition, that often burdens them with high health care spend.”
The researcher also highlighted that with annual U.S. health care spending on IBD having increased significantly in recent years, getting patients well and out of the hospital in a timely manner is key and that “cannabis might help in this aim.”
Cannabis use is legalized in some U.S. states for medical treatment of several chronic, debilitating disorders, especially cancer. Currently, there is no direct Food and Drug Administration approval for use for IBD. “Utilizing it would be considered off-label and investigational,” Dr. Dasu pointed out.
Patients report cannabis, as a pain control treatment, is effective for acute flares and chronic IBD, said Dr. Dasu. “It is an excellent agent for pain control that is not a narcotic, as with opioids, which can cause dependence and addiction. These could ultimately harm patients in the long term,” she addedin an interview. “Opioids can also cause drowsiness and side effects, which harm a person’s quality of life.”
Patients with IBD using cannabis concurrently
Dr. Dasu and her coresearchers aimed to see if outcomes including mortality and pain could be modified with “a very accessible and cost-efficient agent that does not cause long term addiction or adverse events.”
She added that previous studies had evaluated the clinical response in patients with IBD and concomitant cannabis use, but that their study was novel because it looked at inpatient outcomes as well as overall hospital cost.
Dr. Dasu and colleagues analyzed data over the years 2015-2019, from the Nationwide Inpatient Sample (NIS), a large publicly available all-payer inpatient care database, which encompasses approximately 7 million inpatient hospitalizations annually in the United States.
All included patients had IBD, either ulcerative colitis or Crohn’s disease, were aged 18 years and over, and used cannabis for a concurrent indication.
Odds ratios were calculated for in-hospital mortality, average length of hospital stay, and hospital charges, after adjusting for age, gender, race, primary insurance payer status, hospital type and size (number of beds), hospital region, hospital teaching status, and other demographic characteristics.
Of the 1,198,839 patients with IBD, 29,445 used cannabis for a different indication. Participants had an average age of 38.7 years.
Highly significant drop in mortality and hospital costs
Inpatient mortality shows a significant decrease of 72% (odds ratio, 0.28; confidence interval, 0.19-0.41, P < .0001) in those who concurrently used cannabis, compared with those who did not. Hospital length of stay also dropped by –0.17 days (95% CI, –0.35 to –0.01; P < .041), and this translated into a significant drop in the total cost of hospitalization from $39,309.00 (IBD without cannabis use) to $28,254.30 (IBD with cannabis use), resulting in an $11,054.70 savings (95% CI, –$13,681.15 to –$8,427.24; P < .0001).
As a chronic inflammatory disease, IBD involves immune dysregulation leading to symptoms of nausea, vomiting, bleeding, and abdominal pain; however, the pathophysiologic mechanism is not fully understood. She added that studies in mice had shown that cannabis acts via cannabinoid 1 and 2 receptors, located in the nervous system, to decrease pain, nausea, and vomiting. “Mechanisms of cannabis’s analgesic effect also involves inhibition of the release of neurotransmitters involved in pain and inflammation.”
Asked how she felt about the future for cannabis treatment in IBD, Dr. Dasu remarked that it would most likely require decriminalizing marijuana use on a federal level, although individual states currently offer exemptions.
“Further research should be done to evaluate the medical benefits of cannabis use in patients with IBD, with studies warranted to investigate the factors that may be driving these differences, as well warranted to investigations into the effect of cannabis on remission rates, rates of hospitalization, potential complications, and quality of life,” concluded Dr. Dasu.
Commenting on the study, Mary-Jane Williams, MD, a gastroenterology fellow at East Carolina University Health Medical Center, Greenville, N.C., told this news organization that the study was “a pleasant breath of information on the topic of cannabis use in IBD,” adding that providers often face questions about cannabis use from patients.
“Modulation of the endocannabinoid system ... plays a key role in the pathogenesis of IBD including pain control, limiting intestinal inflammation, and decreasing intestinal motility,” Dr. Williams said, adding that, “Its use in IBD has promising improvement in the therapeutic effect and overall quality of life.”
“This study highlights and supports substantial therapeutic effects of cannabis in the management of IBD patients, be it their pain control, improving nausea, appetite and sleep, remission rates, earlier time to recovery, shortened hospitalization and faster endoscopic improvement,” she pointed out, noting the need for further studies, but also that most organizations, including the Crohn’s and Colitis Foundation, support policies that facilitate the conduct of clinical research using objective parameters and the potential development of cannabinoid-based medications in the management of our patients with IBD.
Dr. Dasu, Dr. Blair, and Dr. Williams have declared no financial disclosures.
COPENHAGEN – Mortality rate, length of hospital stay, and cost of hospitalization all drop significantly in patients with inflammatory bowel disease (IBD) concurrently using cannabis, shows a study that supports wider availability of the substance for specified medical use.
Inpatient mortality dropped by more than 70% in those patients concurrently using cannabis for another indication, compared with those not taking the drug, while total cost of hospitalization dropped by more than $11,000.
The findings were presented as a poster by Neethi Dasu, DO, PGY 6 Gastroenterology Fellow, at Jefferson Health Hospital, N.J., at the annual congress of the European Crohn’s and Colitis Organization. Dr. Dasu worked with coinvestigator Brian Blair, DO, FACOI, Gastroenterology Program Director, IBD specialist, at the same hospital.
Dr. Dasu said. “Not only do patients spend less time in hospital, but they also have a decrease in mortality and hospital cost, which can be significant for patients with IBD, a chronic condition, that often burdens them with high health care spend.”
The researcher also highlighted that with annual U.S. health care spending on IBD having increased significantly in recent years, getting patients well and out of the hospital in a timely manner is key and that “cannabis might help in this aim.”
Cannabis use is legalized in some U.S. states for medical treatment of several chronic, debilitating disorders, especially cancer. Currently, there is no direct Food and Drug Administration approval for use for IBD. “Utilizing it would be considered off-label and investigational,” Dr. Dasu pointed out.
Patients report cannabis, as a pain control treatment, is effective for acute flares and chronic IBD, said Dr. Dasu. “It is an excellent agent for pain control that is not a narcotic, as with opioids, which can cause dependence and addiction. These could ultimately harm patients in the long term,” she addedin an interview. “Opioids can also cause drowsiness and side effects, which harm a person’s quality of life.”
Patients with IBD using cannabis concurrently
Dr. Dasu and her coresearchers aimed to see if outcomes including mortality and pain could be modified with “a very accessible and cost-efficient agent that does not cause long term addiction or adverse events.”
She added that previous studies had evaluated the clinical response in patients with IBD and concomitant cannabis use, but that their study was novel because it looked at inpatient outcomes as well as overall hospital cost.
Dr. Dasu and colleagues analyzed data over the years 2015-2019, from the Nationwide Inpatient Sample (NIS), a large publicly available all-payer inpatient care database, which encompasses approximately 7 million inpatient hospitalizations annually in the United States.
All included patients had IBD, either ulcerative colitis or Crohn’s disease, were aged 18 years and over, and used cannabis for a concurrent indication.
Odds ratios were calculated for in-hospital mortality, average length of hospital stay, and hospital charges, after adjusting for age, gender, race, primary insurance payer status, hospital type and size (number of beds), hospital region, hospital teaching status, and other demographic characteristics.
Of the 1,198,839 patients with IBD, 29,445 used cannabis for a different indication. Participants had an average age of 38.7 years.
Highly significant drop in mortality and hospital costs
Inpatient mortality shows a significant decrease of 72% (odds ratio, 0.28; confidence interval, 0.19-0.41, P < .0001) in those who concurrently used cannabis, compared with those who did not. Hospital length of stay also dropped by –0.17 days (95% CI, –0.35 to –0.01; P < .041), and this translated into a significant drop in the total cost of hospitalization from $39,309.00 (IBD without cannabis use) to $28,254.30 (IBD with cannabis use), resulting in an $11,054.70 savings (95% CI, –$13,681.15 to –$8,427.24; P < .0001).
As a chronic inflammatory disease, IBD involves immune dysregulation leading to symptoms of nausea, vomiting, bleeding, and abdominal pain; however, the pathophysiologic mechanism is not fully understood. She added that studies in mice had shown that cannabis acts via cannabinoid 1 and 2 receptors, located in the nervous system, to decrease pain, nausea, and vomiting. “Mechanisms of cannabis’s analgesic effect also involves inhibition of the release of neurotransmitters involved in pain and inflammation.”
Asked how she felt about the future for cannabis treatment in IBD, Dr. Dasu remarked that it would most likely require decriminalizing marijuana use on a federal level, although individual states currently offer exemptions.
“Further research should be done to evaluate the medical benefits of cannabis use in patients with IBD, with studies warranted to investigate the factors that may be driving these differences, as well warranted to investigations into the effect of cannabis on remission rates, rates of hospitalization, potential complications, and quality of life,” concluded Dr. Dasu.
Commenting on the study, Mary-Jane Williams, MD, a gastroenterology fellow at East Carolina University Health Medical Center, Greenville, N.C., told this news organization that the study was “a pleasant breath of information on the topic of cannabis use in IBD,” adding that providers often face questions about cannabis use from patients.
“Modulation of the endocannabinoid system ... plays a key role in the pathogenesis of IBD including pain control, limiting intestinal inflammation, and decreasing intestinal motility,” Dr. Williams said, adding that, “Its use in IBD has promising improvement in the therapeutic effect and overall quality of life.”
“This study highlights and supports substantial therapeutic effects of cannabis in the management of IBD patients, be it their pain control, improving nausea, appetite and sleep, remission rates, earlier time to recovery, shortened hospitalization and faster endoscopic improvement,” she pointed out, noting the need for further studies, but also that most organizations, including the Crohn’s and Colitis Foundation, support policies that facilitate the conduct of clinical research using objective parameters and the potential development of cannabinoid-based medications in the management of our patients with IBD.
Dr. Dasu, Dr. Blair, and Dr. Williams have declared no financial disclosures.
COPENHAGEN – Mortality rate, length of hospital stay, and cost of hospitalization all drop significantly in patients with inflammatory bowel disease (IBD) concurrently using cannabis, shows a study that supports wider availability of the substance for specified medical use.
Inpatient mortality dropped by more than 70% in those patients concurrently using cannabis for another indication, compared with those not taking the drug, while total cost of hospitalization dropped by more than $11,000.
The findings were presented as a poster by Neethi Dasu, DO, PGY 6 Gastroenterology Fellow, at Jefferson Health Hospital, N.J., at the annual congress of the European Crohn’s and Colitis Organization. Dr. Dasu worked with coinvestigator Brian Blair, DO, FACOI, Gastroenterology Program Director, IBD specialist, at the same hospital.
Dr. Dasu said. “Not only do patients spend less time in hospital, but they also have a decrease in mortality and hospital cost, which can be significant for patients with IBD, a chronic condition, that often burdens them with high health care spend.”
The researcher also highlighted that with annual U.S. health care spending on IBD having increased significantly in recent years, getting patients well and out of the hospital in a timely manner is key and that “cannabis might help in this aim.”
Cannabis use is legalized in some U.S. states for medical treatment of several chronic, debilitating disorders, especially cancer. Currently, there is no direct Food and Drug Administration approval for use for IBD. “Utilizing it would be considered off-label and investigational,” Dr. Dasu pointed out.
Patients report cannabis, as a pain control treatment, is effective for acute flares and chronic IBD, said Dr. Dasu. “It is an excellent agent for pain control that is not a narcotic, as with opioids, which can cause dependence and addiction. These could ultimately harm patients in the long term,” she addedin an interview. “Opioids can also cause drowsiness and side effects, which harm a person’s quality of life.”
Patients with IBD using cannabis concurrently
Dr. Dasu and her coresearchers aimed to see if outcomes including mortality and pain could be modified with “a very accessible and cost-efficient agent that does not cause long term addiction or adverse events.”
She added that previous studies had evaluated the clinical response in patients with IBD and concomitant cannabis use, but that their study was novel because it looked at inpatient outcomes as well as overall hospital cost.
Dr. Dasu and colleagues analyzed data over the years 2015-2019, from the Nationwide Inpatient Sample (NIS), a large publicly available all-payer inpatient care database, which encompasses approximately 7 million inpatient hospitalizations annually in the United States.
All included patients had IBD, either ulcerative colitis or Crohn’s disease, were aged 18 years and over, and used cannabis for a concurrent indication.
Odds ratios were calculated for in-hospital mortality, average length of hospital stay, and hospital charges, after adjusting for age, gender, race, primary insurance payer status, hospital type and size (number of beds), hospital region, hospital teaching status, and other demographic characteristics.
Of the 1,198,839 patients with IBD, 29,445 used cannabis for a different indication. Participants had an average age of 38.7 years.
Highly significant drop in mortality and hospital costs
Inpatient mortality shows a significant decrease of 72% (odds ratio, 0.28; confidence interval, 0.19-0.41, P < .0001) in those who concurrently used cannabis, compared with those who did not. Hospital length of stay also dropped by –0.17 days (95% CI, –0.35 to –0.01; P < .041), and this translated into a significant drop in the total cost of hospitalization from $39,309.00 (IBD without cannabis use) to $28,254.30 (IBD with cannabis use), resulting in an $11,054.70 savings (95% CI, –$13,681.15 to –$8,427.24; P < .0001).
As a chronic inflammatory disease, IBD involves immune dysregulation leading to symptoms of nausea, vomiting, bleeding, and abdominal pain; however, the pathophysiologic mechanism is not fully understood. She added that studies in mice had shown that cannabis acts via cannabinoid 1 and 2 receptors, located in the nervous system, to decrease pain, nausea, and vomiting. “Mechanisms of cannabis’s analgesic effect also involves inhibition of the release of neurotransmitters involved in pain and inflammation.”
Asked how she felt about the future for cannabis treatment in IBD, Dr. Dasu remarked that it would most likely require decriminalizing marijuana use on a federal level, although individual states currently offer exemptions.
“Further research should be done to evaluate the medical benefits of cannabis use in patients with IBD, with studies warranted to investigate the factors that may be driving these differences, as well warranted to investigations into the effect of cannabis on remission rates, rates of hospitalization, potential complications, and quality of life,” concluded Dr. Dasu.
Commenting on the study, Mary-Jane Williams, MD, a gastroenterology fellow at East Carolina University Health Medical Center, Greenville, N.C., told this news organization that the study was “a pleasant breath of information on the topic of cannabis use in IBD,” adding that providers often face questions about cannabis use from patients.
“Modulation of the endocannabinoid system ... plays a key role in the pathogenesis of IBD including pain control, limiting intestinal inflammation, and decreasing intestinal motility,” Dr. Williams said, adding that, “Its use in IBD has promising improvement in the therapeutic effect and overall quality of life.”
“This study highlights and supports substantial therapeutic effects of cannabis in the management of IBD patients, be it their pain control, improving nausea, appetite and sleep, remission rates, earlier time to recovery, shortened hospitalization and faster endoscopic improvement,” she pointed out, noting the need for further studies, but also that most organizations, including the Crohn’s and Colitis Foundation, support policies that facilitate the conduct of clinical research using objective parameters and the potential development of cannabinoid-based medications in the management of our patients with IBD.
Dr. Dasu, Dr. Blair, and Dr. Williams have declared no financial disclosures.
AT ECCO 2023
NP-PA turf fights: Where the relationship can improve
– The U.S. Bureau of Labor Statistics forecasts a 40% increase in the NP workforce by 2031, coupled with a 28% rise in PAs.
In recent reports on the quality of the relationships involving these health care professions, survey respondents mostly gave positive accounts of collaboration, using words such as like “comradery,” “teamwork,” “congenial,” and “cohesion.” But all was not perfect. Where and how could these important health care provider relationships improve?
PAs: “Competition and collaboration’ with RNs
In a Medscape survey of more than 770 PAs about their working relationships with other health care professionals; 83% of them supported the idea of PAs and NPs practicing more independently from physicians, but sometimes it’s not easy to stay in their individual lanes.
One PA respondent complained that NPs get “more opportunities and preference,” another pointed to PA-NP “turf issues,” and a third griped about NPs’ “strong unions,” which have stoked more fighting about practice abilities and available settings.
Robert Blumm, MA, PA-C, a retired surgical and emergency medicine PA who regards himself as an advocate for both PAs and NPs, describes their interaction as a “mixture of competition and collaboration.”
On one hand, the two groups typically “cooperate and do an excellent job, incurring patient errors similar to or less than physician colleagues or senior residents.” On the other hand, Mr. Blumm conceded, there is some jealousy among PAs over NPs’ advantage in staffing and hiring decisions, “since they don’t need [direct physician] supervision ... and there are limits on how many PAs can be supervised by one physician.”
Most PA-NP interactions are collaborative, although many people emphasize the relatively few conflicts, said Jennifer Orozco, DMSc, PA-C, president and chair of the American Academy of PAs.
“We see that a lot in this country,” she said. “People try to drive a wedge, but it’s often a misnomer that there’s a lot of arguing and infighting.”
NPs: Different backgrounds, same goal
The Medscape survey also included information from 750 NPs on working relationships; 93% of them favored nurses and PAs working more independently from doctors.
April Kapu, DNP, ARPN, has worked closely with PAs for more than 20 years. “In my experience ... they complement one another as health team members, although the education and training are somewhat different,” said Ms. Kapu, , president of the American Association of Nurse Practitioners.
Some respondents noted the different educational trajectories for NPs and PAs. “Doctors and PAs are taught using the same model, but NPs are taught under the nursing model,” wrote a family medicine PA.
In emergency departments where Mr. Blumm has worked, ICU NPs have an edge over PAs in terms of preparation, organization, and the tabulation of formulas. On the other hand, some of Mr. Blumm’s fellow PAs were also emergency medicine technicians or respiratory therapists, who had “2 years of classroom training, on par with that of medical students.”
Must these differences in training and education foment conflict between NPs and PAs? “We all bring something different to the table,” said Ms. Kapu, who also is associate dean for clinical and community partnerships at Vanderbilt University, Nashville, Tenn. “It is important to respect each person’s entry point, education, and training.”
Differing personalities and environments
Numerous PA respondents said that individual personalities and work environments are more likely to trigger issues with NPs than are differences in training.
“It depends on the team and situation and who the people are, not the letters behind their names,” an emergency medicine PA wrote. A surgical PA noted that “group dynamics and work culture differ from place to place,” while a third PA agreed that “it’s personality dependent, not title dependent.”
No single formula will resolve areas of NP-PA conflict, Ms. Orozco said. “What works in Chicago might not work in rural Colorado or Texas or California, but we do have to come together. The overall focus should be on greater flexibility for PAs and NPs. Patients will fare better.”
Joint research, publishing could help
About a decade ago, Mr. Blumm joined with another PA and an NP to form the American College of Clinicians, the first joint PA-NP national professional organization. Although it disbanded after 6 years, owing to low membership, he hopes a similar collaboration will take off in the future.
“I also recommend that PAs and NPs publish articles together, with research as an excellent place to start,” he added. “PAs and NPs should stand together and be a source of healing for all our patients. Regardless of our titles, our responsibility is to bring healing together.”
A version of this article first appeared on Medscape.com.
– The U.S. Bureau of Labor Statistics forecasts a 40% increase in the NP workforce by 2031, coupled with a 28% rise in PAs.
In recent reports on the quality of the relationships involving these health care professions, survey respondents mostly gave positive accounts of collaboration, using words such as like “comradery,” “teamwork,” “congenial,” and “cohesion.” But all was not perfect. Where and how could these important health care provider relationships improve?
PAs: “Competition and collaboration’ with RNs
In a Medscape survey of more than 770 PAs about their working relationships with other health care professionals; 83% of them supported the idea of PAs and NPs practicing more independently from physicians, but sometimes it’s not easy to stay in their individual lanes.
One PA respondent complained that NPs get “more opportunities and preference,” another pointed to PA-NP “turf issues,” and a third griped about NPs’ “strong unions,” which have stoked more fighting about practice abilities and available settings.
Robert Blumm, MA, PA-C, a retired surgical and emergency medicine PA who regards himself as an advocate for both PAs and NPs, describes their interaction as a “mixture of competition and collaboration.”
On one hand, the two groups typically “cooperate and do an excellent job, incurring patient errors similar to or less than physician colleagues or senior residents.” On the other hand, Mr. Blumm conceded, there is some jealousy among PAs over NPs’ advantage in staffing and hiring decisions, “since they don’t need [direct physician] supervision ... and there are limits on how many PAs can be supervised by one physician.”
Most PA-NP interactions are collaborative, although many people emphasize the relatively few conflicts, said Jennifer Orozco, DMSc, PA-C, president and chair of the American Academy of PAs.
“We see that a lot in this country,” she said. “People try to drive a wedge, but it’s often a misnomer that there’s a lot of arguing and infighting.”
NPs: Different backgrounds, same goal
The Medscape survey also included information from 750 NPs on working relationships; 93% of them favored nurses and PAs working more independently from doctors.
April Kapu, DNP, ARPN, has worked closely with PAs for more than 20 years. “In my experience ... they complement one another as health team members, although the education and training are somewhat different,” said Ms. Kapu, , president of the American Association of Nurse Practitioners.
Some respondents noted the different educational trajectories for NPs and PAs. “Doctors and PAs are taught using the same model, but NPs are taught under the nursing model,” wrote a family medicine PA.
In emergency departments where Mr. Blumm has worked, ICU NPs have an edge over PAs in terms of preparation, organization, and the tabulation of formulas. On the other hand, some of Mr. Blumm’s fellow PAs were also emergency medicine technicians or respiratory therapists, who had “2 years of classroom training, on par with that of medical students.”
Must these differences in training and education foment conflict between NPs and PAs? “We all bring something different to the table,” said Ms. Kapu, who also is associate dean for clinical and community partnerships at Vanderbilt University, Nashville, Tenn. “It is important to respect each person’s entry point, education, and training.”
Differing personalities and environments
Numerous PA respondents said that individual personalities and work environments are more likely to trigger issues with NPs than are differences in training.
“It depends on the team and situation and who the people are, not the letters behind their names,” an emergency medicine PA wrote. A surgical PA noted that “group dynamics and work culture differ from place to place,” while a third PA agreed that “it’s personality dependent, not title dependent.”
No single formula will resolve areas of NP-PA conflict, Ms. Orozco said. “What works in Chicago might not work in rural Colorado or Texas or California, but we do have to come together. The overall focus should be on greater flexibility for PAs and NPs. Patients will fare better.”
Joint research, publishing could help
About a decade ago, Mr. Blumm joined with another PA and an NP to form the American College of Clinicians, the first joint PA-NP national professional organization. Although it disbanded after 6 years, owing to low membership, he hopes a similar collaboration will take off in the future.
“I also recommend that PAs and NPs publish articles together, with research as an excellent place to start,” he added. “PAs and NPs should stand together and be a source of healing for all our patients. Regardless of our titles, our responsibility is to bring healing together.”
A version of this article first appeared on Medscape.com.
– The U.S. Bureau of Labor Statistics forecasts a 40% increase in the NP workforce by 2031, coupled with a 28% rise in PAs.
In recent reports on the quality of the relationships involving these health care professions, survey respondents mostly gave positive accounts of collaboration, using words such as like “comradery,” “teamwork,” “congenial,” and “cohesion.” But all was not perfect. Where and how could these important health care provider relationships improve?
PAs: “Competition and collaboration’ with RNs
In a Medscape survey of more than 770 PAs about their working relationships with other health care professionals; 83% of them supported the idea of PAs and NPs practicing more independently from physicians, but sometimes it’s not easy to stay in their individual lanes.
One PA respondent complained that NPs get “more opportunities and preference,” another pointed to PA-NP “turf issues,” and a third griped about NPs’ “strong unions,” which have stoked more fighting about practice abilities and available settings.
Robert Blumm, MA, PA-C, a retired surgical and emergency medicine PA who regards himself as an advocate for both PAs and NPs, describes their interaction as a “mixture of competition and collaboration.”
On one hand, the two groups typically “cooperate and do an excellent job, incurring patient errors similar to or less than physician colleagues or senior residents.” On the other hand, Mr. Blumm conceded, there is some jealousy among PAs over NPs’ advantage in staffing and hiring decisions, “since they don’t need [direct physician] supervision ... and there are limits on how many PAs can be supervised by one physician.”
Most PA-NP interactions are collaborative, although many people emphasize the relatively few conflicts, said Jennifer Orozco, DMSc, PA-C, president and chair of the American Academy of PAs.
“We see that a lot in this country,” she said. “People try to drive a wedge, but it’s often a misnomer that there’s a lot of arguing and infighting.”
NPs: Different backgrounds, same goal
The Medscape survey also included information from 750 NPs on working relationships; 93% of them favored nurses and PAs working more independently from doctors.
April Kapu, DNP, ARPN, has worked closely with PAs for more than 20 years. “In my experience ... they complement one another as health team members, although the education and training are somewhat different,” said Ms. Kapu, , president of the American Association of Nurse Practitioners.
Some respondents noted the different educational trajectories for NPs and PAs. “Doctors and PAs are taught using the same model, but NPs are taught under the nursing model,” wrote a family medicine PA.
In emergency departments where Mr. Blumm has worked, ICU NPs have an edge over PAs in terms of preparation, organization, and the tabulation of formulas. On the other hand, some of Mr. Blumm’s fellow PAs were also emergency medicine technicians or respiratory therapists, who had “2 years of classroom training, on par with that of medical students.”
Must these differences in training and education foment conflict between NPs and PAs? “We all bring something different to the table,” said Ms. Kapu, who also is associate dean for clinical and community partnerships at Vanderbilt University, Nashville, Tenn. “It is important to respect each person’s entry point, education, and training.”
Differing personalities and environments
Numerous PA respondents said that individual personalities and work environments are more likely to trigger issues with NPs than are differences in training.
“It depends on the team and situation and who the people are, not the letters behind their names,” an emergency medicine PA wrote. A surgical PA noted that “group dynamics and work culture differ from place to place,” while a third PA agreed that “it’s personality dependent, not title dependent.”
No single formula will resolve areas of NP-PA conflict, Ms. Orozco said. “What works in Chicago might not work in rural Colorado or Texas or California, but we do have to come together. The overall focus should be on greater flexibility for PAs and NPs. Patients will fare better.”
Joint research, publishing could help
About a decade ago, Mr. Blumm joined with another PA and an NP to form the American College of Clinicians, the first joint PA-NP national professional organization. Although it disbanded after 6 years, owing to low membership, he hopes a similar collaboration will take off in the future.
“I also recommend that PAs and NPs publish articles together, with research as an excellent place to start,” he added. “PAs and NPs should stand together and be a source of healing for all our patients. Regardless of our titles, our responsibility is to bring healing together.”
A version of this article first appeared on Medscape.com.
Ovarian cancer risk lower with daily aspirin, despite genetics
new research suggests.
The study found that daily or almost daily aspirin use was associated with a 13% reduction in ovarian cancer risk, which was not modified by an individual’s polygenic score (PGS).
“Our findings suggest that frequent use of aspirin is associated with reduced ovarian cancer risk, regardless of whether a woman has lower or higher genetic susceptibility to ovarian cancer, as predicted by a set of known, common risk variants,” said lead author Lauren M. Hurwitz, PhD, MHS, division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.
The study was published online in JAMA Network Open.
Patients diagnosed with ovarian cancer face difficult survival odds, which make preventive strategies especially important. Evidence suggests that frequent aspirin use can reduce the risk for ovarian cancer by about 13%, but it’s unclear whether genetic factors change those odds.
Although promising for chemoprevention, aspirin use can also come with downsides, including gastric ulcer and hemorrhagic stroke, which is why identifying and targeting individuals at higher risk for ovarian cancer who may benefit from frequent aspirin use is important.
In the current analysis, Dr. Hurwitz and colleagues used a PGS to determine whether the protective effects of daily or near-daily aspirin use for 6 months or more could be modified by genetics.
The study was a pooled analysis of eight case-controlled studies from the Ovarian Cancer Association Consortium conducted in the United Kingdom, the United States, and Australia over a 14-year period. The researchers looked at genetic data and data on frequent aspirin use among 4,476 case patients with nonmucinous ovarian cancer (average age, 57) and 6,659 control participants (average age, 58). Overall, 575 patients (13%) and 1,030 controls (15%) reported frequent aspirin use.
The authors used a PGS previously developed using 22 single-nucleotide variants. Because this PGS was developed for nonmucinous epithelial ovarian cancer, only these patients were included in the analysis.
Consistent with previous evidence, the authors found that frequent aspirin use was associated with a 13% lower risk for nonmucinous ovarian cancer (odds ratio, 0.87). And, notably, this association did not differ by PGS. Risk reductions were greatest for high-grade serous (OR, 0.83) and endometrioid tumors (OR, 0.73), with no evidence that PGS modified this association.
Overall, “we observed consistent protective associations between frequent aspirin use and nonmucinous ovarian cancer across strata of genetic susceptibility to ovarian cancer,” the authors conclude. “This work expands on the evidence base to suggest that chemoprevention programs could target individuals at higher risk of ovarian cancer.”
However, the authors noted that they were unable to test for effect modifications by specific pathogenic variants, such as BRCA1 or BRCA2.
“Our study did not address whether aspirin use is associated with reduced ovarian cancer risk among BRCA or other pathogenic variant carriers, and so our findings should not be used to inform discussions around aspirin use for these specific high-risk groups,” Dr. Hurwitz said. “Women with higher genetic susceptibility to ovarian cancer based on these common risk variants should discuss with their doctor the benefits and harms of taking aspirin for disease prevention.”
This study was supported by a grant from the DoD Ovarian Cancer Research Program. Dr. Hurwitz reports no relevant financial relationships, but several coauthors did report funding and support.
A version of this article first appeared on Medscape.com.
new research suggests.
The study found that daily or almost daily aspirin use was associated with a 13% reduction in ovarian cancer risk, which was not modified by an individual’s polygenic score (PGS).
“Our findings suggest that frequent use of aspirin is associated with reduced ovarian cancer risk, regardless of whether a woman has lower or higher genetic susceptibility to ovarian cancer, as predicted by a set of known, common risk variants,” said lead author Lauren M. Hurwitz, PhD, MHS, division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.
The study was published online in JAMA Network Open.
Patients diagnosed with ovarian cancer face difficult survival odds, which make preventive strategies especially important. Evidence suggests that frequent aspirin use can reduce the risk for ovarian cancer by about 13%, but it’s unclear whether genetic factors change those odds.
Although promising for chemoprevention, aspirin use can also come with downsides, including gastric ulcer and hemorrhagic stroke, which is why identifying and targeting individuals at higher risk for ovarian cancer who may benefit from frequent aspirin use is important.
In the current analysis, Dr. Hurwitz and colleagues used a PGS to determine whether the protective effects of daily or near-daily aspirin use for 6 months or more could be modified by genetics.
The study was a pooled analysis of eight case-controlled studies from the Ovarian Cancer Association Consortium conducted in the United Kingdom, the United States, and Australia over a 14-year period. The researchers looked at genetic data and data on frequent aspirin use among 4,476 case patients with nonmucinous ovarian cancer (average age, 57) and 6,659 control participants (average age, 58). Overall, 575 patients (13%) and 1,030 controls (15%) reported frequent aspirin use.
The authors used a PGS previously developed using 22 single-nucleotide variants. Because this PGS was developed for nonmucinous epithelial ovarian cancer, only these patients were included in the analysis.
Consistent with previous evidence, the authors found that frequent aspirin use was associated with a 13% lower risk for nonmucinous ovarian cancer (odds ratio, 0.87). And, notably, this association did not differ by PGS. Risk reductions were greatest for high-grade serous (OR, 0.83) and endometrioid tumors (OR, 0.73), with no evidence that PGS modified this association.
Overall, “we observed consistent protective associations between frequent aspirin use and nonmucinous ovarian cancer across strata of genetic susceptibility to ovarian cancer,” the authors conclude. “This work expands on the evidence base to suggest that chemoprevention programs could target individuals at higher risk of ovarian cancer.”
However, the authors noted that they were unable to test for effect modifications by specific pathogenic variants, such as BRCA1 or BRCA2.
“Our study did not address whether aspirin use is associated with reduced ovarian cancer risk among BRCA or other pathogenic variant carriers, and so our findings should not be used to inform discussions around aspirin use for these specific high-risk groups,” Dr. Hurwitz said. “Women with higher genetic susceptibility to ovarian cancer based on these common risk variants should discuss with their doctor the benefits and harms of taking aspirin for disease prevention.”
This study was supported by a grant from the DoD Ovarian Cancer Research Program. Dr. Hurwitz reports no relevant financial relationships, but several coauthors did report funding and support.
A version of this article first appeared on Medscape.com.
new research suggests.
The study found that daily or almost daily aspirin use was associated with a 13% reduction in ovarian cancer risk, which was not modified by an individual’s polygenic score (PGS).
“Our findings suggest that frequent use of aspirin is associated with reduced ovarian cancer risk, regardless of whether a woman has lower or higher genetic susceptibility to ovarian cancer, as predicted by a set of known, common risk variants,” said lead author Lauren M. Hurwitz, PhD, MHS, division of cancer epidemiology and genetics at the National Cancer Institute, Rockville, Md.
The study was published online in JAMA Network Open.
Patients diagnosed with ovarian cancer face difficult survival odds, which make preventive strategies especially important. Evidence suggests that frequent aspirin use can reduce the risk for ovarian cancer by about 13%, but it’s unclear whether genetic factors change those odds.
Although promising for chemoprevention, aspirin use can also come with downsides, including gastric ulcer and hemorrhagic stroke, which is why identifying and targeting individuals at higher risk for ovarian cancer who may benefit from frequent aspirin use is important.
In the current analysis, Dr. Hurwitz and colleagues used a PGS to determine whether the protective effects of daily or near-daily aspirin use for 6 months or more could be modified by genetics.
The study was a pooled analysis of eight case-controlled studies from the Ovarian Cancer Association Consortium conducted in the United Kingdom, the United States, and Australia over a 14-year period. The researchers looked at genetic data and data on frequent aspirin use among 4,476 case patients with nonmucinous ovarian cancer (average age, 57) and 6,659 control participants (average age, 58). Overall, 575 patients (13%) and 1,030 controls (15%) reported frequent aspirin use.
The authors used a PGS previously developed using 22 single-nucleotide variants. Because this PGS was developed for nonmucinous epithelial ovarian cancer, only these patients were included in the analysis.
Consistent with previous evidence, the authors found that frequent aspirin use was associated with a 13% lower risk for nonmucinous ovarian cancer (odds ratio, 0.87). And, notably, this association did not differ by PGS. Risk reductions were greatest for high-grade serous (OR, 0.83) and endometrioid tumors (OR, 0.73), with no evidence that PGS modified this association.
Overall, “we observed consistent protective associations between frequent aspirin use and nonmucinous ovarian cancer across strata of genetic susceptibility to ovarian cancer,” the authors conclude. “This work expands on the evidence base to suggest that chemoprevention programs could target individuals at higher risk of ovarian cancer.”
However, the authors noted that they were unable to test for effect modifications by specific pathogenic variants, such as BRCA1 or BRCA2.
“Our study did not address whether aspirin use is associated with reduced ovarian cancer risk among BRCA or other pathogenic variant carriers, and so our findings should not be used to inform discussions around aspirin use for these specific high-risk groups,” Dr. Hurwitz said. “Women with higher genetic susceptibility to ovarian cancer based on these common risk variants should discuss with their doctor the benefits and harms of taking aspirin for disease prevention.”
This study was supported by a grant from the DoD Ovarian Cancer Research Program. Dr. Hurwitz reports no relevant financial relationships, but several coauthors did report funding and support.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Docs struggle to keep up with the flood of new medical knowledge. Here’s advice
making it much tougher for physicians to identify innovative findings and newer guidelines for helping patients. Yet not keeping up with the latest information can put doctors at risk.
“Most doctors are feeling lost about keeping up to date,” said John P.A. Ioannidis, MD, professor of medicine at Stanford (Calif.) University School of Medicine. “The vast majority of new studies are either wrong or not useful, but physicians cannot sort out which are those studies.”
The sheer number of new studies may even force some doctors to retreat from areas where they have not kept up, said Stephen A. Martin, MD, professor of family medicine and community health at the University of Massachusetts, Worcester. “When doctors don’t feel they can stay current, they may refer more cases to specialists or narrow their focus,” he said.
Some specialties have a greater challenge than others
Dr. Martin said the deluge of studies heavily impacts generalists because they have a wider field of information to keep up with. However, certain specialties like oncology are particularly flooded with new findings.
Specialties with the greatest number of published studies are reportedly oncology, cardiology, and neurology. A 2021 study found that the number of articles with the word “stroke” in them increased five times from 2000 to 2020. And investigative treatments targeting cancer nearly quadrupled just between 2010 and 2020.
What’s more, physicians spend a great deal of time sifting through studies that are ultimately useless. In a survey of internists by Univadis, which is part of WebMD/Medscape, 82% said that fewer than half of the studies they read actually had an impact on how they practice medicine.
“You often have to dig into an article and learn more about a finding before you now whether it’s useful,” Dr. Martin said. “And in the end, relatively few new findings are truly novel ones that are useful for patient care.”
So what can a physician do? First, find out what you don’t know
Looking for new findings needs to be carried out systematically, according to William B. Cutrer, MD, MEd, a pediatric intensivist who is associate dean for undergraduate medical education at Vanderbilt University School of Medicine, Nashville, Tenn.
“Before you start, you have to know what you don’t know, and that’s often not so easy,” he said. “You may get a spark about what you don’t know in an encounter with a patient or colleague or through patient outcomes data,” he said.
Dr. Martin, on the other hand, advocates a broad approach that involves finding out at least a little about everything in one’s field. “If you have a good base, you’re not starting from zero when you encounter a new clinical situation,” he said.
“The idea is that you don’t need to memorize most things, but you do need to know how to access them,” Dr. Martin said. “I memorize the things I do all the time, such as dosing or indicated testing, but I look up things that I don’t see that often and ones that have some complexity.”
Updating the old ways
For generations, doctors have stayed current by going to meetings, conversing with colleagues, and reading journals, but many physicians have updated these methods through various resources on the internet.
For example, meetings went virtual during the pandemic, and now that face-to-face meetings are back, many of them retain a virtual option, said Kevin Campbell, MD, a cardiologist at Health First Medical Group, Melbourne, Fla. “I typically go to one or two conferences a year, but I also learn a lot digitally,” he said.
As to journal reading, “assessing an article is an essential skill,” Dr. Cutrer said. “It’s important to quickly decide whether a journal article is worth reading or not. One answer to this problem is to consult summaries of important articles. But summaries are sometimes unhelpful, and it is hard to know which articles are significant. Therefore, doctors have been reaching out to others who can research the articles for them.”
For many years, some physicians have pooled their resources in journal clubs. “You get a chance to cross-cultivate your skills with others,” Dr. Ioannidis said. “But you need someone who is well informed and dedicated to run the journal club, using evidence-based principles.”
Dr. Cutrer said physicians like to cast their net wide because they are understandably wary of changing their practice based on one study. “Unless there is one large study that is really well designed, doctors will need two or more findings to be convinced,” he said. This requires having the ability to match studies across many journals.
Using research summaries
In the past two decades, physicians have gained access to countless summaries of journal articles prepared by armies of clinical experts working for review services such as the New England Journal of Medicine’s “Journal Watch,” Annals of Internal Medicine’s “In the Clinic,” and BMJ’s “State of the Arts.”
In addition to summarizing findings from a wide variety of journals in plain language, reviewers may compare them to similar studies and assess the validity of the finding by assigning a level of evidence.
Some commercial ventures provide similar services. Betsy Jones, executive vice president of clinical decisions at EBSCO, said the DynaMed service is now available through an app on the physician’s smartphone or through the electronic health record.
Physicians like this approach. Many specialists have noted that reading full-length articles was not an efficient use of their time, while even more said that reviews are efficient.
Exchanging information online
Physicians are increasingly keeping current by using the internet, especially on social media, Dr. Cutrer said. “Young doctors in particular are more likely to keep up digitally,” he said.
Internet-based information has become so widespread that disparities in health care from region to region have somewhat abated, according to Stuart J. Fischer, MD, an orthopedic surgeon at Summit Orthopaedics and Sports Medicine, New Jersey. “One positive outcome of this plethora of information today is that geographic disparities in clinical practice are not as great as they used to be,” he said.
Rather than chatting up colleagues in the hallway, many physicians have come to rely on internet-based discussion boards.
Blogs, podcasts, and Twitter
Blogs and podcasts, often focused on a specialty, can be a great way for physicians to keep up, said UMass Chan professor Dr. Martin. “Podcasts in particular have enhanced the ability to stay current,” he said. “You want to find someone you trust.”
Internal medicine podcasts include Annals on Call, where doctors discuss articles in the Annals of Internal Medicine, and the Curbsiders, where two internists interview a guest expert.
Orthopedic surgeons can visit podcasts like Nailed it, Orthobullets, the Ortho Show, and Inside Orthopedics. Neurologists can consult Brainwaves, Neurology Podcast, Practical Neurology Podcast, and Clinical Neurology with KD. And pediatricians can drop in on Talking Pediatrics, The Cribsiders, and PedsCases.
Meanwhile, Twitter has become a particularly effective way to broadcast new findings, speeding up the transition from the bench to the bedside, said Dr. Campbell, the Florida cardiologist.
“I visit cardio-specific resources on Twitter,” he said. “They can be real-time video chats or posted messages. They spur discussion like a journal club. Colleagues present cases and drop in and out of the discussion.”
Others are not as enthusiastic. Although Stanford’s Dr. Ioannidis is in the heart of the Silicon Valley, he is leery of some of the new digital methods. “I don’t use Twitter,” he says. “You just add more people to the process, which could only make things more confusing. I want to be able to think a lot about it.”
Cutting-edge knowledge at the point of care
Consulting the literature often takes place at the point of care, when a particular patient requires treatment. This can be done by using clinical decision support (CDS) and by using clinical practice guidelines (CPGs), which are typically developed by panels of doctors at specialty societies.
“It used to be that the doctor was expected to know everything,” said Ms. Jones at DynaMed. “Today there is no way to keep up with it all. Doctors often need a quick memory jog.”
Ms. Jones said the CDS result always requires the doctor’s interpretation. “It is up to the doctor to decide whether a new finding is the best choice for his or her patient,” she said.
Dr. Martin recommends going easy on point-of-care resources. “They can be used for showing a patient a differential diagnosis list or checking the cost of a procedure, but they are harder to use for novel developments that require time and context to evaluate their impact,” he said.
CPGs, meanwhile, have a high profile in the research world. In a 2018 study, Dr. Ioannidis found that 8 of the 15 most-cited articles were CPGs, disease definitions, or disease statistics.
Dr. Fischer said CPGs are typically based on thorough reviews of the literature, but they do involve experts’ interpretation of the science. “It can be difficult to obtain specific answers to some medical questions, especially for problems with complex treatments or variations,” he said.
As a result, Dr. Fischer said doctors have to use their judgment in applying CPGs to a specific patient. “For example, the orthopedic surgeon would normally recommend a total hip replacement for patients with a bad hip, but it might not be appropriate for an overweight patient.”
Stay skeptical
There are many novel ways for physicians to keep current, including summaries of articles, discussion boards, blogs, podcasts, Twitter, clinical decision support, and clinical practice guidelines.
Even with all these new services, though, doctors need to retain a healthy amount of skepticism about new research findings, Dr. Ioannidis said. “Ask yourself questions such as: Does it deal with a real problem? Am I getting the real information? Is it relevant to real patients? Is it offering good value for money?”
A version of this article first appeared on Medscape.com.
making it much tougher for physicians to identify innovative findings and newer guidelines for helping patients. Yet not keeping up with the latest information can put doctors at risk.
“Most doctors are feeling lost about keeping up to date,” said John P.A. Ioannidis, MD, professor of medicine at Stanford (Calif.) University School of Medicine. “The vast majority of new studies are either wrong or not useful, but physicians cannot sort out which are those studies.”
The sheer number of new studies may even force some doctors to retreat from areas where they have not kept up, said Stephen A. Martin, MD, professor of family medicine and community health at the University of Massachusetts, Worcester. “When doctors don’t feel they can stay current, they may refer more cases to specialists or narrow their focus,” he said.
Some specialties have a greater challenge than others
Dr. Martin said the deluge of studies heavily impacts generalists because they have a wider field of information to keep up with. However, certain specialties like oncology are particularly flooded with new findings.
Specialties with the greatest number of published studies are reportedly oncology, cardiology, and neurology. A 2021 study found that the number of articles with the word “stroke” in them increased five times from 2000 to 2020. And investigative treatments targeting cancer nearly quadrupled just between 2010 and 2020.
What’s more, physicians spend a great deal of time sifting through studies that are ultimately useless. In a survey of internists by Univadis, which is part of WebMD/Medscape, 82% said that fewer than half of the studies they read actually had an impact on how they practice medicine.
“You often have to dig into an article and learn more about a finding before you now whether it’s useful,” Dr. Martin said. “And in the end, relatively few new findings are truly novel ones that are useful for patient care.”
So what can a physician do? First, find out what you don’t know
Looking for new findings needs to be carried out systematically, according to William B. Cutrer, MD, MEd, a pediatric intensivist who is associate dean for undergraduate medical education at Vanderbilt University School of Medicine, Nashville, Tenn.
“Before you start, you have to know what you don’t know, and that’s often not so easy,” he said. “You may get a spark about what you don’t know in an encounter with a patient or colleague or through patient outcomes data,” he said.
Dr. Martin, on the other hand, advocates a broad approach that involves finding out at least a little about everything in one’s field. “If you have a good base, you’re not starting from zero when you encounter a new clinical situation,” he said.
“The idea is that you don’t need to memorize most things, but you do need to know how to access them,” Dr. Martin said. “I memorize the things I do all the time, such as dosing or indicated testing, but I look up things that I don’t see that often and ones that have some complexity.”
Updating the old ways
For generations, doctors have stayed current by going to meetings, conversing with colleagues, and reading journals, but many physicians have updated these methods through various resources on the internet.
For example, meetings went virtual during the pandemic, and now that face-to-face meetings are back, many of them retain a virtual option, said Kevin Campbell, MD, a cardiologist at Health First Medical Group, Melbourne, Fla. “I typically go to one or two conferences a year, but I also learn a lot digitally,” he said.
As to journal reading, “assessing an article is an essential skill,” Dr. Cutrer said. “It’s important to quickly decide whether a journal article is worth reading or not. One answer to this problem is to consult summaries of important articles. But summaries are sometimes unhelpful, and it is hard to know which articles are significant. Therefore, doctors have been reaching out to others who can research the articles for them.”
For many years, some physicians have pooled their resources in journal clubs. “You get a chance to cross-cultivate your skills with others,” Dr. Ioannidis said. “But you need someone who is well informed and dedicated to run the journal club, using evidence-based principles.”
Dr. Cutrer said physicians like to cast their net wide because they are understandably wary of changing their practice based on one study. “Unless there is one large study that is really well designed, doctors will need two or more findings to be convinced,” he said. This requires having the ability to match studies across many journals.
Using research summaries
In the past two decades, physicians have gained access to countless summaries of journal articles prepared by armies of clinical experts working for review services such as the New England Journal of Medicine’s “Journal Watch,” Annals of Internal Medicine’s “In the Clinic,” and BMJ’s “State of the Arts.”
In addition to summarizing findings from a wide variety of journals in plain language, reviewers may compare them to similar studies and assess the validity of the finding by assigning a level of evidence.
Some commercial ventures provide similar services. Betsy Jones, executive vice president of clinical decisions at EBSCO, said the DynaMed service is now available through an app on the physician’s smartphone or through the electronic health record.
Physicians like this approach. Many specialists have noted that reading full-length articles was not an efficient use of their time, while even more said that reviews are efficient.
Exchanging information online
Physicians are increasingly keeping current by using the internet, especially on social media, Dr. Cutrer said. “Young doctors in particular are more likely to keep up digitally,” he said.
Internet-based information has become so widespread that disparities in health care from region to region have somewhat abated, according to Stuart J. Fischer, MD, an orthopedic surgeon at Summit Orthopaedics and Sports Medicine, New Jersey. “One positive outcome of this plethora of information today is that geographic disparities in clinical practice are not as great as they used to be,” he said.
Rather than chatting up colleagues in the hallway, many physicians have come to rely on internet-based discussion boards.
Blogs, podcasts, and Twitter
Blogs and podcasts, often focused on a specialty, can be a great way for physicians to keep up, said UMass Chan professor Dr. Martin. “Podcasts in particular have enhanced the ability to stay current,” he said. “You want to find someone you trust.”
Internal medicine podcasts include Annals on Call, where doctors discuss articles in the Annals of Internal Medicine, and the Curbsiders, where two internists interview a guest expert.
Orthopedic surgeons can visit podcasts like Nailed it, Orthobullets, the Ortho Show, and Inside Orthopedics. Neurologists can consult Brainwaves, Neurology Podcast, Practical Neurology Podcast, and Clinical Neurology with KD. And pediatricians can drop in on Talking Pediatrics, The Cribsiders, and PedsCases.
Meanwhile, Twitter has become a particularly effective way to broadcast new findings, speeding up the transition from the bench to the bedside, said Dr. Campbell, the Florida cardiologist.
“I visit cardio-specific resources on Twitter,” he said. “They can be real-time video chats or posted messages. They spur discussion like a journal club. Colleagues present cases and drop in and out of the discussion.”
Others are not as enthusiastic. Although Stanford’s Dr. Ioannidis is in the heart of the Silicon Valley, he is leery of some of the new digital methods. “I don’t use Twitter,” he says. “You just add more people to the process, which could only make things more confusing. I want to be able to think a lot about it.”
Cutting-edge knowledge at the point of care
Consulting the literature often takes place at the point of care, when a particular patient requires treatment. This can be done by using clinical decision support (CDS) and by using clinical practice guidelines (CPGs), which are typically developed by panels of doctors at specialty societies.
“It used to be that the doctor was expected to know everything,” said Ms. Jones at DynaMed. “Today there is no way to keep up with it all. Doctors often need a quick memory jog.”
Ms. Jones said the CDS result always requires the doctor’s interpretation. “It is up to the doctor to decide whether a new finding is the best choice for his or her patient,” she said.
Dr. Martin recommends going easy on point-of-care resources. “They can be used for showing a patient a differential diagnosis list or checking the cost of a procedure, but they are harder to use for novel developments that require time and context to evaluate their impact,” he said.
CPGs, meanwhile, have a high profile in the research world. In a 2018 study, Dr. Ioannidis found that 8 of the 15 most-cited articles were CPGs, disease definitions, or disease statistics.
Dr. Fischer said CPGs are typically based on thorough reviews of the literature, but they do involve experts’ interpretation of the science. “It can be difficult to obtain specific answers to some medical questions, especially for problems with complex treatments or variations,” he said.
As a result, Dr. Fischer said doctors have to use their judgment in applying CPGs to a specific patient. “For example, the orthopedic surgeon would normally recommend a total hip replacement for patients with a bad hip, but it might not be appropriate for an overweight patient.”
Stay skeptical
There are many novel ways for physicians to keep current, including summaries of articles, discussion boards, blogs, podcasts, Twitter, clinical decision support, and clinical practice guidelines.
Even with all these new services, though, doctors need to retain a healthy amount of skepticism about new research findings, Dr. Ioannidis said. “Ask yourself questions such as: Does it deal with a real problem? Am I getting the real information? Is it relevant to real patients? Is it offering good value for money?”
A version of this article first appeared on Medscape.com.
making it much tougher for physicians to identify innovative findings and newer guidelines for helping patients. Yet not keeping up with the latest information can put doctors at risk.
“Most doctors are feeling lost about keeping up to date,” said John P.A. Ioannidis, MD, professor of medicine at Stanford (Calif.) University School of Medicine. “The vast majority of new studies are either wrong or not useful, but physicians cannot sort out which are those studies.”
The sheer number of new studies may even force some doctors to retreat from areas where they have not kept up, said Stephen A. Martin, MD, professor of family medicine and community health at the University of Massachusetts, Worcester. “When doctors don’t feel they can stay current, they may refer more cases to specialists or narrow their focus,” he said.
Some specialties have a greater challenge than others
Dr. Martin said the deluge of studies heavily impacts generalists because they have a wider field of information to keep up with. However, certain specialties like oncology are particularly flooded with new findings.
Specialties with the greatest number of published studies are reportedly oncology, cardiology, and neurology. A 2021 study found that the number of articles with the word “stroke” in them increased five times from 2000 to 2020. And investigative treatments targeting cancer nearly quadrupled just between 2010 and 2020.
What’s more, physicians spend a great deal of time sifting through studies that are ultimately useless. In a survey of internists by Univadis, which is part of WebMD/Medscape, 82% said that fewer than half of the studies they read actually had an impact on how they practice medicine.
“You often have to dig into an article and learn more about a finding before you now whether it’s useful,” Dr. Martin said. “And in the end, relatively few new findings are truly novel ones that are useful for patient care.”
So what can a physician do? First, find out what you don’t know
Looking for new findings needs to be carried out systematically, according to William B. Cutrer, MD, MEd, a pediatric intensivist who is associate dean for undergraduate medical education at Vanderbilt University School of Medicine, Nashville, Tenn.
“Before you start, you have to know what you don’t know, and that’s often not so easy,” he said. “You may get a spark about what you don’t know in an encounter with a patient or colleague or through patient outcomes data,” he said.
Dr. Martin, on the other hand, advocates a broad approach that involves finding out at least a little about everything in one’s field. “If you have a good base, you’re not starting from zero when you encounter a new clinical situation,” he said.
“The idea is that you don’t need to memorize most things, but you do need to know how to access them,” Dr. Martin said. “I memorize the things I do all the time, such as dosing or indicated testing, but I look up things that I don’t see that often and ones that have some complexity.”
Updating the old ways
For generations, doctors have stayed current by going to meetings, conversing with colleagues, and reading journals, but many physicians have updated these methods through various resources on the internet.
For example, meetings went virtual during the pandemic, and now that face-to-face meetings are back, many of them retain a virtual option, said Kevin Campbell, MD, a cardiologist at Health First Medical Group, Melbourne, Fla. “I typically go to one or two conferences a year, but I also learn a lot digitally,” he said.
As to journal reading, “assessing an article is an essential skill,” Dr. Cutrer said. “It’s important to quickly decide whether a journal article is worth reading or not. One answer to this problem is to consult summaries of important articles. But summaries are sometimes unhelpful, and it is hard to know which articles are significant. Therefore, doctors have been reaching out to others who can research the articles for them.”
For many years, some physicians have pooled their resources in journal clubs. “You get a chance to cross-cultivate your skills with others,” Dr. Ioannidis said. “But you need someone who is well informed and dedicated to run the journal club, using evidence-based principles.”
Dr. Cutrer said physicians like to cast their net wide because they are understandably wary of changing their practice based on one study. “Unless there is one large study that is really well designed, doctors will need two or more findings to be convinced,” he said. This requires having the ability to match studies across many journals.
Using research summaries
In the past two decades, physicians have gained access to countless summaries of journal articles prepared by armies of clinical experts working for review services such as the New England Journal of Medicine’s “Journal Watch,” Annals of Internal Medicine’s “In the Clinic,” and BMJ’s “State of the Arts.”
In addition to summarizing findings from a wide variety of journals in plain language, reviewers may compare them to similar studies and assess the validity of the finding by assigning a level of evidence.
Some commercial ventures provide similar services. Betsy Jones, executive vice president of clinical decisions at EBSCO, said the DynaMed service is now available through an app on the physician’s smartphone or through the electronic health record.
Physicians like this approach. Many specialists have noted that reading full-length articles was not an efficient use of their time, while even more said that reviews are efficient.
Exchanging information online
Physicians are increasingly keeping current by using the internet, especially on social media, Dr. Cutrer said. “Young doctors in particular are more likely to keep up digitally,” he said.
Internet-based information has become so widespread that disparities in health care from region to region have somewhat abated, according to Stuart J. Fischer, MD, an orthopedic surgeon at Summit Orthopaedics and Sports Medicine, New Jersey. “One positive outcome of this plethora of information today is that geographic disparities in clinical practice are not as great as they used to be,” he said.
Rather than chatting up colleagues in the hallway, many physicians have come to rely on internet-based discussion boards.
Blogs, podcasts, and Twitter
Blogs and podcasts, often focused on a specialty, can be a great way for physicians to keep up, said UMass Chan professor Dr. Martin. “Podcasts in particular have enhanced the ability to stay current,” he said. “You want to find someone you trust.”
Internal medicine podcasts include Annals on Call, where doctors discuss articles in the Annals of Internal Medicine, and the Curbsiders, where two internists interview a guest expert.
Orthopedic surgeons can visit podcasts like Nailed it, Orthobullets, the Ortho Show, and Inside Orthopedics. Neurologists can consult Brainwaves, Neurology Podcast, Practical Neurology Podcast, and Clinical Neurology with KD. And pediatricians can drop in on Talking Pediatrics, The Cribsiders, and PedsCases.
Meanwhile, Twitter has become a particularly effective way to broadcast new findings, speeding up the transition from the bench to the bedside, said Dr. Campbell, the Florida cardiologist.
“I visit cardio-specific resources on Twitter,” he said. “They can be real-time video chats or posted messages. They spur discussion like a journal club. Colleagues present cases and drop in and out of the discussion.”
Others are not as enthusiastic. Although Stanford’s Dr. Ioannidis is in the heart of the Silicon Valley, he is leery of some of the new digital methods. “I don’t use Twitter,” he says. “You just add more people to the process, which could only make things more confusing. I want to be able to think a lot about it.”
Cutting-edge knowledge at the point of care
Consulting the literature often takes place at the point of care, when a particular patient requires treatment. This can be done by using clinical decision support (CDS) and by using clinical practice guidelines (CPGs), which are typically developed by panels of doctors at specialty societies.
“It used to be that the doctor was expected to know everything,” said Ms. Jones at DynaMed. “Today there is no way to keep up with it all. Doctors often need a quick memory jog.”
Ms. Jones said the CDS result always requires the doctor’s interpretation. “It is up to the doctor to decide whether a new finding is the best choice for his or her patient,” she said.
Dr. Martin recommends going easy on point-of-care resources. “They can be used for showing a patient a differential diagnosis list or checking the cost of a procedure, but they are harder to use for novel developments that require time and context to evaluate their impact,” he said.
CPGs, meanwhile, have a high profile in the research world. In a 2018 study, Dr. Ioannidis found that 8 of the 15 most-cited articles were CPGs, disease definitions, or disease statistics.
Dr. Fischer said CPGs are typically based on thorough reviews of the literature, but they do involve experts’ interpretation of the science. “It can be difficult to obtain specific answers to some medical questions, especially for problems with complex treatments or variations,” he said.
As a result, Dr. Fischer said doctors have to use their judgment in applying CPGs to a specific patient. “For example, the orthopedic surgeon would normally recommend a total hip replacement for patients with a bad hip, but it might not be appropriate for an overweight patient.”
Stay skeptical
There are many novel ways for physicians to keep current, including summaries of articles, discussion boards, blogs, podcasts, Twitter, clinical decision support, and clinical practice guidelines.
Even with all these new services, though, doctors need to retain a healthy amount of skepticism about new research findings, Dr. Ioannidis said. “Ask yourself questions such as: Does it deal with a real problem? Am I getting the real information? Is it relevant to real patients? Is it offering good value for money?”
A version of this article first appeared on Medscape.com.
Celiac disease appears to double COVID-19 hospitalization risk
, a single-center U.S. study shows.
Vaccination against COVID-19 reduced the risk for hospitalization by almost half for both groups, however, the study finds.
“To our knowledge this is the first study that demonstrated a vaccination effect on mitigation of the risk of hospitalization in celiac disease patients with COVID-19 infection,” write Alberto Rubio-Tapia, MD, director, Celiac Disease Program, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, and colleagues.
Despite the increased risk for hospitalization among patients with celiac disease, there were no significant differences between those with and without the condition with respect to intensive care unit requirement, mortality, or thrombosis, the researchers found.
The findings suggest that celiac disease patients with COVID-19 are “not inherently at greater risk for more severe outcomes,” they wrote.
The study was published online in Clinical Gastroenterology and Hepatology.
Comparing outcomes
Although it has been shown that patients with celiac disease have increased susceptibility to viral illnesses, research to date has found similar COVID-19 incidence and outcomes, including hospitalization, between patients with celiac disease and the general population, the researchers wrote.
However, the impact of COVID-19 vaccination is less clear, so the researchers set out to compare the frequency of COVID-19–related outcomes between patients with and without celiac disease before and after vaccination.
Through an analysis of patient medical records, researchers found 171,763 patients diagnosed and treated for COVID-19 at their institution between March 1, 2020, and Jan 1, 2022. Of them, 110 adults had biopsy-proven celiac disease.
The median time from biopsy diagnosis of celiac disease to COVID-19 was 217 months, 66.3% of patients were documented to be following a gluten-free diet, and tissue transglutaminase IgA was positive in 46.2% at the time of COVID-19.
The celiac group was matched by age, ethnicity, sex, and date of COVID-19 diagnosis with a control group of 220 adults without a clinical diagnosis of celiac disease. The two cohorts had similar rates of comorbid obesity, type 2 diabetes, preexisting lung disease, and tobacco use.
Patients with celiac disease were significantly more likely to be hospitalized for COVID-19 than were the control participants, at 24% vs. 11% (hazard ratio, 2.1; P = .009), the researchers wrote.
However, hospitalized patients with celiac disease were less likely to require supplementary oxygen than were the control participants, at 63% vs. 84%.
Vaccination rates for COVID-19 were similar between the two groups, at 64.5% among patients with celiac disease and 70% in the control group. Vaccination was associated with a lower risk for hospitalization on multivariate analysis (HR, 0.53; P = .026).
There was no significant difference in hospitalization rates between vaccinated patients with celiac disease and vaccinated patients in the control group (odds ratio, 1.12; P = .79), the team reported.
The secondary outcomes of ICU requirement, mortality, and thrombosis were minimal in both groups, the researchers wrote.
Vaccination’s importance
The different findings regarding hospitalization risk among patients with celiac disease between this study and previous research are likely due to earlier studies not accounting for vaccination status, the researchers wrote.
“This study shows significantly different rates of hospitalization among patients with [celiac disease] depending on their vaccination status, with strong evidence for mitigation of hospitalization risk through vaccination,” they added.
“Vaccination against COVID-19 should be strongly recommended in patients with celiac disease,” the researchers concluded.
No funding was declared. Dr. Rubio-Tapia reported a relationship with Takeda. No other financial relationships were declared.
A version of this article first appeared on Medscape.com.
, a single-center U.S. study shows.
Vaccination against COVID-19 reduced the risk for hospitalization by almost half for both groups, however, the study finds.
“To our knowledge this is the first study that demonstrated a vaccination effect on mitigation of the risk of hospitalization in celiac disease patients with COVID-19 infection,” write Alberto Rubio-Tapia, MD, director, Celiac Disease Program, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, and colleagues.
Despite the increased risk for hospitalization among patients with celiac disease, there were no significant differences between those with and without the condition with respect to intensive care unit requirement, mortality, or thrombosis, the researchers found.
The findings suggest that celiac disease patients with COVID-19 are “not inherently at greater risk for more severe outcomes,” they wrote.
The study was published online in Clinical Gastroenterology and Hepatology.
Comparing outcomes
Although it has been shown that patients with celiac disease have increased susceptibility to viral illnesses, research to date has found similar COVID-19 incidence and outcomes, including hospitalization, between patients with celiac disease and the general population, the researchers wrote.
However, the impact of COVID-19 vaccination is less clear, so the researchers set out to compare the frequency of COVID-19–related outcomes between patients with and without celiac disease before and after vaccination.
Through an analysis of patient medical records, researchers found 171,763 patients diagnosed and treated for COVID-19 at their institution between March 1, 2020, and Jan 1, 2022. Of them, 110 adults had biopsy-proven celiac disease.
The median time from biopsy diagnosis of celiac disease to COVID-19 was 217 months, 66.3% of patients were documented to be following a gluten-free diet, and tissue transglutaminase IgA was positive in 46.2% at the time of COVID-19.
The celiac group was matched by age, ethnicity, sex, and date of COVID-19 diagnosis with a control group of 220 adults without a clinical diagnosis of celiac disease. The two cohorts had similar rates of comorbid obesity, type 2 diabetes, preexisting lung disease, and tobacco use.
Patients with celiac disease were significantly more likely to be hospitalized for COVID-19 than were the control participants, at 24% vs. 11% (hazard ratio, 2.1; P = .009), the researchers wrote.
However, hospitalized patients with celiac disease were less likely to require supplementary oxygen than were the control participants, at 63% vs. 84%.
Vaccination rates for COVID-19 were similar between the two groups, at 64.5% among patients with celiac disease and 70% in the control group. Vaccination was associated with a lower risk for hospitalization on multivariate analysis (HR, 0.53; P = .026).
There was no significant difference in hospitalization rates between vaccinated patients with celiac disease and vaccinated patients in the control group (odds ratio, 1.12; P = .79), the team reported.
The secondary outcomes of ICU requirement, mortality, and thrombosis were minimal in both groups, the researchers wrote.
Vaccination’s importance
The different findings regarding hospitalization risk among patients with celiac disease between this study and previous research are likely due to earlier studies not accounting for vaccination status, the researchers wrote.
“This study shows significantly different rates of hospitalization among patients with [celiac disease] depending on their vaccination status, with strong evidence for mitigation of hospitalization risk through vaccination,” they added.
“Vaccination against COVID-19 should be strongly recommended in patients with celiac disease,” the researchers concluded.
No funding was declared. Dr. Rubio-Tapia reported a relationship with Takeda. No other financial relationships were declared.
A version of this article first appeared on Medscape.com.
, a single-center U.S. study shows.
Vaccination against COVID-19 reduced the risk for hospitalization by almost half for both groups, however, the study finds.
“To our knowledge this is the first study that demonstrated a vaccination effect on mitigation of the risk of hospitalization in celiac disease patients with COVID-19 infection,” write Alberto Rubio-Tapia, MD, director, Celiac Disease Program, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, and colleagues.
Despite the increased risk for hospitalization among patients with celiac disease, there were no significant differences between those with and without the condition with respect to intensive care unit requirement, mortality, or thrombosis, the researchers found.
The findings suggest that celiac disease patients with COVID-19 are “not inherently at greater risk for more severe outcomes,” they wrote.
The study was published online in Clinical Gastroenterology and Hepatology.
Comparing outcomes
Although it has been shown that patients with celiac disease have increased susceptibility to viral illnesses, research to date has found similar COVID-19 incidence and outcomes, including hospitalization, between patients with celiac disease and the general population, the researchers wrote.
However, the impact of COVID-19 vaccination is less clear, so the researchers set out to compare the frequency of COVID-19–related outcomes between patients with and without celiac disease before and after vaccination.
Through an analysis of patient medical records, researchers found 171,763 patients diagnosed and treated for COVID-19 at their institution between March 1, 2020, and Jan 1, 2022. Of them, 110 adults had biopsy-proven celiac disease.
The median time from biopsy diagnosis of celiac disease to COVID-19 was 217 months, 66.3% of patients were documented to be following a gluten-free diet, and tissue transglutaminase IgA was positive in 46.2% at the time of COVID-19.
The celiac group was matched by age, ethnicity, sex, and date of COVID-19 diagnosis with a control group of 220 adults without a clinical diagnosis of celiac disease. The two cohorts had similar rates of comorbid obesity, type 2 diabetes, preexisting lung disease, and tobacco use.
Patients with celiac disease were significantly more likely to be hospitalized for COVID-19 than were the control participants, at 24% vs. 11% (hazard ratio, 2.1; P = .009), the researchers wrote.
However, hospitalized patients with celiac disease were less likely to require supplementary oxygen than were the control participants, at 63% vs. 84%.
Vaccination rates for COVID-19 were similar between the two groups, at 64.5% among patients with celiac disease and 70% in the control group. Vaccination was associated with a lower risk for hospitalization on multivariate analysis (HR, 0.53; P = .026).
There was no significant difference in hospitalization rates between vaccinated patients with celiac disease and vaccinated patients in the control group (odds ratio, 1.12; P = .79), the team reported.
The secondary outcomes of ICU requirement, mortality, and thrombosis were minimal in both groups, the researchers wrote.
Vaccination’s importance
The different findings regarding hospitalization risk among patients with celiac disease between this study and previous research are likely due to earlier studies not accounting for vaccination status, the researchers wrote.
“This study shows significantly different rates of hospitalization among patients with [celiac disease] depending on their vaccination status, with strong evidence for mitigation of hospitalization risk through vaccination,” they added.
“Vaccination against COVID-19 should be strongly recommended in patients with celiac disease,” the researchers concluded.
No funding was declared. Dr. Rubio-Tapia reported a relationship with Takeda. No other financial relationships were declared.
A version of this article first appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY