Journal of Clinical Outcomes Management

Secukinumab proved highly effective at improving skin symptoms and quality of life in 6- to 17-year-old patients with moderate to severe plaque psoriasis at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.

Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).

He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.

The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.

At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.

Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.

Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.

“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.

“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.

Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”

Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.

MedscapeLIVE! and this news organization are owned by the same parent company.

Secukinumab proved highly effective at improving skin symptoms and quality of life in 6- to 17-year-old patients with moderate to severe plaque psoriasis at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.

Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).

He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.

The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.

At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.

Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.

Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.

“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.

“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.

Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”

Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.

MedscapeLIVE! and this news organization are owned by the same parent company.

Secukinumab proved highly effective at improving skin symptoms and quality of life in 6- to 17-year-old patients with moderate to severe plaque psoriasis at 24 weeks of follow-up in an ongoing 4-year phase 2 clinical trial, Adam Reich, MD, PhD, reported at Innovations in Dermatology: Virtual Spring Conference 2021.

Secukinumab (Cosentyx), a fully human monoclonal antibody that inhibits interleukin-17A, is widely approved for treatment of psoriasis in adults. In August 2020, the biologic received an expanded indication in Europe for treatment of 6- to 17-year-olds. Two phase 3 clinical trials are underway in an effort to gain a similar broadened indication in the United States to help address the high unmet need for new treatments for psoriasis in the pediatric population, said Dr. Reich, professor and head of the department of dermatology at the University of Rzeszow (Poland).

He reported on 84 pediatric patients participating in the open-label, phase 2, international study. They were randomized to one of two weight-based dosing regimens. Those in the low-dose arm received secukinumab dosed at 75 mg if they weighed less than 50 kg and 150 mg if they weighed more. In the high-dose arm, patients got secukinumab 75 mg if they weighed less than 25 kg, 150 mg if they weighed 25-50 kg, and 300 mg if they tipped the scales in excess of 50 kg.

The primary endpoint in the study was the week-12 rate of at least a 75% improvement from baseline in the Psoriasis Area and Severity Index score, or PASI 75. The rates were similar: 92.9% of patients in the high-dose arm achieved this endpoint, as did 90.5% in the low-dose arm. The PASI 90 rates were 83.3% and 78%, the PASI 100 rates were 61.9% and 54.8%, and clear or almost clear skin, as measured by the Investigator Global Assessment, was achieved in 88.7% of the high- and 85.7% of the low-dose groups. In addition,61.9% of those in the high-dose secukinumab group and 50% in the low-dose group had a score of 0 or 1 on the Children’s Dermatology Life Quality Index – indicating psoriasis has no impact on daily quality of life, he said at the conference sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.

At week 24, roughly 95% of patients in both the low- and high-dose secukinumab groups had achieved PASI 75s, 88% reached a PASI 90 response, and 67% were at PASI 100. Nearly 60% of the low-dose and 70% of the high-dose groups had a score of 0 or 1 on the Children’s Dermatology Life Quality Index.

Treatment-emergent adverse event rates were similar in the two study arms. Of note, there was one case of new-onset inflammatory bowel disease in the high-dose group, and one case of vulvovaginal candidiasis as well.

Discussant Bruce E. Strober, MD, PhD, said that, if secukinumab gets a pediatric indication from the Food and Drug Administration, as seems likely, it won’t alter his biologic treatment hierarchy.

“I treat a lot of kids with psoriasis. We have three approved drugs now in etanercept [Enbrel], ustekinumab [Stelara], and ixekizumab [Taltz]. My bias is still towards ustekinumab because it’s infrequently dosed and that’s a huge issue for children. You want to expose them to as few injections as possible, for obvious reasons: It’s easier for parents and other caregivers,” explained Dr. Strober, a dermatologist at Yale University, New Haven, Conn., and Central Connecticut Dermatology, Cromwell, Conn.

“The other issue is in IL-17 inhibition there has been a slight signal of inflammatory bowel disease popping up in children getting these drugs, and therefore you need to screen patients in this age group very carefully – not only the patients themselves, but their family – for IBD risk. If there is any sign of that I would move the IL-17 inhibitors to the back of the line, compared to ustekinumab and etanercept. Ustekinumab is still clearly the one that I think has to be used first line,” he said.

Dr. Strober offered a final word of advice for his colleagues: “You can’t be afraid to treat children with biologic therapies. In fact, preferentially I would use a biologic therapy over methotrexate or light therapy, which is really difficult for children.”

Dr. Reich and Dr. Strober reported receiving research grants from and serving as a consultant to numerous pharmaceutical companies, including Novartis, which markets secukinumab and funded the study.

MedscapeLIVE! and this news organization are owned by the same parent company.

Adults with knee osteoarthritis (OA) who participated in a self-directed, web-based exercise program with automated text-message reminders and encouragement for 6 months showed significant improvement in overall knee pain and physical function, compared with patients who received web-based OA information alone, in a randomized trial of 180 individuals.

copyright Nandyphotos/Thinkstock

The results support a role for web-based exercise intervention to improve knee OA patients’ access to recommended exercises and to assist clinicians in managing patients on a population level, according to the first author of the study, Rachel Kate Nelligan, of the University of Melbourne, and colleagues. Their report is in JAMA Internal Medicine.

“Our free-to-access, unsupervised program could serve as an entry-level intervention, with participants who do not experience clinical benefits progressing to subsequent steps for more intensive, personalized management,” they said. “Such an approach has the potential to better distribute limited health care resources and reduce demand for contact with health professionals, thus improving access for those requiring it.”

Only two other randomized, clinical trials have evaluated web-based interventions for OA without contact from health professionals, according to the authors. While one of those did not find any differences in outcomes at 4 months when comparing a self-directed progressive lower-limb strength, flexibility, and walking program to being on a wait list, a separate trial evaluating a 9-module physical activity program in adults with knee and/or hip OA vs. a wait-list control group found evidence for efficacy for physical function at 3 months, but not quality of life or function in sport and recreation.

For the current study, researchers recruited 206 adults in Australia with clinically diagnosed knee OA via online advertisements and a volunteer database. Participants were aged 45 years or older, and reported activity-related knee pain and morning knee stiffness lasting at least 30 minutes; knee pain on most days for at least 3 months; and average knee pain severity of 4 or higher on an 11-point numeric rating scale in the previous week. In addition, participants were required to own a cell phone with text messaging, have Internet access, and be able to complete assessments.

Patients randomized to the intervention of the My Knee Exercise website received web-based information about OA and the value of exercise, with a 24-week self-directed program of strengthening exercises plus automated text messages to motivate behavior changes and encourage adherence to the exercise program. Controls received access to web-based information about OA and the value of exercise, but without the prescribed exercises or texts. Patients in the intervention group received an average of 60 text messages during the study period, and the average reply rate was 73%.

The primary study outcomes were changes in overall knee pain based on a numeric 0-10 rating scale and changes in physical function based on the Western Ontario and McMaster Universities Osteoarthritis Index 0-68 scale. A total of 180 participants completed both primary outcome measures at 24 weeks. The average age of the participants was 60 years, and 61% were women.

After 24 weeks, the intervention group averaged significantly greater improvement of 1.6 units for overall knee pain (P < .001) and 5.2 units for physical function (P = .002), compared with controls.

In addition, the proportion of patients who exceeded the minimal clinically important difference in pain improvement of at least 1.8 units was significantly higher in the intervention group, compared with controls (72.1% vs. 42.0%; P < .001). Similarly, more intervention-group patients achieved the minimal clinically important difference in WOMAC physical function of improvement of at least 6 units (68.0% vs. 40.8%; P < .001).

Secondary outcomes included additional measures of knee pain, knee function for sport and recreation, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. Between-group differences favored the intervention on most measures, including Knee Injury and Osteoarthritis Outcome Score subscales for pain, sports/recreation, and quality of life; health-related quality of life; Arthritis Self-Efficacy Scale (ASES) pain subscale, individual change since baseline, and overall patient satisfaction. “Changes in PASE [Physical Activity Scale for the Elderly], ASES function, and SEE [Self Efficacy Exercise] were similar in both groups,” the researchers said.

No serious adverse events were reported by any study participants. Eight patients in the intervention group reported knee pain during the study, compared with one of the controls, and use of pain medications was similar between the groups, except that more control participants used massage, heat or cold, and topical anti-inflammatories.

The results suggest that a majority of participants in the intervention group improved pain and function without the need for in-person contact with a health professional, the researchers noted. However, more intensive management may be needed to support the 30% who did not benefit from the unsupervised approach, they said.

The study findings were limited by several factors, including the potential bias of a volunteer study population, possible lack of generalizability to individuals with lower levels of education or self-efficacy, and lack of direct comparison between web-based intervention and clinician-delivered intervention, the researchers noted.

The study was funded by the National Health and Medical Research Council, whose fellowships supported two of the authors. Lead author Ms. Nelligan disclosed a PhD scholarship from the Australian Government Research Training Program and personal fees from the University of Melbourne unrelated to the current study.

Adults with knee osteoarthritis (OA) who participated in a self-directed, web-based exercise program with automated text-message reminders and encouragement for 6 months showed significant improvement in overall knee pain and physical function, compared with patients who received web-based OA information alone, in a randomized trial of 180 individuals.

copyright Nandyphotos/Thinkstock

The results support a role for web-based exercise intervention to improve knee OA patients’ access to recommended exercises and to assist clinicians in managing patients on a population level, according to the first author of the study, Rachel Kate Nelligan, of the University of Melbourne, and colleagues. Their report is in JAMA Internal Medicine.

“Our free-to-access, unsupervised program could serve as an entry-level intervention, with participants who do not experience clinical benefits progressing to subsequent steps for more intensive, personalized management,” they said. “Such an approach has the potential to better distribute limited health care resources and reduce demand for contact with health professionals, thus improving access for those requiring it.”

Only two other randomized, clinical trials have evaluated web-based interventions for OA without contact from health professionals, according to the authors. While one of those did not find any differences in outcomes at 4 months when comparing a self-directed progressive lower-limb strength, flexibility, and walking program to being on a wait list, a separate trial evaluating a 9-module physical activity program in adults with knee and/or hip OA vs. a wait-list control group found evidence for efficacy for physical function at 3 months, but not quality of life or function in sport and recreation.

For the current study, researchers recruited 206 adults in Australia with clinically diagnosed knee OA via online advertisements and a volunteer database. Participants were aged 45 years or older, and reported activity-related knee pain and morning knee stiffness lasting at least 30 minutes; knee pain on most days for at least 3 months; and average knee pain severity of 4 or higher on an 11-point numeric rating scale in the previous week. In addition, participants were required to own a cell phone with text messaging, have Internet access, and be able to complete assessments.

Patients randomized to the intervention of the My Knee Exercise website received web-based information about OA and the value of exercise, with a 24-week self-directed program of strengthening exercises plus automated text messages to motivate behavior changes and encourage adherence to the exercise program. Controls received access to web-based information about OA and the value of exercise, but without the prescribed exercises or texts. Patients in the intervention group received an average of 60 text messages during the study period, and the average reply rate was 73%.

The primary study outcomes were changes in overall knee pain based on a numeric 0-10 rating scale and changes in physical function based on the Western Ontario and McMaster Universities Osteoarthritis Index 0-68 scale. A total of 180 participants completed both primary outcome measures at 24 weeks. The average age of the participants was 60 years, and 61% were women.

After 24 weeks, the intervention group averaged significantly greater improvement of 1.6 units for overall knee pain (P < .001) and 5.2 units for physical function (P = .002), compared with controls.

In addition, the proportion of patients who exceeded the minimal clinically important difference in pain improvement of at least 1.8 units was significantly higher in the intervention group, compared with controls (72.1% vs. 42.0%; P < .001). Similarly, more intervention-group patients achieved the minimal clinically important difference in WOMAC physical function of improvement of at least 6 units (68.0% vs. 40.8%; P < .001).

Secondary outcomes included additional measures of knee pain, knee function for sport and recreation, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. Between-group differences favored the intervention on most measures, including Knee Injury and Osteoarthritis Outcome Score subscales for pain, sports/recreation, and quality of life; health-related quality of life; Arthritis Self-Efficacy Scale (ASES) pain subscale, individual change since baseline, and overall patient satisfaction. “Changes in PASE [Physical Activity Scale for the Elderly], ASES function, and SEE [Self Efficacy Exercise] were similar in both groups,” the researchers said.

No serious adverse events were reported by any study participants. Eight patients in the intervention group reported knee pain during the study, compared with one of the controls, and use of pain medications was similar between the groups, except that more control participants used massage, heat or cold, and topical anti-inflammatories.

The results suggest that a majority of participants in the intervention group improved pain and function without the need for in-person contact with a health professional, the researchers noted. However, more intensive management may be needed to support the 30% who did not benefit from the unsupervised approach, they said.

The study findings were limited by several factors, including the potential bias of a volunteer study population, possible lack of generalizability to individuals with lower levels of education or self-efficacy, and lack of direct comparison between web-based intervention and clinician-delivered intervention, the researchers noted.

The study was funded by the National Health and Medical Research Council, whose fellowships supported two of the authors. Lead author Ms. Nelligan disclosed a PhD scholarship from the Australian Government Research Training Program and personal fees from the University of Melbourne unrelated to the current study.

Adults with knee osteoarthritis (OA) who participated in a self-directed, web-based exercise program with automated text-message reminders and encouragement for 6 months showed significant improvement in overall knee pain and physical function, compared with patients who received web-based OA information alone, in a randomized trial of 180 individuals.

copyright Nandyphotos/Thinkstock

The results support a role for web-based exercise intervention to improve knee OA patients’ access to recommended exercises and to assist clinicians in managing patients on a population level, according to the first author of the study, Rachel Kate Nelligan, of the University of Melbourne, and colleagues. Their report is in JAMA Internal Medicine.

“Our free-to-access, unsupervised program could serve as an entry-level intervention, with participants who do not experience clinical benefits progressing to subsequent steps for more intensive, personalized management,” they said. “Such an approach has the potential to better distribute limited health care resources and reduce demand for contact with health professionals, thus improving access for those requiring it.”

Only two other randomized, clinical trials have evaluated web-based interventions for OA without contact from health professionals, according to the authors. While one of those did not find any differences in outcomes at 4 months when comparing a self-directed progressive lower-limb strength, flexibility, and walking program to being on a wait list, a separate trial evaluating a 9-module physical activity program in adults with knee and/or hip OA vs. a wait-list control group found evidence for efficacy for physical function at 3 months, but not quality of life or function in sport and recreation.

For the current study, researchers recruited 206 adults in Australia with clinically diagnosed knee OA via online advertisements and a volunteer database. Participants were aged 45 years or older, and reported activity-related knee pain and morning knee stiffness lasting at least 30 minutes; knee pain on most days for at least 3 months; and average knee pain severity of 4 or higher on an 11-point numeric rating scale in the previous week. In addition, participants were required to own a cell phone with text messaging, have Internet access, and be able to complete assessments.

Patients randomized to the intervention of the My Knee Exercise website received web-based information about OA and the value of exercise, with a 24-week self-directed program of strengthening exercises plus automated text messages to motivate behavior changes and encourage adherence to the exercise program. Controls received access to web-based information about OA and the value of exercise, but without the prescribed exercises or texts. Patients in the intervention group received an average of 60 text messages during the study period, and the average reply rate was 73%.

The primary study outcomes were changes in overall knee pain based on a numeric 0-10 rating scale and changes in physical function based on the Western Ontario and McMaster Universities Osteoarthritis Index 0-68 scale. A total of 180 participants completed both primary outcome measures at 24 weeks. The average age of the participants was 60 years, and 61% were women.

After 24 weeks, the intervention group averaged significantly greater improvement of 1.6 units for overall knee pain (P < .001) and 5.2 units for physical function (P = .002), compared with controls.

In addition, the proportion of patients who exceeded the minimal clinically important difference in pain improvement of at least 1.8 units was significantly higher in the intervention group, compared with controls (72.1% vs. 42.0%; P < .001). Similarly, more intervention-group patients achieved the minimal clinically important difference in WOMAC physical function of improvement of at least 6 units (68.0% vs. 40.8%; P < .001).

Secondary outcomes included additional measures of knee pain, knee function for sport and recreation, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction. Between-group differences favored the intervention on most measures, including Knee Injury and Osteoarthritis Outcome Score subscales for pain, sports/recreation, and quality of life; health-related quality of life; Arthritis Self-Efficacy Scale (ASES) pain subscale, individual change since baseline, and overall patient satisfaction. “Changes in PASE [Physical Activity Scale for the Elderly], ASES function, and SEE [Self Efficacy Exercise] were similar in both groups,” the researchers said.

No serious adverse events were reported by any study participants. Eight patients in the intervention group reported knee pain during the study, compared with one of the controls, and use of pain medications was similar between the groups, except that more control participants used massage, heat or cold, and topical anti-inflammatories.

The results suggest that a majority of participants in the intervention group improved pain and function without the need for in-person contact with a health professional, the researchers noted. However, more intensive management may be needed to support the 30% who did not benefit from the unsupervised approach, they said.

The study findings were limited by several factors, including the potential bias of a volunteer study population, possible lack of generalizability to individuals with lower levels of education or self-efficacy, and lack of direct comparison between web-based intervention and clinician-delivered intervention, the researchers noted.

The study was funded by the National Health and Medical Research Council, whose fellowships supported two of the authors. Lead author Ms. Nelligan disclosed a PhD scholarship from the Australian Government Research Training Program and personal fees from the University of Melbourne unrelated to the current study.

Loss of smell, loss of taste, dyspnea, and fatigue are the four most common symptoms that health care professionals in Sweden report 8 months after mild COVID-19 illness, new evidence reveals.

Approximately 1 in 10 health care workers experience one or more moderate to severe symptoms that negatively affect their quality of life, according to the study.

Nenad Cavoski/Getty Images

“We see that a substantial portion of health care workers suffer from long-term symptoms after mild COVID-19,” senior author Charlotte Thålin, MD, PhD, said in an interview. She added that loss of smell and taste “may seem trivial, but have a negative impact on work, social, and home life in the long run.”

The study is noteworthy not only for tracking the COVID-19-related experiences of health care workers over time, but also for what it did not find. There was no increased prevalence of cognitive issues – including memory or concentration – that others have linked to what’s often called long-haul COVID-19.

The research letter was published online April 7, 2021, in JAMA.

“Even if you are young and previously healthy, a mild COVID-19 infection may result in long-term consequences,” said Dr. Thålin, from the department of clinical sciences at Danderyd Hospital, Karolinska Institute, Stockholm.

The researchers did not observe an increased risk for long-term symptoms after asymptomatic COVID-19.
 

Adding to existing evidence

This research letter “adds to the growing body of literature showing that people recovering from COVID have reported a diverse array of symptoms lasting for months after initial infection,” Lekshmi Santhosh, MD, said in an interview. She is physician faculty lead at the University of California, San Francisco Post-COVID OPTIMAL Clinic.

Previous research revealed severe long-term symptoms, including heart palpitations and neurologic impairments, among people hospitalized with COVID-19. However, “there is limited data on the long-term effects after mild COVID-19, and these studies are often hampered by selection bias and without proper control groups,” Dr. Thålin said.

The absence of these more severe symptoms after mild COVID-19 is “reassuring,” she added.

The current findings are part of the ongoing COMMUNITY (COVID-19 Biomarker and Immunity) study looking at long-term immunity. Health care professionals enrolled in the research between April 15 and May 8, 2020, and have initial blood tests repeated every 4 months.

Dr. Thålin, lead author Sebastian Havervall, MD, and their colleagues compared symptom reporting between 323 hospital employees who had mild COVID-19 at least 8 months earlier with 1,072 employees who did not have COVID-19 throughout the study.

The results show that 26% of those who had COVID-19 previously had at least one moderate to severe symptom that lasted more than 2 months, compared with 9% in the control group.

The group with a history of mild COVID-19 was a median 43 years old and 83% were women. The controls were a median 47 years old and 86% were women.

“These data mirror what we have seen across long-term cohorts of patients with COVID-19 infection. Notably, mild illness among previously healthy individuals may be associated with long-term persistent symptoms,” Sarah Jolley, MD, a pulmonologist specializing in critical care at the University of Colorado Hospital in Aurora and director of the Post-COVID Clinic, said in an interview.

“In this cohort, similar to others, this seems to be more pronounced in women,” Dr. Jolley added.
 

Key findings on functioning

At 8 months, using a smartphone app, participants reported presence, duration, and severity of 23 predefined symptoms. Researchers used the Sheehan Disability Scale to gauge functional impairment.

A total of 11% participants reported at least one symptom that negatively affected work or social or home life at 8 months versus only 2% of the control group.

Seropositive participants were almost two times more likely to report that their long-term symptoms moderately to markedly disrupted their work life, 8% versus 4% of seronegative healthcare workers (relative risk, 1.8; 95%; confidence interval, 1.2-2.9).

Disruptions to a social life from long-term symptoms were 2.5 times more likely in the seropositive group. A total 15% of this cohort reported moderate to marked effects, compared with 6% of the seronegative group (RR, 2.5; 95% CI, 1.8-3.6).

The researchers also inquired about home life disruptions, which were reported by 12% of the seropositive health care workers and 5% of the seronegative participants (RR, 2.3; 95% CI, 1.6-3.4).

The study’s findings “tracks with a lot of the other work we’re seeing,” David Putrino, PT, PhD, director of rehabilitation innovation at Mount Sinai Health System in New York, said in an interview. He and his colleagues are responsible for managing the rehabilitation of patients with long COVID.

Interestingly, the proportion of people with persistent symptoms might be underestimated in this research, Dr. Putrino said. “Antibodies are not an entirely reliable biomarker. So what the researchers are using here is the most conservative measure of who may have had the virus.”

Potential recall bias and the subjective rating of symptoms were possible limitations of the study.

When asked to speculate why researchers did not find higher levels of cognitive dysfunction, Dr. Putrino said that self-reports are generally less reliable than measures like the Montreal Cognitive Assessment for detecting cognitive impairment.

Furthermore, unlike many of the people with long-haul COVID-19 whom he treats clinically – ones who are “really struggling” – the health care workers studied in Sweden are functioning well enough to perform their duties at the hospital, so the study population may not represent the population at large.
 

More research required

“More research needs to be conducted to investigate the mechanisms underlying these persistent symptoms, and several centers, including UCSF, are conducting research into why this might be,” Dr. Santhosh said.

Dr. Thålin and colleagues plan to continue following participants. “The primary aim of the COMMUNITY study is to investigate long-term immunity after COVID-19, but we will also look into possible underlying pathophysiological mechanisms behind COVID-19–related long-term symptoms,” she said.

“I hope to see that taste and smell will return,” Dr. Thålin added.

“We’re really just starting to understand the long-term effects of COVID-19,” Putrino said. “This is something we’re going to see a lot of moving forward.”

Dr. Thålin, Dr. Santhosh, Dr. Jolley, and Dr. Putrino disclosed no relevant financial relationships. The research was funded by grants from the Knut and Alice Wallenberg Foundation, Jonas and Christina af Jochnick Foundation, Leif Lundblad Family Foundation, Region Stockholm, and Erling-Persson Family Foundation.

A version of this article first appeared on Medscape.com.

Loss of smell, loss of taste, dyspnea, and fatigue are the four most common symptoms that health care professionals in Sweden report 8 months after mild COVID-19 illness, new evidence reveals.

Approximately 1 in 10 health care workers experience one or more moderate to severe symptoms that negatively affect their quality of life, according to the study.

Nenad Cavoski/Getty Images

“We see that a substantial portion of health care workers suffer from long-term symptoms after mild COVID-19,” senior author Charlotte Thålin, MD, PhD, said in an interview. She added that loss of smell and taste “may seem trivial, but have a negative impact on work, social, and home life in the long run.”

The study is noteworthy not only for tracking the COVID-19-related experiences of health care workers over time, but also for what it did not find. There was no increased prevalence of cognitive issues – including memory or concentration – that others have linked to what’s often called long-haul COVID-19.

The research letter was published online April 7, 2021, in JAMA.

“Even if you are young and previously healthy, a mild COVID-19 infection may result in long-term consequences,” said Dr. Thålin, from the department of clinical sciences at Danderyd Hospital, Karolinska Institute, Stockholm.

The researchers did not observe an increased risk for long-term symptoms after asymptomatic COVID-19.
 

Adding to existing evidence

This research letter “adds to the growing body of literature showing that people recovering from COVID have reported a diverse array of symptoms lasting for months after initial infection,” Lekshmi Santhosh, MD, said in an interview. She is physician faculty lead at the University of California, San Francisco Post-COVID OPTIMAL Clinic.

Previous research revealed severe long-term symptoms, including heart palpitations and neurologic impairments, among people hospitalized with COVID-19. However, “there is limited data on the long-term effects after mild COVID-19, and these studies are often hampered by selection bias and without proper control groups,” Dr. Thålin said.

The absence of these more severe symptoms after mild COVID-19 is “reassuring,” she added.

The current findings are part of the ongoing COMMUNITY (COVID-19 Biomarker and Immunity) study looking at long-term immunity. Health care professionals enrolled in the research between April 15 and May 8, 2020, and have initial blood tests repeated every 4 months.

Dr. Thålin, lead author Sebastian Havervall, MD, and their colleagues compared symptom reporting between 323 hospital employees who had mild COVID-19 at least 8 months earlier with 1,072 employees who did not have COVID-19 throughout the study.

The results show that 26% of those who had COVID-19 previously had at least one moderate to severe symptom that lasted more than 2 months, compared with 9% in the control group.

The group with a history of mild COVID-19 was a median 43 years old and 83% were women. The controls were a median 47 years old and 86% were women.

“These data mirror what we have seen across long-term cohorts of patients with COVID-19 infection. Notably, mild illness among previously healthy individuals may be associated with long-term persistent symptoms,” Sarah Jolley, MD, a pulmonologist specializing in critical care at the University of Colorado Hospital in Aurora and director of the Post-COVID Clinic, said in an interview.

“In this cohort, similar to others, this seems to be more pronounced in women,” Dr. Jolley added.
 

Key findings on functioning

At 8 months, using a smartphone app, participants reported presence, duration, and severity of 23 predefined symptoms. Researchers used the Sheehan Disability Scale to gauge functional impairment.

A total of 11% participants reported at least one symptom that negatively affected work or social or home life at 8 months versus only 2% of the control group.

Seropositive participants were almost two times more likely to report that their long-term symptoms moderately to markedly disrupted their work life, 8% versus 4% of seronegative healthcare workers (relative risk, 1.8; 95%; confidence interval, 1.2-2.9).

Disruptions to a social life from long-term symptoms were 2.5 times more likely in the seropositive group. A total 15% of this cohort reported moderate to marked effects, compared with 6% of the seronegative group (RR, 2.5; 95% CI, 1.8-3.6).

The researchers also inquired about home life disruptions, which were reported by 12% of the seropositive health care workers and 5% of the seronegative participants (RR, 2.3; 95% CI, 1.6-3.4).

The study’s findings “tracks with a lot of the other work we’re seeing,” David Putrino, PT, PhD, director of rehabilitation innovation at Mount Sinai Health System in New York, said in an interview. He and his colleagues are responsible for managing the rehabilitation of patients with long COVID.

Interestingly, the proportion of people with persistent symptoms might be underestimated in this research, Dr. Putrino said. “Antibodies are not an entirely reliable biomarker. So what the researchers are using here is the most conservative measure of who may have had the virus.”

Potential recall bias and the subjective rating of symptoms were possible limitations of the study.

When asked to speculate why researchers did not find higher levels of cognitive dysfunction, Dr. Putrino said that self-reports are generally less reliable than measures like the Montreal Cognitive Assessment for detecting cognitive impairment.

Furthermore, unlike many of the people with long-haul COVID-19 whom he treats clinically – ones who are “really struggling” – the health care workers studied in Sweden are functioning well enough to perform their duties at the hospital, so the study population may not represent the population at large.
 

More research required

“More research needs to be conducted to investigate the mechanisms underlying these persistent symptoms, and several centers, including UCSF, are conducting research into why this might be,” Dr. Santhosh said.

Dr. Thålin and colleagues plan to continue following participants. “The primary aim of the COMMUNITY study is to investigate long-term immunity after COVID-19, but we will also look into possible underlying pathophysiological mechanisms behind COVID-19–related long-term symptoms,” she said.

“I hope to see that taste and smell will return,” Dr. Thålin added.

“We’re really just starting to understand the long-term effects of COVID-19,” Putrino said. “This is something we’re going to see a lot of moving forward.”

Dr. Thålin, Dr. Santhosh, Dr. Jolley, and Dr. Putrino disclosed no relevant financial relationships. The research was funded by grants from the Knut and Alice Wallenberg Foundation, Jonas and Christina af Jochnick Foundation, Leif Lundblad Family Foundation, Region Stockholm, and Erling-Persson Family Foundation.

A version of this article first appeared on Medscape.com.

Loss of smell, loss of taste, dyspnea, and fatigue are the four most common symptoms that health care professionals in Sweden report 8 months after mild COVID-19 illness, new evidence reveals.

Approximately 1 in 10 health care workers experience one or more moderate to severe symptoms that negatively affect their quality of life, according to the study.

Nenad Cavoski/Getty Images

“We see that a substantial portion of health care workers suffer from long-term symptoms after mild COVID-19,” senior author Charlotte Thålin, MD, PhD, said in an interview. She added that loss of smell and taste “may seem trivial, but have a negative impact on work, social, and home life in the long run.”

The study is noteworthy not only for tracking the COVID-19-related experiences of health care workers over time, but also for what it did not find. There was no increased prevalence of cognitive issues – including memory or concentration – that others have linked to what’s often called long-haul COVID-19.

The research letter was published online April 7, 2021, in JAMA.

“Even if you are young and previously healthy, a mild COVID-19 infection may result in long-term consequences,” said Dr. Thålin, from the department of clinical sciences at Danderyd Hospital, Karolinska Institute, Stockholm.

The researchers did not observe an increased risk for long-term symptoms after asymptomatic COVID-19.
 

Adding to existing evidence

This research letter “adds to the growing body of literature showing that people recovering from COVID have reported a diverse array of symptoms lasting for months after initial infection,” Lekshmi Santhosh, MD, said in an interview. She is physician faculty lead at the University of California, San Francisco Post-COVID OPTIMAL Clinic.

Previous research revealed severe long-term symptoms, including heart palpitations and neurologic impairments, among people hospitalized with COVID-19. However, “there is limited data on the long-term effects after mild COVID-19, and these studies are often hampered by selection bias and without proper control groups,” Dr. Thålin said.

The absence of these more severe symptoms after mild COVID-19 is “reassuring,” she added.

The current findings are part of the ongoing COMMUNITY (COVID-19 Biomarker and Immunity) study looking at long-term immunity. Health care professionals enrolled in the research between April 15 and May 8, 2020, and have initial blood tests repeated every 4 months.

Dr. Thålin, lead author Sebastian Havervall, MD, and their colleagues compared symptom reporting between 323 hospital employees who had mild COVID-19 at least 8 months earlier with 1,072 employees who did not have COVID-19 throughout the study.

The results show that 26% of those who had COVID-19 previously had at least one moderate to severe symptom that lasted more than 2 months, compared with 9% in the control group.

The group with a history of mild COVID-19 was a median 43 years old and 83% were women. The controls were a median 47 years old and 86% were women.

“These data mirror what we have seen across long-term cohorts of patients with COVID-19 infection. Notably, mild illness among previously healthy individuals may be associated with long-term persistent symptoms,” Sarah Jolley, MD, a pulmonologist specializing in critical care at the University of Colorado Hospital in Aurora and director of the Post-COVID Clinic, said in an interview.

“In this cohort, similar to others, this seems to be more pronounced in women,” Dr. Jolley added.
 

Key findings on functioning

At 8 months, using a smartphone app, participants reported presence, duration, and severity of 23 predefined symptoms. Researchers used the Sheehan Disability Scale to gauge functional impairment.

A total of 11% participants reported at least one symptom that negatively affected work or social or home life at 8 months versus only 2% of the control group.

Seropositive participants were almost two times more likely to report that their long-term symptoms moderately to markedly disrupted their work life, 8% versus 4% of seronegative healthcare workers (relative risk, 1.8; 95%; confidence interval, 1.2-2.9).

Disruptions to a social life from long-term symptoms were 2.5 times more likely in the seropositive group. A total 15% of this cohort reported moderate to marked effects, compared with 6% of the seronegative group (RR, 2.5; 95% CI, 1.8-3.6).

The researchers also inquired about home life disruptions, which were reported by 12% of the seropositive health care workers and 5% of the seronegative participants (RR, 2.3; 95% CI, 1.6-3.4).

The study’s findings “tracks with a lot of the other work we’re seeing,” David Putrino, PT, PhD, director of rehabilitation innovation at Mount Sinai Health System in New York, said in an interview. He and his colleagues are responsible for managing the rehabilitation of patients with long COVID.

Interestingly, the proportion of people with persistent symptoms might be underestimated in this research, Dr. Putrino said. “Antibodies are not an entirely reliable biomarker. So what the researchers are using here is the most conservative measure of who may have had the virus.”

Potential recall bias and the subjective rating of symptoms were possible limitations of the study.

When asked to speculate why researchers did not find higher levels of cognitive dysfunction, Dr. Putrino said that self-reports are generally less reliable than measures like the Montreal Cognitive Assessment for detecting cognitive impairment.

Furthermore, unlike many of the people with long-haul COVID-19 whom he treats clinically – ones who are “really struggling” – the health care workers studied in Sweden are functioning well enough to perform their duties at the hospital, so the study population may not represent the population at large.
 

More research required

“More research needs to be conducted to investigate the mechanisms underlying these persistent symptoms, and several centers, including UCSF, are conducting research into why this might be,” Dr. Santhosh said.

Dr. Thålin and colleagues plan to continue following participants. “The primary aim of the COMMUNITY study is to investigate long-term immunity after COVID-19, but we will also look into possible underlying pathophysiological mechanisms behind COVID-19–related long-term symptoms,” she said.

“I hope to see that taste and smell will return,” Dr. Thålin added.

“We’re really just starting to understand the long-term effects of COVID-19,” Putrino said. “This is something we’re going to see a lot of moving forward.”

Dr. Thålin, Dr. Santhosh, Dr. Jolley, and Dr. Putrino disclosed no relevant financial relationships. The research was funded by grants from the Knut and Alice Wallenberg Foundation, Jonas and Christina af Jochnick Foundation, Leif Lundblad Family Foundation, Region Stockholm, and Erling-Persson Family Foundation.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has granted its first-ever approval of an artificial intelligence device to help find colon lesions during colonoscopy.

The GI Genius (Cosmo Artificial Intelligence) identifies areas of the colon where a colorectal polyp or tumor might be located. Clinicians then follow up with a closer examination and possible treatment.

“With the FDA’s authorization of this device today, clinicians now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise,” said Courtney H. Lias, PhD, acting director of the FDA’s gastrorenal, ob.gyn., general hospital, and urology devices office, in a media release.

The GI Genius consists of both hardware and software designed to work with an endoscope. It uses machine learning to recognize possible polyps during a colonoscopy. It marks these areas with green squares on the video generated by the endoscope’s camera and emits a short, low-volume sound. Clinicians decide if a lesion is truly present and whether to sample or remove such a lesion.

The device does not diagnose the lesions or recommend treatments and is not intended to take the place of laboratory sampling

The FDA based its approval on a trial in which 700 people aged 40-80 years underwent colonoscopies for colorectal cancer screening, surveillance, follow-up from positive results of a fecal occult blood test, or gastrointestinal symptoms of possible colon cancer.

Of these participants, 263 were being screened or surveilled every 3 years or more. The researchers randomly divided patients into a group of 136 who underwent white-light standard colonoscopy with the GI Genius, and 127 who underwent white-light standard colonoscopy without the GI Genius.

Using the GI Genius, clinicians identified adenomas or carcinomas that were later confirmed through lab results in 55.1% of patients. Without the GI Genius, the clinicians identified such lesions in 42.0% of patients.

The patients examined with the GI Genius received more biopsies, including slightly more that were not adenomas. But the biopsies did not lead to any adverse events such as perforations, infections, bleeding, or further biopsies.

More information on the GI Genius is available on the FDA website.

A version of this article first appeared on Medscape.com .

The Food and Drug Administration has granted its first-ever approval of an artificial intelligence device to help find colon lesions during colonoscopy.

The GI Genius (Cosmo Artificial Intelligence) identifies areas of the colon where a colorectal polyp or tumor might be located. Clinicians then follow up with a closer examination and possible treatment.

“With the FDA’s authorization of this device today, clinicians now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise,” said Courtney H. Lias, PhD, acting director of the FDA’s gastrorenal, ob.gyn., general hospital, and urology devices office, in a media release.

The GI Genius consists of both hardware and software designed to work with an endoscope. It uses machine learning to recognize possible polyps during a colonoscopy. It marks these areas with green squares on the video generated by the endoscope’s camera and emits a short, low-volume sound. Clinicians decide if a lesion is truly present and whether to sample or remove such a lesion.

The device does not diagnose the lesions or recommend treatments and is not intended to take the place of laboratory sampling

The FDA based its approval on a trial in which 700 people aged 40-80 years underwent colonoscopies for colorectal cancer screening, surveillance, follow-up from positive results of a fecal occult blood test, or gastrointestinal symptoms of possible colon cancer.

Of these participants, 263 were being screened or surveilled every 3 years or more. The researchers randomly divided patients into a group of 136 who underwent white-light standard colonoscopy with the GI Genius, and 127 who underwent white-light standard colonoscopy without the GI Genius.

Using the GI Genius, clinicians identified adenomas or carcinomas that were later confirmed through lab results in 55.1% of patients. Without the GI Genius, the clinicians identified such lesions in 42.0% of patients.

The patients examined with the GI Genius received more biopsies, including slightly more that were not adenomas. But the biopsies did not lead to any adverse events such as perforations, infections, bleeding, or further biopsies.

More information on the GI Genius is available on the FDA website.

A version of this article first appeared on Medscape.com .

The Food and Drug Administration has granted its first-ever approval of an artificial intelligence device to help find colon lesions during colonoscopy.

The GI Genius (Cosmo Artificial Intelligence) identifies areas of the colon where a colorectal polyp or tumor might be located. Clinicians then follow up with a closer examination and possible treatment.

“With the FDA’s authorization of this device today, clinicians now have a tool that could help improve their ability to detect gastrointestinal lesions they may have missed otherwise,” said Courtney H. Lias, PhD, acting director of the FDA’s gastrorenal, ob.gyn., general hospital, and urology devices office, in a media release.

The GI Genius consists of both hardware and software designed to work with an endoscope. It uses machine learning to recognize possible polyps during a colonoscopy. It marks these areas with green squares on the video generated by the endoscope’s camera and emits a short, low-volume sound. Clinicians decide if a lesion is truly present and whether to sample or remove such a lesion.

The device does not diagnose the lesions or recommend treatments and is not intended to take the place of laboratory sampling

The FDA based its approval on a trial in which 700 people aged 40-80 years underwent colonoscopies for colorectal cancer screening, surveillance, follow-up from positive results of a fecal occult blood test, or gastrointestinal symptoms of possible colon cancer.

Of these participants, 263 were being screened or surveilled every 3 years or more. The researchers randomly divided patients into a group of 136 who underwent white-light standard colonoscopy with the GI Genius, and 127 who underwent white-light standard colonoscopy without the GI Genius.

Using the GI Genius, clinicians identified adenomas or carcinomas that were later confirmed through lab results in 55.1% of patients. Without the GI Genius, the clinicians identified such lesions in 42.0% of patients.

The patients examined with the GI Genius received more biopsies, including slightly more that were not adenomas. But the biopsies did not lead to any adverse events such as perforations, infections, bleeding, or further biopsies.

More information on the GI Genius is available on the FDA website.

A version of this article first appeared on Medscape.com .

The early halt of a phase 3 trial of avelumab plus chemoradiotherapy for the treatment of squamous cell head and neck cancer raises a question: Does combining a checkpoint inhibitor with chemoradiotherapy hurt patients?

The JAVELIN Head and Neck 100 trial randomly assigned 697 patients who had already undergone chemoradiotherapy for locally advanced, untreated disease to receive either avelumab or placebo.

This was the first phase 3 trial in which an immune checkpoint inhibitor was given concurrently with radiotherapy in addition to chemotherapy for any indication, noted the researchers. Checkpoint inhibitors have proved effective for recurrent or metastatic disease after standard options have failed. The current trial was one of the few trials to combine a checkpoint inhibitor with standard-of-care treatment in the first-line setting.

Not only did avelumab fail to improve outcomes, but there was also a trend for better progression-free survival (PFS) in the placebo arm, suggesting that avelumab may have had an “antagonistic effect,” the team reports.

Although not statistically significant, survival curves separated in favor of placebo. There was no obvious explanation for what happened, said lead investigator Nancy Lee, MD, of Memorial Sloan Kettering Cancer Center, New York.

“Be very careful when you are thinking about immunotherapy with fractionated radiotherapy,” Dr. Lee said in an interview.

The trial was terminated early for futility. The results were published online in The Lancet Oncology.
 

Possible detrimental effect?

The trial was conducted in patients with locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity. Overall, 66% of patients had human papillomavirus (HPV)–negative disease, which is associated with poorer prognosis. The rest had HPV-positive disease.

Participants received either avelumab at 10 mg/kg intravenously or placebo along with cisplatin every 3 weeks and 70 Gy of intensity-modulated radiotherapy delivered in 35 fractions during the 9-week concurrent chemoradiotherapy phase of the trial. This was followed by avelumab or placebo maintenance for up to 12 months.

At a median follow-up of almost 15 months, the median PFS was not reached in the avelumab arm (118 events; 95% confidence interval, 16.9 months – not estimable) or in the placebo arm (106 events; 95% CI, 23 months – not estimable).

There was a hint of PFS benefit in a subgroup of 36 patients with tumors showing high PD-LI expression who were taking avelumab.

However, the overall results show that PFS (hazard ratio [HR], 1.21; 95% CI, .93-1.57; P = .920) and overall survival (HR, 1.31; 95% CI, 0.93–1.85; P = .937) trended in favor of placebo.

The findings cannot be explained by increased toxicity in the avelumab arm because there were no substantial safety differences in comparison with placebo, the researchers said.

Concurrent chemotherapy was probably not a problem either. There are robust data on the use of avelumab and other checkpoint inhibitors in combination with chemotherapy for numerous oncology indications. Two such drugs – pembrolizumab and nivolumab – are approved for recurrent or metastatic squamous cell head and neck cancer in combination with chemotherapy.

Dr. Lee suspects the findings could be due to a previously unrecognized negative interaction between avelumab and the high-volume fractionated radiotherapy used for locally advanced head and neck cancer.

“With chemoradiotherapy, we are killing T cells, but we are curing patients. What’s weird is why, when we combine it with immunotherapy, it looks like there’s a detrimental effect. That’s the mystery. We are looking [at tissue samples] to find out mechanistically or biologically why we saw what we saw,” she said.
 

Results from similar study eagerly awaited

A nearly identical phase 3 trial is underway. The KEYNOTE-412 trial is investigating the addition of pembrolizumab to chemoradiotherapy in the first-line treatment of locally advanced squamous cell head and neck cancer.

If this study also suggests worse survival with the immune checkpoint inhibitor, it’s unlikely there was something specific about avelumab that accounts for the JAVELIN findings, and “we can say we shouldn’t consider using immunotherapy with radiation at all,” Dr. Lee said.

“It could be that there is a detrimental effect of the combination of checkpoint inhibitors with definitive radiotherapy,” said Sjoukje Oosting, MD, PhD, medical oncologist at University Medical Center Groningen, the Netherlands. She was commenting after the JAVELIN results with avelumab were presented at a conference last year and said she now “eagerly awaits” the results with pembrolizumab.

For the time being, Dr. Lee said, “We have to be cautious.” Checkpoint inhibitors might still prove useful in some relationship to first-line chemoradiotherapy.

Studies are underway. One trial is investigating the adjuvant use of immunotherapy after upfront chemoradiotherapy for head and neck cancer.

The JAVELIN trial of avelumab was funded by Pfizer and Merck. The KEYNOTE-412 trial of pembrolizumab is funded by Merck. Dr. Lee is an adviser for and has received research funding from both companies. Dr. Oosting has received research grants from Celldex and Novartis.

A version of this article first appeared on Medscape.com.

The early halt of a phase 3 trial of avelumab plus chemoradiotherapy for the treatment of squamous cell head and neck cancer raises a question: Does combining a checkpoint inhibitor with chemoradiotherapy hurt patients?

The JAVELIN Head and Neck 100 trial randomly assigned 697 patients who had already undergone chemoradiotherapy for locally advanced, untreated disease to receive either avelumab or placebo.

This was the first phase 3 trial in which an immune checkpoint inhibitor was given concurrently with radiotherapy in addition to chemotherapy for any indication, noted the researchers. Checkpoint inhibitors have proved effective for recurrent or metastatic disease after standard options have failed. The current trial was one of the few trials to combine a checkpoint inhibitor with standard-of-care treatment in the first-line setting.

Not only did avelumab fail to improve outcomes, but there was also a trend for better progression-free survival (PFS) in the placebo arm, suggesting that avelumab may have had an “antagonistic effect,” the team reports.

Although not statistically significant, survival curves separated in favor of placebo. There was no obvious explanation for what happened, said lead investigator Nancy Lee, MD, of Memorial Sloan Kettering Cancer Center, New York.

“Be very careful when you are thinking about immunotherapy with fractionated radiotherapy,” Dr. Lee said in an interview.

The trial was terminated early for futility. The results were published online in The Lancet Oncology.
 

Possible detrimental effect?

The trial was conducted in patients with locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity. Overall, 66% of patients had human papillomavirus (HPV)–negative disease, which is associated with poorer prognosis. The rest had HPV-positive disease.

Participants received either avelumab at 10 mg/kg intravenously or placebo along with cisplatin every 3 weeks and 70 Gy of intensity-modulated radiotherapy delivered in 35 fractions during the 9-week concurrent chemoradiotherapy phase of the trial. This was followed by avelumab or placebo maintenance for up to 12 months.

At a median follow-up of almost 15 months, the median PFS was not reached in the avelumab arm (118 events; 95% confidence interval, 16.9 months – not estimable) or in the placebo arm (106 events; 95% CI, 23 months – not estimable).

There was a hint of PFS benefit in a subgroup of 36 patients with tumors showing high PD-LI expression who were taking avelumab.

However, the overall results show that PFS (hazard ratio [HR], 1.21; 95% CI, .93-1.57; P = .920) and overall survival (HR, 1.31; 95% CI, 0.93–1.85; P = .937) trended in favor of placebo.

The findings cannot be explained by increased toxicity in the avelumab arm because there were no substantial safety differences in comparison with placebo, the researchers said.

Concurrent chemotherapy was probably not a problem either. There are robust data on the use of avelumab and other checkpoint inhibitors in combination with chemotherapy for numerous oncology indications. Two such drugs – pembrolizumab and nivolumab – are approved for recurrent or metastatic squamous cell head and neck cancer in combination with chemotherapy.

Dr. Lee suspects the findings could be due to a previously unrecognized negative interaction between avelumab and the high-volume fractionated radiotherapy used for locally advanced head and neck cancer.

“With chemoradiotherapy, we are killing T cells, but we are curing patients. What’s weird is why, when we combine it with immunotherapy, it looks like there’s a detrimental effect. That’s the mystery. We are looking [at tissue samples] to find out mechanistically or biologically why we saw what we saw,” she said.
 

Results from similar study eagerly awaited

A nearly identical phase 3 trial is underway. The KEYNOTE-412 trial is investigating the addition of pembrolizumab to chemoradiotherapy in the first-line treatment of locally advanced squamous cell head and neck cancer.

If this study also suggests worse survival with the immune checkpoint inhibitor, it’s unlikely there was something specific about avelumab that accounts for the JAVELIN findings, and “we can say we shouldn’t consider using immunotherapy with radiation at all,” Dr. Lee said.

“It could be that there is a detrimental effect of the combination of checkpoint inhibitors with definitive radiotherapy,” said Sjoukje Oosting, MD, PhD, medical oncologist at University Medical Center Groningen, the Netherlands. She was commenting after the JAVELIN results with avelumab were presented at a conference last year and said she now “eagerly awaits” the results with pembrolizumab.

For the time being, Dr. Lee said, “We have to be cautious.” Checkpoint inhibitors might still prove useful in some relationship to first-line chemoradiotherapy.

Studies are underway. One trial is investigating the adjuvant use of immunotherapy after upfront chemoradiotherapy for head and neck cancer.

The JAVELIN trial of avelumab was funded by Pfizer and Merck. The KEYNOTE-412 trial of pembrolizumab is funded by Merck. Dr. Lee is an adviser for and has received research funding from both companies. Dr. Oosting has received research grants from Celldex and Novartis.

A version of this article first appeared on Medscape.com.

The early halt of a phase 3 trial of avelumab plus chemoradiotherapy for the treatment of squamous cell head and neck cancer raises a question: Does combining a checkpoint inhibitor with chemoradiotherapy hurt patients?

The JAVELIN Head and Neck 100 trial randomly assigned 697 patients who had already undergone chemoradiotherapy for locally advanced, untreated disease to receive either avelumab or placebo.

This was the first phase 3 trial in which an immune checkpoint inhibitor was given concurrently with radiotherapy in addition to chemotherapy for any indication, noted the researchers. Checkpoint inhibitors have proved effective for recurrent or metastatic disease after standard options have failed. The current trial was one of the few trials to combine a checkpoint inhibitor with standard-of-care treatment in the first-line setting.

Not only did avelumab fail to improve outcomes, but there was also a trend for better progression-free survival (PFS) in the placebo arm, suggesting that avelumab may have had an “antagonistic effect,” the team reports.

Although not statistically significant, survival curves separated in favor of placebo. There was no obvious explanation for what happened, said lead investigator Nancy Lee, MD, of Memorial Sloan Kettering Cancer Center, New York.

“Be very careful when you are thinking about immunotherapy with fractionated radiotherapy,” Dr. Lee said in an interview.

The trial was terminated early for futility. The results were published online in The Lancet Oncology.
 

Possible detrimental effect?

The trial was conducted in patients with locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity. Overall, 66% of patients had human papillomavirus (HPV)–negative disease, which is associated with poorer prognosis. The rest had HPV-positive disease.

Participants received either avelumab at 10 mg/kg intravenously or placebo along with cisplatin every 3 weeks and 70 Gy of intensity-modulated radiotherapy delivered in 35 fractions during the 9-week concurrent chemoradiotherapy phase of the trial. This was followed by avelumab or placebo maintenance for up to 12 months.

At a median follow-up of almost 15 months, the median PFS was not reached in the avelumab arm (118 events; 95% confidence interval, 16.9 months – not estimable) or in the placebo arm (106 events; 95% CI, 23 months – not estimable).

There was a hint of PFS benefit in a subgroup of 36 patients with tumors showing high PD-LI expression who were taking avelumab.

However, the overall results show that PFS (hazard ratio [HR], 1.21; 95% CI, .93-1.57; P = .920) and overall survival (HR, 1.31; 95% CI, 0.93–1.85; P = .937) trended in favor of placebo.

The findings cannot be explained by increased toxicity in the avelumab arm because there were no substantial safety differences in comparison with placebo, the researchers said.

Concurrent chemotherapy was probably not a problem either. There are robust data on the use of avelumab and other checkpoint inhibitors in combination with chemotherapy for numerous oncology indications. Two such drugs – pembrolizumab and nivolumab – are approved for recurrent or metastatic squamous cell head and neck cancer in combination with chemotherapy.

Dr. Lee suspects the findings could be due to a previously unrecognized negative interaction between avelumab and the high-volume fractionated radiotherapy used for locally advanced head and neck cancer.

“With chemoradiotherapy, we are killing T cells, but we are curing patients. What’s weird is why, when we combine it with immunotherapy, it looks like there’s a detrimental effect. That’s the mystery. We are looking [at tissue samples] to find out mechanistically or biologically why we saw what we saw,” she said.
 

Results from similar study eagerly awaited

A nearly identical phase 3 trial is underway. The KEYNOTE-412 trial is investigating the addition of pembrolizumab to chemoradiotherapy in the first-line treatment of locally advanced squamous cell head and neck cancer.

If this study also suggests worse survival with the immune checkpoint inhibitor, it’s unlikely there was something specific about avelumab that accounts for the JAVELIN findings, and “we can say we shouldn’t consider using immunotherapy with radiation at all,” Dr. Lee said.

“It could be that there is a detrimental effect of the combination of checkpoint inhibitors with definitive radiotherapy,” said Sjoukje Oosting, MD, PhD, medical oncologist at University Medical Center Groningen, the Netherlands. She was commenting after the JAVELIN results with avelumab were presented at a conference last year and said she now “eagerly awaits” the results with pembrolizumab.

For the time being, Dr. Lee said, “We have to be cautious.” Checkpoint inhibitors might still prove useful in some relationship to first-line chemoradiotherapy.

Studies are underway. One trial is investigating the adjuvant use of immunotherapy after upfront chemoradiotherapy for head and neck cancer.

The JAVELIN trial of avelumab was funded by Pfizer and Merck. The KEYNOTE-412 trial of pembrolizumab is funded by Merck. Dr. Lee is an adviser for and has received research funding from both companies. Dr. Oosting has received research grants from Celldex and Novartis.

A version of this article first appeared on Medscape.com.

Unlike high-risk adenomas (HRAs), low-risk adenomas (LRAs) have a minimal association with risk of metachronous colorectal cancer (CRC), and no relationship with odds of metachronous CRC-related mortality, according to a meta-analysis of more than 500,000 individuals.

These findings should impact surveillance guidelines and make follow-up the same for individuals with LRAs or no adenomas, reported lead author Abhiram Duvvuri, MD, of the division of gastroenterology and hepatology at the University of Kansas, Kansas City, and colleagues. Currently, the United States Multi-Society Task Force on Colorectal Cancer advises colonoscopy intervals of 3 years for individuals with HRAs, 7-10 years for those with LRAs, and 10 years for those without adenomas.

“The evidence supporting these surveillance recommendations for clinically relevant endpoints such as cancer and cancer-related deaths among patients who undergo adenoma removal, particularly LRA, is minimal, because most of the evidence was based on the surrogate risk of metachronous advanced neoplasia,” the investigators wrote in Gastroenterology.

To provide more solid evidence, the investigators performed a systematic review and meta-analysis, ultimately analyzing 12 studies with data from 510,019 individuals at a mean age of 59.2 years. All studies reported rates of LRA, HRA, or no adenoma at baseline colonoscopy, plus incidence of metachronous CRC and/or CRC-related mortality. With these data, the investigators determined incidence of metachronous CRC and CRC-related mortality for each of the adenoma groups and also compared these incidences per 10,000 person-years of follow-up across groups.

After a mean follow-up of 8.5 years, patients with HRAs had a significantly higher rate of CRC compared with patients who had LRAs (13.81 vs. 4.5; odds ratio, 2.35; 95% confidence interval, 1.72-3.20) or no adenomas (13.81 vs. 3.4; OR, 2.92; 95% CI, 2.31-3.69). Similarly, but to a lesser degree, LRAs were associated with significantly greater risk of CRC than that of no adenomas (4.5 vs. 3.4; OR, 1.26; 95% CI, 1.06-1.51).

Data on CRC- related mortality further supported these minimal risk profiles because LRAs did not significantly increase the risk of CRC-related mortality compared with no adenomas (OR, 1.15; 95% CI, 0.76-1.74). In contrast, HRAs were associated with significantly greater risk of CRC-related death than that of both LRAs (OR, 2.48; 95% CI, 1.30-4.75) and no adenomas (OR, 2.69; 95% CI, 1.87-3.87).

The investigators acknowledged certain limitations of their study. For one, there were no randomized controlled trials in the meta-analysis, which can introduce bias. Loss of patients to follow-up is also possible; however, the investigators noted that there was a robust sample of patients available for study outcomes all the same. There is also risk of comparability bias in that HRA and LRA groups underwent more colonoscopies; however, the duration of follow-up and timing of last colonoscopy were similar among groups. Lastly, it’s possible the patient sample wasn’t representative because of healthy screenee bias, but the investigators compared groups against general population to minimize that bias.

The investigators also highlighted several strengths of their study that make their findings more reliable than those of past meta-analyses. For one, their study is the largest of its kind to date, and involved a significantly higher number of patients with LRA and no adenomas. Also, in contrast with previous studies, CRC and CRC-related mortality were evaluated rather than advanced adenomas, they noted.

“Furthermore, we also analyzed CRC incidence and mortality in the LRA group compared with the general population, with the [standardized incidence ratio] being lower and [standardized mortality ratio] being comparable, confirming that it is indeed a low-risk group,” they wrote.

Considering these strengths and the nature of their findings, Dr. Duvvuri and colleagues called for a more conservative approach to CRC surveillance among individuals with LRAs, and more research to investigate extending colonoscopy intervals even further.

“We recommend that the interval for follow-up colonoscopy should be the same in patients with LRAs or no adenomas but that the HRA group should have a more frequent surveillance interval for CRC surveillance compared with these groups,” they concluded. “Future studies should evaluate whether surveillance intervals could be lengthened beyond 10 years in the no-adenoma and LRA groups after an initial high-quality index colonoscopy.”

One author disclosed affiliations with Erbe, Cdx Labs, Aries, and others. Dr. Duvvuri and the remaining authors disclosed no conflicts.

Unlike high-risk adenomas (HRAs), low-risk adenomas (LRAs) have a minimal association with risk of metachronous colorectal cancer (CRC), and no relationship with odds of metachronous CRC-related mortality, according to a meta-analysis of more than 500,000 individuals.

These findings should impact surveillance guidelines and make follow-up the same for individuals with LRAs or no adenomas, reported lead author Abhiram Duvvuri, MD, of the division of gastroenterology and hepatology at the University of Kansas, Kansas City, and colleagues. Currently, the United States Multi-Society Task Force on Colorectal Cancer advises colonoscopy intervals of 3 years for individuals with HRAs, 7-10 years for those with LRAs, and 10 years for those without adenomas.

“The evidence supporting these surveillance recommendations for clinically relevant endpoints such as cancer and cancer-related deaths among patients who undergo adenoma removal, particularly LRA, is minimal, because most of the evidence was based on the surrogate risk of metachronous advanced neoplasia,” the investigators wrote in Gastroenterology.

To provide more solid evidence, the investigators performed a systematic review and meta-analysis, ultimately analyzing 12 studies with data from 510,019 individuals at a mean age of 59.2 years. All studies reported rates of LRA, HRA, or no adenoma at baseline colonoscopy, plus incidence of metachronous CRC and/or CRC-related mortality. With these data, the investigators determined incidence of metachronous CRC and CRC-related mortality for each of the adenoma groups and also compared these incidences per 10,000 person-years of follow-up across groups.

After a mean follow-up of 8.5 years, patients with HRAs had a significantly higher rate of CRC compared with patients who had LRAs (13.81 vs. 4.5; odds ratio, 2.35; 95% confidence interval, 1.72-3.20) or no adenomas (13.81 vs. 3.4; OR, 2.92; 95% CI, 2.31-3.69). Similarly, but to a lesser degree, LRAs were associated with significantly greater risk of CRC than that of no adenomas (4.5 vs. 3.4; OR, 1.26; 95% CI, 1.06-1.51).

Data on CRC- related mortality further supported these minimal risk profiles because LRAs did not significantly increase the risk of CRC-related mortality compared with no adenomas (OR, 1.15; 95% CI, 0.76-1.74). In contrast, HRAs were associated with significantly greater risk of CRC-related death than that of both LRAs (OR, 2.48; 95% CI, 1.30-4.75) and no adenomas (OR, 2.69; 95% CI, 1.87-3.87).

The investigators acknowledged certain limitations of their study. For one, there were no randomized controlled trials in the meta-analysis, which can introduce bias. Loss of patients to follow-up is also possible; however, the investigators noted that there was a robust sample of patients available for study outcomes all the same. There is also risk of comparability bias in that HRA and LRA groups underwent more colonoscopies; however, the duration of follow-up and timing of last colonoscopy were similar among groups. Lastly, it’s possible the patient sample wasn’t representative because of healthy screenee bias, but the investigators compared groups against general population to minimize that bias.

The investigators also highlighted several strengths of their study that make their findings more reliable than those of past meta-analyses. For one, their study is the largest of its kind to date, and involved a significantly higher number of patients with LRA and no adenomas. Also, in contrast with previous studies, CRC and CRC-related mortality were evaluated rather than advanced adenomas, they noted.

“Furthermore, we also analyzed CRC incidence and mortality in the LRA group compared with the general population, with the [standardized incidence ratio] being lower and [standardized mortality ratio] being comparable, confirming that it is indeed a low-risk group,” they wrote.

Considering these strengths and the nature of their findings, Dr. Duvvuri and colleagues called for a more conservative approach to CRC surveillance among individuals with LRAs, and more research to investigate extending colonoscopy intervals even further.

“We recommend that the interval for follow-up colonoscopy should be the same in patients with LRAs or no adenomas but that the HRA group should have a more frequent surveillance interval for CRC surveillance compared with these groups,” they concluded. “Future studies should evaluate whether surveillance intervals could be lengthened beyond 10 years in the no-adenoma and LRA groups after an initial high-quality index colonoscopy.”

One author disclosed affiliations with Erbe, Cdx Labs, Aries, and others. Dr. Duvvuri and the remaining authors disclosed no conflicts.

Unlike high-risk adenomas (HRAs), low-risk adenomas (LRAs) have a minimal association with risk of metachronous colorectal cancer (CRC), and no relationship with odds of metachronous CRC-related mortality, according to a meta-analysis of more than 500,000 individuals.

These findings should impact surveillance guidelines and make follow-up the same for individuals with LRAs or no adenomas, reported lead author Abhiram Duvvuri, MD, of the division of gastroenterology and hepatology at the University of Kansas, Kansas City, and colleagues. Currently, the United States Multi-Society Task Force on Colorectal Cancer advises colonoscopy intervals of 3 years for individuals with HRAs, 7-10 years for those with LRAs, and 10 years for those without adenomas.

“The evidence supporting these surveillance recommendations for clinically relevant endpoints such as cancer and cancer-related deaths among patients who undergo adenoma removal, particularly LRA, is minimal, because most of the evidence was based on the surrogate risk of metachronous advanced neoplasia,” the investigators wrote in Gastroenterology.

To provide more solid evidence, the investigators performed a systematic review and meta-analysis, ultimately analyzing 12 studies with data from 510,019 individuals at a mean age of 59.2 years. All studies reported rates of LRA, HRA, or no adenoma at baseline colonoscopy, plus incidence of metachronous CRC and/or CRC-related mortality. With these data, the investigators determined incidence of metachronous CRC and CRC-related mortality for each of the adenoma groups and also compared these incidences per 10,000 person-years of follow-up across groups.

After a mean follow-up of 8.5 years, patients with HRAs had a significantly higher rate of CRC compared with patients who had LRAs (13.81 vs. 4.5; odds ratio, 2.35; 95% confidence interval, 1.72-3.20) or no adenomas (13.81 vs. 3.4; OR, 2.92; 95% CI, 2.31-3.69). Similarly, but to a lesser degree, LRAs were associated with significantly greater risk of CRC than that of no adenomas (4.5 vs. 3.4; OR, 1.26; 95% CI, 1.06-1.51).

Data on CRC- related mortality further supported these minimal risk profiles because LRAs did not significantly increase the risk of CRC-related mortality compared with no adenomas (OR, 1.15; 95% CI, 0.76-1.74). In contrast, HRAs were associated with significantly greater risk of CRC-related death than that of both LRAs (OR, 2.48; 95% CI, 1.30-4.75) and no adenomas (OR, 2.69; 95% CI, 1.87-3.87).

The investigators acknowledged certain limitations of their study. For one, there were no randomized controlled trials in the meta-analysis, which can introduce bias. Loss of patients to follow-up is also possible; however, the investigators noted that there was a robust sample of patients available for study outcomes all the same. There is also risk of comparability bias in that HRA and LRA groups underwent more colonoscopies; however, the duration of follow-up and timing of last colonoscopy were similar among groups. Lastly, it’s possible the patient sample wasn’t representative because of healthy screenee bias, but the investigators compared groups against general population to minimize that bias.

The investigators also highlighted several strengths of their study that make their findings more reliable than those of past meta-analyses. For one, their study is the largest of its kind to date, and involved a significantly higher number of patients with LRA and no adenomas. Also, in contrast with previous studies, CRC and CRC-related mortality were evaluated rather than advanced adenomas, they noted.

“Furthermore, we also analyzed CRC incidence and mortality in the LRA group compared with the general population, with the [standardized incidence ratio] being lower and [standardized mortality ratio] being comparable, confirming that it is indeed a low-risk group,” they wrote.

Considering these strengths and the nature of their findings, Dr. Duvvuri and colleagues called for a more conservative approach to CRC surveillance among individuals with LRAs, and more research to investigate extending colonoscopy intervals even further.

“We recommend that the interval for follow-up colonoscopy should be the same in patients with LRAs or no adenomas but that the HRA group should have a more frequent surveillance interval for CRC surveillance compared with these groups,” they concluded. “Future studies should evaluate whether surveillance intervals could be lengthened beyond 10 years in the no-adenoma and LRA groups after an initial high-quality index colonoscopy.”

One author disclosed affiliations with Erbe, Cdx Labs, Aries, and others. Dr. Duvvuri and the remaining authors disclosed no conflicts.

Each afternoon, Cyrus Shahpar, MD, the data guru for the White House COVID-19 Response Team, sends an email to staffers with the daily count of COVID-19 vaccinations delivered in the United States.

The numbers, collected from states ahead of the final figures being posted on the Centers for Disease Control and Prevention website, act as a report card of sorts on the team’s efforts.

On Saturday, April 3, it was a new record: 4.1 million vaccinations delivered in a single day, more than the total population of some states.

While the United States has a long way to go before it is done with COVID-19, there’s finally some good news in the nation’s long and blundering slog through the pandemic.

After a rocky start in December 2020 and January 2021, vaccination is happening faster than nearly anyone thought possible. As more people see their friends and family roll up their sleeves, hesitancy is dropping, too.

In settings where large numbers of people are vaccinated, such as nursing homes, COVID-19 cases and deaths have plunged.

Those gains, however, haven’t been shared equally. According to CDC data, 69% of people who are fully vaccinated are White, while just 8% are Black and about 9% are Hispanic, a group that now represents most new COVID-19 cases. 

Officials say that’s partly because the vaccines were rolled out to the elderly first. The average life expectancy for Black people in the United States is now age 72, which means there were fewer people of color represented in the first groups to become eligible. Experts are hopeful that underrepresented groups will start to catch up as more states open up vaccinations to younger people.

Based on overall numbers of daily vaccine doses, the United States ranks third, behind China and India. America ranks fourth – behind Israel, the United Kingdom, and Chile – in the total share of the population that’s been vaccinated, according to the website Our World in Data.
 

A positive development

It’s a stunning turnaround for a country that failed for months to develop effective tests, and still struggles in some quarters to investigate new cases and quarantine their contacts.

The 7-day rolling average of vaccines administered in the United States is currently more than 3 million a day.

“We knew that we needed to get to 3 million a day at some point, if we were going to get most people vaccinated this year, but I don’t think that most people expected it to happen this early,” said Eric Toner, MD, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore.

Before taking office, President Joe Biden pledged to get 100 million shots in arms within his first 100 days in office. After hitting that goal in late March, he doubled it, to 200 million vaccinations by April 30. After first saying all adults should be eligible to get in line for the vaccine by May 1, on April 6, he bumped up that date to April 19. 

Some media reports have seen this repeated moving of the goalposts as calculated – an unstated strategy of underpromising and overdelivering with the aim of rebuilding public trust.

But others pointed out that, even if that’s true, the goals being set aren’t easy, and hitting them has never been a given.

“I think the Biden administration really gets a lot of credit for pushing the companies to get more vaccine out faster than they had planned to,” Dr. Toner said. “And the states have really responded as well as the federal government in terms of getting vaccination sites going. So we’re not only getting the vaccines, we’re getting it into people’s arms faster than expected.”

Others agree.

“We’re doing an amazing job, and I think the U.S. is really beginning to bend the curve,” said Carlos del Rio, MD, an infectious disease specialist and distinguished professor of medicine at Emory University, Atlanta.

“I think overall it’s just that everybody’s putting in a ton of work to get it done,” he said.

On April 3, the day the United States hit its vaccination record, he was volunteering to give vaccinations.

“I mean, of all the bad things we do to people as clinicians, this is one thing that people are very happy about, right?” Dr. del Rio said.

He said he vaccinated a young woman who asked if she could video chat with her mom, who was feeling nervous about getting the shot. He answered her mom’s questions, and later that day, she came down to be vaccinated herself.
 

‘We view it as a war’

The White House COVID-19 Response Team has worked hard to better coordinate the work of so many people at both the federal and state levels, Andy Slavitt, senior adviser for the team, said in an interview.

“We view it as a war, and in a war, you do everything: You bring experienced personnel; you bring all the resources to bear; you create multiple routes,” Mr. Slavitt said. “You don’t leave anything to chance.”

Among the levers the administration has pulled, using the Defense Production Act has helped vaccine manufacturers get needed supplies, Mr. Slavitt said.

The administration has set up an array of Federal Emergency Management Agency–run community vaccination centers and mobile vaccination sites to complement state-led efforts, and it’s activated a federal health law called the Public Readiness and Emergency Preparedness Act, which provides immunity from liability for retired doctors and nurses, among others, who sign up to help give vaccinations. That’s helped get more people into the field giving shots. 

The administration also canceled a plan to allocate vaccines to states based on their pace of administration, which would have punished underperforming states. Instead, doses are allocated based on population. 

In a media call on April 7, when asked whether the administration would send additional vaccines to Michigan, a state that’s seeing a surge of COVID-19 cases with more transmissible variants, Mr. Slavitt said they weren’t managing vaccine supply “according to some formula.”

He said they were distributing based on population “because that’s fundamental,” but were also locating vaccines “surgically in places that have had the greatest disease and where people have the greatest exposure.”

He said sites like community health centers and retail pharmacies have the power to order vaccines directly from the federal government, which helps get more supply to harder-hit areas.

Mr. Slavitt said hitting 4.1 million daily vaccinations on April 3 was gratifying.

“I’ve seen photographs ... of people breaking down in tears when they get their vaccine, people who are giving standing ovations to active military for taking care of them,” he said, “and I think about people who have gone for a long time without hope, or who have been very scared.

“It’s incredibly encouraging to think about maybe a few million people taking a step back to normal life again,” he said.

A version of this article first appeared on Medscape.com.

Each afternoon, Cyrus Shahpar, MD, the data guru for the White House COVID-19 Response Team, sends an email to staffers with the daily count of COVID-19 vaccinations delivered in the United States.

The numbers, collected from states ahead of the final figures being posted on the Centers for Disease Control and Prevention website, act as a report card of sorts on the team’s efforts.

On Saturday, April 3, it was a new record: 4.1 million vaccinations delivered in a single day, more than the total population of some states.

While the United States has a long way to go before it is done with COVID-19, there’s finally some good news in the nation’s long and blundering slog through the pandemic.

After a rocky start in December 2020 and January 2021, vaccination is happening faster than nearly anyone thought possible. As more people see their friends and family roll up their sleeves, hesitancy is dropping, too.

In settings where large numbers of people are vaccinated, such as nursing homes, COVID-19 cases and deaths have plunged.

Those gains, however, haven’t been shared equally. According to CDC data, 69% of people who are fully vaccinated are White, while just 8% are Black and about 9% are Hispanic, a group that now represents most new COVID-19 cases. 

Officials say that’s partly because the vaccines were rolled out to the elderly first. The average life expectancy for Black people in the United States is now age 72, which means there were fewer people of color represented in the first groups to become eligible. Experts are hopeful that underrepresented groups will start to catch up as more states open up vaccinations to younger people.

Based on overall numbers of daily vaccine doses, the United States ranks third, behind China and India. America ranks fourth – behind Israel, the United Kingdom, and Chile – in the total share of the population that’s been vaccinated, according to the website Our World in Data.
 

A positive development

It’s a stunning turnaround for a country that failed for months to develop effective tests, and still struggles in some quarters to investigate new cases and quarantine their contacts.

The 7-day rolling average of vaccines administered in the United States is currently more than 3 million a day.

“We knew that we needed to get to 3 million a day at some point, if we were going to get most people vaccinated this year, but I don’t think that most people expected it to happen this early,” said Eric Toner, MD, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore.

Before taking office, President Joe Biden pledged to get 100 million shots in arms within his first 100 days in office. After hitting that goal in late March, he doubled it, to 200 million vaccinations by April 30. After first saying all adults should be eligible to get in line for the vaccine by May 1, on April 6, he bumped up that date to April 19. 

Some media reports have seen this repeated moving of the goalposts as calculated – an unstated strategy of underpromising and overdelivering with the aim of rebuilding public trust.

But others pointed out that, even if that’s true, the goals being set aren’t easy, and hitting them has never been a given.

“I think the Biden administration really gets a lot of credit for pushing the companies to get more vaccine out faster than they had planned to,” Dr. Toner said. “And the states have really responded as well as the federal government in terms of getting vaccination sites going. So we’re not only getting the vaccines, we’re getting it into people’s arms faster than expected.”

Others agree.

“We’re doing an amazing job, and I think the U.S. is really beginning to bend the curve,” said Carlos del Rio, MD, an infectious disease specialist and distinguished professor of medicine at Emory University, Atlanta.

“I think overall it’s just that everybody’s putting in a ton of work to get it done,” he said.

On April 3, the day the United States hit its vaccination record, he was volunteering to give vaccinations.

“I mean, of all the bad things we do to people as clinicians, this is one thing that people are very happy about, right?” Dr. del Rio said.

He said he vaccinated a young woman who asked if she could video chat with her mom, who was feeling nervous about getting the shot. He answered her mom’s questions, and later that day, she came down to be vaccinated herself.
 

‘We view it as a war’

The White House COVID-19 Response Team has worked hard to better coordinate the work of so many people at both the federal and state levels, Andy Slavitt, senior adviser for the team, said in an interview.

“We view it as a war, and in a war, you do everything: You bring experienced personnel; you bring all the resources to bear; you create multiple routes,” Mr. Slavitt said. “You don’t leave anything to chance.”

Among the levers the administration has pulled, using the Defense Production Act has helped vaccine manufacturers get needed supplies, Mr. Slavitt said.

The administration has set up an array of Federal Emergency Management Agency–run community vaccination centers and mobile vaccination sites to complement state-led efforts, and it’s activated a federal health law called the Public Readiness and Emergency Preparedness Act, which provides immunity from liability for retired doctors and nurses, among others, who sign up to help give vaccinations. That’s helped get more people into the field giving shots. 

The administration also canceled a plan to allocate vaccines to states based on their pace of administration, which would have punished underperforming states. Instead, doses are allocated based on population. 

In a media call on April 7, when asked whether the administration would send additional vaccines to Michigan, a state that’s seeing a surge of COVID-19 cases with more transmissible variants, Mr. Slavitt said they weren’t managing vaccine supply “according to some formula.”

He said they were distributing based on population “because that’s fundamental,” but were also locating vaccines “surgically in places that have had the greatest disease and where people have the greatest exposure.”

He said sites like community health centers and retail pharmacies have the power to order vaccines directly from the federal government, which helps get more supply to harder-hit areas.

Mr. Slavitt said hitting 4.1 million daily vaccinations on April 3 was gratifying.

“I’ve seen photographs ... of people breaking down in tears when they get their vaccine, people who are giving standing ovations to active military for taking care of them,” he said, “and I think about people who have gone for a long time without hope, or who have been very scared.

“It’s incredibly encouraging to think about maybe a few million people taking a step back to normal life again,” he said.

A version of this article first appeared on Medscape.com.

Each afternoon, Cyrus Shahpar, MD, the data guru for the White House COVID-19 Response Team, sends an email to staffers with the daily count of COVID-19 vaccinations delivered in the United States.

The numbers, collected from states ahead of the final figures being posted on the Centers for Disease Control and Prevention website, act as a report card of sorts on the team’s efforts.

On Saturday, April 3, it was a new record: 4.1 million vaccinations delivered in a single day, more than the total population of some states.

While the United States has a long way to go before it is done with COVID-19, there’s finally some good news in the nation’s long and blundering slog through the pandemic.

After a rocky start in December 2020 and January 2021, vaccination is happening faster than nearly anyone thought possible. As more people see their friends and family roll up their sleeves, hesitancy is dropping, too.

In settings where large numbers of people are vaccinated, such as nursing homes, COVID-19 cases and deaths have plunged.

Those gains, however, haven’t been shared equally. According to CDC data, 69% of people who are fully vaccinated are White, while just 8% are Black and about 9% are Hispanic, a group that now represents most new COVID-19 cases. 

Officials say that’s partly because the vaccines were rolled out to the elderly first. The average life expectancy for Black people in the United States is now age 72, which means there were fewer people of color represented in the first groups to become eligible. Experts are hopeful that underrepresented groups will start to catch up as more states open up vaccinations to younger people.

Based on overall numbers of daily vaccine doses, the United States ranks third, behind China and India. America ranks fourth – behind Israel, the United Kingdom, and Chile – in the total share of the population that’s been vaccinated, according to the website Our World in Data.
 

A positive development

It’s a stunning turnaround for a country that failed for months to develop effective tests, and still struggles in some quarters to investigate new cases and quarantine their contacts.

The 7-day rolling average of vaccines administered in the United States is currently more than 3 million a day.

“We knew that we needed to get to 3 million a day at some point, if we were going to get most people vaccinated this year, but I don’t think that most people expected it to happen this early,” said Eric Toner, MD, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore.

Before taking office, President Joe Biden pledged to get 100 million shots in arms within his first 100 days in office. After hitting that goal in late March, he doubled it, to 200 million vaccinations by April 30. After first saying all adults should be eligible to get in line for the vaccine by May 1, on April 6, he bumped up that date to April 19. 

Some media reports have seen this repeated moving of the goalposts as calculated – an unstated strategy of underpromising and overdelivering with the aim of rebuilding public trust.

But others pointed out that, even if that’s true, the goals being set aren’t easy, and hitting them has never been a given.

“I think the Biden administration really gets a lot of credit for pushing the companies to get more vaccine out faster than they had planned to,” Dr. Toner said. “And the states have really responded as well as the federal government in terms of getting vaccination sites going. So we’re not only getting the vaccines, we’re getting it into people’s arms faster than expected.”

Others agree.

“We’re doing an amazing job, and I think the U.S. is really beginning to bend the curve,” said Carlos del Rio, MD, an infectious disease specialist and distinguished professor of medicine at Emory University, Atlanta.

“I think overall it’s just that everybody’s putting in a ton of work to get it done,” he said.

On April 3, the day the United States hit its vaccination record, he was volunteering to give vaccinations.

“I mean, of all the bad things we do to people as clinicians, this is one thing that people are very happy about, right?” Dr. del Rio said.

He said he vaccinated a young woman who asked if she could video chat with her mom, who was feeling nervous about getting the shot. He answered her mom’s questions, and later that day, she came down to be vaccinated herself.
 

‘We view it as a war’

The White House COVID-19 Response Team has worked hard to better coordinate the work of so many people at both the federal and state levels, Andy Slavitt, senior adviser for the team, said in an interview.

“We view it as a war, and in a war, you do everything: You bring experienced personnel; you bring all the resources to bear; you create multiple routes,” Mr. Slavitt said. “You don’t leave anything to chance.”

Among the levers the administration has pulled, using the Defense Production Act has helped vaccine manufacturers get needed supplies, Mr. Slavitt said.

The administration has set up an array of Federal Emergency Management Agency–run community vaccination centers and mobile vaccination sites to complement state-led efforts, and it’s activated a federal health law called the Public Readiness and Emergency Preparedness Act, which provides immunity from liability for retired doctors and nurses, among others, who sign up to help give vaccinations. That’s helped get more people into the field giving shots. 

The administration also canceled a plan to allocate vaccines to states based on their pace of administration, which would have punished underperforming states. Instead, doses are allocated based on population. 

In a media call on April 7, when asked whether the administration would send additional vaccines to Michigan, a state that’s seeing a surge of COVID-19 cases with more transmissible variants, Mr. Slavitt said they weren’t managing vaccine supply “according to some formula.”

He said they were distributing based on population “because that’s fundamental,” but were also locating vaccines “surgically in places that have had the greatest disease and where people have the greatest exposure.”

He said sites like community health centers and retail pharmacies have the power to order vaccines directly from the federal government, which helps get more supply to harder-hit areas.

Mr. Slavitt said hitting 4.1 million daily vaccinations on April 3 was gratifying.

“I’ve seen photographs ... of people breaking down in tears when they get their vaccine, people who are giving standing ovations to active military for taking care of them,” he said, “and I think about people who have gone for a long time without hope, or who have been very scared.

“It’s incredibly encouraging to think about maybe a few million people taking a step back to normal life again,” he said.

A version of this article first appeared on Medscape.com.

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

The use of telehealth may have skyrocketed during the COVID-19 pandemic, but it also exposed a digital divide, speaker after speaker said during a panel discussion at the Society for Pediatric Dermatology (SPD) pre-AAD meeting.

“We have seen large numbers of children struggle with access to school and access to health care because of lack of access to devices, challenges of broadband Internet access, culture, language, and educational barriers – just having trouble being comfortable with this technology,” said Natalie Pageler, MD, a pediatric intensivist and chief medical information officer at Stanford Children’s Health, Palo Alto, Calif.

“There are also privacy concerns, especially in situations where there are multiple families within a household. Finally, it’s important to remember that policy and reimbursement issues may have a significant effect on some of the socioeconomic barriers,” she added. “For example, many of our families who don’t have access to audio and video may be able to do a telephone call, but it’s important that telephone calls be considered a form of telehealth and be reimbursed to help increase the access to health care by these families. It also makes it easier to facilitate coordination of care. All of this leads to decreased time and costs for patients, families, and providers.”

Within the first few weeks of the pandemic, Dr. Pageler and colleagues at Stanford Children’s Health observed an increase from about 20 telehealth visits per day to more than 700 per day, which has held stable. While the benefits of telehealth are clear, many perceived barriers exist. In a study conducted prior to the COVID-19 pandemic, researchers identified a wide variety of barriers to implementation of telehealth, led by reimbursement, followed by poor business model sustainability, lack of provider time, and provider interest.

“Some of the barriers, like patient preferences for inpatient care, lack of provider interest in telehealth, and lack of provider time were easily overcome during the COVID pandemic,” Dr. Pageler said. “We dedicated the time to train immediately, because the need was so great.”

In 2018, Patrick McMahon, MD, and colleagues at Children’s Hospital of Philadelphia, launched a teledermatology program that provided direct-to-patient “E-visits” and recently pivoted to using this service only for acne patients through a program called “Acne Express.” The out-of-pocket cost to patients is $50 per consult and nearly 1,500 cases have been completed since 2018, which has saved patients and their parents an estimated 65,000 miles driving to the clinic.

To optimize the teledermatology experience, he suggested four pillars: educate, optimize, reach out, and tailor. “I think we need to draw upon some of the digital education we already have, including a handout for patients [on the SPD website] that offers tips on taking a clear photograph on their smartphones,” he said. “We’re also trying to use some of the cases and learnings from our teledermatology experiences to teach the providers. We are setting up CME modules that are sort of a flashcard-based teaching mechanism.”

To optimize teledermatology experiences, he continued, tracking demographics, diagnoses, number of cases, and turnaround time is helpful. “We can then track who’s coming in to see us at follow-up after a new visit through telehealth,” Dr. McMahon said. “This helps us repurpose things, pivot as needed, and find any glitches. Surveying the families is also critical. Finally, we need clinical support to tee-up visits and to ensure photos are submitted and efficient, and to match diagnoses and family preference with the right modality.”

Another panelist, Justin M. Ko, MD, MBA, who chairs the American Academy of Dermatology’s Task Force on Augmented Intelligence, said that digitally enabled and artificial intelligence (AI)-augmented care delivery offers a “unique opportunity” for increasing access and increasing the value of care delivered to patients.

“The role that we play as clinicians is central, and I think we can make significant strides by doing two things,” said Dr. Ko, chief of medical dermatology for Stanford (Calif.) Health Care. “One: extending the reach of our expertise, and the second: scaling the impact of the care we deliver by clinician-driven, patient-centered, digitally-enabled, AI-augmented care delivery innovation. This opportunity for digital care transformation is more than just a transition from in-person visits to video visits. We have to look at this as an opportunity to leverage the unique aspects of digital capabilities and fundamentally reimagine how we deliver care.”

The AAD’s Position Statement on Augmented Intelligence was published in 2019.

Between March and June of 2021, Neil S. Prose, MD, conducted about 300 televisits with patients. “I had a few spectacular visits where, for example, a teenage patient who had been challenging showed me all of her artwork and we became instantly more connected,” said Dr. Prose, professor of dermatology, pediatrics, and global health at Duke University, Durham, N.C. “Then there’s the potential for a long-term improvement in health care for some patients.”

[email protected]

Exercise may help prevent cognitive decline in high-risk patients with early Parkinson’s disease, new research suggests. Investigators found that patients with Parkinson’s disease who were APOE epsilon4 carriers had greater cognitive decline compared with non-APOE epsilon4 carriers, but the findings also revealed higher physical activity appeared to slow cognitive decline in this higher risk group.

“The main finding of the current study is that higher physical activity was related to slower APOE epsilon4-associated cognitive decline in patients with early Parkinson’s disease, which was shown to be robust in sensitivity analyses,” wrote the researchers, led by Ryul Kim, MD, Inha University Hospital, Incheon, Korea.

The study was published online March 31 in Neurology.
 

Unclear mechanism

The APOE epsilon4 allele is known to be a “major risk factor” for Alzheimer’s disease, but “accumulating evidence shows that this allele also has a potential role in cognitive impairment in Parkinson’s disease,” the authors noted.

Previous research shows physical activity has beneficial effects in patients with Parkinson’s disease, but the mechanisms underlying these effects are “not well understood.” Additional data suggest physical activity modifies the APOE epsilon4 effect on the development and progression of Alzheimer’s disease.

“These observations led us to hypothesize that physical activity also plays a role in modulating the association between APOE [epsilon4] and cognition in Parkinson’s disease,” but no studies have yet reported on this interaction in patients with Parkinson’s disease, the authors noted.

To investigate, they drew on data from the Parkinson’s Progression Markers Initiative (PPMI) – a cohort study conducted to identify Parkinson’s disease progression markers.

The current analysis included 173 patients recently diagnosed with Parkinson’s disease but not yet treated for the condition. The cohort’s mean age was 63.3 ± 10.0 years, age of Parkinson’s disease onset was 59.4 ± 10.0 years, and 68% were male. Of these participants, 46 were APOE epsilon4 carriers.

Dopamine transporter (DAT) activity was assessed using imaging at enrollment and again at years 2 and 4. Cognitive function was assessed at years 2, 3, and 4 using the Montreal Cognitive Assessment (MoCA) test.
 

Protective effect

Although APOE epsilon4 carriers tended to be younger than noncarriers, the age of Parkinson’s disease onset did not differ between the 2 groups, and there were also no significant differences between the groups in demographic and clinical variables.

There were larger declines in MoCA scores in the APOE epsilon4 carriers versus the noncarriers (0.21 ± 1.40 and 0.08 ± 1.15 respectively).

The APOE epsilon4 allele was associated with a “steeper” rate of cognitive decline, compared with the non-APOE epsilon4 allele (estimate −1.33 [95% confidence interval, −2.12 to −0.47, P = .002).

There was a significant interaction of physical activity, APOE epsilon4, and time: Higher physical activity was associated with slower APOE epsilon4-related cognitive decline (estimate 0.007 [0.003 to 0.011, P = .001).

However, the researchers found no significant main effects of the APOE epsilon4 allele or physical activity on the change in the MoCA score.

“Considering that dopaminergic treatment may affect cognitive function, particularly in the early stage of Parkinson’s disease, we additionally included the levodopa daily equivalent dose (LEDD) and its interaction with time as covariates in the model,” the investigators noted.

They found that the interactive association between physical activity and the APOE epsilon4 allele on cognitive decline remained significant, even when participants who had normal cognitive performance at year 2 were included in the study population or when LEDD variables were included as covariates in the model.

Both high- and low-intensity exercise were significantly associated with slower APOE epsilon4-related cognitive decline.

There was no significant interaction between physical activity and APOE epsilon4 with changes in striatal DAT activities.

“Increased physical activity attenuated APOE epsilon4-related vulnerability to early cognitive decline in patients with Parkinson’s disease,” the authors noted, adding that the effect “did not appear to be mediated by striatal dopamine activity.”

They hypothesized that physical activity may “offer a greater protective effect” on cerebral amyloid accumulation in APOE epsilon4 carriers. It is also possible that physical activity will counteract the negative impact of the APOE epsilon4 allele through improved brain mechanism and decreased neuroinflammation.
 

‘The next blockbuster drug’

Commenting on the study in an interview, Bastiaan R. Bloem, MD, PhD, director of the center of expertise for Parkinson & movement disorders, Radboud University Medical Center, Nijmegen, Netherlands, said exercise might be seen as “the next blockbuster drug.”

Dr. Bloem, who was not involved in the study, noted there is “quite robust evidence now that exercise acts as symptomatic therapy, like a drug, alleviating sleep [disturbances], depression, constipation, and motor symptoms.”

The study “sheds new light on the idea of exercise as not only alleviating symptoms but actually as a potential disease modifier,” said Dr. Bloem, whose research has focused on the beneficial effects of a rigorous exercise program, combined with tablet-based gamificaton and a reward system in stabilizing motor symptoms in patients with Parkinson’s disease over time.

“The reward system created additional motivation for the patients with Parkinson’s disease who often experience depression and apathy that interfere with motivation,” he said.

The current study has important take-home messages for practicing clinicians. “Physicians should encourage exercise in patients, and patients should also take the lead themselves,” Dr. Bloem said. “It doesn’t matter what type of exercise you do, but it should have an aerobic component, should be safe so the patient doesn’t fall down, should have enough intensity to cause the patient to pant, and should be individualized and enjoyable so the patients stick to it,” he emphasized.

Dr. Bloem noted that yoga and mindfulness are also helpful. “If we’ve learned anything from the COVID-19 crisis, it’s that chronic stress is deleterious to all of us and particularly bad for people with PD, because you need dopamine to be able to handle stress, and the lack of dopamine in people with PD makes them deteriorate faster.”

The study was supported by a research grant of National Research Foundation by the Ministry of Science and ICT (MSIT) in Korea. The authors and Dr. Bloem have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Exercise may help prevent cognitive decline in high-risk patients with early Parkinson’s disease, new research suggests. Investigators found that patients with Parkinson’s disease who were APOE epsilon4 carriers had greater cognitive decline compared with non-APOE epsilon4 carriers, but the findings also revealed higher physical activity appeared to slow cognitive decline in this higher risk group.

“The main finding of the current study is that higher physical activity was related to slower APOE epsilon4-associated cognitive decline in patients with early Parkinson’s disease, which was shown to be robust in sensitivity analyses,” wrote the researchers, led by Ryul Kim, MD, Inha University Hospital, Incheon, Korea.

The study was published online March 31 in Neurology.
 

Unclear mechanism

The APOE epsilon4 allele is known to be a “major risk factor” for Alzheimer’s disease, but “accumulating evidence shows that this allele also has a potential role in cognitive impairment in Parkinson’s disease,” the authors noted.

Previous research shows physical activity has beneficial effects in patients with Parkinson’s disease, but the mechanisms underlying these effects are “not well understood.” Additional data suggest physical activity modifies the APOE epsilon4 effect on the development and progression of Alzheimer’s disease.

“These observations led us to hypothesize that physical activity also plays a role in modulating the association between APOE [epsilon4] and cognition in Parkinson’s disease,” but no studies have yet reported on this interaction in patients with Parkinson’s disease, the authors noted.

To investigate, they drew on data from the Parkinson’s Progression Markers Initiative (PPMI) – a cohort study conducted to identify Parkinson’s disease progression markers.

The current analysis included 173 patients recently diagnosed with Parkinson’s disease but not yet treated for the condition. The cohort’s mean age was 63.3 ± 10.0 years, age of Parkinson’s disease onset was 59.4 ± 10.0 years, and 68% were male. Of these participants, 46 were APOE epsilon4 carriers.

Dopamine transporter (DAT) activity was assessed using imaging at enrollment and again at years 2 and 4. Cognitive function was assessed at years 2, 3, and 4 using the Montreal Cognitive Assessment (MoCA) test.
 

Protective effect

Although APOE epsilon4 carriers tended to be younger than noncarriers, the age of Parkinson’s disease onset did not differ between the 2 groups, and there were also no significant differences between the groups in demographic and clinical variables.

There were larger declines in MoCA scores in the APOE epsilon4 carriers versus the noncarriers (0.21 ± 1.40 and 0.08 ± 1.15 respectively).

The APOE epsilon4 allele was associated with a “steeper” rate of cognitive decline, compared with the non-APOE epsilon4 allele (estimate −1.33 [95% confidence interval, −2.12 to −0.47, P = .002).

There was a significant interaction of physical activity, APOE epsilon4, and time: Higher physical activity was associated with slower APOE epsilon4-related cognitive decline (estimate 0.007 [0.003 to 0.011, P = .001).

However, the researchers found no significant main effects of the APOE epsilon4 allele or physical activity on the change in the MoCA score.

“Considering that dopaminergic treatment may affect cognitive function, particularly in the early stage of Parkinson’s disease, we additionally included the levodopa daily equivalent dose (LEDD) and its interaction with time as covariates in the model,” the investigators noted.

They found that the interactive association between physical activity and the APOE epsilon4 allele on cognitive decline remained significant, even when participants who had normal cognitive performance at year 2 were included in the study population or when LEDD variables were included as covariates in the model.

Both high- and low-intensity exercise were significantly associated with slower APOE epsilon4-related cognitive decline.

There was no significant interaction between physical activity and APOE epsilon4 with changes in striatal DAT activities.

“Increased physical activity attenuated APOE epsilon4-related vulnerability to early cognitive decline in patients with Parkinson’s disease,” the authors noted, adding that the effect “did not appear to be mediated by striatal dopamine activity.”

They hypothesized that physical activity may “offer a greater protective effect” on cerebral amyloid accumulation in APOE epsilon4 carriers. It is also possible that physical activity will counteract the negative impact of the APOE epsilon4 allele through improved brain mechanism and decreased neuroinflammation.
 

‘The next blockbuster drug’

Commenting on the study in an interview, Bastiaan R. Bloem, MD, PhD, director of the center of expertise for Parkinson & movement disorders, Radboud University Medical Center, Nijmegen, Netherlands, said exercise might be seen as “the next blockbuster drug.”

Dr. Bloem, who was not involved in the study, noted there is “quite robust evidence now that exercise acts as symptomatic therapy, like a drug, alleviating sleep [disturbances], depression, constipation, and motor symptoms.”

The study “sheds new light on the idea of exercise as not only alleviating symptoms but actually as a potential disease modifier,” said Dr. Bloem, whose research has focused on the beneficial effects of a rigorous exercise program, combined with tablet-based gamificaton and a reward system in stabilizing motor symptoms in patients with Parkinson’s disease over time.

“The reward system created additional motivation for the patients with Parkinson’s disease who often experience depression and apathy that interfere with motivation,” he said.

The current study has important take-home messages for practicing clinicians. “Physicians should encourage exercise in patients, and patients should also take the lead themselves,” Dr. Bloem said. “It doesn’t matter what type of exercise you do, but it should have an aerobic component, should be safe so the patient doesn’t fall down, should have enough intensity to cause the patient to pant, and should be individualized and enjoyable so the patients stick to it,” he emphasized.

Dr. Bloem noted that yoga and mindfulness are also helpful. “If we’ve learned anything from the COVID-19 crisis, it’s that chronic stress is deleterious to all of us and particularly bad for people with PD, because you need dopamine to be able to handle stress, and the lack of dopamine in people with PD makes them deteriorate faster.”

The study was supported by a research grant of National Research Foundation by the Ministry of Science and ICT (MSIT) in Korea. The authors and Dr. Bloem have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Exercise may help prevent cognitive decline in high-risk patients with early Parkinson’s disease, new research suggests. Investigators found that patients with Parkinson’s disease who were APOE epsilon4 carriers had greater cognitive decline compared with non-APOE epsilon4 carriers, but the findings also revealed higher physical activity appeared to slow cognitive decline in this higher risk group.

“The main finding of the current study is that higher physical activity was related to slower APOE epsilon4-associated cognitive decline in patients with early Parkinson’s disease, which was shown to be robust in sensitivity analyses,” wrote the researchers, led by Ryul Kim, MD, Inha University Hospital, Incheon, Korea.

The study was published online March 31 in Neurology.
 

Unclear mechanism

The APOE epsilon4 allele is known to be a “major risk factor” for Alzheimer’s disease, but “accumulating evidence shows that this allele also has a potential role in cognitive impairment in Parkinson’s disease,” the authors noted.

Previous research shows physical activity has beneficial effects in patients with Parkinson’s disease, but the mechanisms underlying these effects are “not well understood.” Additional data suggest physical activity modifies the APOE epsilon4 effect on the development and progression of Alzheimer’s disease.

“These observations led us to hypothesize that physical activity also plays a role in modulating the association between APOE [epsilon4] and cognition in Parkinson’s disease,” but no studies have yet reported on this interaction in patients with Parkinson’s disease, the authors noted.

To investigate, they drew on data from the Parkinson’s Progression Markers Initiative (PPMI) – a cohort study conducted to identify Parkinson’s disease progression markers.

The current analysis included 173 patients recently diagnosed with Parkinson’s disease but not yet treated for the condition. The cohort’s mean age was 63.3 ± 10.0 years, age of Parkinson’s disease onset was 59.4 ± 10.0 years, and 68% were male. Of these participants, 46 were APOE epsilon4 carriers.

Dopamine transporter (DAT) activity was assessed using imaging at enrollment and again at years 2 and 4. Cognitive function was assessed at years 2, 3, and 4 using the Montreal Cognitive Assessment (MoCA) test.
 

Protective effect

Although APOE epsilon4 carriers tended to be younger than noncarriers, the age of Parkinson’s disease onset did not differ between the 2 groups, and there were also no significant differences between the groups in demographic and clinical variables.

There were larger declines in MoCA scores in the APOE epsilon4 carriers versus the noncarriers (0.21 ± 1.40 and 0.08 ± 1.15 respectively).

The APOE epsilon4 allele was associated with a “steeper” rate of cognitive decline, compared with the non-APOE epsilon4 allele (estimate −1.33 [95% confidence interval, −2.12 to −0.47, P = .002).

There was a significant interaction of physical activity, APOE epsilon4, and time: Higher physical activity was associated with slower APOE epsilon4-related cognitive decline (estimate 0.007 [0.003 to 0.011, P = .001).

However, the researchers found no significant main effects of the APOE epsilon4 allele or physical activity on the change in the MoCA score.

“Considering that dopaminergic treatment may affect cognitive function, particularly in the early stage of Parkinson’s disease, we additionally included the levodopa daily equivalent dose (LEDD) and its interaction with time as covariates in the model,” the investigators noted.

They found that the interactive association between physical activity and the APOE epsilon4 allele on cognitive decline remained significant, even when participants who had normal cognitive performance at year 2 were included in the study population or when LEDD variables were included as covariates in the model.

Both high- and low-intensity exercise were significantly associated with slower APOE epsilon4-related cognitive decline.

There was no significant interaction between physical activity and APOE epsilon4 with changes in striatal DAT activities.

“Increased physical activity attenuated APOE epsilon4-related vulnerability to early cognitive decline in patients with Parkinson’s disease,” the authors noted, adding that the effect “did not appear to be mediated by striatal dopamine activity.”

They hypothesized that physical activity may “offer a greater protective effect” on cerebral amyloid accumulation in APOE epsilon4 carriers. It is also possible that physical activity will counteract the negative impact of the APOE epsilon4 allele through improved brain mechanism and decreased neuroinflammation.
 

‘The next blockbuster drug’

Commenting on the study in an interview, Bastiaan R. Bloem, MD, PhD, director of the center of expertise for Parkinson & movement disorders, Radboud University Medical Center, Nijmegen, Netherlands, said exercise might be seen as “the next blockbuster drug.”

Dr. Bloem, who was not involved in the study, noted there is “quite robust evidence now that exercise acts as symptomatic therapy, like a drug, alleviating sleep [disturbances], depression, constipation, and motor symptoms.”

The study “sheds new light on the idea of exercise as not only alleviating symptoms but actually as a potential disease modifier,” said Dr. Bloem, whose research has focused on the beneficial effects of a rigorous exercise program, combined with tablet-based gamificaton and a reward system in stabilizing motor symptoms in patients with Parkinson’s disease over time.

“The reward system created additional motivation for the patients with Parkinson’s disease who often experience depression and apathy that interfere with motivation,” he said.

The current study has important take-home messages for practicing clinicians. “Physicians should encourage exercise in patients, and patients should also take the lead themselves,” Dr. Bloem said. “It doesn’t matter what type of exercise you do, but it should have an aerobic component, should be safe so the patient doesn’t fall down, should have enough intensity to cause the patient to pant, and should be individualized and enjoyable so the patients stick to it,” he emphasized.

Dr. Bloem noted that yoga and mindfulness are also helpful. “If we’ve learned anything from the COVID-19 crisis, it’s that chronic stress is deleterious to all of us and particularly bad for people with PD, because you need dopamine to be able to handle stress, and the lack of dopamine in people with PD makes them deteriorate faster.”

The study was supported by a research grant of National Research Foundation by the Ministry of Science and ICT (MSIT) in Korea. The authors and Dr. Bloem have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Specialty palliative care interventions improve outcomes in patients with hematologic malignancies but are underutilized, according to findings from a systematic literature review.

Outcomes that were improved, as demonstrated by 16 studies that met inclusion criteria for the review, included symptom management, inpatient mortality, health care utilization, health care costs, and caregiver-reported outcomes, Elizabeth Elliott, DO, a hematology and oncology fellow at the Cardinal Bernardin Cancer Center, Loyola University, Maywood, Ill., and colleagues reported.

The findings were published online in the Journal of Pain and Symptom Management.
 

Palliative care needs

Patients with hematologic malignancies, including leukemia, myeloma, and lymphoma, have a high need for supportive care, the authors noted, adding that, although its use has increased over time, palliative care (PC) is often provided late in the disease course – sometimes only in the final days of life.

“Compared with their solid tumor counterparts, patients with hematologic malignancies experience higher symptom burdens, have higher rates of cancer-directed care near death, and are more likely to die while hospitalized than at home or in hospice,” they wrote. “Despite this need, specialist palliative care is less commonly utilized in patients with hematologic malignancies than other cancer types.”

Given the high health care utilization among patients with hematologic malignancies, earlier and more widespread utilization of PC in this population may significantly reduce health care costs, they added.
 

Palliative care benefits

Of 5,345 studies published between 2005 and 2020 and screened for the current review, 16 met inclusion criteria, including 10 retrospective cohort studies; 4 prospective cohort studies; and 2 randomized, controlled studies.

Nine studies included only patients with hematologic malignancies and seven included both patients with solid tumors and patients with hematologic malignancies. Each study assessed as being of moderate quality.

Benefits of PC as demonstrated in the studies included:

Symptom management: One study, for example, showed that an integrated psychological and PC intervention improved traumatic stress levels, degree and number of physical symptoms, pain intensity, depressive symptoms, and quality of life, compared with no intervention. Another showed that the percentage of patients reporting moderate to severe pain improved from 57% to 18% with a PC intervention, and the number reporting depressive episodes improved from 13% to 5%.

Reduced in-patient death: Findings from eight studies showed that 21.9%-83% of those receiving PC died at home, compared with 6.0%-8.9% of controls. Two studies showed that PC provided at least 20 days prior to death decreased the likelihood of inpatient death and death in an ICU, compared with controls, and one showed that the rate of in-hospital deaths was 30% for those with home PC or hospice, compared with 80% of controls.

Health care utilization: The studies showed that hospitalization occurred in 45%-76.3% of hematologic malignancy patients who received PC, compared with 98% of controls. The odds ratio for hospitalization among acute leukemia patients receiving PC was 0.64, compared with 2.53 among those in a historical control group.

Caregiver-reported outcomes: One randomized, controlled study showed that PC was associated with smaller increases in depression scores, improved coping, and improved scores in multiple quality of life domains in caregivers versus controls.

Survival: One study showed that a larger percentage of hematologic malignancy patients who died 1-6 months after diagnosis had not received PC (28% vs. 23%), whereas more of those who died 6-12 months or 12 or more months after diagnosis had received PC (23.9 vs. 14.9% and 42.5% vs. 22.0%).

Health care costs: Two studies showed a decrease in inpatient costs after a palliative care consultation. Decreases in hospitalization costs were $2,321 and $1,506 for less medically complex patients and $3,515 and $5,617 for more medically complex patient.

Improving PC utilization

One potential strategy to promote earlier referrals to PC is improved education for hematologists, the authors said, citing a study showing that 98% of oncology fellows at one center reported improvement in their ability to assess and manage patient symptoms after completion of a 4-week mandatory PC rotation.

“Another strategy to improve referrals to PC of hematologic malignancies patients could be the creation of programs which facilitate collaboration between PC providers and hematologists, such as the palliative and supportive care special interest group within the American Society for Transplantation and Cellular Therapy,” they wrote.

A third strategy “could be to provide a concurrent care model, in which cancer directed therapy (such as transfusions) is provided at the same time as hospice care,” they added, explaining that such an approach was shown in a study of patients with advanced non–small cell lung cancer to be associated with less aggressive medical treatment and lower costs.

The authors also stressed that patient with solid tumors and those with hematologic malignancies have differing supportive care needs and health care utilization, but several studies included in the current review included both types of cancer.

“Further studies investigating PC use exclusively in patients with hematologic malignancies are needed. Our results demonstrate a strong argument for hematologists to refer their patients early and often for specialized PC,” they concluded.

Indeed, when PC is integrated within hematologic malignancies, impacts occur that are similar to those seen in a variety of other diseases and include improved symptom control, enhanced caregiver experience, and reduced burdens on the health care system, Toby C Campbell, MD, said in an interview.

“The benefits of providing palliative care concurrent with standard cancer care is felt by all the major stakeholders in this care: the patients, their caregivers, and the health care system around them,” said Dr. Campbell, a thoracic medical oncologist and professor in the division of hematology, medical oncology, and palliative care at the University of Wisconsin–Madison.
 

Overcoming challenges

However, this is “new territory” for most programs, added Dr. Campbell, who also is the University of Wisconsin health chief of palliative care and holds the Ellen and Peter O. Johnson Chair in Palliative Care .

“The palliative care clinicians have a lot of learning to do if they’re going to enter this space and provide expert care,” he said, adding that expert care is what is needed and what was studied in this review. “Providing palliative care to patients with hematologic malignancies has a unique pace and a number of subspecialized therapeutic options with which the palliative care clinician must become familiar.”

Examples include bone marrow transplantation with prolonged hospitalizations and transfusion support, he said.

“Palliative care programs, in order to provide high quality care, will need to familiarize themselves with these therapies and develop close partnership with hematologists to integrate seamlessly into the patient’s care,” he added. “At some centers, culture changes will be necessary concurrent with the clinical practice change of integrating palliative care and it is the responsibility of the palliative care clinicians to bring their very best to these new relationships and patient populations.”

The authors reported having no disclosures. Dr. Campbell also reported having no disclosures.

[email protected]

Specialty palliative care interventions improve outcomes in patients with hematologic malignancies but are underutilized, according to findings from a systematic literature review.

Outcomes that were improved, as demonstrated by 16 studies that met inclusion criteria for the review, included symptom management, inpatient mortality, health care utilization, health care costs, and caregiver-reported outcomes, Elizabeth Elliott, DO, a hematology and oncology fellow at the Cardinal Bernardin Cancer Center, Loyola University, Maywood, Ill., and colleagues reported.

The findings were published online in the Journal of Pain and Symptom Management.
 

Palliative care needs

Patients with hematologic malignancies, including leukemia, myeloma, and lymphoma, have a high need for supportive care, the authors noted, adding that, although its use has increased over time, palliative care (PC) is often provided late in the disease course – sometimes only in the final days of life.

“Compared with their solid tumor counterparts, patients with hematologic malignancies experience higher symptom burdens, have higher rates of cancer-directed care near death, and are more likely to die while hospitalized than at home or in hospice,” they wrote. “Despite this need, specialist palliative care is less commonly utilized in patients with hematologic malignancies than other cancer types.”

Given the high health care utilization among patients with hematologic malignancies, earlier and more widespread utilization of PC in this population may significantly reduce health care costs, they added.
 

Palliative care benefits

Of 5,345 studies published between 2005 and 2020 and screened for the current review, 16 met inclusion criteria, including 10 retrospective cohort studies; 4 prospective cohort studies; and 2 randomized, controlled studies.

Nine studies included only patients with hematologic malignancies and seven included both patients with solid tumors and patients with hematologic malignancies. Each study assessed as being of moderate quality.

Benefits of PC as demonstrated in the studies included:

Symptom management: One study, for example, showed that an integrated psychological and PC intervention improved traumatic stress levels, degree and number of physical symptoms, pain intensity, depressive symptoms, and quality of life, compared with no intervention. Another showed that the percentage of patients reporting moderate to severe pain improved from 57% to 18% with a PC intervention, and the number reporting depressive episodes improved from 13% to 5%.

Reduced in-patient death: Findings from eight studies showed that 21.9%-83% of those receiving PC died at home, compared with 6.0%-8.9% of controls. Two studies showed that PC provided at least 20 days prior to death decreased the likelihood of inpatient death and death in an ICU, compared with controls, and one showed that the rate of in-hospital deaths was 30% for those with home PC or hospice, compared with 80% of controls.

Health care utilization: The studies showed that hospitalization occurred in 45%-76.3% of hematologic malignancy patients who received PC, compared with 98% of controls. The odds ratio for hospitalization among acute leukemia patients receiving PC was 0.64, compared with 2.53 among those in a historical control group.

Caregiver-reported outcomes: One randomized, controlled study showed that PC was associated with smaller increases in depression scores, improved coping, and improved scores in multiple quality of life domains in caregivers versus controls.

Survival: One study showed that a larger percentage of hematologic malignancy patients who died 1-6 months after diagnosis had not received PC (28% vs. 23%), whereas more of those who died 6-12 months or 12 or more months after diagnosis had received PC (23.9 vs. 14.9% and 42.5% vs. 22.0%).

Health care costs: Two studies showed a decrease in inpatient costs after a palliative care consultation. Decreases in hospitalization costs were $2,321 and $1,506 for less medically complex patients and $3,515 and $5,617 for more medically complex patient.

Improving PC utilization

One potential strategy to promote earlier referrals to PC is improved education for hematologists, the authors said, citing a study showing that 98% of oncology fellows at one center reported improvement in their ability to assess and manage patient symptoms after completion of a 4-week mandatory PC rotation.

“Another strategy to improve referrals to PC of hematologic malignancies patients could be the creation of programs which facilitate collaboration between PC providers and hematologists, such as the palliative and supportive care special interest group within the American Society for Transplantation and Cellular Therapy,” they wrote.

A third strategy “could be to provide a concurrent care model, in which cancer directed therapy (such as transfusions) is provided at the same time as hospice care,” they added, explaining that such an approach was shown in a study of patients with advanced non–small cell lung cancer to be associated with less aggressive medical treatment and lower costs.

The authors also stressed that patient with solid tumors and those with hematologic malignancies have differing supportive care needs and health care utilization, but several studies included in the current review included both types of cancer.

“Further studies investigating PC use exclusively in patients with hematologic malignancies are needed. Our results demonstrate a strong argument for hematologists to refer their patients early and often for specialized PC,” they concluded.

Indeed, when PC is integrated within hematologic malignancies, impacts occur that are similar to those seen in a variety of other diseases and include improved symptom control, enhanced caregiver experience, and reduced burdens on the health care system, Toby C Campbell, MD, said in an interview.

“The benefits of providing palliative care concurrent with standard cancer care is felt by all the major stakeholders in this care: the patients, their caregivers, and the health care system around them,” said Dr. Campbell, a thoracic medical oncologist and professor in the division of hematology, medical oncology, and palliative care at the University of Wisconsin–Madison.
 

Overcoming challenges

However, this is “new territory” for most programs, added Dr. Campbell, who also is the University of Wisconsin health chief of palliative care and holds the Ellen and Peter O. Johnson Chair in Palliative Care .

“The palliative care clinicians have a lot of learning to do if they’re going to enter this space and provide expert care,” he said, adding that expert care is what is needed and what was studied in this review. “Providing palliative care to patients with hematologic malignancies has a unique pace and a number of subspecialized therapeutic options with which the palliative care clinician must become familiar.”

Examples include bone marrow transplantation with prolonged hospitalizations and transfusion support, he said.

“Palliative care programs, in order to provide high quality care, will need to familiarize themselves with these therapies and develop close partnership with hematologists to integrate seamlessly into the patient’s care,” he added. “At some centers, culture changes will be necessary concurrent with the clinical practice change of integrating palliative care and it is the responsibility of the palliative care clinicians to bring their very best to these new relationships and patient populations.”

The authors reported having no disclosures. Dr. Campbell also reported having no disclosures.

[email protected]

Specialty palliative care interventions improve outcomes in patients with hematologic malignancies but are underutilized, according to findings from a systematic literature review.

Outcomes that were improved, as demonstrated by 16 studies that met inclusion criteria for the review, included symptom management, inpatient mortality, health care utilization, health care costs, and caregiver-reported outcomes, Elizabeth Elliott, DO, a hematology and oncology fellow at the Cardinal Bernardin Cancer Center, Loyola University, Maywood, Ill., and colleagues reported.

The findings were published online in the Journal of Pain and Symptom Management.
 

Palliative care needs

Patients with hematologic malignancies, including leukemia, myeloma, and lymphoma, have a high need for supportive care, the authors noted, adding that, although its use has increased over time, palliative care (PC) is often provided late in the disease course – sometimes only in the final days of life.

“Compared with their solid tumor counterparts, patients with hematologic malignancies experience higher symptom burdens, have higher rates of cancer-directed care near death, and are more likely to die while hospitalized than at home or in hospice,” they wrote. “Despite this need, specialist palliative care is less commonly utilized in patients with hematologic malignancies than other cancer types.”

Given the high health care utilization among patients with hematologic malignancies, earlier and more widespread utilization of PC in this population may significantly reduce health care costs, they added.
 

Palliative care benefits

Of 5,345 studies published between 2005 and 2020 and screened for the current review, 16 met inclusion criteria, including 10 retrospective cohort studies; 4 prospective cohort studies; and 2 randomized, controlled studies.

Nine studies included only patients with hematologic malignancies and seven included both patients with solid tumors and patients with hematologic malignancies. Each study assessed as being of moderate quality.

Benefits of PC as demonstrated in the studies included:

Symptom management: One study, for example, showed that an integrated psychological and PC intervention improved traumatic stress levels, degree and number of physical symptoms, pain intensity, depressive symptoms, and quality of life, compared with no intervention. Another showed that the percentage of patients reporting moderate to severe pain improved from 57% to 18% with a PC intervention, and the number reporting depressive episodes improved from 13% to 5%.

Reduced in-patient death: Findings from eight studies showed that 21.9%-83% of those receiving PC died at home, compared with 6.0%-8.9% of controls. Two studies showed that PC provided at least 20 days prior to death decreased the likelihood of inpatient death and death in an ICU, compared with controls, and one showed that the rate of in-hospital deaths was 30% for those with home PC or hospice, compared with 80% of controls.

Health care utilization: The studies showed that hospitalization occurred in 45%-76.3% of hematologic malignancy patients who received PC, compared with 98% of controls. The odds ratio for hospitalization among acute leukemia patients receiving PC was 0.64, compared with 2.53 among those in a historical control group.

Caregiver-reported outcomes: One randomized, controlled study showed that PC was associated with smaller increases in depression scores, improved coping, and improved scores in multiple quality of life domains in caregivers versus controls.

Survival: One study showed that a larger percentage of hematologic malignancy patients who died 1-6 months after diagnosis had not received PC (28% vs. 23%), whereas more of those who died 6-12 months or 12 or more months after diagnosis had received PC (23.9 vs. 14.9% and 42.5% vs. 22.0%).

Health care costs: Two studies showed a decrease in inpatient costs after a palliative care consultation. Decreases in hospitalization costs were $2,321 and $1,506 for less medically complex patients and $3,515 and $5,617 for more medically complex patient.

Improving PC utilization

One potential strategy to promote earlier referrals to PC is improved education for hematologists, the authors said, citing a study showing that 98% of oncology fellows at one center reported improvement in their ability to assess and manage patient symptoms after completion of a 4-week mandatory PC rotation.

“Another strategy to improve referrals to PC of hematologic malignancies patients could be the creation of programs which facilitate collaboration between PC providers and hematologists, such as the palliative and supportive care special interest group within the American Society for Transplantation and Cellular Therapy,” they wrote.

A third strategy “could be to provide a concurrent care model, in which cancer directed therapy (such as transfusions) is provided at the same time as hospice care,” they added, explaining that such an approach was shown in a study of patients with advanced non–small cell lung cancer to be associated with less aggressive medical treatment and lower costs.

The authors also stressed that patient with solid tumors and those with hematologic malignancies have differing supportive care needs and health care utilization, but several studies included in the current review included both types of cancer.

“Further studies investigating PC use exclusively in patients with hematologic malignancies are needed. Our results demonstrate a strong argument for hematologists to refer their patients early and often for specialized PC,” they concluded.

Indeed, when PC is integrated within hematologic malignancies, impacts occur that are similar to those seen in a variety of other diseases and include improved symptom control, enhanced caregiver experience, and reduced burdens on the health care system, Toby C Campbell, MD, said in an interview.

“The benefits of providing palliative care concurrent with standard cancer care is felt by all the major stakeholders in this care: the patients, their caregivers, and the health care system around them,” said Dr. Campbell, a thoracic medical oncologist and professor in the division of hematology, medical oncology, and palliative care at the University of Wisconsin–Madison.
 

Overcoming challenges

However, this is “new territory” for most programs, added Dr. Campbell, who also is the University of Wisconsin health chief of palliative care and holds the Ellen and Peter O. Johnson Chair in Palliative Care .

“The palliative care clinicians have a lot of learning to do if they’re going to enter this space and provide expert care,” he said, adding that expert care is what is needed and what was studied in this review. “Providing palliative care to patients with hematologic malignancies has a unique pace and a number of subspecialized therapeutic options with which the palliative care clinician must become familiar.”

Examples include bone marrow transplantation with prolonged hospitalizations and transfusion support, he said.

“Palliative care programs, in order to provide high quality care, will need to familiarize themselves with these therapies and develop close partnership with hematologists to integrate seamlessly into the patient’s care,” he added. “At some centers, culture changes will be necessary concurrent with the clinical practice change of integrating palliative care and it is the responsibility of the palliative care clinicians to bring their very best to these new relationships and patient populations.”

The authors reported having no disclosures. Dr. Campbell also reported having no disclosures.

[email protected]