During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.

“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”

Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.

Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.

“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
 

Study details

The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:

• A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
• An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
• A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.

The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).

At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.

There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
 

Moving from step-up therapy to early-combination treatment

Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.

”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”

Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.

While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”

The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.

”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”

Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.

The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.

Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.

“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”

Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.

Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.

“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
 

Study details

The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:

• A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
• An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
• A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.

The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).

At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.

There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
 

Moving from step-up therapy to early-combination treatment

Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.

”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”

Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.

While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”

The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.

”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”

Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.

The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.

Initiating treatment of polyarticular juvenile idiopathic arthritis (polyJIA) with both a conventional synthetic disease-modifying antirheumatic drug and a biologic DMARD resulted in more patients achieving clinical inactive disease 2 years later than did starting with only a csDMARD and stepping up to a biologic, according to data presented at the virtual annual meeting of the American College of Rheumatology.

“The 24-month results support the 12-month primary results that suggested that the early-combination group was superior and that, at 24 months, more early combination CTP [consensus treatment plan] patients achieve CID [clinical inactive disease], compared to step up,” Yukiko Kimura, MD, division chief of pediatric rheumatology at HMH Hackensack (N.J.) University Medical Center, told attendees. “This suggests that starting biologics early in polyJIA may lead to better long-term outcomes in many patients.”

Dr. Kimura noted that polyarticular JIA patients are already at risk for poor outcomes, and initial therapy can especially impact outcomes. Further, little evidence exists to suggest when the best time is to start biologics, a gap this study aimed to address.

Diane Brown, MD, PhD, a pediatric rheumatologist at Children’s Hospital Los Angeles who was not involved in the study, was pleased to see the results, which she said support her own preferences and practice patterns.

“Starting sooner with combination therapy, taking advantage of the advances with biologics and our long history with methotrexate at the same time, gives better outcomes for the long run,” Dr. Brown said in an interview. “Having studies like this to back up my own recommendations can be very powerful when talking to families, and it is absolutely invaluable when battling with insurance companies who always want you to take the cheapest road.”
 

Study details

The findings were an update of 12-month results in the CARRA STOP-JIA study that enrolled 400 untreated patients with polyJIA and compared three Childhood Arthritis and Rheumatology Research Alliance (CARRA) CTPs. Overall, 49.5% of participants received biologics within 3 months of starting the study. For these updated results, 275 participants had complete data at 24 months for the three CTPs:

• A step-up group of 177 patients who started therapy with a csDMARD and added a biologic if needed at least 3 months later
• An early-combination group of 73 patients who started therapy with a csDMARD and biologic together
• A biologic-first group of 25 patients who started with biologic monotherapy, adding a csDMARD only if needed at least 3 months later.

The primary outcome was the percentage of participants who reached CID without taking glucocorticoids at 24 months. Since the participants were not randomized, the researchers made adjustments to account for baseline differences between the groups, including differences in JIA categories, number of active joints, physician global assessment of disease activity, and the clinical Juvenile Arthritis Disease Activity Score based on 10 joints (cJADAS10).

At 24 months in an intention to treat analysis, 59.4% of the early-combination group had achieved CID, compared with 48% of the biologic-first group and 40.1% of the step-up group (P = .009 for early combination vs. step up). All three groups had improved since the 12-month time point, when 37% of the early-combination group, 24% of the biologic-first group, and 32% of the step-up group had reached CID.

There were no significant differences between the groups in secondary outcomes of achieving cJADAS10 inactive disease of 2.5 or less or 70% improvement in pediatric ACR response criteria at 24 months. All groups improved in PROMIS pain interference or mobility measures from baseline. Most of the 17 severe adverse events were infections.
 

Moving from step-up therapy to early-combination treatment

Dr. Brown said that she spent many years in her practice using the step-up therapy because it was difficult to get insurance companies to pay for biologics without first showing that methotrexate was insufficient.

”But methotrexate takes so long to control the disease that you need a lot of steroids, with all of their side effects, at least temporarily, or you must simply accept a longer period of active and symptomatic disease before you get to that desired state of clinically inactive disease,” Dr. Brown said. “And during that time, you can be accumulating what may be permanent damage to joints, as well as increase in risk of contractures and deconditioning for that child who is too uncomfortable to move and exercise and play normally.”

Dr. Brown is also wary of using a biologic as an initial therapy by itself because the actions of biologics are so specific. ”I like to back up the powerful, rapid, and specific actions of a biologic with the broader, if slower, action of methotrexate to minimize chances that the immune system is going to find a way around blockade of a single cytokine by your biologic,” she said.

While patient preference will also play a role in what CTP patients with polyJIA start with, Dr. Brown said that she believes more medication upfront can result in less medication and better outcomes in the long run, as the findings of this study suggest. The results here are helpful when speaking with families who are anxious about “so much medicine” or “such powerful medicines,” she said. ”I hope it will also help ease the fears of other providers who share the same concerns about ‘so much medicine.’ ”

The study’s biggest limitation is not being a randomized, controlled trial, but Dr. Brown said the researchers demonstrated effectively that the disease burden remains similar across the groups at baseline.

”It would also be useful to have a clear breakdown of adverse events and opportunistic infections because an excess of opportunistic infections would be a key concern with early combination therapy,” she said, although she added that the study overall was a ”beautiful example of the value of registry data.”

Dr. Kimura emphasized that polyJIA remains a challenging disease to treat, with 40%-60% of participants not reaching CID at 24 months. The registry follow-up will continue for up to 10 years to hopefully provide more information about longer-term outcomes from different treatments.

The research was funded by a grant from Genentech to CARRA. Dr. Kimura reported royalties from UpToDate and salary support from CARRA. Dr. Brown had no disclosures.

A number of late-phase clinical trials in lymphoma and multiple myeloma (MM) have opened in recent months. Maybe one of your patients could benefit from being enrolled? 

Untreated peripheral T-cell lymphoma 

Adult patients with peripheral T-cell lymphoma who have received no therapy except corticosteroids are invited to join a phase 2 study testing duvelisib (Copiktra) added to usual chemotherapy. Duvelisib is currently used in relapsed/refractory patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or follicular lymphoma; this study explores first-line use in a different type of lymphoma, so it may be a potential new indication for the drug. All participants will receive a 5-month chemotherapy regimen of cyclophosphamide, doxorubicin (Adriamycin, Rubex), vincristine (Oncovin), prednisone, and etoposide (VePesid). One group will also take oral azacitidine (Vidaza) while the third (experimental) group has oral duvelisib. The primary outcome is complete remission rate; overall survival (OS) is a secondary outcome. Quality of life (QoL) is not measured apart from mood and fatigue. The study opened at Memorial Sloan Kettering Cancer Center on July 30 for up to 170 participants. 

Untreated CLL/SLL 

Patients with CLL/SLL, no 17p deletions, and no prior systemic therapy can join a phase 3 study of pirtobrutinib, an investigational oral tyrosine-kinase inhibitor. Pirtobrutinib targets Bruton's tyrosine kinase, an intracellular signaler that is crucial to the proliferation and survival of leukemic cells. The trial will involve treatment for up to 5 years, with either oral pirtobrutinib or a standard combination of intravenous bendamustine (Treakisym, Treanda, Ribomustin) and rituximab (Ruxience, Riabni, Truxima, Rituxan, MabThera). Investigators at the study site, the California Research Institute in Los Angeles, started recruiting on Sept. 23 hoping for 250 participants. Progression-free survival is the primary outcome, OS is a secondary measure, and QoL will not be tracked.  

Relapsed or refractory follicular lymphoma after one line of therapy

 Adult patients who have CD20-positive follicular lymphoma (grades 1-3A) who have received at least one prior systemic lymphoma therapy can join a phase 3 trial of investigational drug mosunetuzumab combined with lenalidomide (Revlimid, Linamide). Participants in the mosunetuzumab group will be treated with the drug combo for approximately 1 year then followed for 8 years. People in the comparator group will receive a rituximab-lenalidomide combination instead. The trial planned to start enrolling on Oct. 31, looking for a total of 400 people in 144 study locations worldwide, including in nine U.S. states. The primary outcome is progression-free survival. OS is a secondary outcome and, apart from fatigue, QoL parameters will not be assessed.  

Relapsed or refractory follicular lymphoma after two lines of therapy 

Adults with follicular lymphoma (grades 1-3A) despite two or more treatment regimens, including at least one anti-CD20 therapy, are eligible for a phase 2 study of loncastuximab tesirine (Zynlonta). The drug already has an FDA accelerated approval this year for a different lymphoma, relapsed/refractory large B-cell lymphoma, so this could be a new indication. In this trial, it will be compared with idelalisib (Zydelig), which is already approved for follicular lymphoma. Participants will get either an infusion of loncastuximab every 3 weeks or a twice-daily tablet of idelalisib for up to 30 months. Investigators started recruiting on Oct. 30 and hope for 150 participants in Nevada and New Jersey. Complete response rate is the primary outcome. OS and QoL are secondary outcome measures. 

Untreated multiple myeloma not eligible for autologous stem-cell transplant (ASCT) 

Adults with untreated multiple myeloma who are not eligible for stem-cell transplantation are sought for a phase 2 study testing the performance of selinexor (Xpovio) plus dexamethasone. (Prior treatment with emergency steroids and radiation therapy is allowed.) Selinexor plus dexamethasone was approved in 2019 for multiple myeloma after four prior therapies; the goal of this study is to assess its performance as frontline treatment. Participants will receive oral selinexor and dexamethasone for up to 3 years in addition to subcutaneous daratumumab (Darzalex) and capsules of lenalidomide. The study opened Sept. 10, aiming for 100 participants at sites in Arizona, Colorado, Maryland, New York, Oregon, Texas, and Virginia. OS is a secondary outcome measure; QoL will not be assessed.  

Newly diagnosed multiple myeloma where ASCT not planned 

Patients with newly diagnosed multiple myeloma who are not having ASCT as initial therapy are eligible for a phase 3 study of the investigational CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel). This product targets B-cell maturation antigen (BCMA), which is expressed on the surface of mature B lymphocytes and malignant plasma cells; it is in late-stage clinical trials for multiple myeloma but has not yet been approved. In this study, the control-group participants will receive standard therapy for up to approximately 4 years - a regimen of bortezomib (Velcade), lenalidomide, and dexamethasone. Patients destined for cilta-cel will undergo apheresis to garner their T cells, which will then be genetically engineered to express the synthetic antigen receptor, duplicated, and re-infused. During the 6-month wait between apheresis and the cilta-cel infusion, the CAR T patients will receive similar treatment to the control group. Recruitment started for 650 patients across 12 U.S. states and 24 countries on August 19. The primary outcome is progression-free survival. OS and QoL are secondary measures and will be tracked for approximately 12 years. 

All trial information is from the National Institutes of Health U.S. National Library of Medicine.

A version of this article first appeared on Medscape.com

A number of late-phase clinical trials in lymphoma and multiple myeloma (MM) have opened in recent months. Maybe one of your patients could benefit from being enrolled? 

Untreated peripheral T-cell lymphoma 

Adult patients with peripheral T-cell lymphoma who have received no therapy except corticosteroids are invited to join a phase 2 study testing duvelisib (Copiktra) added to usual chemotherapy. Duvelisib is currently used in relapsed/refractory patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or follicular lymphoma; this study explores first-line use in a different type of lymphoma, so it may be a potential new indication for the drug. All participants will receive a 5-month chemotherapy regimen of cyclophosphamide, doxorubicin (Adriamycin, Rubex), vincristine (Oncovin), prednisone, and etoposide (VePesid). One group will also take oral azacitidine (Vidaza) while the third (experimental) group has oral duvelisib. The primary outcome is complete remission rate; overall survival (OS) is a secondary outcome. Quality of life (QoL) is not measured apart from mood and fatigue. The study opened at Memorial Sloan Kettering Cancer Center on July 30 for up to 170 participants. 

Untreated CLL/SLL 

Patients with CLL/SLL, no 17p deletions, and no prior systemic therapy can join a phase 3 study of pirtobrutinib, an investigational oral tyrosine-kinase inhibitor. Pirtobrutinib targets Bruton's tyrosine kinase, an intracellular signaler that is crucial to the proliferation and survival of leukemic cells. The trial will involve treatment for up to 5 years, with either oral pirtobrutinib or a standard combination of intravenous bendamustine (Treakisym, Treanda, Ribomustin) and rituximab (Ruxience, Riabni, Truxima, Rituxan, MabThera). Investigators at the study site, the California Research Institute in Los Angeles, started recruiting on Sept. 23 hoping for 250 participants. Progression-free survival is the primary outcome, OS is a secondary measure, and QoL will not be tracked.  

Relapsed or refractory follicular lymphoma after one line of therapy

 Adult patients who have CD20-positive follicular lymphoma (grades 1-3A) who have received at least one prior systemic lymphoma therapy can join a phase 3 trial of investigational drug mosunetuzumab combined with lenalidomide (Revlimid, Linamide). Participants in the mosunetuzumab group will be treated with the drug combo for approximately 1 year then followed for 8 years. People in the comparator group will receive a rituximab-lenalidomide combination instead. The trial planned to start enrolling on Oct. 31, looking for a total of 400 people in 144 study locations worldwide, including in nine U.S. states. The primary outcome is progression-free survival. OS is a secondary outcome and, apart from fatigue, QoL parameters will not be assessed.  

Relapsed or refractory follicular lymphoma after two lines of therapy 

Adults with follicular lymphoma (grades 1-3A) despite two or more treatment regimens, including at least one anti-CD20 therapy, are eligible for a phase 2 study of loncastuximab tesirine (Zynlonta). The drug already has an FDA accelerated approval this year for a different lymphoma, relapsed/refractory large B-cell lymphoma, so this could be a new indication. In this trial, it will be compared with idelalisib (Zydelig), which is already approved for follicular lymphoma. Participants will get either an infusion of loncastuximab every 3 weeks or a twice-daily tablet of idelalisib for up to 30 months. Investigators started recruiting on Oct. 30 and hope for 150 participants in Nevada and New Jersey. Complete response rate is the primary outcome. OS and QoL are secondary outcome measures. 

Untreated multiple myeloma not eligible for autologous stem-cell transplant (ASCT) 

Adults with untreated multiple myeloma who are not eligible for stem-cell transplantation are sought for a phase 2 study testing the performance of selinexor (Xpovio) plus dexamethasone. (Prior treatment with emergency steroids and radiation therapy is allowed.) Selinexor plus dexamethasone was approved in 2019 for multiple myeloma after four prior therapies; the goal of this study is to assess its performance as frontline treatment. Participants will receive oral selinexor and dexamethasone for up to 3 years in addition to subcutaneous daratumumab (Darzalex) and capsules of lenalidomide. The study opened Sept. 10, aiming for 100 participants at sites in Arizona, Colorado, Maryland, New York, Oregon, Texas, and Virginia. OS is a secondary outcome measure; QoL will not be assessed.  

Newly diagnosed multiple myeloma where ASCT not planned 

Patients with newly diagnosed multiple myeloma who are not having ASCT as initial therapy are eligible for a phase 3 study of the investigational CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel). This product targets B-cell maturation antigen (BCMA), which is expressed on the surface of mature B lymphocytes and malignant plasma cells; it is in late-stage clinical trials for multiple myeloma but has not yet been approved. In this study, the control-group participants will receive standard therapy for up to approximately 4 years - a regimen of bortezomib (Velcade), lenalidomide, and dexamethasone. Patients destined for cilta-cel will undergo apheresis to garner their T cells, which will then be genetically engineered to express the synthetic antigen receptor, duplicated, and re-infused. During the 6-month wait between apheresis and the cilta-cel infusion, the CAR T patients will receive similar treatment to the control group. Recruitment started for 650 patients across 12 U.S. states and 24 countries on August 19. The primary outcome is progression-free survival. OS and QoL are secondary measures and will be tracked for approximately 12 years. 

All trial information is from the National Institutes of Health U.S. National Library of Medicine.

A version of this article first appeared on Medscape.com

A number of late-phase clinical trials in lymphoma and multiple myeloma (MM) have opened in recent months. Maybe one of your patients could benefit from being enrolled? 

Untreated peripheral T-cell lymphoma 

Adult patients with peripheral T-cell lymphoma who have received no therapy except corticosteroids are invited to join a phase 2 study testing duvelisib (Copiktra) added to usual chemotherapy. Duvelisib is currently used in relapsed/refractory patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or follicular lymphoma; this study explores first-line use in a different type of lymphoma, so it may be a potential new indication for the drug. All participants will receive a 5-month chemotherapy regimen of cyclophosphamide, doxorubicin (Adriamycin, Rubex), vincristine (Oncovin), prednisone, and etoposide (VePesid). One group will also take oral azacitidine (Vidaza) while the third (experimental) group has oral duvelisib. The primary outcome is complete remission rate; overall survival (OS) is a secondary outcome. Quality of life (QoL) is not measured apart from mood and fatigue. The study opened at Memorial Sloan Kettering Cancer Center on July 30 for up to 170 participants. 

Untreated CLL/SLL 

Patients with CLL/SLL, no 17p deletions, and no prior systemic therapy can join a phase 3 study of pirtobrutinib, an investigational oral tyrosine-kinase inhibitor. Pirtobrutinib targets Bruton's tyrosine kinase, an intracellular signaler that is crucial to the proliferation and survival of leukemic cells. The trial will involve treatment for up to 5 years, with either oral pirtobrutinib or a standard combination of intravenous bendamustine (Treakisym, Treanda, Ribomustin) and rituximab (Ruxience, Riabni, Truxima, Rituxan, MabThera). Investigators at the study site, the California Research Institute in Los Angeles, started recruiting on Sept. 23 hoping for 250 participants. Progression-free survival is the primary outcome, OS is a secondary measure, and QoL will not be tracked.  

Relapsed or refractory follicular lymphoma after one line of therapy

 Adult patients who have CD20-positive follicular lymphoma (grades 1-3A) who have received at least one prior systemic lymphoma therapy can join a phase 3 trial of investigational drug mosunetuzumab combined with lenalidomide (Revlimid, Linamide). Participants in the mosunetuzumab group will be treated with the drug combo for approximately 1 year then followed for 8 years. People in the comparator group will receive a rituximab-lenalidomide combination instead. The trial planned to start enrolling on Oct. 31, looking for a total of 400 people in 144 study locations worldwide, including in nine U.S. states. The primary outcome is progression-free survival. OS is a secondary outcome and, apart from fatigue, QoL parameters will not be assessed.  

Relapsed or refractory follicular lymphoma after two lines of therapy 

Adults with follicular lymphoma (grades 1-3A) despite two or more treatment regimens, including at least one anti-CD20 therapy, are eligible for a phase 2 study of loncastuximab tesirine (Zynlonta). The drug already has an FDA accelerated approval this year for a different lymphoma, relapsed/refractory large B-cell lymphoma, so this could be a new indication. In this trial, it will be compared with idelalisib (Zydelig), which is already approved for follicular lymphoma. Participants will get either an infusion of loncastuximab every 3 weeks or a twice-daily tablet of idelalisib for up to 30 months. Investigators started recruiting on Oct. 30 and hope for 150 participants in Nevada and New Jersey. Complete response rate is the primary outcome. OS and QoL are secondary outcome measures. 

Untreated multiple myeloma not eligible for autologous stem-cell transplant (ASCT) 

Adults with untreated multiple myeloma who are not eligible for stem-cell transplantation are sought for a phase 2 study testing the performance of selinexor (Xpovio) plus dexamethasone. (Prior treatment with emergency steroids and radiation therapy is allowed.) Selinexor plus dexamethasone was approved in 2019 for multiple myeloma after four prior therapies; the goal of this study is to assess its performance as frontline treatment. Participants will receive oral selinexor and dexamethasone for up to 3 years in addition to subcutaneous daratumumab (Darzalex) and capsules of lenalidomide. The study opened Sept. 10, aiming for 100 participants at sites in Arizona, Colorado, Maryland, New York, Oregon, Texas, and Virginia. OS is a secondary outcome measure; QoL will not be assessed.  

Newly diagnosed multiple myeloma where ASCT not planned 

Patients with newly diagnosed multiple myeloma who are not having ASCT as initial therapy are eligible for a phase 3 study of the investigational CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel). This product targets B-cell maturation antigen (BCMA), which is expressed on the surface of mature B lymphocytes and malignant plasma cells; it is in late-stage clinical trials for multiple myeloma but has not yet been approved. In this study, the control-group participants will receive standard therapy for up to approximately 4 years - a regimen of bortezomib (Velcade), lenalidomide, and dexamethasone. Patients destined for cilta-cel will undergo apheresis to garner their T cells, which will then be genetically engineered to express the synthetic antigen receptor, duplicated, and re-infused. During the 6-month wait between apheresis and the cilta-cel infusion, the CAR T patients will receive similar treatment to the control group. Recruitment started for 650 patients across 12 U.S. states and 24 countries on August 19. The primary outcome is progression-free survival. OS and QoL are secondary measures and will be tracked for approximately 12 years. 

All trial information is from the National Institutes of Health U.S. National Library of Medicine.

A version of this article first appeared on Medscape.com

He always dressed the same at conferences: dark suit, white shirt, bright red bow tie.

Courtesy of Beck Institute for Cognitive Behavior Therapy

For all his fame, he was very kind, warmly greeting those who wanted to see him and immediately turning attention toward their research rather than his own. Aaron Beck actually didn’t lecture much; he preferred to roleplay cognitive therapy with an audience member acting as the patient. He would engage in what he called Socratic questioning, or more formally, cognitive restructuring, with warmth and true curiosity:

• What might be another explanation or viewpoint?
• What are the effects of thinking this way?
• Can you think of any evidence that supports the opposite view?

The audience member/patient would benefit not only from thinking about things differently, but also from the captivating interaction with the man, Aaron Temkin Beck, MD, (who went by Tim), youngest child of Jewish immigrants from the Ukraine.

When written up in treatment manuals, cognitive restructuring can seem cold and overly logical, but in person, Dr. Beck made it come to life. This ability to nurture curiosity was a special talent; his friend and fellow cognitive psychologist Donald Meichenbaum, PhD, recalls that even over lunch, he never stopped asking questions, personal and professional, on a wide range of topics.

It is widely accepted that Dr. Beck, who died Nov. 1 at the age of 100 in suburban Philadelphia, was the most important figure in the field of cognitive-behavioral therapy (CBT).

He didn’t invent the field. Behaviorism predated him by generations, founded by figures such as John Watson and B.F. Skinner. Those psychologists set up behaviorism as an alternative to the reigning power of Freudian psychoanalysis, but they ran a distant second.

It wasn’t until Dr. Beck added a new approach, cognitive therapy, to the behavioristic movement that the new mélange, CBT, began to gain traction with clinicians and researchers. Dr. Beck, who had trained in psychiatry, developed his ideas in the 1960s while observing what he believed were limitations in the classic Freudian methods. He recognized that patients had “automatic thoughts,” not just unconscious emotions, when they engaged in Freudian free association, saying whatever came to their minds.

These thoughts often distorted reality, he observed; they were “maladaptive beliefs,” and when they changed, patients’ emotional states improved.

Dr. Beck wasn’t alone. The psychologist Albert Ellis, PhD, in New York, had come to similar conclusions a decade earlier, though with a more coldly logical and challenging style. The prominent British psychologist Hans Eysenck, PhD, had argued strongly that Freudian psychoanalysis was ineffective and that behavioral approaches were better.

Dr. Beck turned the Freudian equation around: Instead of emotion as cause and thought as effect, it was thought which affected emotion, for better or worse. Once you connected behavior as the outcome, you had the essence of CBT: thought, emotion, and behavior – each affecting the other, with thought being the strongest axis of change.

The process wasn’t bloodless. Behaviorists defended their turf against cognitivists, just as much as Freudians rejected both. At one point the behaviorists in the Association for the Advancement of Behavior Therapy tried to expel the advocates of a cognitive approach. Dr. Beck responded by leading the cognitivists in creating a new journal; he emphasized the importance of research being the main mechanism to decide what treatments worked the best.

Putting these ideas out in the 1960s and 1970s, Dr. Beck garnered support from researchers when he manualized the approach. Freudian psychoanalysis was idiosyncratic; it was almost impossible to study empirically, because the therapist would be responding to the unpredictable dreams and memories of patients engaged in free association. Each case was unique.

But CBT was systematic: The same general approach was taken to all patients; the same negative cognitions were found in depression, for instance, like all-or-nothing thinking or overgeneralization. Once manualized, CBT became the standard method of psychotherapy studied with the newly developed method of randomized controlled trials (RCTs).

By the 1980s, RCTs had proven the efficacy of CBT in depression, and the approach took off.

Dr. Beck already had developed a series of rating scales: the Beck Depression Inventory, the Beck Scale for Suicidal Ideation, the Beck Anxiety Inventory, the Beck Hopelessness Scale. Widely used, these scales extended his influence enormously. Copyrighted, they created a new industry of psychological research.

Dr. Beck’s own work was mainly in depression, but his followers extended it everywhere else: anxiety disorders and phobias, eating disorders, substance abuse, bipolar illness, even schizophrenia. Meanwhile, Freudian psychoanalysis fell into a steep decline from which it never recovered.

Dr. Beck’s CBT became king of the hill in psychotherapy, but it wasn’t without criticism.

Some argued that it was abetted by insurance restrictions on psychotherapy, which favored shorter-term CBT; others that its research was biased in its favor because psychotherapy treatments, unlike medications, cannot be blinded; others that its efficacy could not be shown to be specific to its theory, as opposed to the interpersonal relationship between therapist and client.

Still, CBT has transformed psychotherapy and continues to expand its influence. Computer-based CBT has been proven effective, and digital CBT has become a standard approach in many smartphone applications and is central to the claims of multiple new biotechnology companies advocating for digital psychotherapy.

Aaron Beck continued publishing scientific articles to age 98. His last papers reviewed his life’s work. He characteristically gave credit to others, calmly recollected how he traveled away from psychoanalysis, described how his work started and ended in schizophrenia, and noted that the “working relationship with the therapist” remained a key factor for the success of CBT.

That parting comment reminds us that behind all the technology and research stands the kindly man in the dark suit, white shirt, and bright red bow tie, looking at you warmly, asking about your thoughts, and curiously wondering what might be another explanation or viewpoint you hadn’t considered.
 

Nassir Ghaemi, MD, MPH, is a professor of psychiatry at Tufts Medical Center and a lecturer in psychiatry at Harvard Medical School. He is the author of several general-interest books on psychiatry. A version of this article first appeared on Medscape.com.

He always dressed the same at conferences: dark suit, white shirt, bright red bow tie.

Courtesy of Beck Institute for Cognitive Behavior Therapy

For all his fame, he was very kind, warmly greeting those who wanted to see him and immediately turning attention toward their research rather than his own. Aaron Beck actually didn’t lecture much; he preferred to roleplay cognitive therapy with an audience member acting as the patient. He would engage in what he called Socratic questioning, or more formally, cognitive restructuring, with warmth and true curiosity:

• What might be another explanation or viewpoint?
• What are the effects of thinking this way?
• Can you think of any evidence that supports the opposite view?

The audience member/patient would benefit not only from thinking about things differently, but also from the captivating interaction with the man, Aaron Temkin Beck, MD, (who went by Tim), youngest child of Jewish immigrants from the Ukraine.

When written up in treatment manuals, cognitive restructuring can seem cold and overly logical, but in person, Dr. Beck made it come to life. This ability to nurture curiosity was a special talent; his friend and fellow cognitive psychologist Donald Meichenbaum, PhD, recalls that even over lunch, he never stopped asking questions, personal and professional, on a wide range of topics.

It is widely accepted that Dr. Beck, who died Nov. 1 at the age of 100 in suburban Philadelphia, was the most important figure in the field of cognitive-behavioral therapy (CBT).

He didn’t invent the field. Behaviorism predated him by generations, founded by figures such as John Watson and B.F. Skinner. Those psychologists set up behaviorism as an alternative to the reigning power of Freudian psychoanalysis, but they ran a distant second.

It wasn’t until Dr. Beck added a new approach, cognitive therapy, to the behavioristic movement that the new mélange, CBT, began to gain traction with clinicians and researchers. Dr. Beck, who had trained in psychiatry, developed his ideas in the 1960s while observing what he believed were limitations in the classic Freudian methods. He recognized that patients had “automatic thoughts,” not just unconscious emotions, when they engaged in Freudian free association, saying whatever came to their minds.

These thoughts often distorted reality, he observed; they were “maladaptive beliefs,” and when they changed, patients’ emotional states improved.

Dr. Beck wasn’t alone. The psychologist Albert Ellis, PhD, in New York, had come to similar conclusions a decade earlier, though with a more coldly logical and challenging style. The prominent British psychologist Hans Eysenck, PhD, had argued strongly that Freudian psychoanalysis was ineffective and that behavioral approaches were better.

Dr. Beck turned the Freudian equation around: Instead of emotion as cause and thought as effect, it was thought which affected emotion, for better or worse. Once you connected behavior as the outcome, you had the essence of CBT: thought, emotion, and behavior – each affecting the other, with thought being the strongest axis of change.

The process wasn’t bloodless. Behaviorists defended their turf against cognitivists, just as much as Freudians rejected both. At one point the behaviorists in the Association for the Advancement of Behavior Therapy tried to expel the advocates of a cognitive approach. Dr. Beck responded by leading the cognitivists in creating a new journal; he emphasized the importance of research being the main mechanism to decide what treatments worked the best.

Putting these ideas out in the 1960s and 1970s, Dr. Beck garnered support from researchers when he manualized the approach. Freudian psychoanalysis was idiosyncratic; it was almost impossible to study empirically, because the therapist would be responding to the unpredictable dreams and memories of patients engaged in free association. Each case was unique.

But CBT was systematic: The same general approach was taken to all patients; the same negative cognitions were found in depression, for instance, like all-or-nothing thinking or overgeneralization. Once manualized, CBT became the standard method of psychotherapy studied with the newly developed method of randomized controlled trials (RCTs).

By the 1980s, RCTs had proven the efficacy of CBT in depression, and the approach took off.

Dr. Beck already had developed a series of rating scales: the Beck Depression Inventory, the Beck Scale for Suicidal Ideation, the Beck Anxiety Inventory, the Beck Hopelessness Scale. Widely used, these scales extended his influence enormously. Copyrighted, they created a new industry of psychological research.

Dr. Beck’s own work was mainly in depression, but his followers extended it everywhere else: anxiety disorders and phobias, eating disorders, substance abuse, bipolar illness, even schizophrenia. Meanwhile, Freudian psychoanalysis fell into a steep decline from which it never recovered.

Dr. Beck’s CBT became king of the hill in psychotherapy, but it wasn’t without criticism.

Some argued that it was abetted by insurance restrictions on psychotherapy, which favored shorter-term CBT; others that its research was biased in its favor because psychotherapy treatments, unlike medications, cannot be blinded; others that its efficacy could not be shown to be specific to its theory, as opposed to the interpersonal relationship between therapist and client.

Still, CBT has transformed psychotherapy and continues to expand its influence. Computer-based CBT has been proven effective, and digital CBT has become a standard approach in many smartphone applications and is central to the claims of multiple new biotechnology companies advocating for digital psychotherapy.

Aaron Beck continued publishing scientific articles to age 98. His last papers reviewed his life’s work. He characteristically gave credit to others, calmly recollected how he traveled away from psychoanalysis, described how his work started and ended in schizophrenia, and noted that the “working relationship with the therapist” remained a key factor for the success of CBT.

That parting comment reminds us that behind all the technology and research stands the kindly man in the dark suit, white shirt, and bright red bow tie, looking at you warmly, asking about your thoughts, and curiously wondering what might be another explanation or viewpoint you hadn’t considered.
 

Nassir Ghaemi, MD, MPH, is a professor of psychiatry at Tufts Medical Center and a lecturer in psychiatry at Harvard Medical School. He is the author of several general-interest books on psychiatry. A version of this article first appeared on Medscape.com.

He always dressed the same at conferences: dark suit, white shirt, bright red bow tie.

Courtesy of Beck Institute for Cognitive Behavior Therapy

For all his fame, he was very kind, warmly greeting those who wanted to see him and immediately turning attention toward their research rather than his own. Aaron Beck actually didn’t lecture much; he preferred to roleplay cognitive therapy with an audience member acting as the patient. He would engage in what he called Socratic questioning, or more formally, cognitive restructuring, with warmth and true curiosity:

• What might be another explanation or viewpoint?
• What are the effects of thinking this way?
• Can you think of any evidence that supports the opposite view?

The audience member/patient would benefit not only from thinking about things differently, but also from the captivating interaction with the man, Aaron Temkin Beck, MD, (who went by Tim), youngest child of Jewish immigrants from the Ukraine.

When written up in treatment manuals, cognitive restructuring can seem cold and overly logical, but in person, Dr. Beck made it come to life. This ability to nurture curiosity was a special talent; his friend and fellow cognitive psychologist Donald Meichenbaum, PhD, recalls that even over lunch, he never stopped asking questions, personal and professional, on a wide range of topics.

It is widely accepted that Dr. Beck, who died Nov. 1 at the age of 100 in suburban Philadelphia, was the most important figure in the field of cognitive-behavioral therapy (CBT).

He didn’t invent the field. Behaviorism predated him by generations, founded by figures such as John Watson and B.F. Skinner. Those psychologists set up behaviorism as an alternative to the reigning power of Freudian psychoanalysis, but they ran a distant second.

It wasn’t until Dr. Beck added a new approach, cognitive therapy, to the behavioristic movement that the new mélange, CBT, began to gain traction with clinicians and researchers. Dr. Beck, who had trained in psychiatry, developed his ideas in the 1960s while observing what he believed were limitations in the classic Freudian methods. He recognized that patients had “automatic thoughts,” not just unconscious emotions, when they engaged in Freudian free association, saying whatever came to their minds.

These thoughts often distorted reality, he observed; they were “maladaptive beliefs,” and when they changed, patients’ emotional states improved.

Dr. Beck wasn’t alone. The psychologist Albert Ellis, PhD, in New York, had come to similar conclusions a decade earlier, though with a more coldly logical and challenging style. The prominent British psychologist Hans Eysenck, PhD, had argued strongly that Freudian psychoanalysis was ineffective and that behavioral approaches were better.

Dr. Beck turned the Freudian equation around: Instead of emotion as cause and thought as effect, it was thought which affected emotion, for better or worse. Once you connected behavior as the outcome, you had the essence of CBT: thought, emotion, and behavior – each affecting the other, with thought being the strongest axis of change.

The process wasn’t bloodless. Behaviorists defended their turf against cognitivists, just as much as Freudians rejected both. At one point the behaviorists in the Association for the Advancement of Behavior Therapy tried to expel the advocates of a cognitive approach. Dr. Beck responded by leading the cognitivists in creating a new journal; he emphasized the importance of research being the main mechanism to decide what treatments worked the best.

Putting these ideas out in the 1960s and 1970s, Dr. Beck garnered support from researchers when he manualized the approach. Freudian psychoanalysis was idiosyncratic; it was almost impossible to study empirically, because the therapist would be responding to the unpredictable dreams and memories of patients engaged in free association. Each case was unique.

But CBT was systematic: The same general approach was taken to all patients; the same negative cognitions were found in depression, for instance, like all-or-nothing thinking or overgeneralization. Once manualized, CBT became the standard method of psychotherapy studied with the newly developed method of randomized controlled trials (RCTs).

By the 1980s, RCTs had proven the efficacy of CBT in depression, and the approach took off.

Dr. Beck already had developed a series of rating scales: the Beck Depression Inventory, the Beck Scale for Suicidal Ideation, the Beck Anxiety Inventory, the Beck Hopelessness Scale. Widely used, these scales extended his influence enormously. Copyrighted, they created a new industry of psychological research.

Dr. Beck’s own work was mainly in depression, but his followers extended it everywhere else: anxiety disorders and phobias, eating disorders, substance abuse, bipolar illness, even schizophrenia. Meanwhile, Freudian psychoanalysis fell into a steep decline from which it never recovered.

Dr. Beck’s CBT became king of the hill in psychotherapy, but it wasn’t without criticism.

Some argued that it was abetted by insurance restrictions on psychotherapy, which favored shorter-term CBT; others that its research was biased in its favor because psychotherapy treatments, unlike medications, cannot be blinded; others that its efficacy could not be shown to be specific to its theory, as opposed to the interpersonal relationship between therapist and client.

Still, CBT has transformed psychotherapy and continues to expand its influence. Computer-based CBT has been proven effective, and digital CBT has become a standard approach in many smartphone applications and is central to the claims of multiple new biotechnology companies advocating for digital psychotherapy.

Aaron Beck continued publishing scientific articles to age 98. His last papers reviewed his life’s work. He characteristically gave credit to others, calmly recollected how he traveled away from psychoanalysis, described how his work started and ended in schizophrenia, and noted that the “working relationship with the therapist” remained a key factor for the success of CBT.

That parting comment reminds us that behind all the technology and research stands the kindly man in the dark suit, white shirt, and bright red bow tie, looking at you warmly, asking about your thoughts, and curiously wondering what might be another explanation or viewpoint you hadn’t considered.
 

Nassir Ghaemi, MD, MPH, is a professor of psychiatry at Tufts Medical Center and a lecturer in psychiatry at Harvard Medical School. He is the author of several general-interest books on psychiatry. A version of this article first appeared on Medscape.com.

LAS VEGAS – Risankizumab (Skyrizi, AbbVie) provides early and lasting benefits for patients with Crohn’s disease, phase 3 trials indicate.

Based on these and other recent findings, the drug could be used as a first-line treatment and even displace ustekinumab (Stelara, Janssen), which itself was approved by the Food and Drug Administration for Crohn’s disease in 2016, according to David Rubin, MD, the Joseph B. Kirsner Professor of Medicine at the University of Chicago.

“The drug works fast,” Dr. Rubin said in an interview. “If you start this therapy in patients with moderate to severe Crohn’s disease, they’re likely to feel better within the first few weeks.”

Dr. Rubin presented the findings on the drug’s early onset at the annual meeting of the American College of Gastroenterology. A related trial presented at the meeting showed the drug continuing to perform well up to 52 weeks.

Advances in immunomodulation have allowed drug companies to feed multiple new therapies into the pipeline for Crohn’s disease and related conditions in recent years, giving hope to the many patients who have not been able to benefit from older classes of drugs, such as biologics.

A humanized immunoglobulin G1 (IgG1) monoclonal antibody, risankizumab blocks interleukin (IL) 23 by binding to its p19 subunit. IL-23 is a cytokine implicated in several chronic immune disorders, including Crohn’s disease and psoriasis. Researchers hope that risankizumab will prove more selective, with a better safety profile, than previous drugs in its class. The FDA approved risankizumab in April 2019 for the treatment of moderate to severe plaque psoriasis.
 

MOTIVATE and ADVANCE studies

The two induction trials for Crohn’s disease enrolled slightly different populations.

The MOTIVATE study enrolled patients who had responded inadequately or were intolerant to biologic therapy. In this trial, the investigators assigned 205 patients to 1,200 mg of risankizumab, 206 patients to 600 mg of risankizumab, and 207 patients to placebo.

The ADVANCE study enrolled patients who had responded inadequately or could not tolerate either biologic or conventional therapy. In this trial, investigators randomly assigned 372 patients to 1,200 mg of risankizumab, 373 patients to 600 mg of risankizumab, and 186 patients to placebo.

In both trials, intravenous injections were given at weeks 0, 4, and 8.

The researchers defined a Crohn’s Disease Activity Index (CDAI) clinical remission as a score less than 150. They defined a Stool Frequency and Abdominal Pain Score (SF/APS) clinical remission as a soft stool frequency of no more than 2.8, and an abdominal pain score of no more than 1 and not worse than baseline.

A CDAI clinical response was at least a 100-point decrease from baseline. The SF/APS enhanced clinical response was at least a 60% decrease in average daily stool frequency or at least a 35% decrease in average daily abdominal pain, with both not worse than baseline.

At 4 weeks, the researchers found that the percentage of patients who achieved CDAI clinical remission in both risankizumab groups of both studies was greater than in the placebo group. The difference was statistically significant (P ≤ .01 in ADVANCE and P ≤ .05 in MOTIVATE), and it continued to grow at 8 weeks and 12 weeks.

By 12 weeks in the ADVANCE trial, according to a press release from AbbVie, 45% of patients on the 600-mg dose of risankizumab and 42% on the 1,200-mg dose of risankizumab had achieved CDAI clinical remission, compared with 25% of those on placebo, which was statistically significant (P < .001). For the MOTIVATE trial, the results were significantly better for patients in the risankizumab groups than for those in the placebo group.

In both trials, the treated groups continued to improve faster than the placebo groups through 12 weeks. Improvements in SF/APS enhanced clinical response largely paralleled those for CDAI clinical remission.

“It did show very good results,” session moderator Jonathan Leighton, MD, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix, Ariz., said in an interview with Medscape Medical News. “But basically, it’s so early that we don’t have all the data.” In particular, he would have liked to see whether patients responded to the drug before week 4.
 

FORTIFY study

In FORTIFY, the maintenance trial that followed, the researchers rerandomized those patients who had responded to risankizumab into three groups. Two groups received subcutaneous injections of risankizumab, with 179 patients getting 360 mg and another 179 patients getting 180 mg. The placebo group included the remaining 184 patients.

At week 52, 40.9% of patients in the placebo group were in clinical remission, compared with 52.2% in the 360-mg group and 55.4% in the 180-mg group, which was statistically significant (P = .005 for 360 mg, and P = .003 for 180 mg.)

“It showed us that [risankizumab] could achieve deep remission, which means patients achieving remission endoscopically in combination with clinical remission,” the presenter, Marla Dubinsky, MD, professor of pediatrics and medicine in the division of pediatric gastroenterology at Icahn School of Medicine at Mount Sinai in New York, said in an interview.

Over the 52 weeks, deep remission and endoscopic remission rates increased in the 360-mg group, held steady in the 180-mg group, and decreased in the placebo group. Mean fecal calprotectin and C-reactive protein levels decreased in the risankizumab groups and increased in the placebo group.

There were more total treatment-emergent adverse events per 100 patient-years in the placebo group (339.7) than in the 360-mg group (269.3) or the 180-mg group (283.5). The same difference between groups was true of severe treatment-emergent adverse events. Serious events and events leading to discontinuation were similar in the three groups.

Dr. Leighton reports financial relationships to Olympus and Pfizer. Dr. Rubin reports financial relationships to AbbVie, AltruBio, Allergan, Arena Pharmaceuticals, Athos Therapeutics, Bellatrix, Boehringer Ingelheim, Bristol Myers Squibb, Celgene/Syneos, Connect Biopharma, GalenPharma/Atlantica, Genentech/Roche, Gilead, InDex Pharmaceuticals, Ironwood, Iterative Scopes, Janssen, Lilly, Materia Prima Farmaceutica, Pfizer, Prometheus Biosciences, Reistone, Takeda, and TECHLAB. Dr. Dubinsky reports financial relationships to all or most of the companies making drugs for inflammatory bowel disease. The studies were funded by AbbVie.

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

LAS VEGAS – Risankizumab (Skyrizi, AbbVie) provides early and lasting benefits for patients with Crohn’s disease, phase 3 trials indicate.

Based on these and other recent findings, the drug could be used as a first-line treatment and even displace ustekinumab (Stelara, Janssen), which itself was approved by the Food and Drug Administration for Crohn’s disease in 2016, according to David Rubin, MD, the Joseph B. Kirsner Professor of Medicine at the University of Chicago.

“The drug works fast,” Dr. Rubin said in an interview. “If you start this therapy in patients with moderate to severe Crohn’s disease, they’re likely to feel better within the first few weeks.”

Dr. Rubin presented the findings on the drug’s early onset at the annual meeting of the American College of Gastroenterology. A related trial presented at the meeting showed the drug continuing to perform well up to 52 weeks.

Advances in immunomodulation have allowed drug companies to feed multiple new therapies into the pipeline for Crohn’s disease and related conditions in recent years, giving hope to the many patients who have not been able to benefit from older classes of drugs, such as biologics.

A humanized immunoglobulin G1 (IgG1) monoclonal antibody, risankizumab blocks interleukin (IL) 23 by binding to its p19 subunit. IL-23 is a cytokine implicated in several chronic immune disorders, including Crohn’s disease and psoriasis. Researchers hope that risankizumab will prove more selective, with a better safety profile, than previous drugs in its class. The FDA approved risankizumab in April 2019 for the treatment of moderate to severe plaque psoriasis.
 

MOTIVATE and ADVANCE studies

The two induction trials for Crohn’s disease enrolled slightly different populations.

The MOTIVATE study enrolled patients who had responded inadequately or were intolerant to biologic therapy. In this trial, the investigators assigned 205 patients to 1,200 mg of risankizumab, 206 patients to 600 mg of risankizumab, and 207 patients to placebo.

The ADVANCE study enrolled patients who had responded inadequately or could not tolerate either biologic or conventional therapy. In this trial, investigators randomly assigned 372 patients to 1,200 mg of risankizumab, 373 patients to 600 mg of risankizumab, and 186 patients to placebo.

In both trials, intravenous injections were given at weeks 0, 4, and 8.

The researchers defined a Crohn’s Disease Activity Index (CDAI) clinical remission as a score less than 150. They defined a Stool Frequency and Abdominal Pain Score (SF/APS) clinical remission as a soft stool frequency of no more than 2.8, and an abdominal pain score of no more than 1 and not worse than baseline.

A CDAI clinical response was at least a 100-point decrease from baseline. The SF/APS enhanced clinical response was at least a 60% decrease in average daily stool frequency or at least a 35% decrease in average daily abdominal pain, with both not worse than baseline.

At 4 weeks, the researchers found that the percentage of patients who achieved CDAI clinical remission in both risankizumab groups of both studies was greater than in the placebo group. The difference was statistically significant (P ≤ .01 in ADVANCE and P ≤ .05 in MOTIVATE), and it continued to grow at 8 weeks and 12 weeks.

By 12 weeks in the ADVANCE trial, according to a press release from AbbVie, 45% of patients on the 600-mg dose of risankizumab and 42% on the 1,200-mg dose of risankizumab had achieved CDAI clinical remission, compared with 25% of those on placebo, which was statistically significant (P < .001). For the MOTIVATE trial, the results were significantly better for patients in the risankizumab groups than for those in the placebo group.

In both trials, the treated groups continued to improve faster than the placebo groups through 12 weeks. Improvements in SF/APS enhanced clinical response largely paralleled those for CDAI clinical remission.

“It did show very good results,” session moderator Jonathan Leighton, MD, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix, Ariz., said in an interview with Medscape Medical News. “But basically, it’s so early that we don’t have all the data.” In particular, he would have liked to see whether patients responded to the drug before week 4.
 

FORTIFY study

In FORTIFY, the maintenance trial that followed, the researchers rerandomized those patients who had responded to risankizumab into three groups. Two groups received subcutaneous injections of risankizumab, with 179 patients getting 360 mg and another 179 patients getting 180 mg. The placebo group included the remaining 184 patients.

At week 52, 40.9% of patients in the placebo group were in clinical remission, compared with 52.2% in the 360-mg group and 55.4% in the 180-mg group, which was statistically significant (P = .005 for 360 mg, and P = .003 for 180 mg.)

“It showed us that [risankizumab] could achieve deep remission, which means patients achieving remission endoscopically in combination with clinical remission,” the presenter, Marla Dubinsky, MD, professor of pediatrics and medicine in the division of pediatric gastroenterology at Icahn School of Medicine at Mount Sinai in New York, said in an interview.

Over the 52 weeks, deep remission and endoscopic remission rates increased in the 360-mg group, held steady in the 180-mg group, and decreased in the placebo group. Mean fecal calprotectin and C-reactive protein levels decreased in the risankizumab groups and increased in the placebo group.

There were more total treatment-emergent adverse events per 100 patient-years in the placebo group (339.7) than in the 360-mg group (269.3) or the 180-mg group (283.5). The same difference between groups was true of severe treatment-emergent adverse events. Serious events and events leading to discontinuation were similar in the three groups.

Dr. Leighton reports financial relationships to Olympus and Pfizer. Dr. Rubin reports financial relationships to AbbVie, AltruBio, Allergan, Arena Pharmaceuticals, Athos Therapeutics, Bellatrix, Boehringer Ingelheim, Bristol Myers Squibb, Celgene/Syneos, Connect Biopharma, GalenPharma/Atlantica, Genentech/Roche, Gilead, InDex Pharmaceuticals, Ironwood, Iterative Scopes, Janssen, Lilly, Materia Prima Farmaceutica, Pfizer, Prometheus Biosciences, Reistone, Takeda, and TECHLAB. Dr. Dubinsky reports financial relationships to all or most of the companies making drugs for inflammatory bowel disease. The studies were funded by AbbVie.

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

LAS VEGAS – Risankizumab (Skyrizi, AbbVie) provides early and lasting benefits for patients with Crohn’s disease, phase 3 trials indicate.

Based on these and other recent findings, the drug could be used as a first-line treatment and even displace ustekinumab (Stelara, Janssen), which itself was approved by the Food and Drug Administration for Crohn’s disease in 2016, according to David Rubin, MD, the Joseph B. Kirsner Professor of Medicine at the University of Chicago.

“The drug works fast,” Dr. Rubin said in an interview. “If you start this therapy in patients with moderate to severe Crohn’s disease, they’re likely to feel better within the first few weeks.”

Dr. Rubin presented the findings on the drug’s early onset at the annual meeting of the American College of Gastroenterology. A related trial presented at the meeting showed the drug continuing to perform well up to 52 weeks.

Advances in immunomodulation have allowed drug companies to feed multiple new therapies into the pipeline for Crohn’s disease and related conditions in recent years, giving hope to the many patients who have not been able to benefit from older classes of drugs, such as biologics.

A humanized immunoglobulin G1 (IgG1) monoclonal antibody, risankizumab blocks interleukin (IL) 23 by binding to its p19 subunit. IL-23 is a cytokine implicated in several chronic immune disorders, including Crohn’s disease and psoriasis. Researchers hope that risankizumab will prove more selective, with a better safety profile, than previous drugs in its class. The FDA approved risankizumab in April 2019 for the treatment of moderate to severe plaque psoriasis.
 

MOTIVATE and ADVANCE studies

The two induction trials for Crohn’s disease enrolled slightly different populations.

The MOTIVATE study enrolled patients who had responded inadequately or were intolerant to biologic therapy. In this trial, the investigators assigned 205 patients to 1,200 mg of risankizumab, 206 patients to 600 mg of risankizumab, and 207 patients to placebo.

The ADVANCE study enrolled patients who had responded inadequately or could not tolerate either biologic or conventional therapy. In this trial, investigators randomly assigned 372 patients to 1,200 mg of risankizumab, 373 patients to 600 mg of risankizumab, and 186 patients to placebo.

In both trials, intravenous injections were given at weeks 0, 4, and 8.

The researchers defined a Crohn’s Disease Activity Index (CDAI) clinical remission as a score less than 150. They defined a Stool Frequency and Abdominal Pain Score (SF/APS) clinical remission as a soft stool frequency of no more than 2.8, and an abdominal pain score of no more than 1 and not worse than baseline.

A CDAI clinical response was at least a 100-point decrease from baseline. The SF/APS enhanced clinical response was at least a 60% decrease in average daily stool frequency or at least a 35% decrease in average daily abdominal pain, with both not worse than baseline.

At 4 weeks, the researchers found that the percentage of patients who achieved CDAI clinical remission in both risankizumab groups of both studies was greater than in the placebo group. The difference was statistically significant (P ≤ .01 in ADVANCE and P ≤ .05 in MOTIVATE), and it continued to grow at 8 weeks and 12 weeks.

By 12 weeks in the ADVANCE trial, according to a press release from AbbVie, 45% of patients on the 600-mg dose of risankizumab and 42% on the 1,200-mg dose of risankizumab had achieved CDAI clinical remission, compared with 25% of those on placebo, which was statistically significant (P < .001). For the MOTIVATE trial, the results were significantly better for patients in the risankizumab groups than for those in the placebo group.

In both trials, the treated groups continued to improve faster than the placebo groups through 12 weeks. Improvements in SF/APS enhanced clinical response largely paralleled those for CDAI clinical remission.

“It did show very good results,” session moderator Jonathan Leighton, MD, professor of medicine and chair of the division of gastroenterology at Mayo Clinic in Phoenix, Ariz., said in an interview with Medscape Medical News. “But basically, it’s so early that we don’t have all the data.” In particular, he would have liked to see whether patients responded to the drug before week 4.
 

FORTIFY study

In FORTIFY, the maintenance trial that followed, the researchers rerandomized those patients who had responded to risankizumab into three groups. Two groups received subcutaneous injections of risankizumab, with 179 patients getting 360 mg and another 179 patients getting 180 mg. The placebo group included the remaining 184 patients.

At week 52, 40.9% of patients in the placebo group were in clinical remission, compared with 52.2% in the 360-mg group and 55.4% in the 180-mg group, which was statistically significant (P = .005 for 360 mg, and P = .003 for 180 mg.)

“It showed us that [risankizumab] could achieve deep remission, which means patients achieving remission endoscopically in combination with clinical remission,” the presenter, Marla Dubinsky, MD, professor of pediatrics and medicine in the division of pediatric gastroenterology at Icahn School of Medicine at Mount Sinai in New York, said in an interview.

Over the 52 weeks, deep remission and endoscopic remission rates increased in the 360-mg group, held steady in the 180-mg group, and decreased in the placebo group. Mean fecal calprotectin and C-reactive protein levels decreased in the risankizumab groups and increased in the placebo group.

There were more total treatment-emergent adverse events per 100 patient-years in the placebo group (339.7) than in the 360-mg group (269.3) or the 180-mg group (283.5). The same difference between groups was true of severe treatment-emergent adverse events. Serious events and events leading to discontinuation were similar in the three groups.

Dr. Leighton reports financial relationships to Olympus and Pfizer. Dr. Rubin reports financial relationships to AbbVie, AltruBio, Allergan, Arena Pharmaceuticals, Athos Therapeutics, Bellatrix, Boehringer Ingelheim, Bristol Myers Squibb, Celgene/Syneos, Connect Biopharma, GalenPharma/Atlantica, Genentech/Roche, Gilead, InDex Pharmaceuticals, Ironwood, Iterative Scopes, Janssen, Lilly, Materia Prima Farmaceutica, Pfizer, Prometheus Biosciences, Reistone, Takeda, and TECHLAB. Dr. Dubinsky reports financial relationships to all or most of the companies making drugs for inflammatory bowel disease. The studies were funded by AbbVie.

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

Dr Nichole Tanner, associate professor at the University of South Carolina, discusses new data on lung cancer biomarker testing from CHEST 2021.  

First, Dr Tanner shares two abstracts that discuss how endobronchial ultrasound (EBUS) demonstrated high-success yields in next-generation sequencing. One of the abstracts looked at EBUS transbronchial needle aspiration in patients with lung cancer, whereas the other examined EBUS-guided fine needle aspiration in patients with nonsquamous non–small cell lung cancer. 

Next, she discusses a small study that demonstrated the ability of the Percepta Genomic Sequencing Classifier to successfully reclassify patients in whom bronchoscopy was nondiagnostic. About half of the patients were either down-classified to low risk, which can help to avoid additional invasive procedures, or up-classified to high risk, which can inform next steps for intervention.  

Dr Tanner concludes by reviewing a retrospective analysis of the PANOPTIC clinical trial, which used the Nodify CDT test to evaluate a panel of seven lung cancer–associated autoantibodies in study patients who had incidentally discovered indeterminate pulmonary nodules. The autoantibodies were able to detect likely malignant nodules regardless of lung cancer type, histology, or stage. 

--

Nichole T. Tanner, MD, MSCR, FCCP, Associate Professor, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina 

Nichole T. Tanner, MD, MSCR, FCCP, has disclosed no relevant financial relationships. 

Dr Nichole Tanner, associate professor at the University of South Carolina, discusses new data on lung cancer biomarker testing from CHEST 2021.  

First, Dr Tanner shares two abstracts that discuss how endobronchial ultrasound (EBUS) demonstrated high-success yields in next-generation sequencing. One of the abstracts looked at EBUS transbronchial needle aspiration in patients with lung cancer, whereas the other examined EBUS-guided fine needle aspiration in patients with nonsquamous non–small cell lung cancer. 

Next, she discusses a small study that demonstrated the ability of the Percepta Genomic Sequencing Classifier to successfully reclassify patients in whom bronchoscopy was nondiagnostic. About half of the patients were either down-classified to low risk, which can help to avoid additional invasive procedures, or up-classified to high risk, which can inform next steps for intervention.  

Dr Tanner concludes by reviewing a retrospective analysis of the PANOPTIC clinical trial, which used the Nodify CDT test to evaluate a panel of seven lung cancer–associated autoantibodies in study patients who had incidentally discovered indeterminate pulmonary nodules. The autoantibodies were able to detect likely malignant nodules regardless of lung cancer type, histology, or stage. 

--

Nichole T. Tanner, MD, MSCR, FCCP, Associate Professor, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina 

Nichole T. Tanner, MD, MSCR, FCCP, has disclosed no relevant financial relationships. 

Dr Nichole Tanner, associate professor at the University of South Carolina, discusses new data on lung cancer biomarker testing from CHEST 2021.  

First, Dr Tanner shares two abstracts that discuss how endobronchial ultrasound (EBUS) demonstrated high-success yields in next-generation sequencing. One of the abstracts looked at EBUS transbronchial needle aspiration in patients with lung cancer, whereas the other examined EBUS-guided fine needle aspiration in patients with nonsquamous non–small cell lung cancer. 

Next, she discusses a small study that demonstrated the ability of the Percepta Genomic Sequencing Classifier to successfully reclassify patients in whom bronchoscopy was nondiagnostic. About half of the patients were either down-classified to low risk, which can help to avoid additional invasive procedures, or up-classified to high risk, which can inform next steps for intervention.  

Dr Tanner concludes by reviewing a retrospective analysis of the PANOPTIC clinical trial, which used the Nodify CDT test to evaluate a panel of seven lung cancer–associated autoantibodies in study patients who had incidentally discovered indeterminate pulmonary nodules. The autoantibodies were able to detect likely malignant nodules regardless of lung cancer type, histology, or stage. 

--

Nichole T. Tanner, MD, MSCR, FCCP, Associate Professor, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina 

Nichole T. Tanner, MD, MSCR, FCCP, has disclosed no relevant financial relationships. 

The rate of major adverse cardiac events (MACE) over 5 years is similar whether revascularization is guided by instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR), according to long-term results of the iFR-SWEDEHEART study.

“The results are about the same as reported at 12 months. There were no significant differences in any outcome we evaluated,” according to Matthias Götberg, MD, PhD.

When the initial results of the noninferiority iFR-SWEDEHEART trial were published after 1 year of follow-up, the primary MACE endpoint of death from any-cause nonfatal myocardial infarction, or unplanned revascularization, was met by 6.7% and 6.1% of those randomized to iFR or FFR, respectively.

These outcomes were not significantly different and placed iFR well within the predefined boundaries of noninferiority (P = .007).

In this new and final follow-up of iFR-SWEDEHEART, which evaluated the same 2,019 patients who were alive at 1 year (none were lost to follow-up), the MACE endpoint was met by 21.5% and 19.9% of those managed with iFR and FFR, respectively. The hazard ratio (1.09) had a wide 95% confidence interval (0.90-1.31) that did not approach statistical significance.
 

No differences seen across outcomes

When broken down into the MACE components, there were no differences between iFR and FFR, respectively, for all-cause death (9.4% vs. 7.9%), MI (5.8% vs. 5.7%) or unplanned revascularization (11.6% vs. 11.3%).

Across predefined subgroups, such as those defined by age, gender, stable versus unstable angina, and presence of risk factors such as diabetes, hypertension, hyperlipidemia, and smoking, there were also no significant differences in outcome.

At the time iFR-SWEDEHART was initiated, FFR had already been accepted as more effective than angiographic assessment to identify lesion ischemia and the need for percutaneous intervention (PCI). The iFR-SWEDEHEART trial tested iFR, a relatively new technology at the time, as a noninferior alternative. Unlike FFR, which requires adenosine to dilate the vessel, adding cost and patient discomfort, iFR measures the resting pressure gradient across the coronary lesion, and it is generally easier to perform.

“The advantage of iFR is that it provides an instantaneous lesion assessment without the need for adenosine,” Dr. Götberg explained in presenting the results at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

When the procedural results were compared in the published study at 1 year, it was noted that the mean number of lesions evaluated per patient was higher (1.55 vs. 1.43; P = .002), but the proportion of lesions found functionally significant was lower (29.2% vs. 36.8%; P < .0001) among those randomized to iFR than in the FFR group.

While most other procedural characteristics, such as PCI access route, fluoroscopy time, and contrast use did not differ significantly, fewer stents were placed in patients managed with iFR (1.58 vs. 1.73; P = .048), and a reduction in the average procedural time of a few minutes approached significance (P = .09).
 

Patient discomfort is greater with FFR

Patient discomfort measured during the procedure did differ, according to Dr. Götberg, an interventional cardiologist at Skåne University Hospital, Lund, Sweden.

Only about 30% in the FFR group reported no discomfort. Most of the others reported mild or moderate discomfort, but nearly 10% characterized the discomfort as severe. In the iFR group, more than 95% reported no discomfort. All of the remaining patients reported discomfort level as mild.

Because differences in MACE would be most likely to occur in the first year after revascularization, the similarity of the 1- and 5-year results were expected, according to Dr. Götberg. However, a 5-year follow-up was considered prudent given the relatively limited experience with iFR when the study was designed. This technique is now well established and widely used.

The study supports the premise that quicker and easier-to-obtain results with iFR are obtained without sacrificing greater relative risk of failing to identify a vulnerable lesion, according to Dr. Götberg.

Nevertheless, iFR and FFR “are not an exact match,” according to Jennifer A. Rymer, MD, an interventional cardiologist and assistant professor of medicine at Duke University, Durham, N.C. Although she called this trial an “excellent” demonstration of comparable utility in distinguishing lesions that do not require intervention from those that do, she implied that some clinicians might still prefer FFR for other reasons.

For example, FFR provides information about coronary flow reserve and microvascular resistance that are relevant to the underlying pathophysiology in a diseased vessel, according to Shmuel Banai, MD, head of interventional cardiology, Tel Aviv Medical Center. Recognizing that this information is not as readily generated by iFR, he is among those who plan to continue to use FFR despite these results.

However, for those who are now routinely performing iFR for the purposes of guiding revascularization, “these data are reassuring,” said David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta. The 5-year data essentially eliminate the likelihood that iFR relative to FFR increases the risk of missing functionally significant lesions for revascularization procedures.

Dr. Götberg reports financial relationships with Abbott, Boston Scientific, Medtronic, and Phillips Healthcare. Dr. Rymer reports no potential financial conflicts of interest. Dr. Banai has a financial relationship with Neovasc. Dr. Kandzari reports financial relationships with Ablative Solutions and Medtronic.

The rate of major adverse cardiac events (MACE) over 5 years is similar whether revascularization is guided by instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR), according to long-term results of the iFR-SWEDEHEART study.

“The results are about the same as reported at 12 months. There were no significant differences in any outcome we evaluated,” according to Matthias Götberg, MD, PhD.

When the initial results of the noninferiority iFR-SWEDEHEART trial were published after 1 year of follow-up, the primary MACE endpoint of death from any-cause nonfatal myocardial infarction, or unplanned revascularization, was met by 6.7% and 6.1% of those randomized to iFR or FFR, respectively.

These outcomes were not significantly different and placed iFR well within the predefined boundaries of noninferiority (P = .007).

In this new and final follow-up of iFR-SWEDEHEART, which evaluated the same 2,019 patients who were alive at 1 year (none were lost to follow-up), the MACE endpoint was met by 21.5% and 19.9% of those managed with iFR and FFR, respectively. The hazard ratio (1.09) had a wide 95% confidence interval (0.90-1.31) that did not approach statistical significance.
 

No differences seen across outcomes

When broken down into the MACE components, there were no differences between iFR and FFR, respectively, for all-cause death (9.4% vs. 7.9%), MI (5.8% vs. 5.7%) or unplanned revascularization (11.6% vs. 11.3%).

Across predefined subgroups, such as those defined by age, gender, stable versus unstable angina, and presence of risk factors such as diabetes, hypertension, hyperlipidemia, and smoking, there were also no significant differences in outcome.

At the time iFR-SWEDEHART was initiated, FFR had already been accepted as more effective than angiographic assessment to identify lesion ischemia and the need for percutaneous intervention (PCI). The iFR-SWEDEHEART trial tested iFR, a relatively new technology at the time, as a noninferior alternative. Unlike FFR, which requires adenosine to dilate the vessel, adding cost and patient discomfort, iFR measures the resting pressure gradient across the coronary lesion, and it is generally easier to perform.

“The advantage of iFR is that it provides an instantaneous lesion assessment without the need for adenosine,” Dr. Götberg explained in presenting the results at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

When the procedural results were compared in the published study at 1 year, it was noted that the mean number of lesions evaluated per patient was higher (1.55 vs. 1.43; P = .002), but the proportion of lesions found functionally significant was lower (29.2% vs. 36.8%; P < .0001) among those randomized to iFR than in the FFR group.

While most other procedural characteristics, such as PCI access route, fluoroscopy time, and contrast use did not differ significantly, fewer stents were placed in patients managed with iFR (1.58 vs. 1.73; P = .048), and a reduction in the average procedural time of a few minutes approached significance (P = .09).
 

Patient discomfort is greater with FFR

Patient discomfort measured during the procedure did differ, according to Dr. Götberg, an interventional cardiologist at Skåne University Hospital, Lund, Sweden.

Only about 30% in the FFR group reported no discomfort. Most of the others reported mild or moderate discomfort, but nearly 10% characterized the discomfort as severe. In the iFR group, more than 95% reported no discomfort. All of the remaining patients reported discomfort level as mild.

Because differences in MACE would be most likely to occur in the first year after revascularization, the similarity of the 1- and 5-year results were expected, according to Dr. Götberg. However, a 5-year follow-up was considered prudent given the relatively limited experience with iFR when the study was designed. This technique is now well established and widely used.

The study supports the premise that quicker and easier-to-obtain results with iFR are obtained without sacrificing greater relative risk of failing to identify a vulnerable lesion, according to Dr. Götberg.

Nevertheless, iFR and FFR “are not an exact match,” according to Jennifer A. Rymer, MD, an interventional cardiologist and assistant professor of medicine at Duke University, Durham, N.C. Although she called this trial an “excellent” demonstration of comparable utility in distinguishing lesions that do not require intervention from those that do, she implied that some clinicians might still prefer FFR for other reasons.

For example, FFR provides information about coronary flow reserve and microvascular resistance that are relevant to the underlying pathophysiology in a diseased vessel, according to Shmuel Banai, MD, head of interventional cardiology, Tel Aviv Medical Center. Recognizing that this information is not as readily generated by iFR, he is among those who plan to continue to use FFR despite these results.

However, for those who are now routinely performing iFR for the purposes of guiding revascularization, “these data are reassuring,” said David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta. The 5-year data essentially eliminate the likelihood that iFR relative to FFR increases the risk of missing functionally significant lesions for revascularization procedures.

Dr. Götberg reports financial relationships with Abbott, Boston Scientific, Medtronic, and Phillips Healthcare. Dr. Rymer reports no potential financial conflicts of interest. Dr. Banai has a financial relationship with Neovasc. Dr. Kandzari reports financial relationships with Ablative Solutions and Medtronic.

The rate of major adverse cardiac events (MACE) over 5 years is similar whether revascularization is guided by instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR), according to long-term results of the iFR-SWEDEHEART study.

“The results are about the same as reported at 12 months. There were no significant differences in any outcome we evaluated,” according to Matthias Götberg, MD, PhD.

When the initial results of the noninferiority iFR-SWEDEHEART trial were published after 1 year of follow-up, the primary MACE endpoint of death from any-cause nonfatal myocardial infarction, or unplanned revascularization, was met by 6.7% and 6.1% of those randomized to iFR or FFR, respectively.

These outcomes were not significantly different and placed iFR well within the predefined boundaries of noninferiority (P = .007).

In this new and final follow-up of iFR-SWEDEHEART, which evaluated the same 2,019 patients who were alive at 1 year (none were lost to follow-up), the MACE endpoint was met by 21.5% and 19.9% of those managed with iFR and FFR, respectively. The hazard ratio (1.09) had a wide 95% confidence interval (0.90-1.31) that did not approach statistical significance.
 

No differences seen across outcomes

When broken down into the MACE components, there were no differences between iFR and FFR, respectively, for all-cause death (9.4% vs. 7.9%), MI (5.8% vs. 5.7%) or unplanned revascularization (11.6% vs. 11.3%).

Across predefined subgroups, such as those defined by age, gender, stable versus unstable angina, and presence of risk factors such as diabetes, hypertension, hyperlipidemia, and smoking, there were also no significant differences in outcome.

At the time iFR-SWEDEHART was initiated, FFR had already been accepted as more effective than angiographic assessment to identify lesion ischemia and the need for percutaneous intervention (PCI). The iFR-SWEDEHEART trial tested iFR, a relatively new technology at the time, as a noninferior alternative. Unlike FFR, which requires adenosine to dilate the vessel, adding cost and patient discomfort, iFR measures the resting pressure gradient across the coronary lesion, and it is generally easier to perform.

“The advantage of iFR is that it provides an instantaneous lesion assessment without the need for adenosine,” Dr. Götberg explained in presenting the results at the Transcatheter Cardiovascular Therapeutics annual meeting, held virtually and live in Orlando.

When the procedural results were compared in the published study at 1 year, it was noted that the mean number of lesions evaluated per patient was higher (1.55 vs. 1.43; P = .002), but the proportion of lesions found functionally significant was lower (29.2% vs. 36.8%; P < .0001) among those randomized to iFR than in the FFR group.

While most other procedural characteristics, such as PCI access route, fluoroscopy time, and contrast use did not differ significantly, fewer stents were placed in patients managed with iFR (1.58 vs. 1.73; P = .048), and a reduction in the average procedural time of a few minutes approached significance (P = .09).
 

Patient discomfort is greater with FFR

Patient discomfort measured during the procedure did differ, according to Dr. Götberg, an interventional cardiologist at Skåne University Hospital, Lund, Sweden.

Only about 30% in the FFR group reported no discomfort. Most of the others reported mild or moderate discomfort, but nearly 10% characterized the discomfort as severe. In the iFR group, more than 95% reported no discomfort. All of the remaining patients reported discomfort level as mild.

Because differences in MACE would be most likely to occur in the first year after revascularization, the similarity of the 1- and 5-year results were expected, according to Dr. Götberg. However, a 5-year follow-up was considered prudent given the relatively limited experience with iFR when the study was designed. This technique is now well established and widely used.

The study supports the premise that quicker and easier-to-obtain results with iFR are obtained without sacrificing greater relative risk of failing to identify a vulnerable lesion, according to Dr. Götberg.

Nevertheless, iFR and FFR “are not an exact match,” according to Jennifer A. Rymer, MD, an interventional cardiologist and assistant professor of medicine at Duke University, Durham, N.C. Although she called this trial an “excellent” demonstration of comparable utility in distinguishing lesions that do not require intervention from those that do, she implied that some clinicians might still prefer FFR for other reasons.

For example, FFR provides information about coronary flow reserve and microvascular resistance that are relevant to the underlying pathophysiology in a diseased vessel, according to Shmuel Banai, MD, head of interventional cardiology, Tel Aviv Medical Center. Recognizing that this information is not as readily generated by iFR, he is among those who plan to continue to use FFR despite these results.

However, for those who are now routinely performing iFR for the purposes of guiding revascularization, “these data are reassuring,” said David Kandzari, MD, director of interventional cardiology, Piedmont Hart Institute, Atlanta. The 5-year data essentially eliminate the likelihood that iFR relative to FFR increases the risk of missing functionally significant lesions for revascularization procedures.

Dr. Götberg reports financial relationships with Abbott, Boston Scientific, Medtronic, and Phillips Healthcare. Dr. Rymer reports no potential financial conflicts of interest. Dr. Banai has a financial relationship with Neovasc. Dr. Kandzari reports financial relationships with Ablative Solutions and Medtronic.

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

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

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

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

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

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

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

A weekend, for most of us in solo practice, doesn’t really signify time off from work. It just means we’re not seeing patients at the office.

There’s always business stuff to do like payroll and paying bills, records to review, the never-ending forms for a million things, and all the other stuff there never seems to be enough time to do on weekdays.

This weekend I started attacking the pile after dinner on Friday and found myself done by Saturday afternoon, which is rare. Usually I spend the better part of a weekend at my desk.

And then, unexpectedly faced with an empty desk, I found myself wondering what to do next.

Boredom is one of the odder human conditions. I have no idea if any other animal experiences it. Certainly, at least for us, there are more ways to entertain ourselves now than there ever have been – TV, Netflix, phone games, TikTok, books, just to name a few.

But do we always have to be entertained? Many great scientists have said that world-changing ideas have come to them when they weren’t working, such as while showering or riding to work. Leo Szilard was crossing a London street in 1933 when he suddenly saw how a nuclear chain reaction would be self-sustaining once initiated. Fortunately he wasn’t hit by a car in the process.

But I’m not Szilard. So I rationalized a reason not to exercise and sat on the couch with a book.

The remarkable human brain doesn’t shut down easily. With nothing else to do, most mammals tend do doze off. But not us. Our brains are always on, trying to think of the next goal, the next move, the next whatever.

Having nothing to do sounds like a great idea, until you have nothing to do. It may be fine for a few days, but after a while you realize there’s only so long you can stare at the waves or mountains before your mind turns back to “what’s next.” Many patients tell me how retirement sounded good until they got there and then found themselves volunteering or taking new jobs just to keep busy.

This isn’t a bad thing. Being bored is probably constructive. Without realizing it we use it to form new ideas and start new plans.

Maybe this is why we are where we are. The mind that keeps working is a powerful tool, driving us forward in all walks of life. Perhaps it’s this feature that pushed the development of intelligence further and led us to form civilizations.

It’s how we keep moving forward.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”

At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.

The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. Dr. Gupta advised obtaining phone numbers for crisis services relevant to the location of the patient, and this requires confirming that the patient is where he or she was expected to be.

In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.

The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.

One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.

Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.

Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.

Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.

During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.

“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.

Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.

Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.

“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
 

Uncertainty about future use

Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.

“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.

It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.

“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.

Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.

“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.

For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”

At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.

The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. Dr. Gupta advised obtaining phone numbers for crisis services relevant to the location of the patient, and this requires confirming that the patient is where he or she was expected to be.

In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.

The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.

One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.

Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.

Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.

Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.

During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.

“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.

Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.

Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.

“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
 

Uncertainty about future use

Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.

“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.

It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.

“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.

Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.

“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.

For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”

At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.

The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. Dr. Gupta advised obtaining phone numbers for crisis services relevant to the location of the patient, and this requires confirming that the patient is where he or she was expected to be.

In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.

The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.

One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.

Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.

Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.

Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.

During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.

“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.

Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.

Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.

“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
 

Uncertainty about future use

Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.

“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.

It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.

“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.

Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.

“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.