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Exercise tied to reduced Parkinson’s motor symptoms and increased well-being
A systematic review of 156 clinical trials involving 8,000 patients with Parkinson’s disease showed dancing and aquatic exercise, in particular, were most likely to improve motor symptoms, while swimming, endurance training, and mind-body training were most likely to benefit quality of life.
“For most types of exercise we studied, we observed positive effects on both the severity of motor signs and quality of life. These results highlight the importance of exercise in general, as they suggest people with Parkinson’s disease can benefit from a variety of exercises,” said study investigator Moritz Ernst, MSc, deputy head of the working group on evidence-based medicine at the University Hospital Cologne (Germany).
“Clinicians and people with Parkinson’s disease may have several options of exercise programs to choose from when establishing an individual training routine,” he added, emphasizing that overall those with Parkinson’s disease should seek professional advice, including assessment of motor and nonmotor symptoms, to develop a training agenda based on their individual needs.
The study was published online in the Cochrane Database of Systematic Reviews.
May I have this dance?
The investigators analyzed data from randomized, controlled trials comparing different types of exercise and no exercise and the subsequent effect on Parkinson’s disease symptoms. Exercise included dance, strength-resistance training, mind-body training such as tai chi and yoga, water-based training, resistance training, gait/balance/functional training, and endurance training.
The average age of study participants ranged from 60 to 74 years, and most of the studies included patients with mild to moderate Parkinson’s disease. The mean length of the various interventions was 12 weeks.
When the researchers examined the effect of exercise on motor symptoms, they found that dance (P = .88), aqua-based training (P = .69), and gait/balance/functional training (P = .67) were most likely to reduce symptom severity.
Aqua-based training (P = .95), endurance training (P = .77), and mind-body training (P = .75) were most were most likely to benefit quality of life, although the investigators caution that these findings were at risk of bias because quality of life was self-reported.
The investigators noted other study limitations including the fact that most of the studies included in the review had small sample sizes and their study only included patients with mild to moderate versus severe Parkinson’s disease.
The authors said that future research should include larger samples, report intent-to-treat analyses, and involve participants with more advanced forms of Parkinson’s disease who may also have cognitive difficulties.
Prescribe exercise
“We should be giving our patients, no matter where they are in their disease stage, a ‘prescription’ to exercise,” said Mitra Afshari, MD, MPH. Dr. Afshari was not involved in the study but leads her own research on Parkinson’s disease and exercise as the site principal investigator on the National Institutes of Health–funded SPARX3 Study in Parkinson’s Disease and Exercise at Rush University in Chicago. She said that, based on her experience caring for patients with Parkinson’s disease at all disease stages, “patients who have been physically active their whole lives and can maintain that activity despite their diagnosis fare the best.”
However, she added, those who initiate physical exercise after diagnosis can also do very well and reap benefits, including improved motor symptoms.
The study was funded by University Hospital of Cologne, Faculty of Medicine and University Hospital, University of Cologne, and the German Ministry of Education and Research. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A systematic review of 156 clinical trials involving 8,000 patients with Parkinson’s disease showed dancing and aquatic exercise, in particular, were most likely to improve motor symptoms, while swimming, endurance training, and mind-body training were most likely to benefit quality of life.
“For most types of exercise we studied, we observed positive effects on both the severity of motor signs and quality of life. These results highlight the importance of exercise in general, as they suggest people with Parkinson’s disease can benefit from a variety of exercises,” said study investigator Moritz Ernst, MSc, deputy head of the working group on evidence-based medicine at the University Hospital Cologne (Germany).
“Clinicians and people with Parkinson’s disease may have several options of exercise programs to choose from when establishing an individual training routine,” he added, emphasizing that overall those with Parkinson’s disease should seek professional advice, including assessment of motor and nonmotor symptoms, to develop a training agenda based on their individual needs.
The study was published online in the Cochrane Database of Systematic Reviews.
May I have this dance?
The investigators analyzed data from randomized, controlled trials comparing different types of exercise and no exercise and the subsequent effect on Parkinson’s disease symptoms. Exercise included dance, strength-resistance training, mind-body training such as tai chi and yoga, water-based training, resistance training, gait/balance/functional training, and endurance training.
The average age of study participants ranged from 60 to 74 years, and most of the studies included patients with mild to moderate Parkinson’s disease. The mean length of the various interventions was 12 weeks.
When the researchers examined the effect of exercise on motor symptoms, they found that dance (P = .88), aqua-based training (P = .69), and gait/balance/functional training (P = .67) were most likely to reduce symptom severity.
Aqua-based training (P = .95), endurance training (P = .77), and mind-body training (P = .75) were most were most likely to benefit quality of life, although the investigators caution that these findings were at risk of bias because quality of life was self-reported.
The investigators noted other study limitations including the fact that most of the studies included in the review had small sample sizes and their study only included patients with mild to moderate versus severe Parkinson’s disease.
The authors said that future research should include larger samples, report intent-to-treat analyses, and involve participants with more advanced forms of Parkinson’s disease who may also have cognitive difficulties.
Prescribe exercise
“We should be giving our patients, no matter where they are in their disease stage, a ‘prescription’ to exercise,” said Mitra Afshari, MD, MPH. Dr. Afshari was not involved in the study but leads her own research on Parkinson’s disease and exercise as the site principal investigator on the National Institutes of Health–funded SPARX3 Study in Parkinson’s Disease and Exercise at Rush University in Chicago. She said that, based on her experience caring for patients with Parkinson’s disease at all disease stages, “patients who have been physically active their whole lives and can maintain that activity despite their diagnosis fare the best.”
However, she added, those who initiate physical exercise after diagnosis can also do very well and reap benefits, including improved motor symptoms.
The study was funded by University Hospital of Cologne, Faculty of Medicine and University Hospital, University of Cologne, and the German Ministry of Education and Research. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A systematic review of 156 clinical trials involving 8,000 patients with Parkinson’s disease showed dancing and aquatic exercise, in particular, were most likely to improve motor symptoms, while swimming, endurance training, and mind-body training were most likely to benefit quality of life.
“For most types of exercise we studied, we observed positive effects on both the severity of motor signs and quality of life. These results highlight the importance of exercise in general, as they suggest people with Parkinson’s disease can benefit from a variety of exercises,” said study investigator Moritz Ernst, MSc, deputy head of the working group on evidence-based medicine at the University Hospital Cologne (Germany).
“Clinicians and people with Parkinson’s disease may have several options of exercise programs to choose from when establishing an individual training routine,” he added, emphasizing that overall those with Parkinson’s disease should seek professional advice, including assessment of motor and nonmotor symptoms, to develop a training agenda based on their individual needs.
The study was published online in the Cochrane Database of Systematic Reviews.
May I have this dance?
The investigators analyzed data from randomized, controlled trials comparing different types of exercise and no exercise and the subsequent effect on Parkinson’s disease symptoms. Exercise included dance, strength-resistance training, mind-body training such as tai chi and yoga, water-based training, resistance training, gait/balance/functional training, and endurance training.
The average age of study participants ranged from 60 to 74 years, and most of the studies included patients with mild to moderate Parkinson’s disease. The mean length of the various interventions was 12 weeks.
When the researchers examined the effect of exercise on motor symptoms, they found that dance (P = .88), aqua-based training (P = .69), and gait/balance/functional training (P = .67) were most likely to reduce symptom severity.
Aqua-based training (P = .95), endurance training (P = .77), and mind-body training (P = .75) were most were most likely to benefit quality of life, although the investigators caution that these findings were at risk of bias because quality of life was self-reported.
The investigators noted other study limitations including the fact that most of the studies included in the review had small sample sizes and their study only included patients with mild to moderate versus severe Parkinson’s disease.
The authors said that future research should include larger samples, report intent-to-treat analyses, and involve participants with more advanced forms of Parkinson’s disease who may also have cognitive difficulties.
Prescribe exercise
“We should be giving our patients, no matter where they are in their disease stage, a ‘prescription’ to exercise,” said Mitra Afshari, MD, MPH. Dr. Afshari was not involved in the study but leads her own research on Parkinson’s disease and exercise as the site principal investigator on the National Institutes of Health–funded SPARX3 Study in Parkinson’s Disease and Exercise at Rush University in Chicago. She said that, based on her experience caring for patients with Parkinson’s disease at all disease stages, “patients who have been physically active their whole lives and can maintain that activity despite their diagnosis fare the best.”
However, she added, those who initiate physical exercise after diagnosis can also do very well and reap benefits, including improved motor symptoms.
The study was funded by University Hospital of Cologne, Faculty of Medicine and University Hospital, University of Cologne, and the German Ministry of Education and Research. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE COCHRANE DATABASE OF SYSTEMATIC REVIEWS
Telehealth services tied to a major reduction in opioid overdose deaths
, a new study of Medicare beneficiaries shows.
Telehealth services for opioid use disorder (OUD) were used far more often during the pandemic than before COVID-19, and those who used them were 33% less likely to die of a drug overdose.
Investigators also found a significant increase in MOUD use during the pandemic. Fatal drug overdoses were 59% less likely among individuals who received MOUD from an opioid treatment program and 38% less likely among those treated with buprenorphine in an office-based setting.
The results come as policymakers are preparing for the end of the public health emergency that prompted the expansion of OUD-related telehealth and MOUD prescribing and are deciding whether to make those expansions permanent.
“The expansion of telehealth during the COVID-19 pandemic appears to have had positive effects on patients receiving MOUD, improved retention among patients who received MOUD, and lowered risks for both nonfatal and fatal overdose,” lead investigator Christopher M. Jones, PharmD, DrPH, director of the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention, Atlanta, Georgia, told this news organization. “Our results suggest that telehealth is a valuable tool in the toolbox for expanding access to and improving retention on MOUD.”
The findings were published online in JAMA Psychiatry.
Increase in treatment
The study included 105,162 Medicare beneficiaries who began OUD treatment between March and August in 2019 (prepandemic cohort; 67.6%
aged 45-74 years), and 70,479 who began treatment between March and August of 2020 (pandemic cohort; 66.3% aged 45-74 years).
Participants had not received OUD treatment in the 6 months leading up to study enrollment and were followed for 6 months after treatment began.
Significantly more study participants received OUD-related telehealth services during the pandemic than prior to 2019 (19.6% vs. 0.6%; P < .001). Receipt of MOUD was also significantly higher in the pandemic cohort (12.6% vs. 10.8%; P < .001).
The rate of drug overdose deaths was higher in the pandemic cohort (5.1 deaths vs. 3.7 deaths per 1,000 beneficiaries; P < .001). But the percentage of deaths from drug overdoses did not differ between groups (4.8% in the prepandemic cohort vs. 5.1% in the pandemic cohort; P = .49).
In the pandemic cohort, fatal drug overdoses were 33% less likely among those who received OUD-related telehealth services (adjusted odds ratio, 0.67; 95% confidence interval, 0.48-0.92); 59% less likely among those who received MOUD from opioid treatment programs (aOR, 0.41; 95% CI, 0.25-0.68), and 38% less likely among those who received buprenorphine in office-based settings (aOR, 0.62; 95% CI, 0.43-0.91).
Risk of fatal overdose was significantly lower among women and those aged 65 years and older. There were no significant differences in risk based on urban or rural residency or on ethnicity.
“Against the backdrop of a highly potent illicit drug supply driven by illicit fentanyl and fentanyl analogues and historically large increases in overdose deaths during the COVID-19 pandemic, MOUD was still highly effective at reducing risk for fatal overdose,” Dr. Jones said.
While the use of buprenorphine in office-based settings was associated with a decreased risk of overdose death, use of extended-release naltrexone was not.
“Prior research has demonstrated the effectiveness of extended-release naltrexone in the treatment of opioid use disorder,” Dr. Jones said. “However, research has also shown that patients have challenges getting started, or inducted, on extended-release naltrexone.”
An earlier study by Dr. Jones and colleagues showed that rates of retention were lower with extended-release naltrexone, compared with buprenorphine in office-based settings or MOUD from opioid treatment programs.
The new study included only a small number of individuals who were receiving extended-release naltrexone, which may have influenced the findings. In addition, challenges with induction and retention may be driving the results, Dr. Jones noted.
“Efforts to improve induction and retention with extended-release naltrexone are important areas for future research and clinical practice,” he added.
An important engagement tool
A number of questions about telehealth care for OUD remain, including whether increased access to care accounts for the reduction in drug overdose risk that the investigators found or whether other factors are at play.
“There is still more we need to understand about telehealth, such as the quality of care provided and the particular aspects of care provided by telehealth and how this influences health outcomes,” Dr. Jones said.
The results also suggest treatments for OUD are still not finding their way to patients who might benefit, he added.
“Despite the positive findings and the prior research showing that MOUD is highly effective, we found that only one in five patients received telehealth services and only one in eight received any MOUD. This really underscores the need to expand these services across clinical settings,” he added.
These and earlier findings demonstrate the potential benefits of continuing pandemic-era expansion of OUD-related telehealth services and MOUD access, Dr. Jones said.
In preparation for the end of the public health emergency on May 1, the Drug Enforcement Agency recently released a proposal that would allow providers to prescribe a 30-day supply of buprenorphine, but for patients to receive additional prescriptions, a face-to-face meeting would be required. The proposal has drawn criticism from addiction medicine specialists.
The current study didn’t explore if or how the proposal might affect patients with OUD or whether it could blunt the positive effects of the findings.
“Prior research shows that keeping individuals engaged in treatment, including on medications, is a critical part of reducing the negative health and social impacts of opioid use disorder. Our results suggest that telehealth can be an important tool in helping patients engage in and stay connected in care,” said Dr. Jones.
The study was funded by the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, and the National Institutes of Health. Dr. Johnson reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
, a new study of Medicare beneficiaries shows.
Telehealth services for opioid use disorder (OUD) were used far more often during the pandemic than before COVID-19, and those who used them were 33% less likely to die of a drug overdose.
Investigators also found a significant increase in MOUD use during the pandemic. Fatal drug overdoses were 59% less likely among individuals who received MOUD from an opioid treatment program and 38% less likely among those treated with buprenorphine in an office-based setting.
The results come as policymakers are preparing for the end of the public health emergency that prompted the expansion of OUD-related telehealth and MOUD prescribing and are deciding whether to make those expansions permanent.
“The expansion of telehealth during the COVID-19 pandemic appears to have had positive effects on patients receiving MOUD, improved retention among patients who received MOUD, and lowered risks for both nonfatal and fatal overdose,” lead investigator Christopher M. Jones, PharmD, DrPH, director of the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention, Atlanta, Georgia, told this news organization. “Our results suggest that telehealth is a valuable tool in the toolbox for expanding access to and improving retention on MOUD.”
The findings were published online in JAMA Psychiatry.
Increase in treatment
The study included 105,162 Medicare beneficiaries who began OUD treatment between March and August in 2019 (prepandemic cohort; 67.6%
aged 45-74 years), and 70,479 who began treatment between March and August of 2020 (pandemic cohort; 66.3% aged 45-74 years).
Participants had not received OUD treatment in the 6 months leading up to study enrollment and were followed for 6 months after treatment began.
Significantly more study participants received OUD-related telehealth services during the pandemic than prior to 2019 (19.6% vs. 0.6%; P < .001). Receipt of MOUD was also significantly higher in the pandemic cohort (12.6% vs. 10.8%; P < .001).
The rate of drug overdose deaths was higher in the pandemic cohort (5.1 deaths vs. 3.7 deaths per 1,000 beneficiaries; P < .001). But the percentage of deaths from drug overdoses did not differ between groups (4.8% in the prepandemic cohort vs. 5.1% in the pandemic cohort; P = .49).
In the pandemic cohort, fatal drug overdoses were 33% less likely among those who received OUD-related telehealth services (adjusted odds ratio, 0.67; 95% confidence interval, 0.48-0.92); 59% less likely among those who received MOUD from opioid treatment programs (aOR, 0.41; 95% CI, 0.25-0.68), and 38% less likely among those who received buprenorphine in office-based settings (aOR, 0.62; 95% CI, 0.43-0.91).
Risk of fatal overdose was significantly lower among women and those aged 65 years and older. There were no significant differences in risk based on urban or rural residency or on ethnicity.
“Against the backdrop of a highly potent illicit drug supply driven by illicit fentanyl and fentanyl analogues and historically large increases in overdose deaths during the COVID-19 pandemic, MOUD was still highly effective at reducing risk for fatal overdose,” Dr. Jones said.
While the use of buprenorphine in office-based settings was associated with a decreased risk of overdose death, use of extended-release naltrexone was not.
“Prior research has demonstrated the effectiveness of extended-release naltrexone in the treatment of opioid use disorder,” Dr. Jones said. “However, research has also shown that patients have challenges getting started, or inducted, on extended-release naltrexone.”
An earlier study by Dr. Jones and colleagues showed that rates of retention were lower with extended-release naltrexone, compared with buprenorphine in office-based settings or MOUD from opioid treatment programs.
The new study included only a small number of individuals who were receiving extended-release naltrexone, which may have influenced the findings. In addition, challenges with induction and retention may be driving the results, Dr. Jones noted.
“Efforts to improve induction and retention with extended-release naltrexone are important areas for future research and clinical practice,” he added.
An important engagement tool
A number of questions about telehealth care for OUD remain, including whether increased access to care accounts for the reduction in drug overdose risk that the investigators found or whether other factors are at play.
“There is still more we need to understand about telehealth, such as the quality of care provided and the particular aspects of care provided by telehealth and how this influences health outcomes,” Dr. Jones said.
The results also suggest treatments for OUD are still not finding their way to patients who might benefit, he added.
“Despite the positive findings and the prior research showing that MOUD is highly effective, we found that only one in five patients received telehealth services and only one in eight received any MOUD. This really underscores the need to expand these services across clinical settings,” he added.
These and earlier findings demonstrate the potential benefits of continuing pandemic-era expansion of OUD-related telehealth services and MOUD access, Dr. Jones said.
In preparation for the end of the public health emergency on May 1, the Drug Enforcement Agency recently released a proposal that would allow providers to prescribe a 30-day supply of buprenorphine, but for patients to receive additional prescriptions, a face-to-face meeting would be required. The proposal has drawn criticism from addiction medicine specialists.
The current study didn’t explore if or how the proposal might affect patients with OUD or whether it could blunt the positive effects of the findings.
“Prior research shows that keeping individuals engaged in treatment, including on medications, is a critical part of reducing the negative health and social impacts of opioid use disorder. Our results suggest that telehealth can be an important tool in helping patients engage in and stay connected in care,” said Dr. Jones.
The study was funded by the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, and the National Institutes of Health. Dr. Johnson reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
, a new study of Medicare beneficiaries shows.
Telehealth services for opioid use disorder (OUD) were used far more often during the pandemic than before COVID-19, and those who used them were 33% less likely to die of a drug overdose.
Investigators also found a significant increase in MOUD use during the pandemic. Fatal drug overdoses were 59% less likely among individuals who received MOUD from an opioid treatment program and 38% less likely among those treated with buprenorphine in an office-based setting.
The results come as policymakers are preparing for the end of the public health emergency that prompted the expansion of OUD-related telehealth and MOUD prescribing and are deciding whether to make those expansions permanent.
“The expansion of telehealth during the COVID-19 pandemic appears to have had positive effects on patients receiving MOUD, improved retention among patients who received MOUD, and lowered risks for both nonfatal and fatal overdose,” lead investigator Christopher M. Jones, PharmD, DrPH, director of the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention, Atlanta, Georgia, told this news organization. “Our results suggest that telehealth is a valuable tool in the toolbox for expanding access to and improving retention on MOUD.”
The findings were published online in JAMA Psychiatry.
Increase in treatment
The study included 105,162 Medicare beneficiaries who began OUD treatment between March and August in 2019 (prepandemic cohort; 67.6%
aged 45-74 years), and 70,479 who began treatment between March and August of 2020 (pandemic cohort; 66.3% aged 45-74 years).
Participants had not received OUD treatment in the 6 months leading up to study enrollment and were followed for 6 months after treatment began.
Significantly more study participants received OUD-related telehealth services during the pandemic than prior to 2019 (19.6% vs. 0.6%; P < .001). Receipt of MOUD was also significantly higher in the pandemic cohort (12.6% vs. 10.8%; P < .001).
The rate of drug overdose deaths was higher in the pandemic cohort (5.1 deaths vs. 3.7 deaths per 1,000 beneficiaries; P < .001). But the percentage of deaths from drug overdoses did not differ between groups (4.8% in the prepandemic cohort vs. 5.1% in the pandemic cohort; P = .49).
In the pandemic cohort, fatal drug overdoses were 33% less likely among those who received OUD-related telehealth services (adjusted odds ratio, 0.67; 95% confidence interval, 0.48-0.92); 59% less likely among those who received MOUD from opioid treatment programs (aOR, 0.41; 95% CI, 0.25-0.68), and 38% less likely among those who received buprenorphine in office-based settings (aOR, 0.62; 95% CI, 0.43-0.91).
Risk of fatal overdose was significantly lower among women and those aged 65 years and older. There were no significant differences in risk based on urban or rural residency or on ethnicity.
“Against the backdrop of a highly potent illicit drug supply driven by illicit fentanyl and fentanyl analogues and historically large increases in overdose deaths during the COVID-19 pandemic, MOUD was still highly effective at reducing risk for fatal overdose,” Dr. Jones said.
While the use of buprenorphine in office-based settings was associated with a decreased risk of overdose death, use of extended-release naltrexone was not.
“Prior research has demonstrated the effectiveness of extended-release naltrexone in the treatment of opioid use disorder,” Dr. Jones said. “However, research has also shown that patients have challenges getting started, or inducted, on extended-release naltrexone.”
An earlier study by Dr. Jones and colleagues showed that rates of retention were lower with extended-release naltrexone, compared with buprenorphine in office-based settings or MOUD from opioid treatment programs.
The new study included only a small number of individuals who were receiving extended-release naltrexone, which may have influenced the findings. In addition, challenges with induction and retention may be driving the results, Dr. Jones noted.
“Efforts to improve induction and retention with extended-release naltrexone are important areas for future research and clinical practice,” he added.
An important engagement tool
A number of questions about telehealth care for OUD remain, including whether increased access to care accounts for the reduction in drug overdose risk that the investigators found or whether other factors are at play.
“There is still more we need to understand about telehealth, such as the quality of care provided and the particular aspects of care provided by telehealth and how this influences health outcomes,” Dr. Jones said.
The results also suggest treatments for OUD are still not finding their way to patients who might benefit, he added.
“Despite the positive findings and the prior research showing that MOUD is highly effective, we found that only one in five patients received telehealth services and only one in eight received any MOUD. This really underscores the need to expand these services across clinical settings,” he added.
These and earlier findings demonstrate the potential benefits of continuing pandemic-era expansion of OUD-related telehealth services and MOUD access, Dr. Jones said.
In preparation for the end of the public health emergency on May 1, the Drug Enforcement Agency recently released a proposal that would allow providers to prescribe a 30-day supply of buprenorphine, but for patients to receive additional prescriptions, a face-to-face meeting would be required. The proposal has drawn criticism from addiction medicine specialists.
The current study didn’t explore if or how the proposal might affect patients with OUD or whether it could blunt the positive effects of the findings.
“Prior research shows that keeping individuals engaged in treatment, including on medications, is a critical part of reducing the negative health and social impacts of opioid use disorder. Our results suggest that telehealth can be an important tool in helping patients engage in and stay connected in care,” said Dr. Jones.
The study was funded by the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, and the National Institutes of Health. Dr. Johnson reports no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Biosimilars and patients: Discussions should address safety, cost, and anxiety about change
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar. 
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar.
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
Rheumatologist Marcus Snow, MD, is comfortable with prescribing biosimilars as a first-line, first-time biologic, and discussing them with patients.
“If a biosimilar is on the market, it has gone through rigorous study proving its effectiveness and equivalence to a bio-originator,” said Dr. Snow, a rheumatologist with the University of Nebraska Medical Center, Omaha, and chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
The formulary makes a big difference in the conversation about options, he said. “The formularies dictate what we can prescribe. It may not be appropriate, but it is reality. The cost of biologics for a patient without insurance coverage makes it impossible to afford.”
He will often tell patients that he’ll fight any changes or formulary restrictions he does not agree with. “However, when I see patients in follow-up, even if there is no known change on the horizon, I may bring up biosimilars when we have a moment to chat about them to familiarize them with what may happen in the future.”
The need for patient education on biosimilars presents a barrier to realizing their potential to save money and expand choice, noted Cardinal Health in its 2023 biosimilars report. Of 103 rheumatologists who responded to a Cardinal Health survey, 85% agreed that patient education was important. But those conversations can take an uncomfortable turn if the patient pushes back against taking a biosimilar owing to cost or safety concerns.
It’s not uncommon for a patient to express some anxiety about biosimilars, especially if they’re doing well on a current treatment plan. Most patients do not want any changes that may lead to worsening disease control, Dr. Snow said.
Patients and physicians alike often don’t understand the mechanics of biosimilars. “There’s a lot of misinformation about this,” said Sameer Awsare, MD, an associate executive director for The Permanente Medical Group in Campbell, Calif. Patients should know that a biosimilar will be as clinically efficacious as the medicine they’ve been on, with the same safety profiles, said Dr. Awsare, who works with Kaiser Permanente’s pharmacy partners on biosimilars.
Insurance often drives the conversation
The global anti-inflammatory biologics market is anticipated to reach $150 billion by 2027, according to a recent CVS report. As of March 2023, the Food and Drug Administration had approved 40 biosimilars to 11 different reference products. There are 28 on the U.S. market and 100 more in development. Projected to save more than $180 billion over the next 5 years, they are anticipated to expand choice and drive competition.
Rheumatologists, dermatologists, and gastroenterologists are frequent prescribers, although their choices for immune-mediated inflammatory diseases are limited to tumor necrosis factor inhibitors (infliximab [Remicade] originator and adalimumab [Humira] originator) and anti-CD20 agents, such as rituximab (Rituxan) originator.
Benefit design or formulary usually dictates what medicine a patient receives. “Because of significantly higher out-of-pocket cost or formulary positioning, patients may end up with a generic or a biosimilar instead of a brand-name medicine or branded biologic,” said Robert Popovian, PharmD, MS, chief science policy officer of the Global Healthy Living Foundation.
Insurers rarely offer both Remicade and biosimilar infliximab, allowing the doctor to choose, said Miguel Regueiro, MD, chair of the Cleveland Clinic’s Digestive Disease & Surgery Institute, who prescribes infliximab biosimilars. Most often, the payer will choose the lower-cost biosimilar. “I am fine with the biosimilar, either as a new start or a switch from the reference product.”
However, the patient might feel differently. They can form an attachment to the reference medication if it has prevented severe illness. “They do not want to change, as they feel they are going on a ‘new’ medication that will not work as well,” Dr. Regueiro said.
This is where the education comes in: to reassure patients that a biosimilar will work just as well as the reference product. “For patients who have done well for years on a biologic, more time needs to be spent reassuring them and answering questions,” compared with a patient just starting on a biosimilar, he advised.
But not all physicians are quick to prescribe biosimilars.
Especially with psoriasis, which has so many strong options for reference drugs, a switch may be hard to justify, said dermatologist Stephanie K. Fabbro, MD, assistant professor at Northeast Ohio Medical University, Rootstown. “If I have a preference, I would rather switch a patient to a drug from a different class without a biosimilar option to reduce the possibility of pushback.”
Dr. Fabbro, part of the core faculty in the Riverside Methodist Hospital Dermatology Residency Program in Columbus, will share data from clinical trials and postmarket surveillance with patients to support her decision.
Conversations about cost
Patients may also push back if they don’t save money when switching to a biosimilar. “This dilemma raises the question of who is profiting when a biosimilar is dispensed,” Dr. Popovian said. Insurers and pharmacy benefit managers (PBMs) that take additional concessions from biopharmaceutical manufacturers in the form of rebates and fees will often pocket this money as profit instead of passing savings back to the patient to help reduce their out-of-pocket requirement, he added.
If an originator biologic and a biosimilar are available, “as a pharmacist, I will choose the medicine that will incur the lowest out-of-pocket cost for the patient,” Dr. Popovian said.
Discussing cost – and who dictates which biosimilar is on the formulary – is an important conversation to have with patients, said Vivek Kaul, MD, Segal-Watson Professor of Medicine at the University of Rochester (N.Y.) Medical Center.
Providing equivalent clinical efficacy while saving costs is the economic reality of biosimilars, Dr. Kaul said. Third-party payers regularly evaluate how to provide the same quality of care while saving money. Physicians and patients alike “must be mindful that as time goes on, if the science on biosimilars stays robust, if the adoption is more widespread and the cost-saving proposition turns out to be true, more formularies will be attracted to replacing the reference product with the biosimilar counterpart.”
Providers and patients can weigh the options if a formulary suddenly switches to a biosimilar, Dr. Kaul continued. “You can accept the novel product on the formulary or may have to face out-of-pocket expenses as a patient.” If providers and patients have concerns about the biosimilar, they can always appeal if there’s solid scientific evidence that supports reverting back to the reference product.
“If you think the biosimilar is equally efficacious, comes at a lower cost, and is right for the patient, then the providers should tell the patient that,” he added.
Some studies have questioned whether the biosimilars will save money, compared with the reference drug, Dr. Fabbro noted. Medicare, for example, may pay only for a certain percentage of an approved biosimilar, saddling the patient with a monthly copay costing thousands of dollars. “It is unclear whether biosimilar manufacturers will have the same level of patient support programs as the reference drug companies.”
For that reason, physicians should also inform patients about the robust patient assistance and copay assistance programs many reference drug manufacturers offer, she said.
Biosimilars 101: Familiarizing patients
Safety and ease of use are other common concerns about biosimilars. Patients may ask if the application is different, or why it’s advantageous to switch to a biosimilar, Dr. Awsare said.
Sometimes the syringe or injector for a biosimilar might look different from that of the originator drug, he said.
Anecdotally, Dr. Fabbro has heard stories of patients having injection reactions that they did not experience with the reference drug or having a disease flare-up after starting a biosimilar.
As is the case with reference products, in their conversations with patients, clinicians should address the adverse event profile of biosimilars, offering data points from published studies and clinical guidelines that support the use of these products. “There should be an emphasis on patient education around efficacy and any side effects, and how the profile of the reference product compares with a proposed biosimilar,” Dr. Kaul suggested.
When Dr. Snow discusses biosimilars and generics, “I make sure to share this in an understandable way based on the patient’s scientific background, or lack thereof,” he said. If there is enough time, he also discusses how European- and U.S.-sourced biologics are slightly different.
Pharmacists should tell patients to expect the same clinical outcomes from a biosimilar, Dr. Popovian said. However, if they have any reduction in efficacy or potential safety concerns, they should communicate with their physician or pharmacist immediately.
In Dr. Regueiro’s practice, a pharmacist specializing in inflammatory bowel disease often has a one-on-one meeting with patients to educate and answer questions. “Additionally, we provide them the Crohn’s and Colitis Foundation web link on biosimilars,” said Dr. Regueiro.
A village approach to education
When biosimilars first came out, there were no formal education materials, Dr. Awsare said. Kaiser Permanente decided to create its own educational materials, not just for patients but also to help educate its primary care doctors; the rheumatologists, dermatologists, and gastroenterologists using the biosimilars; the nurses infusing patients; and the pharmacists preparing the biosimilars.
The health system also has a different approach to choosing medication. Instead of having an insurance company or PBM decide what’s in the formulary, clinicians work with the pharmacists at Kaiser to look at clinical evidence and decide which biosimilar to use. Most of its plans also provide lower copays to patients when they use the biosimilar.
This was the approach for Humira biosimilars, Dr. Awsare said. Eight will be on the market in 2023. “Our rheumatologists, dermatologists, and gastroenterologists looked at the data from Europe, looked at some real-world evidence, and then said: ‘We think this one’s going to be the best one for our patients.’ ”
Having clinicians choose the biosimilar instead of a health plan makes it a lot easier to have conversations with patients, he said. “Once we’ve moved that market share to that particular biosimilar, we give our physicians the time to have those discussions.”
Clinical pharmacists also provide educational support, offering guidance on issues such as side effects, as patients transition to the biosimilar. “We like to use the word ‘transition’ because it’s essentially the same biologic. So, you’re not actually switching,” Dr. Awsare said.
No consensus on interchangeability
Whether the conversation on interchangeability will affect patient conversations with physicians depends on who you ask.
If a biosimilar has an interchangeability designation, it means that the pharmacist can substitute it without the intervention of the clinician who prescribed the reference product. It does not relate to the quality, safety, or effectiveness of biosimilars or interchangeable biosimilar products, Dr. Popovian said.
The United States is the only country that has this designation. Even though it’s not identical to the originator drug, a biosimilar has the same clinical efficacy and safety profile. “So clinically, interchangeability is meaningless,” Dr. Awsare said.
In its report on biosimilars in the autoimmune category, CVS acknowledged that interchangeability was important but would not be a significant factor in driving adoption of biosimilars. However, in a Cardinal Health survey of 72 gastroenterologists, 38% cited the interchangeability of biosimilars as a top concern for adalimumab biosimilars, along with transitioning patients from Humira to a biosimilar (44%).
“Patient education regarding biosimilar safety, efficacy, and interchangeability appears paramount to the acceptance of these products, particularly for patients who are switched from a reference product,” Dr. Kaul noted in the Cardinal Health report.
Wherever supported by data, Dr. Kaul recommends incorporating biosimilar use and interchangeability into best practice guidelines going forward. “That will go a long way in disseminating the latest information on this topic and position this paradigm for increased adoption among providers.”
Some physicians like Dr. Snow aren’t that concerned with interchangeability. This hasn’t affected conversations with patients, he said. Multiple studies demonstrating the lack of antibody formation with multiple switches from different biosimilar drugs has eased his concern about multiple switches causing problems.
“Initially, there was a gap in demonstrating the long-term effect of multiple switches on antibody production and drug effectiveness. That gap has started to close as more data from Europe’s experience with biosimilars becomes available,” Dr. Snow said.
Resources for physicians, patients
The federal government has taken steps to advance biosimilars education and adoption. In 2021, President Biden signed the Advancing Education on Biosimilars Act into law, which directs the FDA to develop or improve continuing education programs that address prescribing of biosimilars and biological products.
The FDA provides educational materials on its website, including a comprehensive curriculum toolkit. The Accreditation Council for Medical Affairs has also created an online 40-hour curriculum for health care professionals called the Board-Certified Biologics and Biosimilars Specialist Program.
Dr. Fabbro recommended patients use the FDA page Biosimilar Basics for Patients to educate themselves on biosimilars. The Global Healthy Living Foundation’s podcast, Breaking Down Biosimilars, is another free resource for patients.
“While much has changed, the continued need for multistakeholder education, awareness, and dedicated research remains even more important as we expand into newer therapeutic areas and classes,” wrote the authors of the Cardinal Health report.
Help patients understand biologics and biosimilars by using AGA resources for providers and patients available at gastro.org/biosimilars.
Dr. Regueiro is on advisory boards and consults for AbbVie, Janssen, UCB, Takeda, Pfizer, Bristol-Myers Squibb, Organon, Amgen, Genentech, Gilead, Salix, Prometheus, Lilly, Celgene, TARGET PharmaSolutions, Trellis, and Boehringer Ingelheim. Dr. Fabbro is a principal investigator for Castle Biosciences, on the speakers bureau for Valchlor, and on the advisory boards of Janssen and Bristol-Myers Squibb. Dr. Popovian, Dr. Snow, Dr. Awsare, and Dr. Kaul had no disclosures.
A version of this article originally appeared on Medscape.com.
Meta-analysis compares efficacy of lasmiditan, rimegepant, and ubrogepant for acute treatment of migraine
Key clinical point: Lasmiditan, rimegepant, and ubrogepant demonstrated superior efficacy over placebo for the acute treatment of migraine attacks, with lasmiditan being the most effective at high doses but with higher odds of adverse events.
Major finding: Compared with placebo, 200 mg lasmiditan (odds ratio [OR] 2.88; 95% CI 2.22-3.73), followed by 100 mg lasmiditan (OR 2.28; 95% CI 1.75-2.96), rimegepant (OR 2.0; 95% CI 1.45-2.75), and 100 mg ubrogepant (OR 1.97; 95% CI 1.27-3.07) were more efficacious for achieving pain freedom at 2 hours post-dose before the use of any rescue medication. However, the odds of dizziness, nausea, and somnolence were greater with all doses of lasmiditan.
Study details: This network meta-analysis of seven phase 3 randomized controlled trials included 12,859 patients with migraine
Disclosures: This study did not report the funding source. PJ Goadsby and C Tassorelli declared receiving grants or personal fees or participating in advisory boards or lecturing at symposia for various sources.
Source: Puledda F et al. Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature. Cephalalgia. 2023;43(3): 03331024231151419 (Feb 14). Doi: 10.1177/03331024231151419
Key clinical point: Lasmiditan, rimegepant, and ubrogepant demonstrated superior efficacy over placebo for the acute treatment of migraine attacks, with lasmiditan being the most effective at high doses but with higher odds of adverse events.
Major finding: Compared with placebo, 200 mg lasmiditan (odds ratio [OR] 2.88; 95% CI 2.22-3.73), followed by 100 mg lasmiditan (OR 2.28; 95% CI 1.75-2.96), rimegepant (OR 2.0; 95% CI 1.45-2.75), and 100 mg ubrogepant (OR 1.97; 95% CI 1.27-3.07) were more efficacious for achieving pain freedom at 2 hours post-dose before the use of any rescue medication. However, the odds of dizziness, nausea, and somnolence were greater with all doses of lasmiditan.
Study details: This network meta-analysis of seven phase 3 randomized controlled trials included 12,859 patients with migraine
Disclosures: This study did not report the funding source. PJ Goadsby and C Tassorelli declared receiving grants or personal fees or participating in advisory boards or lecturing at symposia for various sources.
Source: Puledda F et al. Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature. Cephalalgia. 2023;43(3): 03331024231151419 (Feb 14). Doi: 10.1177/03331024231151419
Key clinical point: Lasmiditan, rimegepant, and ubrogepant demonstrated superior efficacy over placebo for the acute treatment of migraine attacks, with lasmiditan being the most effective at high doses but with higher odds of adverse events.
Major finding: Compared with placebo, 200 mg lasmiditan (odds ratio [OR] 2.88; 95% CI 2.22-3.73), followed by 100 mg lasmiditan (OR 2.28; 95% CI 1.75-2.96), rimegepant (OR 2.0; 95% CI 1.45-2.75), and 100 mg ubrogepant (OR 1.97; 95% CI 1.27-3.07) were more efficacious for achieving pain freedom at 2 hours post-dose before the use of any rescue medication. However, the odds of dizziness, nausea, and somnolence were greater with all doses of lasmiditan.
Study details: This network meta-analysis of seven phase 3 randomized controlled trials included 12,859 patients with migraine
Disclosures: This study did not report the funding source. PJ Goadsby and C Tassorelli declared receiving grants or personal fees or participating in advisory boards or lecturing at symposia for various sources.
Source: Puledda F et al. Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: A systematic review and network meta-analysis of the literature. Cephalalgia. 2023;43(3): 03331024231151419 (Feb 14). Doi: 10.1177/03331024231151419
Real-world study compares benefits for patients with migraine of mAb against CGRP and its receptor
Key clinical point: Both types of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), those against CGRP ligand (anti-CGRP) and those against CGRP receptor (anti-CGRP-R), showed benefits as preventive treatments for migraine; however, the proportion of anti-CGRP super responders was higher.
Major finding: Patients receiving anti-CGRP vs anti-CGRP-R had a significantly lower Migraine Disability Assessment scale score at 1 (P = .040) and 3 (P = .048) months and mean migraine days at 3 months (P = .01). The proportion of super responders were significantly higher in the anti-CGRP vs anti-CGRP-R group at 3-month (P = .041) and 6-month (P = .047) follow-ups.
Study details: This retrospective observational study included 152 patients with high-frequency episodic migraine or chronic migraine, of whom 68 were treated with anti-CGRP mAbs and 84 were treated with anti-CGRP-R mAbs.
Disclosures: This study did not receive any specific funding. Three authors declared serving as consultants and on scientific advisory boards or receiving speaker honoraria from various sources.
Source: Schiano di Cola F et al. An observational study on monoclonal antibodies against CGRP and its receptor. Eur J Neurol. 2023 (Mar 1). Doi: 10.1111/ene.15761
Key clinical point: Both types of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), those against CGRP ligand (anti-CGRP) and those against CGRP receptor (anti-CGRP-R), showed benefits as preventive treatments for migraine; however, the proportion of anti-CGRP super responders was higher.
Major finding: Patients receiving anti-CGRP vs anti-CGRP-R had a significantly lower Migraine Disability Assessment scale score at 1 (P = .040) and 3 (P = .048) months and mean migraine days at 3 months (P = .01). The proportion of super responders were significantly higher in the anti-CGRP vs anti-CGRP-R group at 3-month (P = .041) and 6-month (P = .047) follow-ups.
Study details: This retrospective observational study included 152 patients with high-frequency episodic migraine or chronic migraine, of whom 68 were treated with anti-CGRP mAbs and 84 were treated with anti-CGRP-R mAbs.
Disclosures: This study did not receive any specific funding. Three authors declared serving as consultants and on scientific advisory boards or receiving speaker honoraria from various sources.
Source: Schiano di Cola F et al. An observational study on monoclonal antibodies against CGRP and its receptor. Eur J Neurol. 2023 (Mar 1). Doi: 10.1111/ene.15761
Key clinical point: Both types of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), those against CGRP ligand (anti-CGRP) and those against CGRP receptor (anti-CGRP-R), showed benefits as preventive treatments for migraine; however, the proportion of anti-CGRP super responders was higher.
Major finding: Patients receiving anti-CGRP vs anti-CGRP-R had a significantly lower Migraine Disability Assessment scale score at 1 (P = .040) and 3 (P = .048) months and mean migraine days at 3 months (P = .01). The proportion of super responders were significantly higher in the anti-CGRP vs anti-CGRP-R group at 3-month (P = .041) and 6-month (P = .047) follow-ups.
Study details: This retrospective observational study included 152 patients with high-frequency episodic migraine or chronic migraine, of whom 68 were treated with anti-CGRP mAbs and 84 were treated with anti-CGRP-R mAbs.
Disclosures: This study did not receive any specific funding. Three authors declared serving as consultants and on scientific advisory boards or receiving speaker honoraria from various sources.
Source: Schiano di Cola F et al. An observational study on monoclonal antibodies against CGRP and its receptor. Eur J Neurol. 2023 (Mar 1). Doi: 10.1111/ene.15761
Fremanezumab shows favorable benefit-risk profile in difficult-to-treat migraine
Key clinical point: Real-world data support fremanezumab as an effective, safe, and well-tolerated treatment option in patients with difficult-to-treat migraine and multiple preventive treatment failures.
Major finding: Overall, 83.5% and 62.6% of patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM) receiving fremanezumab achieved ≥50% reduction in monthly headache days (MHD), respectively, along with a significant improvement in mean MHD, MHD with peak headache intensity of ≤5, intake of any abortive medications, migraine-related disability, and quality of life (all P < .001). Only 36 cases of mild adverse events were reported.
Study details: This open-label, single-arm, prospective, multicenter, clinical study included 204 patients with HFEM (n = 97) or CM (n = 107) who received ≥3 monthly courses of fremanezumab.
Disclosures: This study did not receive any funding. Some authors declared receiving investigator fees or travel grants from, or serving as consultants or advisory board members for various sources.
Source: Argyriou AA et al. Efficacy and safety of fremanezumab for migraine prophylaxis in patients with at least three previous preventive failures: Prospective, multicenter, real-world data from a Greek registry. Eur J Neurol. 2023 (Feb 11). Doi: 10.1111/ene.15740
Key clinical point: Real-world data support fremanezumab as an effective, safe, and well-tolerated treatment option in patients with difficult-to-treat migraine and multiple preventive treatment failures.
Major finding: Overall, 83.5% and 62.6% of patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM) receiving fremanezumab achieved ≥50% reduction in monthly headache days (MHD), respectively, along with a significant improvement in mean MHD, MHD with peak headache intensity of ≤5, intake of any abortive medications, migraine-related disability, and quality of life (all P < .001). Only 36 cases of mild adverse events were reported.
Study details: This open-label, single-arm, prospective, multicenter, clinical study included 204 patients with HFEM (n = 97) or CM (n = 107) who received ≥3 monthly courses of fremanezumab.
Disclosures: This study did not receive any funding. Some authors declared receiving investigator fees or travel grants from, or serving as consultants or advisory board members for various sources.
Source: Argyriou AA et al. Efficacy and safety of fremanezumab for migraine prophylaxis in patients with at least three previous preventive failures: Prospective, multicenter, real-world data from a Greek registry. Eur J Neurol. 2023 (Feb 11). Doi: 10.1111/ene.15740
Key clinical point: Real-world data support fremanezumab as an effective, safe, and well-tolerated treatment option in patients with difficult-to-treat migraine and multiple preventive treatment failures.
Major finding: Overall, 83.5% and 62.6% of patients with high-frequency episodic migraine (HFEM) and chronic migraine (CM) receiving fremanezumab achieved ≥50% reduction in monthly headache days (MHD), respectively, along with a significant improvement in mean MHD, MHD with peak headache intensity of ≤5, intake of any abortive medications, migraine-related disability, and quality of life (all P < .001). Only 36 cases of mild adverse events were reported.
Study details: This open-label, single-arm, prospective, multicenter, clinical study included 204 patients with HFEM (n = 97) or CM (n = 107) who received ≥3 monthly courses of fremanezumab.
Disclosures: This study did not receive any funding. Some authors declared receiving investigator fees or travel grants from, or serving as consultants or advisory board members for various sources.
Source: Argyriou AA et al. Efficacy and safety of fremanezumab for migraine prophylaxis in patients with at least three previous preventive failures: Prospective, multicenter, real-world data from a Greek registry. Eur J Neurol. 2023 (Feb 11). Doi: 10.1111/ene.15740
Migraine: Identifying clinical traits of super-responders vs non-responders to CGRP-R mAb
Key clinical point: Clinical characteristics differed significantly among patients with migraine who experienced ≥75% (super-responders [SR]) vs ≤25% (non-responders [NR]) reduction in monthly headache days in the third month after initiating prophylactic treatment with calcitonin gene-related peptide receptor (CGRP-R) monoclonal antibodies (mAb).
Major finding: SR vs NR were more likely to report vomiting (P = .031) and a significant improvement in acute migraine headache with triptan treatment (P = .010). However, NR vs SR experienced chronic migraine (P = .001), medication overuse headache (P = .024), and concomitant depression (P = .005) more frequently.
Study details: This was a retrospective real-world study including 260 patients with migraine who received ≥1 treatment with CGRP-R mAbs for migraine prevention, of which 29 and 26 were SR and NR, respectively.
Disclosures: This study did not report the source of funding. Four authors declared receiving research grants, personal fees, or honoraria for consulting and lectures from various sources.
Source: Raffaelli B et al. Clinical evaluation of super-responders vs non-responders to CGRP(-receptor) monoclonal antibodies: A real-world experience. J Headache Pain. 2023;24(1):16 (Feb 27). Doi: 10.1186/s10194-023-01552-x
Key clinical point: Clinical characteristics differed significantly among patients with migraine who experienced ≥75% (super-responders [SR]) vs ≤25% (non-responders [NR]) reduction in monthly headache days in the third month after initiating prophylactic treatment with calcitonin gene-related peptide receptor (CGRP-R) monoclonal antibodies (mAb).
Major finding: SR vs NR were more likely to report vomiting (P = .031) and a significant improvement in acute migraine headache with triptan treatment (P = .010). However, NR vs SR experienced chronic migraine (P = .001), medication overuse headache (P = .024), and concomitant depression (P = .005) more frequently.
Study details: This was a retrospective real-world study including 260 patients with migraine who received ≥1 treatment with CGRP-R mAbs for migraine prevention, of which 29 and 26 were SR and NR, respectively.
Disclosures: This study did not report the source of funding. Four authors declared receiving research grants, personal fees, or honoraria for consulting and lectures from various sources.
Source: Raffaelli B et al. Clinical evaluation of super-responders vs non-responders to CGRP(-receptor) monoclonal antibodies: A real-world experience. J Headache Pain. 2023;24(1):16 (Feb 27). Doi: 10.1186/s10194-023-01552-x
Key clinical point: Clinical characteristics differed significantly among patients with migraine who experienced ≥75% (super-responders [SR]) vs ≤25% (non-responders [NR]) reduction in monthly headache days in the third month after initiating prophylactic treatment with calcitonin gene-related peptide receptor (CGRP-R) monoclonal antibodies (mAb).
Major finding: SR vs NR were more likely to report vomiting (P = .031) and a significant improvement in acute migraine headache with triptan treatment (P = .010). However, NR vs SR experienced chronic migraine (P = .001), medication overuse headache (P = .024), and concomitant depression (P = .005) more frequently.
Study details: This was a retrospective real-world study including 260 patients with migraine who received ≥1 treatment with CGRP-R mAbs for migraine prevention, of which 29 and 26 were SR and NR, respectively.
Disclosures: This study did not report the source of funding. Four authors declared receiving research grants, personal fees, or honoraria for consulting and lectures from various sources.
Source: Raffaelli B et al. Clinical evaluation of super-responders vs non-responders to CGRP(-receptor) monoclonal antibodies: A real-world experience. J Headache Pain. 2023;24(1):16 (Feb 27). Doi: 10.1186/s10194-023-01552-x
Traumatic brain injury raises risk for subsequent migraine
Key clinical point: Patients with traumatic brain injury (TBI) were at a significantly higher risk for subsequent migraine, with the risk being even higher among patients with TBI who were hospitalized and those who had a major trauma.
Major finding: The risk for migraine was significantly higher among patients with vs without TBI (adjusted hazard ratio [aHR] 1.484), with migraine incidence being higher after major vs minor trauma (aHR 1.670) and among hospitalized patients vs patients visiting the outpatient department (aHR 1.557; all P < .001).
Study details: This retrospective cohort study included 151,098 patients with newly diagnosed TBI and 604,394 propensity score-matched patients without TBI.
Disclosures: This study was supported by the National Science and Technology Council of the Republic of China, Cardinal Tien Hospital, and Tri-Service General Hospital Research Foundation. The authors declared no conflicts of interest.
Source: Chen MH et al. Risk of migraine after traumatic brain injury and effects of injury management levels and treatment modalities: A nationwide population-based cohort study in Taiwan. J Clin Med. 2023;12(4):1530 (Feb 15). Doi: 10.3390/jcm12041530
Key clinical point: Patients with traumatic brain injury (TBI) were at a significantly higher risk for subsequent migraine, with the risk being even higher among patients with TBI who were hospitalized and those who had a major trauma.
Major finding: The risk for migraine was significantly higher among patients with vs without TBI (adjusted hazard ratio [aHR] 1.484), with migraine incidence being higher after major vs minor trauma (aHR 1.670) and among hospitalized patients vs patients visiting the outpatient department (aHR 1.557; all P < .001).
Study details: This retrospective cohort study included 151,098 patients with newly diagnosed TBI and 604,394 propensity score-matched patients without TBI.
Disclosures: This study was supported by the National Science and Technology Council of the Republic of China, Cardinal Tien Hospital, and Tri-Service General Hospital Research Foundation. The authors declared no conflicts of interest.
Source: Chen MH et al. Risk of migraine after traumatic brain injury and effects of injury management levels and treatment modalities: A nationwide population-based cohort study in Taiwan. J Clin Med. 2023;12(4):1530 (Feb 15). Doi: 10.3390/jcm12041530
Key clinical point: Patients with traumatic brain injury (TBI) were at a significantly higher risk for subsequent migraine, with the risk being even higher among patients with TBI who were hospitalized and those who had a major trauma.
Major finding: The risk for migraine was significantly higher among patients with vs without TBI (adjusted hazard ratio [aHR] 1.484), with migraine incidence being higher after major vs minor trauma (aHR 1.670) and among hospitalized patients vs patients visiting the outpatient department (aHR 1.557; all P < .001).
Study details: This retrospective cohort study included 151,098 patients with newly diagnosed TBI and 604,394 propensity score-matched patients without TBI.
Disclosures: This study was supported by the National Science and Technology Council of the Republic of China, Cardinal Tien Hospital, and Tri-Service General Hospital Research Foundation. The authors declared no conflicts of interest.
Source: Chen MH et al. Risk of migraine after traumatic brain injury and effects of injury management levels and treatment modalities: A nationwide population-based cohort study in Taiwan. J Clin Med. 2023;12(4):1530 (Feb 15). Doi: 10.3390/jcm12041530
Benign paroxysmal positional vertigo associated with higher risk for migraine
Key clinical point: Patients with benign paroxysmal positional vertigo (BPPV) are at a higher risk for migraine diagnosis, with female sex, hyperlipidemia, and anxiety being significant risk factors for migraine among patients with BPPV.
Major finding: In 11 years of follow-up, 1.35% vs 0.41% of participants with vs without BPPV had migraine, respectively. The risk for migraine was 2.96-fold higher among those with BPPV (adjusted hazard ratio [aHR] 2.96; 95% CI 2.30-3.80; P < .001) and significantly higher among women (aHR 2.91; 95% CI 2.30-3.80), those with hyperlipidemia (aHR 1.77; 95% CI 1.16-2.70), and those with anxiety (aHR 1.49; 95% CI 1.03-2.14).
Study details: Findings are from a retrospective cohort study including 1386 patients with BPPV and 5544 age- and sex-matched control individuals without a history of BPPV or migraine.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Shih I-A et al. Benign paroxysmal positional vertigo is associated with an increased risk for migraine diagnosis: A nationwide population-based cohort study. Int J Environ Res Public Health. 2023;20(4):3563 (Feb 17). Doi: 10.3390/ijerph20043563
Key clinical point: Patients with benign paroxysmal positional vertigo (BPPV) are at a higher risk for migraine diagnosis, with female sex, hyperlipidemia, and anxiety being significant risk factors for migraine among patients with BPPV.
Major finding: In 11 years of follow-up, 1.35% vs 0.41% of participants with vs without BPPV had migraine, respectively. The risk for migraine was 2.96-fold higher among those with BPPV (adjusted hazard ratio [aHR] 2.96; 95% CI 2.30-3.80; P < .001) and significantly higher among women (aHR 2.91; 95% CI 2.30-3.80), those with hyperlipidemia (aHR 1.77; 95% CI 1.16-2.70), and those with anxiety (aHR 1.49; 95% CI 1.03-2.14).
Study details: Findings are from a retrospective cohort study including 1386 patients with BPPV and 5544 age- and sex-matched control individuals without a history of BPPV or migraine.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Shih I-A et al. Benign paroxysmal positional vertigo is associated with an increased risk for migraine diagnosis: A nationwide population-based cohort study. Int J Environ Res Public Health. 2023;20(4):3563 (Feb 17). Doi: 10.3390/ijerph20043563
Key clinical point: Patients with benign paroxysmal positional vertigo (BPPV) are at a higher risk for migraine diagnosis, with female sex, hyperlipidemia, and anxiety being significant risk factors for migraine among patients with BPPV.
Major finding: In 11 years of follow-up, 1.35% vs 0.41% of participants with vs without BPPV had migraine, respectively. The risk for migraine was 2.96-fold higher among those with BPPV (adjusted hazard ratio [aHR] 2.96; 95% CI 2.30-3.80; P < .001) and significantly higher among women (aHR 2.91; 95% CI 2.30-3.80), those with hyperlipidemia (aHR 1.77; 95% CI 1.16-2.70), and those with anxiety (aHR 1.49; 95% CI 1.03-2.14).
Study details: Findings are from a retrospective cohort study including 1386 patients with BPPV and 5544 age- and sex-matched control individuals without a history of BPPV or migraine.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Shih I-A et al. Benign paroxysmal positional vertigo is associated with an increased risk for migraine diagnosis: A nationwide population-based cohort study. Int J Environ Res Public Health. 2023;20(4):3563 (Feb 17). Doi: 10.3390/ijerph20043563
Real-world study: Predictors of poor response to galcanezumab in chronic migraine
Key clinical point: About two-thirds of patients with chronic migraine (CM) showed response to galcanezumab, and everyday headache, presence of depression, and absence of accompanying symptoms were independent predictors of a poor response to galcanezumab treatment.
Major finding: After 3 months, 64.3% of patients receiving galcanezumab achieved ≥50% reduction in monthly migraine days, with everyday headache (odds ratio [OR] 0.351; P = .017), presence of depression (OR 0.439; P = .024), and absence of accompanying symptoms (OR 0.314; P = .020) being significant predictors of response to galcanezumab.
Study details: The data come from a real-world, prospective observational study including 238 patients aged ≥18 years with CM who received preventive treatment with galcanezumab injections for 3 months.
Disclosures: This study did not report the source of funding. BK Kim declared receiving honoraria and personal fees, serving on advisory boards, and being a principal investigator of trials sponsored by various sources.
Source: Lee HC et al. Predictors of response to galcanezumab in patients with chronic migraine: A real-world prospective observational study. Neurol Sci. 2023 (Feb 24). Doi: 10.1007/s10072-023-06683-2.
Key clinical point: About two-thirds of patients with chronic migraine (CM) showed response to galcanezumab, and everyday headache, presence of depression, and absence of accompanying symptoms were independent predictors of a poor response to galcanezumab treatment.
Major finding: After 3 months, 64.3% of patients receiving galcanezumab achieved ≥50% reduction in monthly migraine days, with everyday headache (odds ratio [OR] 0.351; P = .017), presence of depression (OR 0.439; P = .024), and absence of accompanying symptoms (OR 0.314; P = .020) being significant predictors of response to galcanezumab.
Study details: The data come from a real-world, prospective observational study including 238 patients aged ≥18 years with CM who received preventive treatment with galcanezumab injections for 3 months.
Disclosures: This study did not report the source of funding. BK Kim declared receiving honoraria and personal fees, serving on advisory boards, and being a principal investigator of trials sponsored by various sources.
Source: Lee HC et al. Predictors of response to galcanezumab in patients with chronic migraine: A real-world prospective observational study. Neurol Sci. 2023 (Feb 24). Doi: 10.1007/s10072-023-06683-2.
Key clinical point: About two-thirds of patients with chronic migraine (CM) showed response to galcanezumab, and everyday headache, presence of depression, and absence of accompanying symptoms were independent predictors of a poor response to galcanezumab treatment.
Major finding: After 3 months, 64.3% of patients receiving galcanezumab achieved ≥50% reduction in monthly migraine days, with everyday headache (odds ratio [OR] 0.351; P = .017), presence of depression (OR 0.439; P = .024), and absence of accompanying symptoms (OR 0.314; P = .020) being significant predictors of response to galcanezumab.
Study details: The data come from a real-world, prospective observational study including 238 patients aged ≥18 years with CM who received preventive treatment with galcanezumab injections for 3 months.
Disclosures: This study did not report the source of funding. BK Kim declared receiving honoraria and personal fees, serving on advisory boards, and being a principal investigator of trials sponsored by various sources.
Source: Lee HC et al. Predictors of response to galcanezumab in patients with chronic migraine: A real-world prospective observational study. Neurol Sci. 2023 (Feb 24). Doi: 10.1007/s10072-023-06683-2.