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Long-term freedom from NMOSD relapse with satralizumab
DENVER – , new research shows.
“In long-term observations, we are seeing a nice, sustained suppression of relapses early, as well as late, in treatment,” said study investigator Anthony Traboulsee, MD, University of British Columbia, Vancouver, in presenting the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“It remains very tolerable with no participants discontinuing because of side effects,” he said. “And importantly, [there are] no signs of a delayed risk of infections for both monotherapy and combination therapy.”
Satralizumab, a monoclonal recycling antibody, targets the interleukin (IL)–6 receptor, which is elevated in the serum and cerebrospinal fluid of patients in NMOSD.
The drug was approved by the Food and Drug Administration in 2020 for the treatment of AQP4 antibody–positive NMOSD after favorable results from two key trials: SAkuraSky and SAkuraStar.
The FDA approval marked satralizumab as the third therapy for NMOSD, following eculizumab (Soliris) and inebilizumab (Uplizna).
Satralizumab is administered in subcutaneous injections every 4 weeks after a run-in period of injections at weeks 0, 2, and 4.
Longest trial to date
To evaluate the drug’s long-term efficacy in the treatment of AQP4 IgG–positive NMOSD, patients from the two previous phase 3 trials were entered into the single arm, open-label SAkuraMoon study and continued treatment with the satralizumab 120 mg injections once monthly, with or without immunosuppressive therapy.
The study included 106 patients (mean age 44 years, 89.6% women), all of whom had received one or more doses of satralizumab by the data cutoff of January 2022.
With a median duration of satralizumab exposure of 5 years, the overall adjusted annualized rate of investigator protocol-defined relapse (ARR) was 0.09.
Longitudinal assessment further showed no significant increase in the relapse rate over the course of the study, with an ARR rate of 0.16 at year 1; 0.10 at year 2; 0.05 at year 3; and 0.07 at year 4.
At week 240 (4.6 years), 72% of satralizumab-treated patients were relapse-free, with 91% free from severe relapse.
In addition, 85% of patients had no sustained disability, as measured by Expanded Disability Status Scale (EDSS) worsening, over the study period.
Asked if there are potential subgroups of patients who may be more susceptible to the worsening of disability, Dr. Traboulsee responded “not that we can tell as of yet.”
“I would like to explore this further as this is a relatively new observation, and, as far as I know, this is the longest follow-up for an NMO treatment trial cohort,” he said.
Favorable safety profile
The safety profile was also favorable, consistent with results in the earlier trials. The longer exposure to satralizumab was not associated with a higher risk of severe (grade 3 or higher) laboratory changes versus the double-blind studies. “Rates of adverse events and serious adverse events with overall satralizumab treatment were comparable with the double-blind periods,” said Dr. Traboulsee.
“With satralizumab combined with immunosuppressant therapy, we’re not seeing an increased rate of infections, because it’s not an immune suppressant – it doesn’t suppress lymphocytes or lower immunoglobulin,” he added.
While the use of combination therapy has been an important clinical concern, Dr. Traboulsee noted that “this does not appear to be the case with satralizumab when combined with daily prednisone or daily azathioprine.”
“There is no increased risk of infections, compared with placebo, and it interestingly appears lower than patients on prednisone or azathioprine alone,” he said.
While the median follow-up was 5 years, some in the clinical trial population have been on treatment for up to 7.9 years.
“Based on the current safety and efficacy data, they could stay on this therapy indefinitely, in my opinion,” Dr. Traboulsee said.
In addition to its long-term safety and efficacy, satralizumab “is easy for patients to take and does not require access to an infusion center. It’s easy for physicians to monitor safety, especially since no additional vaccinations or precautions are required beyond what is done in routine care.”
“What I conclude from that clinically is that this is a highly effective and safe therapy by itself or in combination with another agent,” Dr. Traboulsee said.
He noted that the lack of a bump in infections is “really encouraging and very important with a chronic disease that affects elderly patients. So far, so good,” he added.
‘A good first-line therapy’
Commenting on the study, Shailee Shah, MD, an assistant professor in the neuroimmunology division at Vanderbilt University Medical Center, Nashville, Tenn., agreed that the findings bode well for satralizumab’s long-term benefits.
“These are promising results and suggest that satralizumab is very effective in the long term, and even when patients relapse, those relapses are less severe than they would likely be if the patient were off therapy,” she said.
She noted that, while the ability to self-administer injections with satralizumab is convenient, preferences vary.
“This is patient dependent,” Dr. Shah said. “For some patients an injectable medication is ideal but for others an infusion medication [such as eculizumab] is preferred.”
Overall, however, Dr. Shah described satralizumab as “a good first-line therapy for patients with NMOSD in addition to eculizumab/ravulizumab and inebilizumab.”
“It is reasonable to consider this medication in isolation or with concomitant immunosuppressive therapy,” she said.
Dr. Traboulsee’s disclosures include relationships with Novartis, Roche, Sanofi (Genzyme), Ingo Kleiter, Alexion, Almirall, Bayer, Biogen, Celgene, Genentech, Hexal, Horizon, Merck, and Sanofi. Dr. Shah reports that she has served on advisory boards for Horizon, Alexion, and Genentech.
DENVER – , new research shows.
“In long-term observations, we are seeing a nice, sustained suppression of relapses early, as well as late, in treatment,” said study investigator Anthony Traboulsee, MD, University of British Columbia, Vancouver, in presenting the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“It remains very tolerable with no participants discontinuing because of side effects,” he said. “And importantly, [there are] no signs of a delayed risk of infections for both monotherapy and combination therapy.”
Satralizumab, a monoclonal recycling antibody, targets the interleukin (IL)–6 receptor, which is elevated in the serum and cerebrospinal fluid of patients in NMOSD.
The drug was approved by the Food and Drug Administration in 2020 for the treatment of AQP4 antibody–positive NMOSD after favorable results from two key trials: SAkuraSky and SAkuraStar.
The FDA approval marked satralizumab as the third therapy for NMOSD, following eculizumab (Soliris) and inebilizumab (Uplizna).
Satralizumab is administered in subcutaneous injections every 4 weeks after a run-in period of injections at weeks 0, 2, and 4.
Longest trial to date
To evaluate the drug’s long-term efficacy in the treatment of AQP4 IgG–positive NMOSD, patients from the two previous phase 3 trials were entered into the single arm, open-label SAkuraMoon study and continued treatment with the satralizumab 120 mg injections once monthly, with or without immunosuppressive therapy.
The study included 106 patients (mean age 44 years, 89.6% women), all of whom had received one or more doses of satralizumab by the data cutoff of January 2022.
With a median duration of satralizumab exposure of 5 years, the overall adjusted annualized rate of investigator protocol-defined relapse (ARR) was 0.09.
Longitudinal assessment further showed no significant increase in the relapse rate over the course of the study, with an ARR rate of 0.16 at year 1; 0.10 at year 2; 0.05 at year 3; and 0.07 at year 4.
At week 240 (4.6 years), 72% of satralizumab-treated patients were relapse-free, with 91% free from severe relapse.
In addition, 85% of patients had no sustained disability, as measured by Expanded Disability Status Scale (EDSS) worsening, over the study period.
Asked if there are potential subgroups of patients who may be more susceptible to the worsening of disability, Dr. Traboulsee responded “not that we can tell as of yet.”
“I would like to explore this further as this is a relatively new observation, and, as far as I know, this is the longest follow-up for an NMO treatment trial cohort,” he said.
Favorable safety profile
The safety profile was also favorable, consistent with results in the earlier trials. The longer exposure to satralizumab was not associated with a higher risk of severe (grade 3 or higher) laboratory changes versus the double-blind studies. “Rates of adverse events and serious adverse events with overall satralizumab treatment were comparable with the double-blind periods,” said Dr. Traboulsee.
“With satralizumab combined with immunosuppressant therapy, we’re not seeing an increased rate of infections, because it’s not an immune suppressant – it doesn’t suppress lymphocytes or lower immunoglobulin,” he added.
While the use of combination therapy has been an important clinical concern, Dr. Traboulsee noted that “this does not appear to be the case with satralizumab when combined with daily prednisone or daily azathioprine.”
“There is no increased risk of infections, compared with placebo, and it interestingly appears lower than patients on prednisone or azathioprine alone,” he said.
While the median follow-up was 5 years, some in the clinical trial population have been on treatment for up to 7.9 years.
“Based on the current safety and efficacy data, they could stay on this therapy indefinitely, in my opinion,” Dr. Traboulsee said.
In addition to its long-term safety and efficacy, satralizumab “is easy for patients to take and does not require access to an infusion center. It’s easy for physicians to monitor safety, especially since no additional vaccinations or precautions are required beyond what is done in routine care.”
“What I conclude from that clinically is that this is a highly effective and safe therapy by itself or in combination with another agent,” Dr. Traboulsee said.
He noted that the lack of a bump in infections is “really encouraging and very important with a chronic disease that affects elderly patients. So far, so good,” he added.
‘A good first-line therapy’
Commenting on the study, Shailee Shah, MD, an assistant professor in the neuroimmunology division at Vanderbilt University Medical Center, Nashville, Tenn., agreed that the findings bode well for satralizumab’s long-term benefits.
“These are promising results and suggest that satralizumab is very effective in the long term, and even when patients relapse, those relapses are less severe than they would likely be if the patient were off therapy,” she said.
She noted that, while the ability to self-administer injections with satralizumab is convenient, preferences vary.
“This is patient dependent,” Dr. Shah said. “For some patients an injectable medication is ideal but for others an infusion medication [such as eculizumab] is preferred.”
Overall, however, Dr. Shah described satralizumab as “a good first-line therapy for patients with NMOSD in addition to eculizumab/ravulizumab and inebilizumab.”
“It is reasonable to consider this medication in isolation or with concomitant immunosuppressive therapy,” she said.
Dr. Traboulsee’s disclosures include relationships with Novartis, Roche, Sanofi (Genzyme), Ingo Kleiter, Alexion, Almirall, Bayer, Biogen, Celgene, Genentech, Hexal, Horizon, Merck, and Sanofi. Dr. Shah reports that she has served on advisory boards for Horizon, Alexion, and Genentech.
DENVER – , new research shows.
“In long-term observations, we are seeing a nice, sustained suppression of relapses early, as well as late, in treatment,” said study investigator Anthony Traboulsee, MD, University of British Columbia, Vancouver, in presenting the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“It remains very tolerable with no participants discontinuing because of side effects,” he said. “And importantly, [there are] no signs of a delayed risk of infections for both monotherapy and combination therapy.”
Satralizumab, a monoclonal recycling antibody, targets the interleukin (IL)–6 receptor, which is elevated in the serum and cerebrospinal fluid of patients in NMOSD.
The drug was approved by the Food and Drug Administration in 2020 for the treatment of AQP4 antibody–positive NMOSD after favorable results from two key trials: SAkuraSky and SAkuraStar.
The FDA approval marked satralizumab as the third therapy for NMOSD, following eculizumab (Soliris) and inebilizumab (Uplizna).
Satralizumab is administered in subcutaneous injections every 4 weeks after a run-in period of injections at weeks 0, 2, and 4.
Longest trial to date
To evaluate the drug’s long-term efficacy in the treatment of AQP4 IgG–positive NMOSD, patients from the two previous phase 3 trials were entered into the single arm, open-label SAkuraMoon study and continued treatment with the satralizumab 120 mg injections once monthly, with or without immunosuppressive therapy.
The study included 106 patients (mean age 44 years, 89.6% women), all of whom had received one or more doses of satralizumab by the data cutoff of January 2022.
With a median duration of satralizumab exposure of 5 years, the overall adjusted annualized rate of investigator protocol-defined relapse (ARR) was 0.09.
Longitudinal assessment further showed no significant increase in the relapse rate over the course of the study, with an ARR rate of 0.16 at year 1; 0.10 at year 2; 0.05 at year 3; and 0.07 at year 4.
At week 240 (4.6 years), 72% of satralizumab-treated patients were relapse-free, with 91% free from severe relapse.
In addition, 85% of patients had no sustained disability, as measured by Expanded Disability Status Scale (EDSS) worsening, over the study period.
Asked if there are potential subgroups of patients who may be more susceptible to the worsening of disability, Dr. Traboulsee responded “not that we can tell as of yet.”
“I would like to explore this further as this is a relatively new observation, and, as far as I know, this is the longest follow-up for an NMO treatment trial cohort,” he said.
Favorable safety profile
The safety profile was also favorable, consistent with results in the earlier trials. The longer exposure to satralizumab was not associated with a higher risk of severe (grade 3 or higher) laboratory changes versus the double-blind studies. “Rates of adverse events and serious adverse events with overall satralizumab treatment were comparable with the double-blind periods,” said Dr. Traboulsee.
“With satralizumab combined with immunosuppressant therapy, we’re not seeing an increased rate of infections, because it’s not an immune suppressant – it doesn’t suppress lymphocytes or lower immunoglobulin,” he added.
While the use of combination therapy has been an important clinical concern, Dr. Traboulsee noted that “this does not appear to be the case with satralizumab when combined with daily prednisone or daily azathioprine.”
“There is no increased risk of infections, compared with placebo, and it interestingly appears lower than patients on prednisone or azathioprine alone,” he said.
While the median follow-up was 5 years, some in the clinical trial population have been on treatment for up to 7.9 years.
“Based on the current safety and efficacy data, they could stay on this therapy indefinitely, in my opinion,” Dr. Traboulsee said.
In addition to its long-term safety and efficacy, satralizumab “is easy for patients to take and does not require access to an infusion center. It’s easy for physicians to monitor safety, especially since no additional vaccinations or precautions are required beyond what is done in routine care.”
“What I conclude from that clinically is that this is a highly effective and safe therapy by itself or in combination with another agent,” Dr. Traboulsee said.
He noted that the lack of a bump in infections is “really encouraging and very important with a chronic disease that affects elderly patients. So far, so good,” he added.
‘A good first-line therapy’
Commenting on the study, Shailee Shah, MD, an assistant professor in the neuroimmunology division at Vanderbilt University Medical Center, Nashville, Tenn., agreed that the findings bode well for satralizumab’s long-term benefits.
“These are promising results and suggest that satralizumab is very effective in the long term, and even when patients relapse, those relapses are less severe than they would likely be if the patient were off therapy,” she said.
She noted that, while the ability to self-administer injections with satralizumab is convenient, preferences vary.
“This is patient dependent,” Dr. Shah said. “For some patients an injectable medication is ideal but for others an infusion medication [such as eculizumab] is preferred.”
Overall, however, Dr. Shah described satralizumab as “a good first-line therapy for patients with NMOSD in addition to eculizumab/ravulizumab and inebilizumab.”
“It is reasonable to consider this medication in isolation or with concomitant immunosuppressive therapy,” she said.
Dr. Traboulsee’s disclosures include relationships with Novartis, Roche, Sanofi (Genzyme), Ingo Kleiter, Alexion, Almirall, Bayer, Biogen, Celgene, Genentech, Hexal, Horizon, Merck, and Sanofi. Dr. Shah reports that she has served on advisory boards for Horizon, Alexion, and Genentech.
AT CMSC 2023
MDs with chronic illness live in a different medical world
Linda Bluestein remembers all the doctors who missed, ignored, or incompletely diagnosed her chronic illness.
There was the orthopedic surgeon who noted her hyperextended elbows but failed to check any of her other joints. The gastroenterologist who insisted on performing multiple scoping procedures but wouldn’t discuss how to manage her symptoms. The other surgeon who, after performing arthroscopy on her injured knee, yelled at her: “There is nothing wrong with your knee! You’re fine!” in a room full of people.
And then there was the rheumatologist who said: “Oh, you want something to be wrong with you?”
“No,” she replied, “I want an explanation. I want to keep working. I just want to know why these things keep happening to me.”
The medical frustration she experienced was especially difficult because, like her health care providers, Linda Bluestein has an MD after her name. She is a board-certified anesthesiologist and integrative medicine physician.
Along with the physically demanding schedule of medical practice, they must cope with what many call a “culture of invincibility” within medicine. Doctors are not supposed to get sick. In fact, the unwritten rule is presenteeism – to function without adequate food or sleep and to never prioritize their own self-care over their dedication to their patients.
Whether their conditions are visible, such as muscular dystrophy and multiple sclerosis, or invisible, such as fibromyalgia and mental illnesses – and now, long COVID – these doctors often meet significant stigma. They fight the assumption that they are less capable than their colleagues.
But they also experience an invaluable benefit: They gain firsthand knowledge of the patient experience, a profound understanding which, they say, enhances how they care for their own patients.
What it takes to become a doctor when you have a chronic condition
In short, it’s not easy.
Data from the 2018 National Health Interview Survey show that more than half of U.S. adults had at least one of several chronic conditions, including rheumatoid arthritis, asthma, diabetes, hypertension, and kidney problems. Nearly a third of respondents had more than one condition. But fewer than 5% of medical students and 3% of practicing physicians report having a chronic illness or disability, according to studies from 2019 and 2021.
While that could mean that fewer people with chronic illness enter medicine, cases also exist in which aspiring physicians with conditions were dissuaded from pursuing a career in medicine at all.
Amy Stenehjem, MD, a physical medicine and rehabilitation physician, is one of the exceptions. Diagnosed with several autoimmune-related conditions as a teenager and young adult, Dr. Stenehjem was determined to become a doctor. In her 20s, her health was relatively stable, and she was able to manage medical school and residency. Her training institutions agreed to provide some accommodations that helped her succeed.
“They let me build some flexibility into the training,” Dr. Stenehjem said. “In medical school, when I knew I wasn’t going to be able to do a particular specialty as a career, they let me work with an attending doctor that did not require a lot of on-call time during that particular rotation.”
Dr. Stenehjem specialized in chronic neck and back disorders, fibromyalgia, chronic fatigue syndrome (myalgic encephalomyelitis), and autoimmune-related diseases. She practiced for more than a decade. But in 2011, her condition spiraled. She couldn’t walk a few steps or even sit upright without experiencing dizziness and shortness of breath. She had debilitating fatigue and episodes of fever, rash, headaches, and joint pain.
It would take 7 years and more than 20 doctors to determine Dr. Stenehjem’s multiple diagnoses. In addition to her autoimmune diseases, she was diagnosed with postural orthostatic tachycardia syndrome, autoinflammatory periodic fever syndrome, Lyme disease, and reactivated Epstein-Barr infection.
While she suspects that her providers gave her more “leeway” because she was a physician, many did not show a deep understanding of the severity of her symptoms and the impact those symptoms had.
“When I was practicing, I really didn’t fully understand the impact chronic illness had on my patients,” Dr. Stenehjem said. “Things like chronic dizziness, headaches, fatigue, pain, or brain fog can be really hard to understand unless you’ve experienced these symptoms. When I got sick, I finally realized, ‘Oh my goodness, when a patient says they’re dealing with fatigue, this is not your normal, I’m-super-tired-from-being-on-call fatigue. This is I-can’t-get-out-of-bed fatigue.’ That’s what people with chronic illness often deal with on a daily basis.”
Treating the individual
Dr. Stenehjem was aware that her chronic illness would affect her medical career. For Jason Baker, MD, an endocrinologist at Weill Cornell Medicine, New York, it came as a shock. Dr. Baker was a third-year medical student when he experienced increased urination and rapid weight loss. It was only when friends pressed him to visit student health that a blood test revealed type 1 diabetes. Dr. Baker suddenly found himself lying in a hospital bed.
He remembers an attending physician who simply handed him a textbook on diabetic ketoacidosis (DKA) and a resident who informed him that he had kidney damage, which turned out to be untrue. Neither discussed the psychological issues from a frightening diagnosis that would require lifelong, daily management.
“There certainly could have been a bit more empathy from some of the people I dealt with early on,” he said.
Although his training gave him a stark picture of worst-case scenarios, Dr. Baker found that knowledge motivating. “I’d already seen patients come in who had diabetes complications,” Dr. Baker says. “I vowed to never ever get those complications. It was a good balance of fear and motivation.”
Dr. Baker had not planned to specialize in endocrinology, but he quickly realized that his personal diagnosis could help others. Now he often shares his experience with his patients who have diabetes, which he says makes them more comfortable discussing their own problems.
His approach, Dr. Baker explained, is to treat everyone as an individual. Trying to neatly classify patients with chronic illness is a common mistake he notices among physicians.
“There’s a lot of misunderstanding about type 1 versus type 2 [diabetes],” Dr. Baker said, “and trying to categorize people when sometimes people can’t be categorized. That’s really with any chronic condition; there’s no one size fits all.”
Managing his health is still a time-consuming task. At work, he needs breaks to eat, check his blood sugar, or take insulin. “During the workday seeing patients, I have to also remember that I’m a patient,” Dr. Baker said. “I have to be okay with prioritizing my own health. Otherwise I can’t help anybody.”
‘I am not the doctor for you’
Chronic diseases such as diabetes or hypertension are familiar to most doctors, and with good management, patients can usually function normally. When chronic conditions become disabling, however, attitudes in the medical field can change.
According to data from the Centers for Disease Control and Prevention and from studies, people with disabilities experience significant disparities and barriers to care. Some of this can be linked to social determinants of health. People with disabilities are more likely to be poor and to rely on Medicare and Medicaid for insurance coverage. But lack of training, unwillingness to provide accommodations, ignorance of legal requirements, and inaccurate assumptions among physicians also play a role.
These are themes that Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School, Boston, has heard from hundreds of patients with disabilities during the more than 25 years that she has conducted research.
In late 2019, Dr. Iezzoni and coinvestigators fielded a national survey of 714 practicing physicians. Only 40.7% reported they were “very confident” that they could provide the same quality of care to patients with disabilities as they do for other patients. And only 56.5% “strongly agreed” that they welcomed these patients into their practices.
The survey was conducted through a series of small focus groups that Dr. Iezzoni held with physicians in 2018. These yielded views that were startling, and in some cases, overtly discriminatory:
- Doctors complained about the “burden” of caring for a patient with a disability.
- They lacked the time or equipment, such as accessible exam tables or weight scales.
- They admitted to inventing excuses for why appointments were not available or routine diagnostic tests were not performed.
- They described being fearful of lawsuits under the Americans with Disabilities Act.
The overall message was summed up in one doctor’s statement: “I am not the doctor for you.”
“Doctors are people too,” Dr. Iezzoni pointed out. “And so they reflect the same prejudices and stigmatized attitudes of the rest of the population. It might be implicit, so they might not be aware of it. [But] it might be explicit.”
Ableism in the medical field is all too familiar to Dr. Iezzoni. She was diagnosed with multiple sclerosis at age 26 during her first year at Harvard Medical School in the early 1980s. Despite symptom flare-ups, Dr. Iezzoni was able to graduate with her class, but many instructors and administrators had little interest in accommodating her physical limitations. In fact, several physicians discouraged her from continuing to train.
Unable to take call, run up flights of stairs, or stand for hours at a time, Dr. Iezzoni remembers being told by a senior surgeon that she shouldn’t become a doctor since she lacked the “most important quality,” which was “24/7 availability.” A hospital CEO informed her: “There are too many doctors in the country right now for us to worry about training a handicapped physician. If that means that some people get left by the wayside, so be it.”
Ultimately, Harvard Medical School declined to write Dr. Iezzoni a letter of recommendation for an internship. She would never practice medicine. “My career was just truncated from the start,” Dr. Iezzoni said. “It never happened because of discrimination.”
She later learned the legal term for her treatment: constructive dismissal.
“The medical school didn’t outright say, ‘Go away. We’re not allowing you to graduate.’ ” Dr. Iezzoni explained. “But they made my life so difficult that I did so voluntarily.”
Dr. Iezzoni graduated in 1984, before the passage of the ADA in 1990, and she refers to her experience as a “ghost from the past,” a historical reminder of how the legal landscape has changed – even though the tendency toward bias may not have.
The fight for inclusion
Zainub Dhanani, a fifth-year medical student at Stanford (Calif.) University, won’t forget an interview at one of the other schools to which she applied. The interviewer asked how she expected to be in a hospital all day if she had a chronic illness.
“Does it really make sense?” he wanted to know.
The question shocked her in the moment, but now she sees this type of bias as linked to the inequalities that many marginalized groups face in health care and beyond. That’s also why she believes physician-patients are crucial to improve the quality of care for people with chronic illness and other groups that face discrimination.
Who else, she wonders, could provide that “reaffirming” experience for patients or have that “unique edge” other than a provider who has navigated the same world?
Ms. Dhanani is the executive director and founder of Medical Students With Disability and Chronic Illness, an organization dedicated to empowering these students through advocacy, education, accessibility, and community. The group now has 19 chapters at medical schools across the country.
Ms. Dhanani said she has received excellent accommodations from Stanford for her own condition (which she prefers not to disclose), but all medical schools are not as responsive to students with various physical needs. Her organization offers support and resources to inform these future physicians about their options and rights.
“Disability justice is also racial justice,” Ms. Dhanani stressed. “It’s also environmental justice. It’s also gender and sexuality-based justice. Those compounded layers of biases lead to worse and worse levels of care. As a patient, it’s terrifying. And as a future physician, it’s tragic to know that this is something so pervasive and yet so under-addressed in medicine.”
Soldiering on
Unfortunately, for some physicians with chronic illness, there are no practical accommodations that could save their careers in clinical practice.
Dr. Stenehjem now works part-time as a health consultant, helping those with chronic illnesses navigate their health care systems.
Dr. Bluestein offers a similar coaching service to patients with Ehlers-Danlos syndrome (EDS) and other connective tissue and hypermobility disorders. Because of her own EDS, she can no longer practice as an anesthesiologist but instead opened an integrative pain management practice for patients with complex pain conditions..
She believes the idea that doctors are “invincible” needs to change. She recalls the time her former group practice told her in no uncertain terms to “never call in sick.”
The stories she hears from her current clients are similar to her own. She can empathize, knowing firsthand the physical and psychological damage these attitudes can cause.
“When I was at my worst physically, I was also at my worst psychologically,” said Dr. Bluestein. “We tend to think of them as separate, but they go hand in hand. If we can validate people’s experiences rather than disregard them, it has a positive forward cycle, as opposed to the reverse, which is what usually happens.”
A version of this article first appeared on Medscape.com.
Linda Bluestein remembers all the doctors who missed, ignored, or incompletely diagnosed her chronic illness.
There was the orthopedic surgeon who noted her hyperextended elbows but failed to check any of her other joints. The gastroenterologist who insisted on performing multiple scoping procedures but wouldn’t discuss how to manage her symptoms. The other surgeon who, after performing arthroscopy on her injured knee, yelled at her: “There is nothing wrong with your knee! You’re fine!” in a room full of people.
And then there was the rheumatologist who said: “Oh, you want something to be wrong with you?”
“No,” she replied, “I want an explanation. I want to keep working. I just want to know why these things keep happening to me.”
The medical frustration she experienced was especially difficult because, like her health care providers, Linda Bluestein has an MD after her name. She is a board-certified anesthesiologist and integrative medicine physician.
Along with the physically demanding schedule of medical practice, they must cope with what many call a “culture of invincibility” within medicine. Doctors are not supposed to get sick. In fact, the unwritten rule is presenteeism – to function without adequate food or sleep and to never prioritize their own self-care over their dedication to their patients.
Whether their conditions are visible, such as muscular dystrophy and multiple sclerosis, or invisible, such as fibromyalgia and mental illnesses – and now, long COVID – these doctors often meet significant stigma. They fight the assumption that they are less capable than their colleagues.
But they also experience an invaluable benefit: They gain firsthand knowledge of the patient experience, a profound understanding which, they say, enhances how they care for their own patients.
What it takes to become a doctor when you have a chronic condition
In short, it’s not easy.
Data from the 2018 National Health Interview Survey show that more than half of U.S. adults had at least one of several chronic conditions, including rheumatoid arthritis, asthma, diabetes, hypertension, and kidney problems. Nearly a third of respondents had more than one condition. But fewer than 5% of medical students and 3% of practicing physicians report having a chronic illness or disability, according to studies from 2019 and 2021.
While that could mean that fewer people with chronic illness enter medicine, cases also exist in which aspiring physicians with conditions were dissuaded from pursuing a career in medicine at all.
Amy Stenehjem, MD, a physical medicine and rehabilitation physician, is one of the exceptions. Diagnosed with several autoimmune-related conditions as a teenager and young adult, Dr. Stenehjem was determined to become a doctor. In her 20s, her health was relatively stable, and she was able to manage medical school and residency. Her training institutions agreed to provide some accommodations that helped her succeed.
“They let me build some flexibility into the training,” Dr. Stenehjem said. “In medical school, when I knew I wasn’t going to be able to do a particular specialty as a career, they let me work with an attending doctor that did not require a lot of on-call time during that particular rotation.”
Dr. Stenehjem specialized in chronic neck and back disorders, fibromyalgia, chronic fatigue syndrome (myalgic encephalomyelitis), and autoimmune-related diseases. She practiced for more than a decade. But in 2011, her condition spiraled. She couldn’t walk a few steps or even sit upright without experiencing dizziness and shortness of breath. She had debilitating fatigue and episodes of fever, rash, headaches, and joint pain.
It would take 7 years and more than 20 doctors to determine Dr. Stenehjem’s multiple diagnoses. In addition to her autoimmune diseases, she was diagnosed with postural orthostatic tachycardia syndrome, autoinflammatory periodic fever syndrome, Lyme disease, and reactivated Epstein-Barr infection.
While she suspects that her providers gave her more “leeway” because she was a physician, many did not show a deep understanding of the severity of her symptoms and the impact those symptoms had.
“When I was practicing, I really didn’t fully understand the impact chronic illness had on my patients,” Dr. Stenehjem said. “Things like chronic dizziness, headaches, fatigue, pain, or brain fog can be really hard to understand unless you’ve experienced these symptoms. When I got sick, I finally realized, ‘Oh my goodness, when a patient says they’re dealing with fatigue, this is not your normal, I’m-super-tired-from-being-on-call fatigue. This is I-can’t-get-out-of-bed fatigue.’ That’s what people with chronic illness often deal with on a daily basis.”
Treating the individual
Dr. Stenehjem was aware that her chronic illness would affect her medical career. For Jason Baker, MD, an endocrinologist at Weill Cornell Medicine, New York, it came as a shock. Dr. Baker was a third-year medical student when he experienced increased urination and rapid weight loss. It was only when friends pressed him to visit student health that a blood test revealed type 1 diabetes. Dr. Baker suddenly found himself lying in a hospital bed.
He remembers an attending physician who simply handed him a textbook on diabetic ketoacidosis (DKA) and a resident who informed him that he had kidney damage, which turned out to be untrue. Neither discussed the psychological issues from a frightening diagnosis that would require lifelong, daily management.
“There certainly could have been a bit more empathy from some of the people I dealt with early on,” he said.
Although his training gave him a stark picture of worst-case scenarios, Dr. Baker found that knowledge motivating. “I’d already seen patients come in who had diabetes complications,” Dr. Baker says. “I vowed to never ever get those complications. It was a good balance of fear and motivation.”
Dr. Baker had not planned to specialize in endocrinology, but he quickly realized that his personal diagnosis could help others. Now he often shares his experience with his patients who have diabetes, which he says makes them more comfortable discussing their own problems.
His approach, Dr. Baker explained, is to treat everyone as an individual. Trying to neatly classify patients with chronic illness is a common mistake he notices among physicians.
“There’s a lot of misunderstanding about type 1 versus type 2 [diabetes],” Dr. Baker said, “and trying to categorize people when sometimes people can’t be categorized. That’s really with any chronic condition; there’s no one size fits all.”
Managing his health is still a time-consuming task. At work, he needs breaks to eat, check his blood sugar, or take insulin. “During the workday seeing patients, I have to also remember that I’m a patient,” Dr. Baker said. “I have to be okay with prioritizing my own health. Otherwise I can’t help anybody.”
‘I am not the doctor for you’
Chronic diseases such as diabetes or hypertension are familiar to most doctors, and with good management, patients can usually function normally. When chronic conditions become disabling, however, attitudes in the medical field can change.
According to data from the Centers for Disease Control and Prevention and from studies, people with disabilities experience significant disparities and barriers to care. Some of this can be linked to social determinants of health. People with disabilities are more likely to be poor and to rely on Medicare and Medicaid for insurance coverage. But lack of training, unwillingness to provide accommodations, ignorance of legal requirements, and inaccurate assumptions among physicians also play a role.
These are themes that Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School, Boston, has heard from hundreds of patients with disabilities during the more than 25 years that she has conducted research.
In late 2019, Dr. Iezzoni and coinvestigators fielded a national survey of 714 practicing physicians. Only 40.7% reported they were “very confident” that they could provide the same quality of care to patients with disabilities as they do for other patients. And only 56.5% “strongly agreed” that they welcomed these patients into their practices.
The survey was conducted through a series of small focus groups that Dr. Iezzoni held with physicians in 2018. These yielded views that were startling, and in some cases, overtly discriminatory:
- Doctors complained about the “burden” of caring for a patient with a disability.
- They lacked the time or equipment, such as accessible exam tables or weight scales.
- They admitted to inventing excuses for why appointments were not available or routine diagnostic tests were not performed.
- They described being fearful of lawsuits under the Americans with Disabilities Act.
The overall message was summed up in one doctor’s statement: “I am not the doctor for you.”
“Doctors are people too,” Dr. Iezzoni pointed out. “And so they reflect the same prejudices and stigmatized attitudes of the rest of the population. It might be implicit, so they might not be aware of it. [But] it might be explicit.”
Ableism in the medical field is all too familiar to Dr. Iezzoni. She was diagnosed with multiple sclerosis at age 26 during her first year at Harvard Medical School in the early 1980s. Despite symptom flare-ups, Dr. Iezzoni was able to graduate with her class, but many instructors and administrators had little interest in accommodating her physical limitations. In fact, several physicians discouraged her from continuing to train.
Unable to take call, run up flights of stairs, or stand for hours at a time, Dr. Iezzoni remembers being told by a senior surgeon that she shouldn’t become a doctor since she lacked the “most important quality,” which was “24/7 availability.” A hospital CEO informed her: “There are too many doctors in the country right now for us to worry about training a handicapped physician. If that means that some people get left by the wayside, so be it.”
Ultimately, Harvard Medical School declined to write Dr. Iezzoni a letter of recommendation for an internship. She would never practice medicine. “My career was just truncated from the start,” Dr. Iezzoni said. “It never happened because of discrimination.”
She later learned the legal term for her treatment: constructive dismissal.
“The medical school didn’t outright say, ‘Go away. We’re not allowing you to graduate.’ ” Dr. Iezzoni explained. “But they made my life so difficult that I did so voluntarily.”
Dr. Iezzoni graduated in 1984, before the passage of the ADA in 1990, and she refers to her experience as a “ghost from the past,” a historical reminder of how the legal landscape has changed – even though the tendency toward bias may not have.
The fight for inclusion
Zainub Dhanani, a fifth-year medical student at Stanford (Calif.) University, won’t forget an interview at one of the other schools to which she applied. The interviewer asked how she expected to be in a hospital all day if she had a chronic illness.
“Does it really make sense?” he wanted to know.
The question shocked her in the moment, but now she sees this type of bias as linked to the inequalities that many marginalized groups face in health care and beyond. That’s also why she believes physician-patients are crucial to improve the quality of care for people with chronic illness and other groups that face discrimination.
Who else, she wonders, could provide that “reaffirming” experience for patients or have that “unique edge” other than a provider who has navigated the same world?
Ms. Dhanani is the executive director and founder of Medical Students With Disability and Chronic Illness, an organization dedicated to empowering these students through advocacy, education, accessibility, and community. The group now has 19 chapters at medical schools across the country.
Ms. Dhanani said she has received excellent accommodations from Stanford for her own condition (which she prefers not to disclose), but all medical schools are not as responsive to students with various physical needs. Her organization offers support and resources to inform these future physicians about their options and rights.
“Disability justice is also racial justice,” Ms. Dhanani stressed. “It’s also environmental justice. It’s also gender and sexuality-based justice. Those compounded layers of biases lead to worse and worse levels of care. As a patient, it’s terrifying. And as a future physician, it’s tragic to know that this is something so pervasive and yet so under-addressed in medicine.”
Soldiering on
Unfortunately, for some physicians with chronic illness, there are no practical accommodations that could save their careers in clinical practice.
Dr. Stenehjem now works part-time as a health consultant, helping those with chronic illnesses navigate their health care systems.
Dr. Bluestein offers a similar coaching service to patients with Ehlers-Danlos syndrome (EDS) and other connective tissue and hypermobility disorders. Because of her own EDS, she can no longer practice as an anesthesiologist but instead opened an integrative pain management practice for patients with complex pain conditions..
She believes the idea that doctors are “invincible” needs to change. She recalls the time her former group practice told her in no uncertain terms to “never call in sick.”
The stories she hears from her current clients are similar to her own. She can empathize, knowing firsthand the physical and psychological damage these attitudes can cause.
“When I was at my worst physically, I was also at my worst psychologically,” said Dr. Bluestein. “We tend to think of them as separate, but they go hand in hand. If we can validate people’s experiences rather than disregard them, it has a positive forward cycle, as opposed to the reverse, which is what usually happens.”
A version of this article first appeared on Medscape.com.
Linda Bluestein remembers all the doctors who missed, ignored, or incompletely diagnosed her chronic illness.
There was the orthopedic surgeon who noted her hyperextended elbows but failed to check any of her other joints. The gastroenterologist who insisted on performing multiple scoping procedures but wouldn’t discuss how to manage her symptoms. The other surgeon who, after performing arthroscopy on her injured knee, yelled at her: “There is nothing wrong with your knee! You’re fine!” in a room full of people.
And then there was the rheumatologist who said: “Oh, you want something to be wrong with you?”
“No,” she replied, “I want an explanation. I want to keep working. I just want to know why these things keep happening to me.”
The medical frustration she experienced was especially difficult because, like her health care providers, Linda Bluestein has an MD after her name. She is a board-certified anesthesiologist and integrative medicine physician.
Along with the physically demanding schedule of medical practice, they must cope with what many call a “culture of invincibility” within medicine. Doctors are not supposed to get sick. In fact, the unwritten rule is presenteeism – to function without adequate food or sleep and to never prioritize their own self-care over their dedication to their patients.
Whether their conditions are visible, such as muscular dystrophy and multiple sclerosis, or invisible, such as fibromyalgia and mental illnesses – and now, long COVID – these doctors often meet significant stigma. They fight the assumption that they are less capable than their colleagues.
But they also experience an invaluable benefit: They gain firsthand knowledge of the patient experience, a profound understanding which, they say, enhances how they care for their own patients.
What it takes to become a doctor when you have a chronic condition
In short, it’s not easy.
Data from the 2018 National Health Interview Survey show that more than half of U.S. adults had at least one of several chronic conditions, including rheumatoid arthritis, asthma, diabetes, hypertension, and kidney problems. Nearly a third of respondents had more than one condition. But fewer than 5% of medical students and 3% of practicing physicians report having a chronic illness or disability, according to studies from 2019 and 2021.
While that could mean that fewer people with chronic illness enter medicine, cases also exist in which aspiring physicians with conditions were dissuaded from pursuing a career in medicine at all.
Amy Stenehjem, MD, a physical medicine and rehabilitation physician, is one of the exceptions. Diagnosed with several autoimmune-related conditions as a teenager and young adult, Dr. Stenehjem was determined to become a doctor. In her 20s, her health was relatively stable, and she was able to manage medical school and residency. Her training institutions agreed to provide some accommodations that helped her succeed.
“They let me build some flexibility into the training,” Dr. Stenehjem said. “In medical school, when I knew I wasn’t going to be able to do a particular specialty as a career, they let me work with an attending doctor that did not require a lot of on-call time during that particular rotation.”
Dr. Stenehjem specialized in chronic neck and back disorders, fibromyalgia, chronic fatigue syndrome (myalgic encephalomyelitis), and autoimmune-related diseases. She practiced for more than a decade. But in 2011, her condition spiraled. She couldn’t walk a few steps or even sit upright without experiencing dizziness and shortness of breath. She had debilitating fatigue and episodes of fever, rash, headaches, and joint pain.
It would take 7 years and more than 20 doctors to determine Dr. Stenehjem’s multiple diagnoses. In addition to her autoimmune diseases, she was diagnosed with postural orthostatic tachycardia syndrome, autoinflammatory periodic fever syndrome, Lyme disease, and reactivated Epstein-Barr infection.
While she suspects that her providers gave her more “leeway” because she was a physician, many did not show a deep understanding of the severity of her symptoms and the impact those symptoms had.
“When I was practicing, I really didn’t fully understand the impact chronic illness had on my patients,” Dr. Stenehjem said. “Things like chronic dizziness, headaches, fatigue, pain, or brain fog can be really hard to understand unless you’ve experienced these symptoms. When I got sick, I finally realized, ‘Oh my goodness, when a patient says they’re dealing with fatigue, this is not your normal, I’m-super-tired-from-being-on-call fatigue. This is I-can’t-get-out-of-bed fatigue.’ That’s what people with chronic illness often deal with on a daily basis.”
Treating the individual
Dr. Stenehjem was aware that her chronic illness would affect her medical career. For Jason Baker, MD, an endocrinologist at Weill Cornell Medicine, New York, it came as a shock. Dr. Baker was a third-year medical student when he experienced increased urination and rapid weight loss. It was only when friends pressed him to visit student health that a blood test revealed type 1 diabetes. Dr. Baker suddenly found himself lying in a hospital bed.
He remembers an attending physician who simply handed him a textbook on diabetic ketoacidosis (DKA) and a resident who informed him that he had kidney damage, which turned out to be untrue. Neither discussed the psychological issues from a frightening diagnosis that would require lifelong, daily management.
“There certainly could have been a bit more empathy from some of the people I dealt with early on,” he said.
Although his training gave him a stark picture of worst-case scenarios, Dr. Baker found that knowledge motivating. “I’d already seen patients come in who had diabetes complications,” Dr. Baker says. “I vowed to never ever get those complications. It was a good balance of fear and motivation.”
Dr. Baker had not planned to specialize in endocrinology, but he quickly realized that his personal diagnosis could help others. Now he often shares his experience with his patients who have diabetes, which he says makes them more comfortable discussing their own problems.
His approach, Dr. Baker explained, is to treat everyone as an individual. Trying to neatly classify patients with chronic illness is a common mistake he notices among physicians.
“There’s a lot of misunderstanding about type 1 versus type 2 [diabetes],” Dr. Baker said, “and trying to categorize people when sometimes people can’t be categorized. That’s really with any chronic condition; there’s no one size fits all.”
Managing his health is still a time-consuming task. At work, he needs breaks to eat, check his blood sugar, or take insulin. “During the workday seeing patients, I have to also remember that I’m a patient,” Dr. Baker said. “I have to be okay with prioritizing my own health. Otherwise I can’t help anybody.”
‘I am not the doctor for you’
Chronic diseases such as diabetes or hypertension are familiar to most doctors, and with good management, patients can usually function normally. When chronic conditions become disabling, however, attitudes in the medical field can change.
According to data from the Centers for Disease Control and Prevention and from studies, people with disabilities experience significant disparities and barriers to care. Some of this can be linked to social determinants of health. People with disabilities are more likely to be poor and to rely on Medicare and Medicaid for insurance coverage. But lack of training, unwillingness to provide accommodations, ignorance of legal requirements, and inaccurate assumptions among physicians also play a role.
These are themes that Lisa Iezzoni, MD, a professor of medicine at Harvard Medical School, Boston, has heard from hundreds of patients with disabilities during the more than 25 years that she has conducted research.
In late 2019, Dr. Iezzoni and coinvestigators fielded a national survey of 714 practicing physicians. Only 40.7% reported they were “very confident” that they could provide the same quality of care to patients with disabilities as they do for other patients. And only 56.5% “strongly agreed” that they welcomed these patients into their practices.
The survey was conducted through a series of small focus groups that Dr. Iezzoni held with physicians in 2018. These yielded views that were startling, and in some cases, overtly discriminatory:
- Doctors complained about the “burden” of caring for a patient with a disability.
- They lacked the time or equipment, such as accessible exam tables or weight scales.
- They admitted to inventing excuses for why appointments were not available or routine diagnostic tests were not performed.
- They described being fearful of lawsuits under the Americans with Disabilities Act.
The overall message was summed up in one doctor’s statement: “I am not the doctor for you.”
“Doctors are people too,” Dr. Iezzoni pointed out. “And so they reflect the same prejudices and stigmatized attitudes of the rest of the population. It might be implicit, so they might not be aware of it. [But] it might be explicit.”
Ableism in the medical field is all too familiar to Dr. Iezzoni. She was diagnosed with multiple sclerosis at age 26 during her first year at Harvard Medical School in the early 1980s. Despite symptom flare-ups, Dr. Iezzoni was able to graduate with her class, but many instructors and administrators had little interest in accommodating her physical limitations. In fact, several physicians discouraged her from continuing to train.
Unable to take call, run up flights of stairs, or stand for hours at a time, Dr. Iezzoni remembers being told by a senior surgeon that she shouldn’t become a doctor since she lacked the “most important quality,” which was “24/7 availability.” A hospital CEO informed her: “There are too many doctors in the country right now for us to worry about training a handicapped physician. If that means that some people get left by the wayside, so be it.”
Ultimately, Harvard Medical School declined to write Dr. Iezzoni a letter of recommendation for an internship. She would never practice medicine. “My career was just truncated from the start,” Dr. Iezzoni said. “It never happened because of discrimination.”
She later learned the legal term for her treatment: constructive dismissal.
“The medical school didn’t outright say, ‘Go away. We’re not allowing you to graduate.’ ” Dr. Iezzoni explained. “But they made my life so difficult that I did so voluntarily.”
Dr. Iezzoni graduated in 1984, before the passage of the ADA in 1990, and she refers to her experience as a “ghost from the past,” a historical reminder of how the legal landscape has changed – even though the tendency toward bias may not have.
The fight for inclusion
Zainub Dhanani, a fifth-year medical student at Stanford (Calif.) University, won’t forget an interview at one of the other schools to which she applied. The interviewer asked how she expected to be in a hospital all day if she had a chronic illness.
“Does it really make sense?” he wanted to know.
The question shocked her in the moment, but now she sees this type of bias as linked to the inequalities that many marginalized groups face in health care and beyond. That’s also why she believes physician-patients are crucial to improve the quality of care for people with chronic illness and other groups that face discrimination.
Who else, she wonders, could provide that “reaffirming” experience for patients or have that “unique edge” other than a provider who has navigated the same world?
Ms. Dhanani is the executive director and founder of Medical Students With Disability and Chronic Illness, an organization dedicated to empowering these students through advocacy, education, accessibility, and community. The group now has 19 chapters at medical schools across the country.
Ms. Dhanani said she has received excellent accommodations from Stanford for her own condition (which she prefers not to disclose), but all medical schools are not as responsive to students with various physical needs. Her organization offers support and resources to inform these future physicians about their options and rights.
“Disability justice is also racial justice,” Ms. Dhanani stressed. “It’s also environmental justice. It’s also gender and sexuality-based justice. Those compounded layers of biases lead to worse and worse levels of care. As a patient, it’s terrifying. And as a future physician, it’s tragic to know that this is something so pervasive and yet so under-addressed in medicine.”
Soldiering on
Unfortunately, for some physicians with chronic illness, there are no practical accommodations that could save their careers in clinical practice.
Dr. Stenehjem now works part-time as a health consultant, helping those with chronic illnesses navigate their health care systems.
Dr. Bluestein offers a similar coaching service to patients with Ehlers-Danlos syndrome (EDS) and other connective tissue and hypermobility disorders. Because of her own EDS, she can no longer practice as an anesthesiologist but instead opened an integrative pain management practice for patients with complex pain conditions..
She believes the idea that doctors are “invincible” needs to change. She recalls the time her former group practice told her in no uncertain terms to “never call in sick.”
The stories she hears from her current clients are similar to her own. She can empathize, knowing firsthand the physical and psychological damage these attitudes can cause.
“When I was at my worst physically, I was also at my worst psychologically,” said Dr. Bluestein. “We tend to think of them as separate, but they go hand in hand. If we can validate people’s experiences rather than disregard them, it has a positive forward cycle, as opposed to the reverse, which is what usually happens.”
A version of this article first appeared on Medscape.com.
Community workers may address psychiatrist shortage
SAN FRANCISCO – promises to bring timely, evidence-based health services to those with little to no access to effective care.
The current shortage of mental health clinicians is driven by increased demand from a population more willing to seek psychiatric help and clinicians leaving the workforce. Both factors were exacerbated by the COVID-19 pandemic.
“It would be costly to address the problem through additional specialist training, and doing so would take decades to see any changes,” project director Milton L. Wainberg, MD, professor of clinical psychiatry at Columbia University, New York, and New York State Psychiatric Institute, said in an interview.
A better solution is to train members of the community to be the entry point to the mental health care system, a strategy that has been proven effective.
Details of the project were discussed at the annual meeting of the American Psychiatric Association.
Half of the United States population will be diagnosed with a mental or substance use disorder in their lifetime, but only about half of those will receive proper treatment. That percentage is even greater among lower-income groups and minorities, said Dr. Wainberg.
Despite the availability of multiple evidence-based therapies, there has been no reduction in the global prevalence of psychiatric illness since 1990 – the first time this burden was determined, he said.
Unfeasible model
“The historic paradigm of ongoing long-term care is costly and not a feasible public mental health model. There is no evidence that it works, and there is increasing demand for brief interventions,” said Dr. Wainberg.
The new initiative – called ENGAGE – has its origins in parts of Africa, where nurses had to be trained during the AIDS crisis as there weren’t enough doctors to roll out antiretroviral therapy.
In the United States, the program trains and certifies community workers who are passionate about their community. “Members of the community want to learn how to help their neighbors,” said Dr. Wainberg. “When we give them the opportunity to learn skills that can actually change community members’ symptoms, they are excited.”
The training involves a didactic component and an experiential component, in which trainees work with at least three cases under supervision to demonstrate competency. Technical assistance and other supports, such as refresher training, are offered for a year after training.
Workers ask three initial questions to quickly determine if a person has a mental health disorder. Asking 10 additional questions tells the worker if the person has a common mental health disorder like depression, anxiety, or posttraumatic stress disorder (PTSD), a substance use disorder involving alcohol or drugs, suicide risk, or a severe disorder requiring referral to a mental health specialist.
Those who do not require a referral are offered an intervention personalized to their need.
The training costs $5,000 per person. “We calculated for New York State it would cost only $18 million to train everybody we need,” said Dr. Wainberg.
Cost effective
He stressed the program, which is funded by the New York Office of Mental Health, is cost effective. Just like patients don’t need to see a plastic surgeon to have a small mole removed, they don’t always need to see a psychiatrist for run-of-the-mill mild depression, he said.
To date, 20 workers have been trained and have started to meet with clients in clinics in four New York City neighborhoods/boroughs (Harlem, Brooklyn, the Bronx, and Washington Heights). Additional clinics in West Harlem and Staten Island are expected to begin training soon.
Dr. Wainberg has been inundated with interest in the initiative. “Over the last 3 months I have been having 15 meetings a day” with parties interested in getting more information or wanting to know how to start such a program.
He plans to examine the program’s effectiveness in a number of areas, including patient symptoms, timeliness of services, access, sustainability, and cost. And he aims to expand the project beyond New York.
Mental health specialists shouldn’t worry about becoming irrelevant with the addition of community workers, as the demand is so great, said Dr. Wainberg. “There will always be a need for the kind of care mental health specialists are trained for. This initiative aims to expand capacity for those with less severe symptoms, who might not need an intensive level of intervention.”
Unique program
In a comment, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences, Montefiore Medical Center and Albert Einstein College of Medicine, New York, said the project is “unique” and an “excellent” idea.
“This is one of the first pilots that I know of in this country to train lay-members of the community to screen for mental illness and substance use disorders and even to provide evidence-based treatment for people who may have more mild symptoms and might not yet need to see a professional but otherwise would not have access to care.”
Dr. Alpert noted the current challenges of accessing care for a mental health or substance abuse disorder. “Many clinics have wait lists of 3-6 months.”
Another issue is the “stigma and lack of trust” among minority communities when it comes to formal mental health treatments. “Having lay-members who know the community, who look like the community, who understand the community, and who are available for screening and treatment is exceptionally important.”
Although this pilot program will have to be assessed for effectiveness, “the concept behind it is very important,” said Dr. Alpert. “If you’re relying on MDs and PhDs to provide mental health services, there just aren’t enough of us to go around.”
Dr. Wainberg and Dr. Alpert report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO – promises to bring timely, evidence-based health services to those with little to no access to effective care.
The current shortage of mental health clinicians is driven by increased demand from a population more willing to seek psychiatric help and clinicians leaving the workforce. Both factors were exacerbated by the COVID-19 pandemic.
“It would be costly to address the problem through additional specialist training, and doing so would take decades to see any changes,” project director Milton L. Wainberg, MD, professor of clinical psychiatry at Columbia University, New York, and New York State Psychiatric Institute, said in an interview.
A better solution is to train members of the community to be the entry point to the mental health care system, a strategy that has been proven effective.
Details of the project were discussed at the annual meeting of the American Psychiatric Association.
Half of the United States population will be diagnosed with a mental or substance use disorder in their lifetime, but only about half of those will receive proper treatment. That percentage is even greater among lower-income groups and minorities, said Dr. Wainberg.
Despite the availability of multiple evidence-based therapies, there has been no reduction in the global prevalence of psychiatric illness since 1990 – the first time this burden was determined, he said.
Unfeasible model
“The historic paradigm of ongoing long-term care is costly and not a feasible public mental health model. There is no evidence that it works, and there is increasing demand for brief interventions,” said Dr. Wainberg.
The new initiative – called ENGAGE – has its origins in parts of Africa, where nurses had to be trained during the AIDS crisis as there weren’t enough doctors to roll out antiretroviral therapy.
In the United States, the program trains and certifies community workers who are passionate about their community. “Members of the community want to learn how to help their neighbors,” said Dr. Wainberg. “When we give them the opportunity to learn skills that can actually change community members’ symptoms, they are excited.”
The training involves a didactic component and an experiential component, in which trainees work with at least three cases under supervision to demonstrate competency. Technical assistance and other supports, such as refresher training, are offered for a year after training.
Workers ask three initial questions to quickly determine if a person has a mental health disorder. Asking 10 additional questions tells the worker if the person has a common mental health disorder like depression, anxiety, or posttraumatic stress disorder (PTSD), a substance use disorder involving alcohol or drugs, suicide risk, or a severe disorder requiring referral to a mental health specialist.
Those who do not require a referral are offered an intervention personalized to their need.
The training costs $5,000 per person. “We calculated for New York State it would cost only $18 million to train everybody we need,” said Dr. Wainberg.
Cost effective
He stressed the program, which is funded by the New York Office of Mental Health, is cost effective. Just like patients don’t need to see a plastic surgeon to have a small mole removed, they don’t always need to see a psychiatrist for run-of-the-mill mild depression, he said.
To date, 20 workers have been trained and have started to meet with clients in clinics in four New York City neighborhoods/boroughs (Harlem, Brooklyn, the Bronx, and Washington Heights). Additional clinics in West Harlem and Staten Island are expected to begin training soon.
Dr. Wainberg has been inundated with interest in the initiative. “Over the last 3 months I have been having 15 meetings a day” with parties interested in getting more information or wanting to know how to start such a program.
He plans to examine the program’s effectiveness in a number of areas, including patient symptoms, timeliness of services, access, sustainability, and cost. And he aims to expand the project beyond New York.
Mental health specialists shouldn’t worry about becoming irrelevant with the addition of community workers, as the demand is so great, said Dr. Wainberg. “There will always be a need for the kind of care mental health specialists are trained for. This initiative aims to expand capacity for those with less severe symptoms, who might not need an intensive level of intervention.”
Unique program
In a comment, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences, Montefiore Medical Center and Albert Einstein College of Medicine, New York, said the project is “unique” and an “excellent” idea.
“This is one of the first pilots that I know of in this country to train lay-members of the community to screen for mental illness and substance use disorders and even to provide evidence-based treatment for people who may have more mild symptoms and might not yet need to see a professional but otherwise would not have access to care.”
Dr. Alpert noted the current challenges of accessing care for a mental health or substance abuse disorder. “Many clinics have wait lists of 3-6 months.”
Another issue is the “stigma and lack of trust” among minority communities when it comes to formal mental health treatments. “Having lay-members who know the community, who look like the community, who understand the community, and who are available for screening and treatment is exceptionally important.”
Although this pilot program will have to be assessed for effectiveness, “the concept behind it is very important,” said Dr. Alpert. “If you’re relying on MDs and PhDs to provide mental health services, there just aren’t enough of us to go around.”
Dr. Wainberg and Dr. Alpert report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO – promises to bring timely, evidence-based health services to those with little to no access to effective care.
The current shortage of mental health clinicians is driven by increased demand from a population more willing to seek psychiatric help and clinicians leaving the workforce. Both factors were exacerbated by the COVID-19 pandemic.
“It would be costly to address the problem through additional specialist training, and doing so would take decades to see any changes,” project director Milton L. Wainberg, MD, professor of clinical psychiatry at Columbia University, New York, and New York State Psychiatric Institute, said in an interview.
A better solution is to train members of the community to be the entry point to the mental health care system, a strategy that has been proven effective.
Details of the project were discussed at the annual meeting of the American Psychiatric Association.
Half of the United States population will be diagnosed with a mental or substance use disorder in their lifetime, but only about half of those will receive proper treatment. That percentage is even greater among lower-income groups and minorities, said Dr. Wainberg.
Despite the availability of multiple evidence-based therapies, there has been no reduction in the global prevalence of psychiatric illness since 1990 – the first time this burden was determined, he said.
Unfeasible model
“The historic paradigm of ongoing long-term care is costly and not a feasible public mental health model. There is no evidence that it works, and there is increasing demand for brief interventions,” said Dr. Wainberg.
The new initiative – called ENGAGE – has its origins in parts of Africa, where nurses had to be trained during the AIDS crisis as there weren’t enough doctors to roll out antiretroviral therapy.
In the United States, the program trains and certifies community workers who are passionate about their community. “Members of the community want to learn how to help their neighbors,” said Dr. Wainberg. “When we give them the opportunity to learn skills that can actually change community members’ symptoms, they are excited.”
The training involves a didactic component and an experiential component, in which trainees work with at least three cases under supervision to demonstrate competency. Technical assistance and other supports, such as refresher training, are offered for a year after training.
Workers ask three initial questions to quickly determine if a person has a mental health disorder. Asking 10 additional questions tells the worker if the person has a common mental health disorder like depression, anxiety, or posttraumatic stress disorder (PTSD), a substance use disorder involving alcohol or drugs, suicide risk, or a severe disorder requiring referral to a mental health specialist.
Those who do not require a referral are offered an intervention personalized to their need.
The training costs $5,000 per person. “We calculated for New York State it would cost only $18 million to train everybody we need,” said Dr. Wainberg.
Cost effective
He stressed the program, which is funded by the New York Office of Mental Health, is cost effective. Just like patients don’t need to see a plastic surgeon to have a small mole removed, they don’t always need to see a psychiatrist for run-of-the-mill mild depression, he said.
To date, 20 workers have been trained and have started to meet with clients in clinics in four New York City neighborhoods/boroughs (Harlem, Brooklyn, the Bronx, and Washington Heights). Additional clinics in West Harlem and Staten Island are expected to begin training soon.
Dr. Wainberg has been inundated with interest in the initiative. “Over the last 3 months I have been having 15 meetings a day” with parties interested in getting more information or wanting to know how to start such a program.
He plans to examine the program’s effectiveness in a number of areas, including patient symptoms, timeliness of services, access, sustainability, and cost. And he aims to expand the project beyond New York.
Mental health specialists shouldn’t worry about becoming irrelevant with the addition of community workers, as the demand is so great, said Dr. Wainberg. “There will always be a need for the kind of care mental health specialists are trained for. This initiative aims to expand capacity for those with less severe symptoms, who might not need an intensive level of intervention.”
Unique program
In a comment, Jonathan E. Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences, Montefiore Medical Center and Albert Einstein College of Medicine, New York, said the project is “unique” and an “excellent” idea.
“This is one of the first pilots that I know of in this country to train lay-members of the community to screen for mental illness and substance use disorders and even to provide evidence-based treatment for people who may have more mild symptoms and might not yet need to see a professional but otherwise would not have access to care.”
Dr. Alpert noted the current challenges of accessing care for a mental health or substance abuse disorder. “Many clinics have wait lists of 3-6 months.”
Another issue is the “stigma and lack of trust” among minority communities when it comes to formal mental health treatments. “Having lay-members who know the community, who look like the community, who understand the community, and who are available for screening and treatment is exceptionally important.”
Although this pilot program will have to be assessed for effectiveness, “the concept behind it is very important,” said Dr. Alpert. “If you’re relying on MDs and PhDs to provide mental health services, there just aren’t enough of us to go around.”
Dr. Wainberg and Dr. Alpert report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM APA 2023
U.S. psychiatrist shortage causing months-long wait times
SAN FRANCISCO –
“Long wait times for mental health care were a huge problem even before the pandemic but especially during the pandemic,” study investigator Erin McDaid, BS, Virginia Tech Carilion School of Medicine, Roanoke, said in an interview.
“It’s not like you have a cold or a virus and maybe you wait a little bit and it goes away. Mental health problems can completely impact your life; you can’t do anything, you can’t go to work, you can’t build relationships, you can’t take care of your kids. It’s a really big issue,” Ms. McDaid said.
The study was presented at the annual meeting of the American Psychiatric Association.
Few psychiatrists taking new patients
To find out just how big an issue wait times are, the researchers examined general psychiatry outpatient availability during the COVID-19 pandemic in five states – New York, California, North Dakota, Virginia, and Wyoming.
Altogether, 948 psychiatrists were sampled. Simulated adult patients made 864 calls seeking an initial psychiatric evaluation for general mental health care. The calls were made late in the pandemic, between May and July 2022.
Only 18.5% of psychiatrists were available to see new patients. The median wait time was 67 days for in-person appointments and 43 days for telepsychiatry appointments (P < .001).
More than half of psychiatrists who were contacted said they were not taking new patients, which was the most common reason given for unavailability.
“This is happening at the worst time, when we are seeing mental health issues spike,” Ms. McDaid said.
Telepsychiatry helpful but no panacea
The fact that wait times were a bit shorter for telepsychiatry is encouraging, Ms. McDaid said.
Telepsychiatry is a potential solution to provider shortages and geographic barriers, but it does not resolve the concerning shortage of psychiatric outpatient care, she noted.
“Psychiatrists adapted very well to telepsychiatry during COVID,” Saul Levin, MD, MPA, chief executive officer and medical director of the APA, noted during a preconference briefing with reporters.
“Before COVID, we always thought that the psychiatrist had to be with the patient in the room,” said Dr. Levin. But now we see that either “sitting inside the room with your psychiatrist or mental health specialist or [being there virtually] has the same effect. The patient is concentrating and working out their problems with you. I think that’s one of the positives – if anything coming out of COVID is positive.”
In an interview, Robert Trestman, MD, chair of the APA Council on Healthcare Systems and Financing, said telepsychiatry “will help, but there is not one simple solution that will fix the problem” regarding access to mental health care.
One promising approach is the collaborative care model, which enlists primary care physicians to provide mental health care in consultation with psychiatry and case management, Dr. Trestman said.
“There’s no question that there aren’t enough providers. There aren’t enough primary care doctors, and there certainly aren’t enough psychiatrists,” Dr. Trestman noted.
Encouragingly, however, the past few years have seen a steady increase in medical students choosing psychiatry.
“Psychiatry is now being thought of as a branch of neuroscience. We are understanding so much more about the field and about the brain. So that’s intriguing and intellectually challenging to many,” Dr. Trestman said.
He also noted that the pandemic has helped to “break down stigma. More people acknowledge and talk about mental health, and when an area is destigmatized, it’s so much easier for people to consider.”
Jack Resneck, Jr., MD, president of the American Medical Association, acknowledged that there is a “severe workforce shortage in health care right now.”
“I’m a physician and the president of the AMA, and it took me way too long to be able to find a primary care physician for myself,” he said.
“I also am a physician who refers patients to rheumatology and endocrinology, psychiatry, and other areas of medicine, and it is, in many geographic areas both rural and urban, a huge struggle right now,” said Dr. Resneck.
The study had no specific funding. Ms. McDaid, Dr. Levin, and Dr. Trestman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO –
“Long wait times for mental health care were a huge problem even before the pandemic but especially during the pandemic,” study investigator Erin McDaid, BS, Virginia Tech Carilion School of Medicine, Roanoke, said in an interview.
“It’s not like you have a cold or a virus and maybe you wait a little bit and it goes away. Mental health problems can completely impact your life; you can’t do anything, you can’t go to work, you can’t build relationships, you can’t take care of your kids. It’s a really big issue,” Ms. McDaid said.
The study was presented at the annual meeting of the American Psychiatric Association.
Few psychiatrists taking new patients
To find out just how big an issue wait times are, the researchers examined general psychiatry outpatient availability during the COVID-19 pandemic in five states – New York, California, North Dakota, Virginia, and Wyoming.
Altogether, 948 psychiatrists were sampled. Simulated adult patients made 864 calls seeking an initial psychiatric evaluation for general mental health care. The calls were made late in the pandemic, between May and July 2022.
Only 18.5% of psychiatrists were available to see new patients. The median wait time was 67 days for in-person appointments and 43 days for telepsychiatry appointments (P < .001).
More than half of psychiatrists who were contacted said they were not taking new patients, which was the most common reason given for unavailability.
“This is happening at the worst time, when we are seeing mental health issues spike,” Ms. McDaid said.
Telepsychiatry helpful but no panacea
The fact that wait times were a bit shorter for telepsychiatry is encouraging, Ms. McDaid said.
Telepsychiatry is a potential solution to provider shortages and geographic barriers, but it does not resolve the concerning shortage of psychiatric outpatient care, she noted.
“Psychiatrists adapted very well to telepsychiatry during COVID,” Saul Levin, MD, MPA, chief executive officer and medical director of the APA, noted during a preconference briefing with reporters.
“Before COVID, we always thought that the psychiatrist had to be with the patient in the room,” said Dr. Levin. But now we see that either “sitting inside the room with your psychiatrist or mental health specialist or [being there virtually] has the same effect. The patient is concentrating and working out their problems with you. I think that’s one of the positives – if anything coming out of COVID is positive.”
In an interview, Robert Trestman, MD, chair of the APA Council on Healthcare Systems and Financing, said telepsychiatry “will help, but there is not one simple solution that will fix the problem” regarding access to mental health care.
One promising approach is the collaborative care model, which enlists primary care physicians to provide mental health care in consultation with psychiatry and case management, Dr. Trestman said.
“There’s no question that there aren’t enough providers. There aren’t enough primary care doctors, and there certainly aren’t enough psychiatrists,” Dr. Trestman noted.
Encouragingly, however, the past few years have seen a steady increase in medical students choosing psychiatry.
“Psychiatry is now being thought of as a branch of neuroscience. We are understanding so much more about the field and about the brain. So that’s intriguing and intellectually challenging to many,” Dr. Trestman said.
He also noted that the pandemic has helped to “break down stigma. More people acknowledge and talk about mental health, and when an area is destigmatized, it’s so much easier for people to consider.”
Jack Resneck, Jr., MD, president of the American Medical Association, acknowledged that there is a “severe workforce shortage in health care right now.”
“I’m a physician and the president of the AMA, and it took me way too long to be able to find a primary care physician for myself,” he said.
“I also am a physician who refers patients to rheumatology and endocrinology, psychiatry, and other areas of medicine, and it is, in many geographic areas both rural and urban, a huge struggle right now,” said Dr. Resneck.
The study had no specific funding. Ms. McDaid, Dr. Levin, and Dr. Trestman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO –
“Long wait times for mental health care were a huge problem even before the pandemic but especially during the pandemic,” study investigator Erin McDaid, BS, Virginia Tech Carilion School of Medicine, Roanoke, said in an interview.
“It’s not like you have a cold or a virus and maybe you wait a little bit and it goes away. Mental health problems can completely impact your life; you can’t do anything, you can’t go to work, you can’t build relationships, you can’t take care of your kids. It’s a really big issue,” Ms. McDaid said.
The study was presented at the annual meeting of the American Psychiatric Association.
Few psychiatrists taking new patients
To find out just how big an issue wait times are, the researchers examined general psychiatry outpatient availability during the COVID-19 pandemic in five states – New York, California, North Dakota, Virginia, and Wyoming.
Altogether, 948 psychiatrists were sampled. Simulated adult patients made 864 calls seeking an initial psychiatric evaluation for general mental health care. The calls were made late in the pandemic, between May and July 2022.
Only 18.5% of psychiatrists were available to see new patients. The median wait time was 67 days for in-person appointments and 43 days for telepsychiatry appointments (P < .001).
More than half of psychiatrists who were contacted said they were not taking new patients, which was the most common reason given for unavailability.
“This is happening at the worst time, when we are seeing mental health issues spike,” Ms. McDaid said.
Telepsychiatry helpful but no panacea
The fact that wait times were a bit shorter for telepsychiatry is encouraging, Ms. McDaid said.
Telepsychiatry is a potential solution to provider shortages and geographic barriers, but it does not resolve the concerning shortage of psychiatric outpatient care, she noted.
“Psychiatrists adapted very well to telepsychiatry during COVID,” Saul Levin, MD, MPA, chief executive officer and medical director of the APA, noted during a preconference briefing with reporters.
“Before COVID, we always thought that the psychiatrist had to be with the patient in the room,” said Dr. Levin. But now we see that either “sitting inside the room with your psychiatrist or mental health specialist or [being there virtually] has the same effect. The patient is concentrating and working out their problems with you. I think that’s one of the positives – if anything coming out of COVID is positive.”
In an interview, Robert Trestman, MD, chair of the APA Council on Healthcare Systems and Financing, said telepsychiatry “will help, but there is not one simple solution that will fix the problem” regarding access to mental health care.
One promising approach is the collaborative care model, which enlists primary care physicians to provide mental health care in consultation with psychiatry and case management, Dr. Trestman said.
“There’s no question that there aren’t enough providers. There aren’t enough primary care doctors, and there certainly aren’t enough psychiatrists,” Dr. Trestman noted.
Encouragingly, however, the past few years have seen a steady increase in medical students choosing psychiatry.
“Psychiatry is now being thought of as a branch of neuroscience. We are understanding so much more about the field and about the brain. So that’s intriguing and intellectually challenging to many,” Dr. Trestman said.
He also noted that the pandemic has helped to “break down stigma. More people acknowledge and talk about mental health, and when an area is destigmatized, it’s so much easier for people to consider.”
Jack Resneck, Jr., MD, president of the American Medical Association, acknowledged that there is a “severe workforce shortage in health care right now.”
“I’m a physician and the president of the AMA, and it took me way too long to be able to find a primary care physician for myself,” he said.
“I also am a physician who refers patients to rheumatology and endocrinology, psychiatry, and other areas of medicine, and it is, in many geographic areas both rural and urban, a huge struggle right now,” said Dr. Resneck.
The study had no specific funding. Ms. McDaid, Dr. Levin, and Dr. Trestman have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT APA 2023
Abrocitinib remains effective at 96 weeks, in older as well as younger adults
WASHINGTON – A substantial proportion of , Andrew F. Alexis, MD, MPH, reported in a late-breaker abstract session at the annual Revolutionizing Atopic Dermatitis conference.
The analysis stratified patients by age – 18-50 and over 50 years – and found that the sustained improvement with the JAK-1 selective inhibitor as monotherapy was seen regardless of age. “In practice, patients who are older tend to have had AD for a longer period of time and tend to be more difficult to treat so it’s reassuring to see that even in the over-50 age group, they show substantial responses, even with more stringent endpoints,” said Dr. Alexis, professor of clinical dermatology at Weill Cornell Medical College, New York.
At week 96, for instance, the proportion of patients who achieved at least a 75% improvement from baseline on the Eczema Area and Severity Index (EASI-75) was 73% with the 100-mg dose and 85% with the 200-mg dose in the younger age group, and 86% and 89%, respectively, in the older age group.
An EASI-90 response – one of the more stringent outcomes – was achieved by 45% and 58% in the 18-50 group and 58% and 73% in the over 50 group (for 100-mg and 200-mg doses, respectively), Dr. Alexis reported.
The interim analysis also showed dose-dependent efficacy overall up to 96 weeks in the younger age group but only up to 48 weeks in the older age group. Response to some outcome measures in patients over age 50 years was “less clearly dose dependent after week 48” than earlier, Dr. Alexis said.
The ongoing JADE EXTEND trial enrolled patients who had participated in the phase 3 JADE clinical trials. This analysis covered 1,309 patients who were enrolled by a September 2021 cutoff. The patient population leaned young: Eighty percent (1,046) were aged 18-50, and 20% (263) were over 50.
Patients who were randomly assigned to abrocitinib 200 mg or 100 mg in the parent trials continued to receive the same dose in JADE EXTEND with blinding maintained. Those who received placebo in the qualifying trial were randomly assigned to abrocitinib 200 mg or 100 mg. And patients from JADE DARE continued with their dosing of 200 mg. Grouping by age for the analysis was made based on the age recorded at the screening visit of the qualifying trial.
IGA, PP-NRS, and DLQI results
At week 96, the proportion of patients 18-50 years of age who achieved the Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline was 44% in the 100-mg group and 55% in the 200-mg group. Among patients over 50, these proportions were 51% and 58%, respectively.
The proportion of patients who achieved at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (PP-NRS) score was 54% and 66% (on 100 mg and 200 mg, respectively) among those aged 18-50, and 79% and 80%, respectively, among those over 50.
Looking at more stringent outcomes, 26% and 38% in the 18-50 group on 100 mg and 200 mg, respectively, achieved a PP-NRS of 0/1, as did 54% and 44% in the over-50 group.
Lastly, a score of less than 2 on the Dermatology Life Quality Index (DLQI 0/1) was achieved by 32% and 41% of patients aged 18-50 and by 51% and 48% of patients over 50, for the 100-mg and 200-mg doses, respectively.
The decline in dose-dependent efficacy in the older age group after 48 weeks may be due to the smaller sample of older patients and/or the fact that a higher proportion of older patients had moderate baseline disease per their IGA score, versus severe disease, compared with the younger patients, Dr. Alexis said. “We see a skewing toward a bit more severe [disease] in the younger age group compared to the older,” he noted.
Abrocitinib (Cibinqo) is approved for the treatment of moderate to severe AD in adolescents aged 12 and up and adults whose disease is not adequately controlled with other systemic treatments or those for whom the use of these drugs is not advised. It is available in a 50-mg dose for dose adjustments in special populations, but this dose was not studied in the clinical trials, Dr. Alexis noted. The interim analysis did not include safety data.
In a separate presentation in which he reviewed long-term data on AD medications, Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that most patients who meet defined endpoints at week 12 of treatment with abrocitinib maintain that response over time. “By and large, there’s a steep initial rise that flattens over the long run, which is what you want to see. People getting that response are generally staying there over the course of treatment,” he said, referring to the JADE EXTEND data up to week 48.
It’s important to also appreciate, however, that the proportion of patients meeting efficacy outcomes in the trials of abrocitinib has grown well beyond 12 weeks, Dr. Chovatiya said.
Pointing to data presented at a 2021 RAD meeting depicting the proportion of 12-week nonresponders achieving a response at weeks 24 and 48 on IGA 0/1, EASI-75, and PP-NRS, Dr. Chovatiya said the level of response grew at both time points. “You’re capturing a chunk of people well beyond the primary endpoint if you keep them on therapy continuously, suggesting that ... we may need to reframe how we’re thinking about oral JAK inhibitors,” he said. “Not only are they rapidly acting, but they are medications that can provide good control and changes in the long run.”
Dr. Alexis and Dr. Chovatiya disclosed ties with Pfizer, which funded the study.
WASHINGTON – A substantial proportion of , Andrew F. Alexis, MD, MPH, reported in a late-breaker abstract session at the annual Revolutionizing Atopic Dermatitis conference.
The analysis stratified patients by age – 18-50 and over 50 years – and found that the sustained improvement with the JAK-1 selective inhibitor as monotherapy was seen regardless of age. “In practice, patients who are older tend to have had AD for a longer period of time and tend to be more difficult to treat so it’s reassuring to see that even in the over-50 age group, they show substantial responses, even with more stringent endpoints,” said Dr. Alexis, professor of clinical dermatology at Weill Cornell Medical College, New York.
At week 96, for instance, the proportion of patients who achieved at least a 75% improvement from baseline on the Eczema Area and Severity Index (EASI-75) was 73% with the 100-mg dose and 85% with the 200-mg dose in the younger age group, and 86% and 89%, respectively, in the older age group.
An EASI-90 response – one of the more stringent outcomes – was achieved by 45% and 58% in the 18-50 group and 58% and 73% in the over 50 group (for 100-mg and 200-mg doses, respectively), Dr. Alexis reported.
The interim analysis also showed dose-dependent efficacy overall up to 96 weeks in the younger age group but only up to 48 weeks in the older age group. Response to some outcome measures in patients over age 50 years was “less clearly dose dependent after week 48” than earlier, Dr. Alexis said.
The ongoing JADE EXTEND trial enrolled patients who had participated in the phase 3 JADE clinical trials. This analysis covered 1,309 patients who were enrolled by a September 2021 cutoff. The patient population leaned young: Eighty percent (1,046) were aged 18-50, and 20% (263) were over 50.
Patients who were randomly assigned to abrocitinib 200 mg or 100 mg in the parent trials continued to receive the same dose in JADE EXTEND with blinding maintained. Those who received placebo in the qualifying trial were randomly assigned to abrocitinib 200 mg or 100 mg. And patients from JADE DARE continued with their dosing of 200 mg. Grouping by age for the analysis was made based on the age recorded at the screening visit of the qualifying trial.
IGA, PP-NRS, and DLQI results
At week 96, the proportion of patients 18-50 years of age who achieved the Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline was 44% in the 100-mg group and 55% in the 200-mg group. Among patients over 50, these proportions were 51% and 58%, respectively.
The proportion of patients who achieved at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (PP-NRS) score was 54% and 66% (on 100 mg and 200 mg, respectively) among those aged 18-50, and 79% and 80%, respectively, among those over 50.
Looking at more stringent outcomes, 26% and 38% in the 18-50 group on 100 mg and 200 mg, respectively, achieved a PP-NRS of 0/1, as did 54% and 44% in the over-50 group.
Lastly, a score of less than 2 on the Dermatology Life Quality Index (DLQI 0/1) was achieved by 32% and 41% of patients aged 18-50 and by 51% and 48% of patients over 50, for the 100-mg and 200-mg doses, respectively.
The decline in dose-dependent efficacy in the older age group after 48 weeks may be due to the smaller sample of older patients and/or the fact that a higher proportion of older patients had moderate baseline disease per their IGA score, versus severe disease, compared with the younger patients, Dr. Alexis said. “We see a skewing toward a bit more severe [disease] in the younger age group compared to the older,” he noted.
Abrocitinib (Cibinqo) is approved for the treatment of moderate to severe AD in adolescents aged 12 and up and adults whose disease is not adequately controlled with other systemic treatments or those for whom the use of these drugs is not advised. It is available in a 50-mg dose for dose adjustments in special populations, but this dose was not studied in the clinical trials, Dr. Alexis noted. The interim analysis did not include safety data.
In a separate presentation in which he reviewed long-term data on AD medications, Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that most patients who meet defined endpoints at week 12 of treatment with abrocitinib maintain that response over time. “By and large, there’s a steep initial rise that flattens over the long run, which is what you want to see. People getting that response are generally staying there over the course of treatment,” he said, referring to the JADE EXTEND data up to week 48.
It’s important to also appreciate, however, that the proportion of patients meeting efficacy outcomes in the trials of abrocitinib has grown well beyond 12 weeks, Dr. Chovatiya said.
Pointing to data presented at a 2021 RAD meeting depicting the proportion of 12-week nonresponders achieving a response at weeks 24 and 48 on IGA 0/1, EASI-75, and PP-NRS, Dr. Chovatiya said the level of response grew at both time points. “You’re capturing a chunk of people well beyond the primary endpoint if you keep them on therapy continuously, suggesting that ... we may need to reframe how we’re thinking about oral JAK inhibitors,” he said. “Not only are they rapidly acting, but they are medications that can provide good control and changes in the long run.”
Dr. Alexis and Dr. Chovatiya disclosed ties with Pfizer, which funded the study.
WASHINGTON – A substantial proportion of , Andrew F. Alexis, MD, MPH, reported in a late-breaker abstract session at the annual Revolutionizing Atopic Dermatitis conference.
The analysis stratified patients by age – 18-50 and over 50 years – and found that the sustained improvement with the JAK-1 selective inhibitor as monotherapy was seen regardless of age. “In practice, patients who are older tend to have had AD for a longer period of time and tend to be more difficult to treat so it’s reassuring to see that even in the over-50 age group, they show substantial responses, even with more stringent endpoints,” said Dr. Alexis, professor of clinical dermatology at Weill Cornell Medical College, New York.
At week 96, for instance, the proportion of patients who achieved at least a 75% improvement from baseline on the Eczema Area and Severity Index (EASI-75) was 73% with the 100-mg dose and 85% with the 200-mg dose in the younger age group, and 86% and 89%, respectively, in the older age group.
An EASI-90 response – one of the more stringent outcomes – was achieved by 45% and 58% in the 18-50 group and 58% and 73% in the over 50 group (for 100-mg and 200-mg doses, respectively), Dr. Alexis reported.
The interim analysis also showed dose-dependent efficacy overall up to 96 weeks in the younger age group but only up to 48 weeks in the older age group. Response to some outcome measures in patients over age 50 years was “less clearly dose dependent after week 48” than earlier, Dr. Alexis said.
The ongoing JADE EXTEND trial enrolled patients who had participated in the phase 3 JADE clinical trials. This analysis covered 1,309 patients who were enrolled by a September 2021 cutoff. The patient population leaned young: Eighty percent (1,046) were aged 18-50, and 20% (263) were over 50.
Patients who were randomly assigned to abrocitinib 200 mg or 100 mg in the parent trials continued to receive the same dose in JADE EXTEND with blinding maintained. Those who received placebo in the qualifying trial were randomly assigned to abrocitinib 200 mg or 100 mg. And patients from JADE DARE continued with their dosing of 200 mg. Grouping by age for the analysis was made based on the age recorded at the screening visit of the qualifying trial.
IGA, PP-NRS, and DLQI results
At week 96, the proportion of patients 18-50 years of age who achieved the Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with at least a 2-grade improvement from baseline was 44% in the 100-mg group and 55% in the 200-mg group. Among patients over 50, these proportions were 51% and 58%, respectively.
The proportion of patients who achieved at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (PP-NRS) score was 54% and 66% (on 100 mg and 200 mg, respectively) among those aged 18-50, and 79% and 80%, respectively, among those over 50.
Looking at more stringent outcomes, 26% and 38% in the 18-50 group on 100 mg and 200 mg, respectively, achieved a PP-NRS of 0/1, as did 54% and 44% in the over-50 group.
Lastly, a score of less than 2 on the Dermatology Life Quality Index (DLQI 0/1) was achieved by 32% and 41% of patients aged 18-50 and by 51% and 48% of patients over 50, for the 100-mg and 200-mg doses, respectively.
The decline in dose-dependent efficacy in the older age group after 48 weeks may be due to the smaller sample of older patients and/or the fact that a higher proportion of older patients had moderate baseline disease per their IGA score, versus severe disease, compared with the younger patients, Dr. Alexis said. “We see a skewing toward a bit more severe [disease] in the younger age group compared to the older,” he noted.
Abrocitinib (Cibinqo) is approved for the treatment of moderate to severe AD in adolescents aged 12 and up and adults whose disease is not adequately controlled with other systemic treatments or those for whom the use of these drugs is not advised. It is available in a 50-mg dose for dose adjustments in special populations, but this dose was not studied in the clinical trials, Dr. Alexis noted. The interim analysis did not include safety data.
In a separate presentation in which he reviewed long-term data on AD medications, Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that most patients who meet defined endpoints at week 12 of treatment with abrocitinib maintain that response over time. “By and large, there’s a steep initial rise that flattens over the long run, which is what you want to see. People getting that response are generally staying there over the course of treatment,” he said, referring to the JADE EXTEND data up to week 48.
It’s important to also appreciate, however, that the proportion of patients meeting efficacy outcomes in the trials of abrocitinib has grown well beyond 12 weeks, Dr. Chovatiya said.
Pointing to data presented at a 2021 RAD meeting depicting the proportion of 12-week nonresponders achieving a response at weeks 24 and 48 on IGA 0/1, EASI-75, and PP-NRS, Dr. Chovatiya said the level of response grew at both time points. “You’re capturing a chunk of people well beyond the primary endpoint if you keep them on therapy continuously, suggesting that ... we may need to reframe how we’re thinking about oral JAK inhibitors,” he said. “Not only are they rapidly acting, but they are medications that can provide good control and changes in the long run.”
Dr. Alexis and Dr. Chovatiya disclosed ties with Pfizer, which funded the study.
AT RAD 2023
Psychiatrists: Don’t fear clozapine in treatment-resistant schizophrenia
SAN FRANCISCO – A trio of psychiatrists urged colleagues at the annual meeting of the American Psychiatric Association to embrace the venerable antipsychotic clozapine in patients with treatment-resistant schizophrenia. They cautioned that clinicians may overestimate the true risk of the adverse effect of neutropenia in minority populations.
“Although clozapine is known to be a life-improving and even potentially lifesaving treatment, it remains underutilized in the U.S.,” said Claire C. Holderness, MD, a psychiatrist at Columbia University Irving Medical Center, New York. “It’s been estimated that between 35% and 40% of all patients with schizophrenia should be considered for a clozapine trial. However, only 4%-5% of patients with schizophrenia in the U.S. have ever received clozapine. This is in sharp contrast to other industrialized countries where approximately 20% or more of patients with schizophrenia are treated with clozapine.”
According to Dr. Holderness, research has shown that clozapine is even less likely to be prescribed to racial and ethnic minorities. A 2022 systematic review, for example, found that Black patients in the United States had between one-third and two-thirds the odds of being treated with the drug, compared with White patients after adjustment for potential confounders such as demographics. Hispanic/Latino patients were also less likely than Whites to be prescribed the drug.
As Dr. Holderness put it, the drug “been shown to be more effective in treatment-resistant schizophrenia than any other antipsychotic medication. Clozapine is also the most cost-effective treatment for treatment-resistant schizophrenia.” So why does this disparity exist despite clozapine’s benefits?
A 2018 systematic review of barriers to the drug’s usage identified several factors: “mandatory blood testing, fear of serious side-effects and lack of adherence by the patients, difficulty in identifying suitable patients, service fragmentation, and inadequate training in or exposure to using clozapine.” A 2016 British study, meanwhile, looked at the reasons that 45% of 316 patients stopped clozapine before 2 years. More than half of these patients stopped because of adverse effects.
Risk of neutropenia
At the APA presentation, psychiatrist Laura Clarke, MD, also of Columbia University Irving Medical Center, noted that there’s concern about one adverse effect in particular: neutropenia, or an abnormally low white blood cell count. Clozapine, she said, has a boxed warning about severe neutropenia that can lead to death.
However, she cautioned that white blood cell counts can be misleading. Some people in non-White ethnic groups have a condition known as benign ethnic neutropenia: their white blood cell counts are abnormal by the standards of people of European heritage, but they’re otherwise healthy. “These individuals do not show an increased risk of infections, and their response to infection is similar to those without them,” she said.
As many as 25%-50% of people of African ancestry may have benign ethnic neutropenia, making their blood levels appear abnormally low. Others with higher levels of the condition include certain Middle Eastern ethnicities and other ethnic groups with darker skin.
In these patents, “clinicians may avoid prescribing clozapine out of the mistaken concern that it can worsen neutropenia,” Dr. Clarke said. In fact, benign ethnic neutropenia “does not increase the risk of clozapine-induced severe neutropenia.”
Dr. Clarke highlighted drug use guidelines from the Clozapine Risk Evaluation and Mitigation Strategy, a Food and Drug Administration–mandated safety program designed to prevent severe neutropenia in patients taking clozapine. The guidelines note that the recommended absolute neutrophil count monitoring algorithm differs when patients are diagnosed with benign ethnic neutropenia.
T. Scott Stroup, MD, MPH, a psychiatrist at Columbia University, New York, urged his colleagues to consider clozapine early on in treatment-resistant schizophrenia. “Don’t go through three, four, or five antipsychotics. Even after trying two, I’d encourage people to [try clozapine].”
However, he acknowledged that “not everyone believes that. Many of my colleagues think that, before you try clozapine, you should have a trial of long-acting injectable medications to rule out pseudo–treatment resistance. I don’t totally agree with that, but I’ve more or less lost that battle,” he added.
In the big picture, Dr. Stroup said, clozapine “is good when other things aren’t working efficacy wise.”
Dr. Holderness and Dr. Clarke have no disclosures. Dr. Stroup discloses grants from the National Institutes of Health and royalties from APA Publishing and UpToDate.
SAN FRANCISCO – A trio of psychiatrists urged colleagues at the annual meeting of the American Psychiatric Association to embrace the venerable antipsychotic clozapine in patients with treatment-resistant schizophrenia. They cautioned that clinicians may overestimate the true risk of the adverse effect of neutropenia in minority populations.
“Although clozapine is known to be a life-improving and even potentially lifesaving treatment, it remains underutilized in the U.S.,” said Claire C. Holderness, MD, a psychiatrist at Columbia University Irving Medical Center, New York. “It’s been estimated that between 35% and 40% of all patients with schizophrenia should be considered for a clozapine trial. However, only 4%-5% of patients with schizophrenia in the U.S. have ever received clozapine. This is in sharp contrast to other industrialized countries where approximately 20% or more of patients with schizophrenia are treated with clozapine.”
According to Dr. Holderness, research has shown that clozapine is even less likely to be prescribed to racial and ethnic minorities. A 2022 systematic review, for example, found that Black patients in the United States had between one-third and two-thirds the odds of being treated with the drug, compared with White patients after adjustment for potential confounders such as demographics. Hispanic/Latino patients were also less likely than Whites to be prescribed the drug.
As Dr. Holderness put it, the drug “been shown to be more effective in treatment-resistant schizophrenia than any other antipsychotic medication. Clozapine is also the most cost-effective treatment for treatment-resistant schizophrenia.” So why does this disparity exist despite clozapine’s benefits?
A 2018 systematic review of barriers to the drug’s usage identified several factors: “mandatory blood testing, fear of serious side-effects and lack of adherence by the patients, difficulty in identifying suitable patients, service fragmentation, and inadequate training in or exposure to using clozapine.” A 2016 British study, meanwhile, looked at the reasons that 45% of 316 patients stopped clozapine before 2 years. More than half of these patients stopped because of adverse effects.
Risk of neutropenia
At the APA presentation, psychiatrist Laura Clarke, MD, also of Columbia University Irving Medical Center, noted that there’s concern about one adverse effect in particular: neutropenia, or an abnormally low white blood cell count. Clozapine, she said, has a boxed warning about severe neutropenia that can lead to death.
However, she cautioned that white blood cell counts can be misleading. Some people in non-White ethnic groups have a condition known as benign ethnic neutropenia: their white blood cell counts are abnormal by the standards of people of European heritage, but they’re otherwise healthy. “These individuals do not show an increased risk of infections, and their response to infection is similar to those without them,” she said.
As many as 25%-50% of people of African ancestry may have benign ethnic neutropenia, making their blood levels appear abnormally low. Others with higher levels of the condition include certain Middle Eastern ethnicities and other ethnic groups with darker skin.
In these patents, “clinicians may avoid prescribing clozapine out of the mistaken concern that it can worsen neutropenia,” Dr. Clarke said. In fact, benign ethnic neutropenia “does not increase the risk of clozapine-induced severe neutropenia.”
Dr. Clarke highlighted drug use guidelines from the Clozapine Risk Evaluation and Mitigation Strategy, a Food and Drug Administration–mandated safety program designed to prevent severe neutropenia in patients taking clozapine. The guidelines note that the recommended absolute neutrophil count monitoring algorithm differs when patients are diagnosed with benign ethnic neutropenia.
T. Scott Stroup, MD, MPH, a psychiatrist at Columbia University, New York, urged his colleagues to consider clozapine early on in treatment-resistant schizophrenia. “Don’t go through three, four, or five antipsychotics. Even after trying two, I’d encourage people to [try clozapine].”
However, he acknowledged that “not everyone believes that. Many of my colleagues think that, before you try clozapine, you should have a trial of long-acting injectable medications to rule out pseudo–treatment resistance. I don’t totally agree with that, but I’ve more or less lost that battle,” he added.
In the big picture, Dr. Stroup said, clozapine “is good when other things aren’t working efficacy wise.”
Dr. Holderness and Dr. Clarke have no disclosures. Dr. Stroup discloses grants from the National Institutes of Health and royalties from APA Publishing and UpToDate.
SAN FRANCISCO – A trio of psychiatrists urged colleagues at the annual meeting of the American Psychiatric Association to embrace the venerable antipsychotic clozapine in patients with treatment-resistant schizophrenia. They cautioned that clinicians may overestimate the true risk of the adverse effect of neutropenia in minority populations.
“Although clozapine is known to be a life-improving and even potentially lifesaving treatment, it remains underutilized in the U.S.,” said Claire C. Holderness, MD, a psychiatrist at Columbia University Irving Medical Center, New York. “It’s been estimated that between 35% and 40% of all patients with schizophrenia should be considered for a clozapine trial. However, only 4%-5% of patients with schizophrenia in the U.S. have ever received clozapine. This is in sharp contrast to other industrialized countries where approximately 20% or more of patients with schizophrenia are treated with clozapine.”
According to Dr. Holderness, research has shown that clozapine is even less likely to be prescribed to racial and ethnic minorities. A 2022 systematic review, for example, found that Black patients in the United States had between one-third and two-thirds the odds of being treated with the drug, compared with White patients after adjustment for potential confounders such as demographics. Hispanic/Latino patients were also less likely than Whites to be prescribed the drug.
As Dr. Holderness put it, the drug “been shown to be more effective in treatment-resistant schizophrenia than any other antipsychotic medication. Clozapine is also the most cost-effective treatment for treatment-resistant schizophrenia.” So why does this disparity exist despite clozapine’s benefits?
A 2018 systematic review of barriers to the drug’s usage identified several factors: “mandatory blood testing, fear of serious side-effects and lack of adherence by the patients, difficulty in identifying suitable patients, service fragmentation, and inadequate training in or exposure to using clozapine.” A 2016 British study, meanwhile, looked at the reasons that 45% of 316 patients stopped clozapine before 2 years. More than half of these patients stopped because of adverse effects.
Risk of neutropenia
At the APA presentation, psychiatrist Laura Clarke, MD, also of Columbia University Irving Medical Center, noted that there’s concern about one adverse effect in particular: neutropenia, or an abnormally low white blood cell count. Clozapine, she said, has a boxed warning about severe neutropenia that can lead to death.
However, she cautioned that white blood cell counts can be misleading. Some people in non-White ethnic groups have a condition known as benign ethnic neutropenia: their white blood cell counts are abnormal by the standards of people of European heritage, but they’re otherwise healthy. “These individuals do not show an increased risk of infections, and their response to infection is similar to those without them,” she said.
As many as 25%-50% of people of African ancestry may have benign ethnic neutropenia, making their blood levels appear abnormally low. Others with higher levels of the condition include certain Middle Eastern ethnicities and other ethnic groups with darker skin.
In these patents, “clinicians may avoid prescribing clozapine out of the mistaken concern that it can worsen neutropenia,” Dr. Clarke said. In fact, benign ethnic neutropenia “does not increase the risk of clozapine-induced severe neutropenia.”
Dr. Clarke highlighted drug use guidelines from the Clozapine Risk Evaluation and Mitigation Strategy, a Food and Drug Administration–mandated safety program designed to prevent severe neutropenia in patients taking clozapine. The guidelines note that the recommended absolute neutrophil count monitoring algorithm differs when patients are diagnosed with benign ethnic neutropenia.
T. Scott Stroup, MD, MPH, a psychiatrist at Columbia University, New York, urged his colleagues to consider clozapine early on in treatment-resistant schizophrenia. “Don’t go through three, four, or five antipsychotics. Even after trying two, I’d encourage people to [try clozapine].”
However, he acknowledged that “not everyone believes that. Many of my colleagues think that, before you try clozapine, you should have a trial of long-acting injectable medications to rule out pseudo–treatment resistance. I don’t totally agree with that, but I’ve more or less lost that battle,” he added.
In the big picture, Dr. Stroup said, clozapine “is good when other things aren’t working efficacy wise.”
Dr. Holderness and Dr. Clarke have no disclosures. Dr. Stroup discloses grants from the National Institutes of Health and royalties from APA Publishing and UpToDate.
AT APA 2023
Higher buprenorphine doses help OUD patients stay in treatment
SAN FRANCISCO – . Eighty-five percent of patients who were titrated up to 32 mg remained in treatment for 1 year vs. 22% of those who never went higher than 16 mg, and those on higher doses stayed in treatment 3.83 times longer than those who didn’t.
“Simply put, we demonstrated better retention in treatment if patients were given higher buprenorphine doses when they complained of opioid craving,” said Andrew Gilbert, a medical student at California Northstate University, Elk Grove, Calif. He is lead author of a poster presented at the 2023 annual meeting of the American Psychiatric Association.
There’s an ongoing debate over ideal doses of buprenorphine (Suboxone), an opioid that’s used to help treat withdrawal symptoms in users of drugs such as heroin and fentanyl. Some sources recommend lower doses. The Substance Abuse and Mental Health Administration, for example, says “ideally, average dosing does not exceed 16 mg” in a guide to the drug’s usage, referring to the sublingual form. (A long-lasting injectable is also available.) Drugs.com says 24 mg is the maximum, and “higher doses have not shown a clinical advantage.
However, some emergency departments have begun providing doses up to 28 mg or higher amid the increased use of the powerful opioid fentanyl. “There are mountains of evidence demonstrating the safety of higher doses at 32 mg, and even several-fold higher than that,” study coauthor Phillip Summers MD, MPH, medical director of the harm-reduction organization Safer Alternatives Thru Networking and Education, Sacramento, Calif., said in an interview. “The question is: Is there clinical benefit to these higher doses?”
‘Significantly higher’ retention
For the new study, researchers tracked 328 patients who were treated for opioid use disorder at the Transitions Buprenorphine Clinic of Sacramento from 2010 to 2017. They were followed until 2022. Their average age was 36, 37.2% were female, 75.0% were White, and 24.1% had a history of overdose.
Clinicians titrated up the doses of buprenorphine to address withdrawal and craving. Five patients never went past 4 mg, and two of them stayed in treatment for a year. Nine of 19 who went up to 8 mg stayed in treatment for 1 year, and 4 of 21 did among those who reached 12 mg.
“Our data suggest that the highest rate of patient dropout is at the beginning of treatment, and that there is significantly higher treatment retention in patients on greater than 24 mg or higher of buprenorphine,” the researchers wrote.
Mr. Gilbert said clinicians start at 8 mg the first day in patients who haven’t taken buprenorphine before, then they go to 16 mg the second day. “We then reevaluate in at least 1 week, oftentimes sooner if the patient’s opioid craving is uncontrolled, and determine if 16 mg is too low, too high, or the correct dosage for the patient.”
If a dose of over 32 mg is needed, clinicians turn to the long-lasting injectable form of the drug, study coauthor Neil Flynn MD, MPH, former medical director of the Transitions Buprenorphine Clinic of Sacramento, said in an interview. “We controlled craving with this form for every patient that did not have opioid craving relief with 32 mg. We believe this form achieved opioid craving cessation due to increased buprenorphine blood levels and increased ratio of unmetabolized buprenorphine to metabolized buprenorphine in our patients.”
According to Dr. Summers, it’s clear that too-low doses hurt the recovery process. “If we prescribe subtherapeutic doses of buprenorphine, our patients will experience opioid craving, which leads to treatment dropout and most likely to relapse. Higher doses of buprenorphine are more likely to cease opioid cravings, leading patients to remain in treatment for longer periods of time.”
Mr. Gilbert said buprenorphine has few side effects, which include decreased libido and hot flashes in both men and women. Testosterone therapy can relieve these symptoms in men, he said, but “unfortunately, we do not have any good medications for reversing this side effect in women. Further research should investigate eliminating this side effect in women.”
Mr. Gilbert declined to comment on the extra cost of higher doses since that is outside the scope of the study.
Medication is the ‘star’
In an interview, addiction specialist Dave Cundiff, MD, MPH, of Ilwaco, Wash., praised the study and agreed with its conclusions about the value of high doses of buprenorphine.
“They’re confirming what the science has already shown, but the world does not accept,” he said, adding that “for opioid use disorder, the medication is the star of the show, although counseling is a necessary adjunct for some patients.”
Dr. Cundiff said he’s coauthored a pending review article that finds that studies support higher doses of buprenorphine.
MaryAnne Murray, DNP, EdD, MBA, a psychiatric mental health nurse practitioner who’s married to Dr. Cundiff, said in an interview that the evolution of the opioid epidemic supports the use of higher doses. “The old way we used to do with heroin users was to wait until they’re in moderate withdrawal, and then start up buprenorphine, usually slowly. With fentanyl, it takes longer, and the wait is often less bearable – unbearable for many people.”
Transitions Buprenorphine Clinic of Sacramento funded the study. The authors, Dr. Cundiff, and Dr. Murray have no disclosures.
SAN FRANCISCO – . Eighty-five percent of patients who were titrated up to 32 mg remained in treatment for 1 year vs. 22% of those who never went higher than 16 mg, and those on higher doses stayed in treatment 3.83 times longer than those who didn’t.
“Simply put, we demonstrated better retention in treatment if patients were given higher buprenorphine doses when they complained of opioid craving,” said Andrew Gilbert, a medical student at California Northstate University, Elk Grove, Calif. He is lead author of a poster presented at the 2023 annual meeting of the American Psychiatric Association.
There’s an ongoing debate over ideal doses of buprenorphine (Suboxone), an opioid that’s used to help treat withdrawal symptoms in users of drugs such as heroin and fentanyl. Some sources recommend lower doses. The Substance Abuse and Mental Health Administration, for example, says “ideally, average dosing does not exceed 16 mg” in a guide to the drug’s usage, referring to the sublingual form. (A long-lasting injectable is also available.) Drugs.com says 24 mg is the maximum, and “higher doses have not shown a clinical advantage.
However, some emergency departments have begun providing doses up to 28 mg or higher amid the increased use of the powerful opioid fentanyl. “There are mountains of evidence demonstrating the safety of higher doses at 32 mg, and even several-fold higher than that,” study coauthor Phillip Summers MD, MPH, medical director of the harm-reduction organization Safer Alternatives Thru Networking and Education, Sacramento, Calif., said in an interview. “The question is: Is there clinical benefit to these higher doses?”
‘Significantly higher’ retention
For the new study, researchers tracked 328 patients who were treated for opioid use disorder at the Transitions Buprenorphine Clinic of Sacramento from 2010 to 2017. They were followed until 2022. Their average age was 36, 37.2% were female, 75.0% were White, and 24.1% had a history of overdose.
Clinicians titrated up the doses of buprenorphine to address withdrawal and craving. Five patients never went past 4 mg, and two of them stayed in treatment for a year. Nine of 19 who went up to 8 mg stayed in treatment for 1 year, and 4 of 21 did among those who reached 12 mg.
“Our data suggest that the highest rate of patient dropout is at the beginning of treatment, and that there is significantly higher treatment retention in patients on greater than 24 mg or higher of buprenorphine,” the researchers wrote.
Mr. Gilbert said clinicians start at 8 mg the first day in patients who haven’t taken buprenorphine before, then they go to 16 mg the second day. “We then reevaluate in at least 1 week, oftentimes sooner if the patient’s opioid craving is uncontrolled, and determine if 16 mg is too low, too high, or the correct dosage for the patient.”
If a dose of over 32 mg is needed, clinicians turn to the long-lasting injectable form of the drug, study coauthor Neil Flynn MD, MPH, former medical director of the Transitions Buprenorphine Clinic of Sacramento, said in an interview. “We controlled craving with this form for every patient that did not have opioid craving relief with 32 mg. We believe this form achieved opioid craving cessation due to increased buprenorphine blood levels and increased ratio of unmetabolized buprenorphine to metabolized buprenorphine in our patients.”
According to Dr. Summers, it’s clear that too-low doses hurt the recovery process. “If we prescribe subtherapeutic doses of buprenorphine, our patients will experience opioid craving, which leads to treatment dropout and most likely to relapse. Higher doses of buprenorphine are more likely to cease opioid cravings, leading patients to remain in treatment for longer periods of time.”
Mr. Gilbert said buprenorphine has few side effects, which include decreased libido and hot flashes in both men and women. Testosterone therapy can relieve these symptoms in men, he said, but “unfortunately, we do not have any good medications for reversing this side effect in women. Further research should investigate eliminating this side effect in women.”
Mr. Gilbert declined to comment on the extra cost of higher doses since that is outside the scope of the study.
Medication is the ‘star’
In an interview, addiction specialist Dave Cundiff, MD, MPH, of Ilwaco, Wash., praised the study and agreed with its conclusions about the value of high doses of buprenorphine.
“They’re confirming what the science has already shown, but the world does not accept,” he said, adding that “for opioid use disorder, the medication is the star of the show, although counseling is a necessary adjunct for some patients.”
Dr. Cundiff said he’s coauthored a pending review article that finds that studies support higher doses of buprenorphine.
MaryAnne Murray, DNP, EdD, MBA, a psychiatric mental health nurse practitioner who’s married to Dr. Cundiff, said in an interview that the evolution of the opioid epidemic supports the use of higher doses. “The old way we used to do with heroin users was to wait until they’re in moderate withdrawal, and then start up buprenorphine, usually slowly. With fentanyl, it takes longer, and the wait is often less bearable – unbearable for many people.”
Transitions Buprenorphine Clinic of Sacramento funded the study. The authors, Dr. Cundiff, and Dr. Murray have no disclosures.
SAN FRANCISCO – . Eighty-five percent of patients who were titrated up to 32 mg remained in treatment for 1 year vs. 22% of those who never went higher than 16 mg, and those on higher doses stayed in treatment 3.83 times longer than those who didn’t.
“Simply put, we demonstrated better retention in treatment if patients were given higher buprenorphine doses when they complained of opioid craving,” said Andrew Gilbert, a medical student at California Northstate University, Elk Grove, Calif. He is lead author of a poster presented at the 2023 annual meeting of the American Psychiatric Association.
There’s an ongoing debate over ideal doses of buprenorphine (Suboxone), an opioid that’s used to help treat withdrawal symptoms in users of drugs such as heroin and fentanyl. Some sources recommend lower doses. The Substance Abuse and Mental Health Administration, for example, says “ideally, average dosing does not exceed 16 mg” in a guide to the drug’s usage, referring to the sublingual form. (A long-lasting injectable is also available.) Drugs.com says 24 mg is the maximum, and “higher doses have not shown a clinical advantage.
However, some emergency departments have begun providing doses up to 28 mg or higher amid the increased use of the powerful opioid fentanyl. “There are mountains of evidence demonstrating the safety of higher doses at 32 mg, and even several-fold higher than that,” study coauthor Phillip Summers MD, MPH, medical director of the harm-reduction organization Safer Alternatives Thru Networking and Education, Sacramento, Calif., said in an interview. “The question is: Is there clinical benefit to these higher doses?”
‘Significantly higher’ retention
For the new study, researchers tracked 328 patients who were treated for opioid use disorder at the Transitions Buprenorphine Clinic of Sacramento from 2010 to 2017. They were followed until 2022. Their average age was 36, 37.2% were female, 75.0% were White, and 24.1% had a history of overdose.
Clinicians titrated up the doses of buprenorphine to address withdrawal and craving. Five patients never went past 4 mg, and two of them stayed in treatment for a year. Nine of 19 who went up to 8 mg stayed in treatment for 1 year, and 4 of 21 did among those who reached 12 mg.
“Our data suggest that the highest rate of patient dropout is at the beginning of treatment, and that there is significantly higher treatment retention in patients on greater than 24 mg or higher of buprenorphine,” the researchers wrote.
Mr. Gilbert said clinicians start at 8 mg the first day in patients who haven’t taken buprenorphine before, then they go to 16 mg the second day. “We then reevaluate in at least 1 week, oftentimes sooner if the patient’s opioid craving is uncontrolled, and determine if 16 mg is too low, too high, or the correct dosage for the patient.”
If a dose of over 32 mg is needed, clinicians turn to the long-lasting injectable form of the drug, study coauthor Neil Flynn MD, MPH, former medical director of the Transitions Buprenorphine Clinic of Sacramento, said in an interview. “We controlled craving with this form for every patient that did not have opioid craving relief with 32 mg. We believe this form achieved opioid craving cessation due to increased buprenorphine blood levels and increased ratio of unmetabolized buprenorphine to metabolized buprenorphine in our patients.”
According to Dr. Summers, it’s clear that too-low doses hurt the recovery process. “If we prescribe subtherapeutic doses of buprenorphine, our patients will experience opioid craving, which leads to treatment dropout and most likely to relapse. Higher doses of buprenorphine are more likely to cease opioid cravings, leading patients to remain in treatment for longer periods of time.”
Mr. Gilbert said buprenorphine has few side effects, which include decreased libido and hot flashes in both men and women. Testosterone therapy can relieve these symptoms in men, he said, but “unfortunately, we do not have any good medications for reversing this side effect in women. Further research should investigate eliminating this side effect in women.”
Mr. Gilbert declined to comment on the extra cost of higher doses since that is outside the scope of the study.
Medication is the ‘star’
In an interview, addiction specialist Dave Cundiff, MD, MPH, of Ilwaco, Wash., praised the study and agreed with its conclusions about the value of high doses of buprenorphine.
“They’re confirming what the science has already shown, but the world does not accept,” he said, adding that “for opioid use disorder, the medication is the star of the show, although counseling is a necessary adjunct for some patients.”
Dr. Cundiff said he’s coauthored a pending review article that finds that studies support higher doses of buprenorphine.
MaryAnne Murray, DNP, EdD, MBA, a psychiatric mental health nurse practitioner who’s married to Dr. Cundiff, said in an interview that the evolution of the opioid epidemic supports the use of higher doses. “The old way we used to do with heroin users was to wait until they’re in moderate withdrawal, and then start up buprenorphine, usually slowly. With fentanyl, it takes longer, and the wait is often less bearable – unbearable for many people.”
Transitions Buprenorphine Clinic of Sacramento funded the study. The authors, Dr. Cundiff, and Dr. Murray have no disclosures.
AT APA 2023
Peak seasons, times for suicidal thoughts, attempts identified
In addition, the results from Harvard University’s Project Implicit Health also show that people are most likely to make an attempt at suicide between 4 and 6 a.m.
“No research has demonstrated a peak in suicidal ideation in winter until our paper,” study investigator Brian O’Shea, PhD, assistant professor of social psychology at the University of Nottingham, England, told this news organization.
“Most people incorrectly assume that suicide behaviours peak in winter and are surprised, as I was, when learning about this phenomenon, that suicide actually peaks in spring/early summer,” he added.
However, at least one expert cautioned that the database, which comprises mostly responses from younger women, doesn’t capture responses from those who are most likely to attempt suicide: older men with substance abuse.
The findings were published online in Translational Psychiatry.
New insight into suicide risk
Previous studies examining the seasonality of suicides and suicide attempts have reported a peak in spring and early summer, but there has been very little information about why this may be, the investigators noted.
Dr. O’Shea and his colleague from the University of Amsterdam, René Freichel, mined one of the databases from Project Implicit Health, which contains self-report measures on suicidal ideation, self-harm, and past suicide attempts, as well as respondents’ implicit biases on these topics.
The analysis included data from 10,000 respondents living in the United States, United Kingdom, and Canada provided between April 2012 and November 2018.
The sample was predominantly young and female, with 38% (3,247) of the sample reporting that they had made at least one suicide attempt.
The researchers found a peak in negative mood and desire to die occurring in December, especially among those who reported attempting suicide (P ≤ .001)
Suicidal ideation peaked approximately 3-4 months before the annual seasonal crest of suicide attempts in early spring and summer.
“Affected individuals may become severely depressed and experience a lack of energy throughout the winter months. Essentially, this period may put them below a threshold of severe suicide risk as the high level of suicidal ideation coincides with a low level of energy,” said Dr. O’Shea.
When the days get longer, brighter, and warmer, these changes likely improve an individuals’ mood, he explained. “Hence, the most at-risk individuals become slightly less depressed and may gain more energy to contemplate and plan their method to attempt suicide,” Dr. O’Shea noted.
A major limitation of the study is that all responses included in analysis were based on self-report.
To confirm the findings, future research should include ecological momentary assessment, which involves using a large community sample to question participants about suicidal intent at various time points, along with real-time monitoring of vital signs, said Dr. O’Shea.
Ideally, the investigators noted, the study’s findings will inform clinician assessments of patients who are at risk for suicide.
A research gap?
Commenting on the findings, Justin Shuster, MD, MPH, assistant professor of psychiatry at the University of Pittsburgh and medical director of two psychiatric units at Western Psychiatric Hospital, noted that the database used in the study did not include responses from those who were most likely to attempt or commit suicide: older men with a history of substance abuse, who require social supports, and who have a family history of suicide.
Though Dr. Shuster agreed with Dr. O’Shea about the possibility that spring brought energy to a desire to take one’s life, he had another theory.
“When people are depressed in the winter, they expect to feel better with the advent of the warmer weather in spring. When they don’t feel better, they may think to themselves, ‘If I’m going to feel like this forever, I may as well follow through with these plans,’ ” he said.
As for the early morning attempts, he noted that 4-6 a.m. is often when people are alone, and there are fewer distractions.
“The other thing I see a great deal of clinically is intoxication,” said Dr. Shuster. “Either intoxication with substances or alcohol, or the fact that intoxication is waning at those early morning hours, and people are becoming desperate as they face a new day,” he said.
The study was funded by a German Academic Exchange Service Scholarship and an EU Horizon 2020 Fellowship. Dr. O’Shea reports being an unpaid member of Project Implicit’s scientific advisory board and is on the executive committee of Project Implicit Health.
A version of this article first appeared on Medscape.com.
In addition, the results from Harvard University’s Project Implicit Health also show that people are most likely to make an attempt at suicide between 4 and 6 a.m.
“No research has demonstrated a peak in suicidal ideation in winter until our paper,” study investigator Brian O’Shea, PhD, assistant professor of social psychology at the University of Nottingham, England, told this news organization.
“Most people incorrectly assume that suicide behaviours peak in winter and are surprised, as I was, when learning about this phenomenon, that suicide actually peaks in spring/early summer,” he added.
However, at least one expert cautioned that the database, which comprises mostly responses from younger women, doesn’t capture responses from those who are most likely to attempt suicide: older men with substance abuse.
The findings were published online in Translational Psychiatry.
New insight into suicide risk
Previous studies examining the seasonality of suicides and suicide attempts have reported a peak in spring and early summer, but there has been very little information about why this may be, the investigators noted.
Dr. O’Shea and his colleague from the University of Amsterdam, René Freichel, mined one of the databases from Project Implicit Health, which contains self-report measures on suicidal ideation, self-harm, and past suicide attempts, as well as respondents’ implicit biases on these topics.
The analysis included data from 10,000 respondents living in the United States, United Kingdom, and Canada provided between April 2012 and November 2018.
The sample was predominantly young and female, with 38% (3,247) of the sample reporting that they had made at least one suicide attempt.
The researchers found a peak in negative mood and desire to die occurring in December, especially among those who reported attempting suicide (P ≤ .001)
Suicidal ideation peaked approximately 3-4 months before the annual seasonal crest of suicide attempts in early spring and summer.
“Affected individuals may become severely depressed and experience a lack of energy throughout the winter months. Essentially, this period may put them below a threshold of severe suicide risk as the high level of suicidal ideation coincides with a low level of energy,” said Dr. O’Shea.
When the days get longer, brighter, and warmer, these changes likely improve an individuals’ mood, he explained. “Hence, the most at-risk individuals become slightly less depressed and may gain more energy to contemplate and plan their method to attempt suicide,” Dr. O’Shea noted.
A major limitation of the study is that all responses included in analysis were based on self-report.
To confirm the findings, future research should include ecological momentary assessment, which involves using a large community sample to question participants about suicidal intent at various time points, along with real-time monitoring of vital signs, said Dr. O’Shea.
Ideally, the investigators noted, the study’s findings will inform clinician assessments of patients who are at risk for suicide.
A research gap?
Commenting on the findings, Justin Shuster, MD, MPH, assistant professor of psychiatry at the University of Pittsburgh and medical director of two psychiatric units at Western Psychiatric Hospital, noted that the database used in the study did not include responses from those who were most likely to attempt or commit suicide: older men with a history of substance abuse, who require social supports, and who have a family history of suicide.
Though Dr. Shuster agreed with Dr. O’Shea about the possibility that spring brought energy to a desire to take one’s life, he had another theory.
“When people are depressed in the winter, they expect to feel better with the advent of the warmer weather in spring. When they don’t feel better, they may think to themselves, ‘If I’m going to feel like this forever, I may as well follow through with these plans,’ ” he said.
As for the early morning attempts, he noted that 4-6 a.m. is often when people are alone, and there are fewer distractions.
“The other thing I see a great deal of clinically is intoxication,” said Dr. Shuster. “Either intoxication with substances or alcohol, or the fact that intoxication is waning at those early morning hours, and people are becoming desperate as they face a new day,” he said.
The study was funded by a German Academic Exchange Service Scholarship and an EU Horizon 2020 Fellowship. Dr. O’Shea reports being an unpaid member of Project Implicit’s scientific advisory board and is on the executive committee of Project Implicit Health.
A version of this article first appeared on Medscape.com.
In addition, the results from Harvard University’s Project Implicit Health also show that people are most likely to make an attempt at suicide between 4 and 6 a.m.
“No research has demonstrated a peak in suicidal ideation in winter until our paper,” study investigator Brian O’Shea, PhD, assistant professor of social psychology at the University of Nottingham, England, told this news organization.
“Most people incorrectly assume that suicide behaviours peak in winter and are surprised, as I was, when learning about this phenomenon, that suicide actually peaks in spring/early summer,” he added.
However, at least one expert cautioned that the database, which comprises mostly responses from younger women, doesn’t capture responses from those who are most likely to attempt suicide: older men with substance abuse.
The findings were published online in Translational Psychiatry.
New insight into suicide risk
Previous studies examining the seasonality of suicides and suicide attempts have reported a peak in spring and early summer, but there has been very little information about why this may be, the investigators noted.
Dr. O’Shea and his colleague from the University of Amsterdam, René Freichel, mined one of the databases from Project Implicit Health, which contains self-report measures on suicidal ideation, self-harm, and past suicide attempts, as well as respondents’ implicit biases on these topics.
The analysis included data from 10,000 respondents living in the United States, United Kingdom, and Canada provided between April 2012 and November 2018.
The sample was predominantly young and female, with 38% (3,247) of the sample reporting that they had made at least one suicide attempt.
The researchers found a peak in negative mood and desire to die occurring in December, especially among those who reported attempting suicide (P ≤ .001)
Suicidal ideation peaked approximately 3-4 months before the annual seasonal crest of suicide attempts in early spring and summer.
“Affected individuals may become severely depressed and experience a lack of energy throughout the winter months. Essentially, this period may put them below a threshold of severe suicide risk as the high level of suicidal ideation coincides with a low level of energy,” said Dr. O’Shea.
When the days get longer, brighter, and warmer, these changes likely improve an individuals’ mood, he explained. “Hence, the most at-risk individuals become slightly less depressed and may gain more energy to contemplate and plan their method to attempt suicide,” Dr. O’Shea noted.
A major limitation of the study is that all responses included in analysis were based on self-report.
To confirm the findings, future research should include ecological momentary assessment, which involves using a large community sample to question participants about suicidal intent at various time points, along with real-time monitoring of vital signs, said Dr. O’Shea.
Ideally, the investigators noted, the study’s findings will inform clinician assessments of patients who are at risk for suicide.
A research gap?
Commenting on the findings, Justin Shuster, MD, MPH, assistant professor of psychiatry at the University of Pittsburgh and medical director of two psychiatric units at Western Psychiatric Hospital, noted that the database used in the study did not include responses from those who were most likely to attempt or commit suicide: older men with a history of substance abuse, who require social supports, and who have a family history of suicide.
Though Dr. Shuster agreed with Dr. O’Shea about the possibility that spring brought energy to a desire to take one’s life, he had another theory.
“When people are depressed in the winter, they expect to feel better with the advent of the warmer weather in spring. When they don’t feel better, they may think to themselves, ‘If I’m going to feel like this forever, I may as well follow through with these plans,’ ” he said.
As for the early morning attempts, he noted that 4-6 a.m. is often when people are alone, and there are fewer distractions.
“The other thing I see a great deal of clinically is intoxication,” said Dr. Shuster. “Either intoxication with substances or alcohol, or the fact that intoxication is waning at those early morning hours, and people are becoming desperate as they face a new day,” he said.
The study was funded by a German Academic Exchange Service Scholarship and an EU Horizon 2020 Fellowship. Dr. O’Shea reports being an unpaid member of Project Implicit’s scientific advisory board and is on the executive committee of Project Implicit Health.
A version of this article first appeared on Medscape.com.
FROM TRANSLATIONAL PSYCHIATRY
Oncologist pleads guilty to prescription drug fraud
, according to a press release from the U.S. Attorney’s Office for the District of New Jersey.
Instead, the drug purchases were part of a fraudulent profit-making scheme.
Anise Kachadourian, MD, of Towaco, N.J. – located about 20 miles from Manhattan – now faces a maximum of 3 years in prison and a $10,000 fine. Her sentencing is scheduled for Feb. 6, 2024.
Overall, “Kachadourian was paid more than $170,000 for purchasing and allowing others to purchase in her name millions of dollars in prescription drugs during the scheme, which ran from October 2016 through January 2019,” the office said in the release.
The scheme involved Dr. Kachadourian and others making “numerous false and misleading representations to the pharmaceutical manufacturers and authorized distributors, including that Dr. Kachadourian purchased the drugs to use to treat her patients, and that the drugs would not be resold or redistributed,” the office said.
However, none of the drugs were administered to any of Dr. Kachadourian’s patients.
The press release explained that while working in her medical practice’s offices in various parts of New Jersey, Dr. Kachadourian was recruited by an individual who owned a pharmacy as well as two wholesale prescription drug distributors.
At this individual’s request and at the request of others who worked for him, Dr. Kachadourian used her medical license and allowed others to use it to purchase expensive drugs. The drugs primarily included cold-chain biologic infusion medications, such as trastuzumab and rituximab, often use to treat cancer, macular degeneration, and autoimmune diseases.
In return, Dr. Kachadourian received a kickback of approximately $5,000 per month.
“By recruiting and using Kachadourian and her medical license to purchase the drugs, these individuals were able to obtain prescription drugs from the pharmaceutical manufacturers’ authorized distributors that they would not otherwise have been permitted to purchase,” the DA’s office said.
The drugs were ultimately sold to customers of the two wholesale distributor businesses “at a significant profit.”
For example, according to a court document, on April 26, 2018, trastuzumab 150 mg was purchased for $254,189.04 and then sold by the wholesale distributor businesses at $336,000, for a profit of $81,810.95.
Dr. Kachadourian is the third doctor to plead guilty to the scheme. The press release didn’t name the other two doctors or the pharmacy owner and their two businesses. A court document did name a coconspirator, Jon Paul Dadaian, MD, a board-certified anesthesiologist and pain management specialist who had offices at several locations in New Jersey.
A version of this article first appeared on Medscape.com.
, according to a press release from the U.S. Attorney’s Office for the District of New Jersey.
Instead, the drug purchases were part of a fraudulent profit-making scheme.
Anise Kachadourian, MD, of Towaco, N.J. – located about 20 miles from Manhattan – now faces a maximum of 3 years in prison and a $10,000 fine. Her sentencing is scheduled for Feb. 6, 2024.
Overall, “Kachadourian was paid more than $170,000 for purchasing and allowing others to purchase in her name millions of dollars in prescription drugs during the scheme, which ran from October 2016 through January 2019,” the office said in the release.
The scheme involved Dr. Kachadourian and others making “numerous false and misleading representations to the pharmaceutical manufacturers and authorized distributors, including that Dr. Kachadourian purchased the drugs to use to treat her patients, and that the drugs would not be resold or redistributed,” the office said.
However, none of the drugs were administered to any of Dr. Kachadourian’s patients.
The press release explained that while working in her medical practice’s offices in various parts of New Jersey, Dr. Kachadourian was recruited by an individual who owned a pharmacy as well as two wholesale prescription drug distributors.
At this individual’s request and at the request of others who worked for him, Dr. Kachadourian used her medical license and allowed others to use it to purchase expensive drugs. The drugs primarily included cold-chain biologic infusion medications, such as trastuzumab and rituximab, often use to treat cancer, macular degeneration, and autoimmune diseases.
In return, Dr. Kachadourian received a kickback of approximately $5,000 per month.
“By recruiting and using Kachadourian and her medical license to purchase the drugs, these individuals were able to obtain prescription drugs from the pharmaceutical manufacturers’ authorized distributors that they would not otherwise have been permitted to purchase,” the DA’s office said.
The drugs were ultimately sold to customers of the two wholesale distributor businesses “at a significant profit.”
For example, according to a court document, on April 26, 2018, trastuzumab 150 mg was purchased for $254,189.04 and then sold by the wholesale distributor businesses at $336,000, for a profit of $81,810.95.
Dr. Kachadourian is the third doctor to plead guilty to the scheme. The press release didn’t name the other two doctors or the pharmacy owner and their two businesses. A court document did name a coconspirator, Jon Paul Dadaian, MD, a board-certified anesthesiologist and pain management specialist who had offices at several locations in New Jersey.
A version of this article first appeared on Medscape.com.
, according to a press release from the U.S. Attorney’s Office for the District of New Jersey.
Instead, the drug purchases were part of a fraudulent profit-making scheme.
Anise Kachadourian, MD, of Towaco, N.J. – located about 20 miles from Manhattan – now faces a maximum of 3 years in prison and a $10,000 fine. Her sentencing is scheduled for Feb. 6, 2024.
Overall, “Kachadourian was paid more than $170,000 for purchasing and allowing others to purchase in her name millions of dollars in prescription drugs during the scheme, which ran from October 2016 through January 2019,” the office said in the release.
The scheme involved Dr. Kachadourian and others making “numerous false and misleading representations to the pharmaceutical manufacturers and authorized distributors, including that Dr. Kachadourian purchased the drugs to use to treat her patients, and that the drugs would not be resold or redistributed,” the office said.
However, none of the drugs were administered to any of Dr. Kachadourian’s patients.
The press release explained that while working in her medical practice’s offices in various parts of New Jersey, Dr. Kachadourian was recruited by an individual who owned a pharmacy as well as two wholesale prescription drug distributors.
At this individual’s request and at the request of others who worked for him, Dr. Kachadourian used her medical license and allowed others to use it to purchase expensive drugs. The drugs primarily included cold-chain biologic infusion medications, such as trastuzumab and rituximab, often use to treat cancer, macular degeneration, and autoimmune diseases.
In return, Dr. Kachadourian received a kickback of approximately $5,000 per month.
“By recruiting and using Kachadourian and her medical license to purchase the drugs, these individuals were able to obtain prescription drugs from the pharmaceutical manufacturers’ authorized distributors that they would not otherwise have been permitted to purchase,” the DA’s office said.
The drugs were ultimately sold to customers of the two wholesale distributor businesses “at a significant profit.”
For example, according to a court document, on April 26, 2018, trastuzumab 150 mg was purchased for $254,189.04 and then sold by the wholesale distributor businesses at $336,000, for a profit of $81,810.95.
Dr. Kachadourian is the third doctor to plead guilty to the scheme. The press release didn’t name the other two doctors or the pharmacy owner and their two businesses. A court document did name a coconspirator, Jon Paul Dadaian, MD, a board-certified anesthesiologist and pain management specialist who had offices at several locations in New Jersey.
A version of this article first appeared on Medscape.com.
Antibody-drug conjugate changes standard of care for platinum-resistant ovarian cancer
The conclusion of this study marks the first time that a novel therapy has demonstrated an overall survival (OS) improvement in any phase 3 trial in this population, according to lead investigator Kathleen Moore, MD.
“We believe these data are practice changing and position mirvetuximab [soravtansine] as the new standard of care for patients with folate receptor–alpha positive, platinum-resistant ovarian cancer,” said Dr. Moore during a presentation of the study at a special session of the annual meeting of the American Society of Clinical Oncology devoted solely to the MIRASOL study.
New standard of care
Following Dr. Moore’s presentation, Roisin Eilish O’Cearbhaill, MD, served as a discussant, and she confirmed the trial’s importance.
“It has firmly established the role of mirvetuximab [soravtansine] in folate receptor–alpha high-expression, platinum-resistant ovarian cancer,” said Dr. O’Cearbhaill, who is Research director of the gynecologic medical oncology service and clinical director of the solid tumor, cellular therapy service at Memorial Sloan Kettering Cancer Center, New York.
Mirvetuximab soravtansine received accelerated FDA approval in November based on the results of the single-arm SORAYA trial, which demonstrated a progression-free survival (PFS) benefit in platinum-resistant patients who had been previously treated with one to three treatment regimens, at least one of which having included bevacizumab.
The new study compared MIRV with physician choice chemotherapy and found both a PFS and OS benefit in the MIRV arm. The results garnered significant enthusiasm from the audience, and others reacted positively as well.
“The results that she presented are just astounding, with a significant improvement in both progression-free and overall survival. I think certainly the overall survival needs to be highlighted here, because this is a patient population that’s notoriously difficult to treat,” said Ana Valente, MD, a gynecologic oncologist at the Ochsner Health System in New Orleans. Dr. Valente, who did not attend the presentation but was asked to comment on the study, is also a member of the Society of Gynecological Oncologist communications committee.
Unlike SORAYA, MIRASOL was open to patients who had not received bevacizumab, and Dr. Moore and colleagues found similar survival benefits in patients who had not received bevacizumab as in those who had, said Dr. Moore, who is the associate director of clinical research at Stephenson Cancer Center and director of the Oklahoma TSET Phase 1 Program, both in Oklahoma City. This opens the possibility of using MIRV instead of bevacizumab combined with chemotherapy in platinum-resistant patients.
“I think this data really shows you can move right to mirvetuximab [soravtansine] and feel pretty solid about the decision in a biomarker selected [population],” Dr. Moore said, during an interview.
Not just for high expression levels
MIRASOL was restricted to patients with high levels of expression of folate receptor–alpha, which is MIRV’s target on the surface of tumor cells. High expression is defined as at least 75% of viable tumor cells exhibiting a minimum of 2+ level membrane staining intensity by immunohistochemistry. That represents about 35% of patients, according to Dr. Moore, but she said that the drug also shows promise in patients with medium levels of folate receptor–alpha expression.
“I think it’s just going to be now starting to get those label extension studies launched to branch it out. Then you account for 60% of your population which [have] medium to high [expression levels], and that’s really where you see benefit,” said Dr. Moore. Medium expression levels of folate receptor–alpha are defined as 50% to greater than 75% of tumor cells with 2+ level membrane staining intensity.
She also noted that the FORWARD II trial combining mirvetuximab soravtansine with bevacizumab in platinum-resistant ovarian cancer is showing good results.
“We have really beautiful data [from FORWARD II]. If I have a medium expresser, I’m using the doublet [of MIRV and bevacizumab], and it works,” said Dr. Moore, while also pointing out that this remains an off-label use.
It’s possible that the drug could be extended even to low expression levels, defined as 25% to less than 50% of tumor cells with 2+ level membrane staining intensity. “[We are] currently working on that strategy with already available data,” said Dr. Moore.
She speculated that the improved OS may be attributed to the reduced toxicity of MIRV, compared with chemotherapy agents, which leaves patients feeling better and more able to pursue other treatments, which in turn may increase survival odds.
Dr. O’Cearbhaill touted the benefits of ADCs and their ability to target powerful cytotoxic agents while limiting side effects, and she is looking forward to more new therapies on the horizon.
“There are four [ADCs] in late stages of development [for platinum-resistant ovarian cancer], so hopefully there will be other ones coming online as well,” Dr. O’Cearbhaill said in an interview. “Then we’ll have to figure out how to sequence them, which drug will be best in class. Will we be just giving one or will be giving ADC followed by ADC?”
Study methods and results
The study enrolled 453 patients and randomized them to treatment with MIRV or investigator’s choice of chemotherapy, which could be paclitaxel, pegylated liposomal doxorubicin, or topotecan. The MIRV dose was 6 mg/kg adjusted ideal body weight every 3 weeks. The median age was 62 in the chemotherapy arm and 63 years in the MIRV arm. About 63% of the chemotherapy arm had prior bevacizumab exposure, as did 61% of the MIRV arm.
Median PFS was 5.62 months in the MIRV arm and 3.98 months in the chemotherapy arm (hazard ratio, 0.65; P less than .0001). The overall response rate was 42% in the MIRV arm and 16% in the chemotherapy arm (P < .0001).
The safety outcomes also favored MIRV: 42% experienced grade 3 or higher treatment-emergent adverse events (TEAEs) versus 54% in the chemotherapy group. Severe adverse events were also lower in MIRV, 24% versus 33%. Just 9% of patients in the MIRV discontinued because of TEAEs, compared with 16% in the chemotherapy arm.
MIRV was associated with blurred vision (41%), keratopathy (32%), and dry eye (28%), but these issues were generally manageable through collaboration with optometrists or ophthalmologists.
Dr. Moore and Dr. O’Cearbhaill reported receiving honoraria, research funding, and travel expenses from numerous pharmaceutical companies. Dr. O’Cearbhaill has consulted for or advised Aptitude Health, Bayer, Carina Biotech, Fresenius Kabi, GlaxoSmithKline, GOG Foundation, Immunogen, R-Pharm, Regeneron, and Seagen.
The conclusion of this study marks the first time that a novel therapy has demonstrated an overall survival (OS) improvement in any phase 3 trial in this population, according to lead investigator Kathleen Moore, MD.
“We believe these data are practice changing and position mirvetuximab [soravtansine] as the new standard of care for patients with folate receptor–alpha positive, platinum-resistant ovarian cancer,” said Dr. Moore during a presentation of the study at a special session of the annual meeting of the American Society of Clinical Oncology devoted solely to the MIRASOL study.
New standard of care
Following Dr. Moore’s presentation, Roisin Eilish O’Cearbhaill, MD, served as a discussant, and she confirmed the trial’s importance.
“It has firmly established the role of mirvetuximab [soravtansine] in folate receptor–alpha high-expression, platinum-resistant ovarian cancer,” said Dr. O’Cearbhaill, who is Research director of the gynecologic medical oncology service and clinical director of the solid tumor, cellular therapy service at Memorial Sloan Kettering Cancer Center, New York.
Mirvetuximab soravtansine received accelerated FDA approval in November based on the results of the single-arm SORAYA trial, which demonstrated a progression-free survival (PFS) benefit in platinum-resistant patients who had been previously treated with one to three treatment regimens, at least one of which having included bevacizumab.
The new study compared MIRV with physician choice chemotherapy and found both a PFS and OS benefit in the MIRV arm. The results garnered significant enthusiasm from the audience, and others reacted positively as well.
“The results that she presented are just astounding, with a significant improvement in both progression-free and overall survival. I think certainly the overall survival needs to be highlighted here, because this is a patient population that’s notoriously difficult to treat,” said Ana Valente, MD, a gynecologic oncologist at the Ochsner Health System in New Orleans. Dr. Valente, who did not attend the presentation but was asked to comment on the study, is also a member of the Society of Gynecological Oncologist communications committee.
Unlike SORAYA, MIRASOL was open to patients who had not received bevacizumab, and Dr. Moore and colleagues found similar survival benefits in patients who had not received bevacizumab as in those who had, said Dr. Moore, who is the associate director of clinical research at Stephenson Cancer Center and director of the Oklahoma TSET Phase 1 Program, both in Oklahoma City. This opens the possibility of using MIRV instead of bevacizumab combined with chemotherapy in platinum-resistant patients.
“I think this data really shows you can move right to mirvetuximab [soravtansine] and feel pretty solid about the decision in a biomarker selected [population],” Dr. Moore said, during an interview.
Not just for high expression levels
MIRASOL was restricted to patients with high levels of expression of folate receptor–alpha, which is MIRV’s target on the surface of tumor cells. High expression is defined as at least 75% of viable tumor cells exhibiting a minimum of 2+ level membrane staining intensity by immunohistochemistry. That represents about 35% of patients, according to Dr. Moore, but she said that the drug also shows promise in patients with medium levels of folate receptor–alpha expression.
“I think it’s just going to be now starting to get those label extension studies launched to branch it out. Then you account for 60% of your population which [have] medium to high [expression levels], and that’s really where you see benefit,” said Dr. Moore. Medium expression levels of folate receptor–alpha are defined as 50% to greater than 75% of tumor cells with 2+ level membrane staining intensity.
She also noted that the FORWARD II trial combining mirvetuximab soravtansine with bevacizumab in platinum-resistant ovarian cancer is showing good results.
“We have really beautiful data [from FORWARD II]. If I have a medium expresser, I’m using the doublet [of MIRV and bevacizumab], and it works,” said Dr. Moore, while also pointing out that this remains an off-label use.
It’s possible that the drug could be extended even to low expression levels, defined as 25% to less than 50% of tumor cells with 2+ level membrane staining intensity. “[We are] currently working on that strategy with already available data,” said Dr. Moore.
She speculated that the improved OS may be attributed to the reduced toxicity of MIRV, compared with chemotherapy agents, which leaves patients feeling better and more able to pursue other treatments, which in turn may increase survival odds.
Dr. O’Cearbhaill touted the benefits of ADCs and their ability to target powerful cytotoxic agents while limiting side effects, and she is looking forward to more new therapies on the horizon.
“There are four [ADCs] in late stages of development [for platinum-resistant ovarian cancer], so hopefully there will be other ones coming online as well,” Dr. O’Cearbhaill said in an interview. “Then we’ll have to figure out how to sequence them, which drug will be best in class. Will we be just giving one or will be giving ADC followed by ADC?”
Study methods and results
The study enrolled 453 patients and randomized them to treatment with MIRV or investigator’s choice of chemotherapy, which could be paclitaxel, pegylated liposomal doxorubicin, or topotecan. The MIRV dose was 6 mg/kg adjusted ideal body weight every 3 weeks. The median age was 62 in the chemotherapy arm and 63 years in the MIRV arm. About 63% of the chemotherapy arm had prior bevacizumab exposure, as did 61% of the MIRV arm.
Median PFS was 5.62 months in the MIRV arm and 3.98 months in the chemotherapy arm (hazard ratio, 0.65; P less than .0001). The overall response rate was 42% in the MIRV arm and 16% in the chemotherapy arm (P < .0001).
The safety outcomes also favored MIRV: 42% experienced grade 3 or higher treatment-emergent adverse events (TEAEs) versus 54% in the chemotherapy group. Severe adverse events were also lower in MIRV, 24% versus 33%. Just 9% of patients in the MIRV discontinued because of TEAEs, compared with 16% in the chemotherapy arm.
MIRV was associated with blurred vision (41%), keratopathy (32%), and dry eye (28%), but these issues were generally manageable through collaboration with optometrists or ophthalmologists.
Dr. Moore and Dr. O’Cearbhaill reported receiving honoraria, research funding, and travel expenses from numerous pharmaceutical companies. Dr. O’Cearbhaill has consulted for or advised Aptitude Health, Bayer, Carina Biotech, Fresenius Kabi, GlaxoSmithKline, GOG Foundation, Immunogen, R-Pharm, Regeneron, and Seagen.
The conclusion of this study marks the first time that a novel therapy has demonstrated an overall survival (OS) improvement in any phase 3 trial in this population, according to lead investigator Kathleen Moore, MD.
“We believe these data are practice changing and position mirvetuximab [soravtansine] as the new standard of care for patients with folate receptor–alpha positive, platinum-resistant ovarian cancer,” said Dr. Moore during a presentation of the study at a special session of the annual meeting of the American Society of Clinical Oncology devoted solely to the MIRASOL study.
New standard of care
Following Dr. Moore’s presentation, Roisin Eilish O’Cearbhaill, MD, served as a discussant, and she confirmed the trial’s importance.
“It has firmly established the role of mirvetuximab [soravtansine] in folate receptor–alpha high-expression, platinum-resistant ovarian cancer,” said Dr. O’Cearbhaill, who is Research director of the gynecologic medical oncology service and clinical director of the solid tumor, cellular therapy service at Memorial Sloan Kettering Cancer Center, New York.
Mirvetuximab soravtansine received accelerated FDA approval in November based on the results of the single-arm SORAYA trial, which demonstrated a progression-free survival (PFS) benefit in platinum-resistant patients who had been previously treated with one to three treatment regimens, at least one of which having included bevacizumab.
The new study compared MIRV with physician choice chemotherapy and found both a PFS and OS benefit in the MIRV arm. The results garnered significant enthusiasm from the audience, and others reacted positively as well.
“The results that she presented are just astounding, with a significant improvement in both progression-free and overall survival. I think certainly the overall survival needs to be highlighted here, because this is a patient population that’s notoriously difficult to treat,” said Ana Valente, MD, a gynecologic oncologist at the Ochsner Health System in New Orleans. Dr. Valente, who did not attend the presentation but was asked to comment on the study, is also a member of the Society of Gynecological Oncologist communications committee.
Unlike SORAYA, MIRASOL was open to patients who had not received bevacizumab, and Dr. Moore and colleagues found similar survival benefits in patients who had not received bevacizumab as in those who had, said Dr. Moore, who is the associate director of clinical research at Stephenson Cancer Center and director of the Oklahoma TSET Phase 1 Program, both in Oklahoma City. This opens the possibility of using MIRV instead of bevacizumab combined with chemotherapy in platinum-resistant patients.
“I think this data really shows you can move right to mirvetuximab [soravtansine] and feel pretty solid about the decision in a biomarker selected [population],” Dr. Moore said, during an interview.
Not just for high expression levels
MIRASOL was restricted to patients with high levels of expression of folate receptor–alpha, which is MIRV’s target on the surface of tumor cells. High expression is defined as at least 75% of viable tumor cells exhibiting a minimum of 2+ level membrane staining intensity by immunohistochemistry. That represents about 35% of patients, according to Dr. Moore, but she said that the drug also shows promise in patients with medium levels of folate receptor–alpha expression.
“I think it’s just going to be now starting to get those label extension studies launched to branch it out. Then you account for 60% of your population which [have] medium to high [expression levels], and that’s really where you see benefit,” said Dr. Moore. Medium expression levels of folate receptor–alpha are defined as 50% to greater than 75% of tumor cells with 2+ level membrane staining intensity.
She also noted that the FORWARD II trial combining mirvetuximab soravtansine with bevacizumab in platinum-resistant ovarian cancer is showing good results.
“We have really beautiful data [from FORWARD II]. If I have a medium expresser, I’m using the doublet [of MIRV and bevacizumab], and it works,” said Dr. Moore, while also pointing out that this remains an off-label use.
It’s possible that the drug could be extended even to low expression levels, defined as 25% to less than 50% of tumor cells with 2+ level membrane staining intensity. “[We are] currently working on that strategy with already available data,” said Dr. Moore.
She speculated that the improved OS may be attributed to the reduced toxicity of MIRV, compared with chemotherapy agents, which leaves patients feeling better and more able to pursue other treatments, which in turn may increase survival odds.
Dr. O’Cearbhaill touted the benefits of ADCs and their ability to target powerful cytotoxic agents while limiting side effects, and she is looking forward to more new therapies on the horizon.
“There are four [ADCs] in late stages of development [for platinum-resistant ovarian cancer], so hopefully there will be other ones coming online as well,” Dr. O’Cearbhaill said in an interview. “Then we’ll have to figure out how to sequence them, which drug will be best in class. Will we be just giving one or will be giving ADC followed by ADC?”
Study methods and results
The study enrolled 453 patients and randomized them to treatment with MIRV or investigator’s choice of chemotherapy, which could be paclitaxel, pegylated liposomal doxorubicin, or topotecan. The MIRV dose was 6 mg/kg adjusted ideal body weight every 3 weeks. The median age was 62 in the chemotherapy arm and 63 years in the MIRV arm. About 63% of the chemotherapy arm had prior bevacizumab exposure, as did 61% of the MIRV arm.
Median PFS was 5.62 months in the MIRV arm and 3.98 months in the chemotherapy arm (hazard ratio, 0.65; P less than .0001). The overall response rate was 42% in the MIRV arm and 16% in the chemotherapy arm (P < .0001).
The safety outcomes also favored MIRV: 42% experienced grade 3 or higher treatment-emergent adverse events (TEAEs) versus 54% in the chemotherapy group. Severe adverse events were also lower in MIRV, 24% versus 33%. Just 9% of patients in the MIRV discontinued because of TEAEs, compared with 16% in the chemotherapy arm.
MIRV was associated with blurred vision (41%), keratopathy (32%), and dry eye (28%), but these issues were generally manageable through collaboration with optometrists or ophthalmologists.
Dr. Moore and Dr. O’Cearbhaill reported receiving honoraria, research funding, and travel expenses from numerous pharmaceutical companies. Dr. O’Cearbhaill has consulted for or advised Aptitude Health, Bayer, Carina Biotech, Fresenius Kabi, GlaxoSmithKline, GOG Foundation, Immunogen, R-Pharm, Regeneron, and Seagen.
AT ASCO 2023