User login
For One Colorado GI, Private Practice Is Anything But Routine
Lisa Mathew, MD, wants to quell any misconceptions that private practice is dull or routine. “That has not been my experience at all,” says Dr. Mathew, a partner with South Denver Gastroenterology in the suburbs of Denver, Colorado.
“It’s an area within GI where we can be quite nimble in trialing new technologies, optimizing patients’ access to care and working to ensure a positive patient experience,” she said.
Nationwide, a flourishing GI private practice community engages in ongoing dialogue about improvements, navigating a changing healthcare environment, and innovation. “That has been a surprising and wonderful twist in my career,” she added.
Dr. Mathew fosters that dialogue through Gastro Broadcast, a podcast she shares with several other GI physicians. Targeted toward private GI practice, it highlights innovations within the community, providing updates on practice management and other technological advances.
In an interview, she spoke frankly about her favorite recent podcast guest, the challenges she’s faced in her career, and why her fellow GI specialists are her “tribe.”
Q: Why did you choose GI?
Dr. Mathew: In medical school at Duke University, I was considering going into ob.gyn., but academically I was a little more drawn toward internal medicine. While I was in my residency at the University of Pennsylvania, I really clicked with the gastroenterologists. I enjoyed their sense of humor. They were dealing with complex medical issues but doing so with a sense of levity and enjoyment in their work. When I entered fellowship at the University of Washington, I felt like I found my tribe. This was a group of people who really love their work, love medicine, love being able to develop their procedural skills, and keep a sense of humor about themselves. I married a cardiologist (and he’s a hilarious cardiologist), but the world of cardiology is a little more buttoned up. I like that GI is a little more relaxed.
Q: What gives you the most joy in your day-to-day practice?
Dr. Mathew: My patients. They are funny and genuine, and they allow you into these moments of vulnerability — it’s an honor to walk through that together. I’m always so grateful for the trust they put in me in those moments. As my practice has matured, it’s been incredible to watch those relationships grow, as well as begin caring for husbands, wives, sons and daughters of my patients. I enjoy being a part of my community.
Q: Can you talk about an interesting recent guest you had on your podcast? Who was it and why did he or she stand out?
Dr. Mathew: Russ Arjal, MD, AGAF, cofounder, chief medical officer and president of Telebelly Health. He’s been working on a platform for exclusively telehealth services that improves access to care; pairing patients with brick-and-mortar gastroenterology to provide any necessary procedural care, such as colonoscopy and upper endoscopy. It was a fantastic interview. I think it’s so refreshing and inspiring to see how people innovate within the field of GI. On the procedural side, you see this all the time. With my advanced endoscopy colleagues, they’re constantly pushing the boundaries of what we can do procedurally. My academic colleagues are constantly thinking through what the next best treatment is or how best can we optimize care. And, in the world of private practice, we’re thinking about practice care delivery — how to improve access and make the experience of being a patient better, with the ultimate goal of improving health outcomes.
Q: What fears did you have to push past to get to where you are in your career?
Dr. Mathew: Imposter Syndrome is a very, very common issue, maybe somewhat more for women in GI. I think it’s something that everybody wrestles with to some degree. For me, it was developing confidence not just in my clinical skills, but in learning all the complexities of running a small business. It takes time to develop confidence in your abilities and judgment. I think to some degree, that’s normal. It just takes a while to settle into whatever your chosen career path is. Having a community and strong mentors to support me has made all the difference.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Mathew: One of the greatest challenges in my career has been navigating COVID — both with just the tremendous sea change it had on our ability to practice, as well as the financial consequences to someone in private practice. Those were very challenging times to deliver the care that was needed, protect staff, and to maintain a small business. Fortunately, as with many practices across the nation, we’ve emerged through that.
We pivoted, we innovated with telehealth and other services that allowed us to care for our patients. But there were a lot of lessons learned and a lot of difficult moments.
Q: What teacher or mentor had the greatest impact on you?
Dr. Mathew: My dad has taught me the value of hard work. Being a physician just comes in tandem with hard work. And my mom, who is a nurse, has always shown the importance of empathy. Without it, everything else is a little empty. Medicine is a combination of skill and hard work, but also an ability to connect with other people. Empathy is essential to that.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Mathew: We have three children who are native Coloradans so skiing is their birthright. Our entire family are diehard skiers. This is our joy. When you talk about the beach versus mountains debate, we are firmly team mountains. On a perfect Saturday afternoon, I’m on the slopes with my little crew, just tearing it up, having a great time.
Lightning Round
Texting or talking?
Texting
Favorite city in U.S. besides the one you live in?
Washington, D.C.
Favorite breakfast?
Avocado toast
Place you most want to travel to?
South America
Favorite junk food?
Candy
Favorite season?
Winter
How many cups of coffee do you drink per day?
2 or 3
If you weren’t a gastroenterologist, what would you be?
Ski coach
Best Halloween costume you ever wore?
Bunch of grapes
Favorite type of music?
Indie folk
Favorite movie genre?
Books, not into movies
Cat person or dog person?
Neither, but I am a certified beekeeper
What song do you have to sing along with when you hear it?
Anything by Queen
Introvert or extrovert?
Extrovert with introverted tendencies
Favorite holiday?
Thanksgiving
Optimist or pessimist?
100% glass half full
Lisa Mathew, MD, wants to quell any misconceptions that private practice is dull or routine. “That has not been my experience at all,” says Dr. Mathew, a partner with South Denver Gastroenterology in the suburbs of Denver, Colorado.
“It’s an area within GI where we can be quite nimble in trialing new technologies, optimizing patients’ access to care and working to ensure a positive patient experience,” she said.
Nationwide, a flourishing GI private practice community engages in ongoing dialogue about improvements, navigating a changing healthcare environment, and innovation. “That has been a surprising and wonderful twist in my career,” she added.
Dr. Mathew fosters that dialogue through Gastro Broadcast, a podcast she shares with several other GI physicians. Targeted toward private GI practice, it highlights innovations within the community, providing updates on practice management and other technological advances.
In an interview, she spoke frankly about her favorite recent podcast guest, the challenges she’s faced in her career, and why her fellow GI specialists are her “tribe.”
Q: Why did you choose GI?
Dr. Mathew: In medical school at Duke University, I was considering going into ob.gyn., but academically I was a little more drawn toward internal medicine. While I was in my residency at the University of Pennsylvania, I really clicked with the gastroenterologists. I enjoyed their sense of humor. They were dealing with complex medical issues but doing so with a sense of levity and enjoyment in their work. When I entered fellowship at the University of Washington, I felt like I found my tribe. This was a group of people who really love their work, love medicine, love being able to develop their procedural skills, and keep a sense of humor about themselves. I married a cardiologist (and he’s a hilarious cardiologist), but the world of cardiology is a little more buttoned up. I like that GI is a little more relaxed.
Q: What gives you the most joy in your day-to-day practice?
Dr. Mathew: My patients. They are funny and genuine, and they allow you into these moments of vulnerability — it’s an honor to walk through that together. I’m always so grateful for the trust they put in me in those moments. As my practice has matured, it’s been incredible to watch those relationships grow, as well as begin caring for husbands, wives, sons and daughters of my patients. I enjoy being a part of my community.
Q: Can you talk about an interesting recent guest you had on your podcast? Who was it and why did he or she stand out?
Dr. Mathew: Russ Arjal, MD, AGAF, cofounder, chief medical officer and president of Telebelly Health. He’s been working on a platform for exclusively telehealth services that improves access to care; pairing patients with brick-and-mortar gastroenterology to provide any necessary procedural care, such as colonoscopy and upper endoscopy. It was a fantastic interview. I think it’s so refreshing and inspiring to see how people innovate within the field of GI. On the procedural side, you see this all the time. With my advanced endoscopy colleagues, they’re constantly pushing the boundaries of what we can do procedurally. My academic colleagues are constantly thinking through what the next best treatment is or how best can we optimize care. And, in the world of private practice, we’re thinking about practice care delivery — how to improve access and make the experience of being a patient better, with the ultimate goal of improving health outcomes.
Q: What fears did you have to push past to get to where you are in your career?
Dr. Mathew: Imposter Syndrome is a very, very common issue, maybe somewhat more for women in GI. I think it’s something that everybody wrestles with to some degree. For me, it was developing confidence not just in my clinical skills, but in learning all the complexities of running a small business. It takes time to develop confidence in your abilities and judgment. I think to some degree, that’s normal. It just takes a while to settle into whatever your chosen career path is. Having a community and strong mentors to support me has made all the difference.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Mathew: One of the greatest challenges in my career has been navigating COVID — both with just the tremendous sea change it had on our ability to practice, as well as the financial consequences to someone in private practice. Those were very challenging times to deliver the care that was needed, protect staff, and to maintain a small business. Fortunately, as with many practices across the nation, we’ve emerged through that.
We pivoted, we innovated with telehealth and other services that allowed us to care for our patients. But there were a lot of lessons learned and a lot of difficult moments.
Q: What teacher or mentor had the greatest impact on you?
Dr. Mathew: My dad has taught me the value of hard work. Being a physician just comes in tandem with hard work. And my mom, who is a nurse, has always shown the importance of empathy. Without it, everything else is a little empty. Medicine is a combination of skill and hard work, but also an ability to connect with other people. Empathy is essential to that.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Mathew: We have three children who are native Coloradans so skiing is their birthright. Our entire family are diehard skiers. This is our joy. When you talk about the beach versus mountains debate, we are firmly team mountains. On a perfect Saturday afternoon, I’m on the slopes with my little crew, just tearing it up, having a great time.
Lightning Round
Texting or talking?
Texting
Favorite city in U.S. besides the one you live in?
Washington, D.C.
Favorite breakfast?
Avocado toast
Place you most want to travel to?
South America
Favorite junk food?
Candy
Favorite season?
Winter
How many cups of coffee do you drink per day?
2 or 3
If you weren’t a gastroenterologist, what would you be?
Ski coach
Best Halloween costume you ever wore?
Bunch of grapes
Favorite type of music?
Indie folk
Favorite movie genre?
Books, not into movies
Cat person or dog person?
Neither, but I am a certified beekeeper
What song do you have to sing along with when you hear it?
Anything by Queen
Introvert or extrovert?
Extrovert with introverted tendencies
Favorite holiday?
Thanksgiving
Optimist or pessimist?
100% glass half full
Lisa Mathew, MD, wants to quell any misconceptions that private practice is dull or routine. “That has not been my experience at all,” says Dr. Mathew, a partner with South Denver Gastroenterology in the suburbs of Denver, Colorado.
“It’s an area within GI where we can be quite nimble in trialing new technologies, optimizing patients’ access to care and working to ensure a positive patient experience,” she said.
Nationwide, a flourishing GI private practice community engages in ongoing dialogue about improvements, navigating a changing healthcare environment, and innovation. “That has been a surprising and wonderful twist in my career,” she added.
Dr. Mathew fosters that dialogue through Gastro Broadcast, a podcast she shares with several other GI physicians. Targeted toward private GI practice, it highlights innovations within the community, providing updates on practice management and other technological advances.
In an interview, she spoke frankly about her favorite recent podcast guest, the challenges she’s faced in her career, and why her fellow GI specialists are her “tribe.”
Q: Why did you choose GI?
Dr. Mathew: In medical school at Duke University, I was considering going into ob.gyn., but academically I was a little more drawn toward internal medicine. While I was in my residency at the University of Pennsylvania, I really clicked with the gastroenterologists. I enjoyed their sense of humor. They were dealing with complex medical issues but doing so with a sense of levity and enjoyment in their work. When I entered fellowship at the University of Washington, I felt like I found my tribe. This was a group of people who really love their work, love medicine, love being able to develop their procedural skills, and keep a sense of humor about themselves. I married a cardiologist (and he’s a hilarious cardiologist), but the world of cardiology is a little more buttoned up. I like that GI is a little more relaxed.
Q: What gives you the most joy in your day-to-day practice?
Dr. Mathew: My patients. They are funny and genuine, and they allow you into these moments of vulnerability — it’s an honor to walk through that together. I’m always so grateful for the trust they put in me in those moments. As my practice has matured, it’s been incredible to watch those relationships grow, as well as begin caring for husbands, wives, sons and daughters of my patients. I enjoy being a part of my community.
Q: Can you talk about an interesting recent guest you had on your podcast? Who was it and why did he or she stand out?
Dr. Mathew: Russ Arjal, MD, AGAF, cofounder, chief medical officer and president of Telebelly Health. He’s been working on a platform for exclusively telehealth services that improves access to care; pairing patients with brick-and-mortar gastroenterology to provide any necessary procedural care, such as colonoscopy and upper endoscopy. It was a fantastic interview. I think it’s so refreshing and inspiring to see how people innovate within the field of GI. On the procedural side, you see this all the time. With my advanced endoscopy colleagues, they’re constantly pushing the boundaries of what we can do procedurally. My academic colleagues are constantly thinking through what the next best treatment is or how best can we optimize care. And, in the world of private practice, we’re thinking about practice care delivery — how to improve access and make the experience of being a patient better, with the ultimate goal of improving health outcomes.
Q: What fears did you have to push past to get to where you are in your career?
Dr. Mathew: Imposter Syndrome is a very, very common issue, maybe somewhat more for women in GI. I think it’s something that everybody wrestles with to some degree. For me, it was developing confidence not just in my clinical skills, but in learning all the complexities of running a small business. It takes time to develop confidence in your abilities and judgment. I think to some degree, that’s normal. It just takes a while to settle into whatever your chosen career path is. Having a community and strong mentors to support me has made all the difference.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Mathew: One of the greatest challenges in my career has been navigating COVID — both with just the tremendous sea change it had on our ability to practice, as well as the financial consequences to someone in private practice. Those were very challenging times to deliver the care that was needed, protect staff, and to maintain a small business. Fortunately, as with many practices across the nation, we’ve emerged through that.
We pivoted, we innovated with telehealth and other services that allowed us to care for our patients. But there were a lot of lessons learned and a lot of difficult moments.
Q: What teacher or mentor had the greatest impact on you?
Dr. Mathew: My dad has taught me the value of hard work. Being a physician just comes in tandem with hard work. And my mom, who is a nurse, has always shown the importance of empathy. Without it, everything else is a little empty. Medicine is a combination of skill and hard work, but also an ability to connect with other people. Empathy is essential to that.
Q: Describe how you would spend a free Saturday afternoon.
Dr. Mathew: We have three children who are native Coloradans so skiing is their birthright. Our entire family are diehard skiers. This is our joy. When you talk about the beach versus mountains debate, we are firmly team mountains. On a perfect Saturday afternoon, I’m on the slopes with my little crew, just tearing it up, having a great time.
Lightning Round
Texting or talking?
Texting
Favorite city in U.S. besides the one you live in?
Washington, D.C.
Favorite breakfast?
Avocado toast
Place you most want to travel to?
South America
Favorite junk food?
Candy
Favorite season?
Winter
How many cups of coffee do you drink per day?
2 or 3
If you weren’t a gastroenterologist, what would you be?
Ski coach
Best Halloween costume you ever wore?
Bunch of grapes
Favorite type of music?
Indie folk
Favorite movie genre?
Books, not into movies
Cat person or dog person?
Neither, but I am a certified beekeeper
What song do you have to sing along with when you hear it?
Anything by Queen
Introvert or extrovert?
Extrovert with introverted tendencies
Favorite holiday?
Thanksgiving
Optimist or pessimist?
100% glass half full
Psoriatic Arthritis Symptoms Relieved with TYK2 Inhibitor in Phase 2 Trial
TOPLINE:
The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.
METHODOLOGY:
- Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
- A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
- The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.
TAKEAWAY:
- More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
- Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
- Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
- The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.
IN PRACTICE:
“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
SOURCE:
Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.
LIMITATIONS:
The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
DISCLOSURES:
The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.
METHODOLOGY:
- Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
- A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
- The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.
TAKEAWAY:
- More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
- Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
- Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
- The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.
IN PRACTICE:
“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
SOURCE:
Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.
LIMITATIONS:
The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
DISCLOSURES:
The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.
METHODOLOGY:
- Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
- A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
- The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.
TAKEAWAY:
- More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
- Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
- Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
- The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.
IN PRACTICE:
“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
SOURCE:
Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.
LIMITATIONS:
The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
DISCLOSURES:
The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
Psoriatic Arthritis Drug Candidate Sonelokimab Yields Significant Improvements in Phase 2 Trial
TOPLINE:
Treatment of patients with active psoriatic arthritis with sonelokimab — an interleukin (IL)-17A- and IL-17F-inhibiting nanobody — led to a higher percentage of patients with 50% or greater improvement in American College of Rheumatology response criteria (ACR50) compared with the placebo in a phase 2 trial.
METHODOLOGY:
- Sonelokimab is a 40-kDa nanobody that binds to IL-17A, IL-17F, and albumin.
- Eligible patients were at least 18 years old with active PsA (at least three swollen and three tender joints) and had a psoriasis diagnosis.
- A total of 207 patients were randomized 1:1:1:1 to every 4 weeks receive placebo, sonelokimab 60 mg with no induction (NI) period, sonelokimab 60 mg with induction, and sonelokimab 120 mg with induction.
- Induction was once every 2 weeks up to week 8 of the trial.
- The primary endpoint was meeting ACR20 response criteria at 12 weeks.
TAKEAWAY:
- About 46% of patients in the sonelokimab 120-mg and 60-mg groups achieved ACR50, compared with 36.6% in the sonelokimab 60-mg NI group and 20% of those assigned to placebo.
- ACR20 and 90% or greater reduction in Psoriasis Area and Severity Index score response rates were higher in all three sonelokimab groups than in the placebo group.
- There were no unexpected safety findings during the trial, and no cases of inflammatory bowel disease or major cardiovascular events.
- There were two cases of oral candidiasis, which did not lead to study discontinuation.
IN PRACTICE:
These data “support further exploration in phase 3 trials of sonelokimab to evaluate its potential for the treatment of PsA,” the authors noted in the presentation.
SOURCE:
Iain B. McInnes, MD, PhD, of the University of Glasgow, Glasgow, Scotland, presented these phase 2 trial results at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Congress, held in Vienna.
LIMITATIONS:
The results are from a phase 2 trial, and more research is needed.
DISCLOSURES:
MoonLake Immunotherapeutics funded the research. Dr. McInnes disclosed relationships with AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Causeway Therapeutics, Cabaletta Bio, Compugen, Evelo, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, MoonLake Immunotherapeutics, Pfizer, Sanofi Regeneron, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
Treatment of patients with active psoriatic arthritis with sonelokimab — an interleukin (IL)-17A- and IL-17F-inhibiting nanobody — led to a higher percentage of patients with 50% or greater improvement in American College of Rheumatology response criteria (ACR50) compared with the placebo in a phase 2 trial.
METHODOLOGY:
- Sonelokimab is a 40-kDa nanobody that binds to IL-17A, IL-17F, and albumin.
- Eligible patients were at least 18 years old with active PsA (at least three swollen and three tender joints) and had a psoriasis diagnosis.
- A total of 207 patients were randomized 1:1:1:1 to every 4 weeks receive placebo, sonelokimab 60 mg with no induction (NI) period, sonelokimab 60 mg with induction, and sonelokimab 120 mg with induction.
- Induction was once every 2 weeks up to week 8 of the trial.
- The primary endpoint was meeting ACR20 response criteria at 12 weeks.
TAKEAWAY:
- About 46% of patients in the sonelokimab 120-mg and 60-mg groups achieved ACR50, compared with 36.6% in the sonelokimab 60-mg NI group and 20% of those assigned to placebo.
- ACR20 and 90% or greater reduction in Psoriasis Area and Severity Index score response rates were higher in all three sonelokimab groups than in the placebo group.
- There were no unexpected safety findings during the trial, and no cases of inflammatory bowel disease or major cardiovascular events.
- There were two cases of oral candidiasis, which did not lead to study discontinuation.
IN PRACTICE:
These data “support further exploration in phase 3 trials of sonelokimab to evaluate its potential for the treatment of PsA,” the authors noted in the presentation.
SOURCE:
Iain B. McInnes, MD, PhD, of the University of Glasgow, Glasgow, Scotland, presented these phase 2 trial results at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Congress, held in Vienna.
LIMITATIONS:
The results are from a phase 2 trial, and more research is needed.
DISCLOSURES:
MoonLake Immunotherapeutics funded the research. Dr. McInnes disclosed relationships with AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Causeway Therapeutics, Cabaletta Bio, Compugen, Evelo, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, MoonLake Immunotherapeutics, Pfizer, Sanofi Regeneron, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
Treatment of patients with active psoriatic arthritis with sonelokimab — an interleukin (IL)-17A- and IL-17F-inhibiting nanobody — led to a higher percentage of patients with 50% or greater improvement in American College of Rheumatology response criteria (ACR50) compared with the placebo in a phase 2 trial.
METHODOLOGY:
- Sonelokimab is a 40-kDa nanobody that binds to IL-17A, IL-17F, and albumin.
- Eligible patients were at least 18 years old with active PsA (at least three swollen and three tender joints) and had a psoriasis diagnosis.
- A total of 207 patients were randomized 1:1:1:1 to every 4 weeks receive placebo, sonelokimab 60 mg with no induction (NI) period, sonelokimab 60 mg with induction, and sonelokimab 120 mg with induction.
- Induction was once every 2 weeks up to week 8 of the trial.
- The primary endpoint was meeting ACR20 response criteria at 12 weeks.
TAKEAWAY:
- About 46% of patients in the sonelokimab 120-mg and 60-mg groups achieved ACR50, compared with 36.6% in the sonelokimab 60-mg NI group and 20% of those assigned to placebo.
- ACR20 and 90% or greater reduction in Psoriasis Area and Severity Index score response rates were higher in all three sonelokimab groups than in the placebo group.
- There were no unexpected safety findings during the trial, and no cases of inflammatory bowel disease or major cardiovascular events.
- There were two cases of oral candidiasis, which did not lead to study discontinuation.
IN PRACTICE:
These data “support further exploration in phase 3 trials of sonelokimab to evaluate its potential for the treatment of PsA,” the authors noted in the presentation.
SOURCE:
Iain B. McInnes, MD, PhD, of the University of Glasgow, Glasgow, Scotland, presented these phase 2 trial results at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Congress, held in Vienna.
LIMITATIONS:
The results are from a phase 2 trial, and more research is needed.
DISCLOSURES:
MoonLake Immunotherapeutics funded the research. Dr. McInnes disclosed relationships with AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Causeway Therapeutics, Cabaletta Bio, Compugen, Evelo, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, MoonLake Immunotherapeutics, Pfizer, Sanofi Regeneron, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
FDA Proposes that Interchangeability Status for Biosimilars Doesn’t Need Switching Studies
The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.
“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”
An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.
While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”
However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.
“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.
“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.
The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.
“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”
An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.
While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”
However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.
“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.
“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.
The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.
“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”
An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.
While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”
However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.
“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.
“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.
The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.
A version of this article first appeared on Medscape.com.
Baricitinib Outperforms TNF Inhibitors in Real-World RA Trial
Baricitinib may be the superior choice to tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA) for whom conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) have failed, according to a new study.
After 12 weeks, patients taking baricitinib achieved a 50% improvement in RA symptoms according to American College of Rheumatology response criteria (ACR50) at twice the rate as in patients assigned to receive TNF inhibitors. In addition, 75% of the baricitinib group achieved a 28-joint Disease Activity Score with C-reactive protein under 2.6, compared with less than half of patients taking TNF inhibitors.
Putting Safety Into the Equation
However, safety concerns also need to be considered when prescribing medication, noted Andrew Wang, MD, PhD, a rheumatologist at Yale School of Medicine in New Haven, Connecticut. He was not involved with the study, called PERFECTRA.
“This category of drugs — JAK-STAT [inhibitors] — are much newer than TNF inhibitors, CTLAs, B-cell depleters, and the other tools we have,” he said, “with relatively less real-world experience and potential downsides in the future.”
Both the ACR and European Alliance of Associations for Rheumatology guidelines recommend that patients who have not achieved target disease activity with csDMARDs can be prescribed either a Janus kinase (JAK) inhibitor or a TNF inhibitor as a treatment option, yet many physicians favor TNF inhibitors because of extensive clinical experience with the drug class and other factors such as biosimilar availability and cost, Celine van de Laar, MSc, of Erasmus University in Rotterdam, the Netherlands, and coauthors explained.
There are also notable safety concerns for using JAK inhibitors: Results from a large postmarketing clinical trial of tofacitinib prompted the US Food and Drug Administration to issue a boxed warning for the medication due to an increased risk for cardiovascular events, cancer, blood clots, and death, in comparison with TNF inhibitors. That warning now includes two other medications in the same drug class: baricitinib and upadacitinib. The European Medicines Agency has also issued guidance to minimize the risk for side effects for these medications.
Some randomized controlled trials have demonstrated that baricitinib “showed significant clinical improvements” in patients with RA, compared with adalimumab and placebo, but these trials do not always reflect treatment in the real world, the study authors wrote. The results were published in RMD Open.
Study Details
In the study, researchers enrolled 199 patients with active RA for which previous use of at least one csDMARD had failed and randomly assigned 97 patients to receive baricitinib and the remainder to receive a TNF inhibitor: 64% started on adalimumab, 33% started on etanercept, and the rest used golimumab or infliximab.
For all patients, the suggested treatment allocation was provided via randomization lists, but physicians and patients ultimately decided treatment via shared decision-making.
Patients were diagnosed less than 5 years ago, had received no previous treatment with biologics or targeted synthetic DMARDs, and had no contraindications for TNF inhibitors or baricitinib. Researchers recruited patients from September 2019 through February 2022 across 15 health centers in the Netherlands and Belgium. The study was funded by Eli Lilly, which manufactures baricitinib, although the study was investigator initiated.
Patients were on average aged 55 years, and about two thirds were women. The average disease duration was 2 years.
At 12 weeks, 42% of the baricitinib group achieved ACR50, compared with 20% of the TNF inhibitor group. All patient-reported outcome measures showed improvement over the study period, favoring baricitinib. More patients receiving baricitinib remained on the medication overall than patients on a TNF inhibitor: At 48 weeks, 70% of patients receiving a TNF inhibitor and 80% of patients receiving baricitinib had continued taking their assigned treatment.
These results are not surprising, Wang noted, as “JAK inhibitors hit many arms of immune signaling, whereas TNF blockers just hit TNF.” However, there is a trade-off between potent, effective drugs and toxicity, he added.
“I would not be as bullish on starting baricitinib in a patient off the bat, in the same way that nobody would want to keep patients on glucocorticoids [any longer than is] minimally necessary.”
While the study was not powered to compare safety between the two drugs, there were no adverse events during the study that had not been previously reported.
“Prescribers have to be aware that cardiovascular and malignant [serious adverse events] are more frequently reported” with JAK inhibitors than with TNF inhibitors, the authors wrote. “Obviously, this has to be considered carefully in risk-benefit discussions with any individual patient.”
Dr. Wang noted that, in general, he and his colleagues would not start with a JAK inhibitor first except for special circumstances: For example, if a patient will not use an injectable medication, or for some reason, it’s impractical for the patient’s lifestyle to use medication that requires constant refrigeration.
“I think the take-home message here is these are, in general, lifelong diseases, and so a rheumatologist and their patients have to develop good relationships to monitor whether or not we’re hitting the sweet spot of keeping disease under control” while also avoiding overmedication and toxicity, he said.
One potential solution, which Dr. Wang has also done in his clinical practice, is to initiate a JAK inhibitor in patients who need it but then switch to a different modality after achieving disease control.
“You can imagine a scenario where you get them to a very low [Disease Activity Score] with baricitinib, for example, and then you switch them to a TNF inhibitor,” he said. “I can imagine that there would be ways that you could get the best of both worlds.”
PERFECTRA was financially supported by an unrestricted grant from Eli Lilly. The authors reported financial relationships with AbbVie, Eli Lilly, Galapagos, and Janssen-Cilag. Dr. Wang serves on NGM Bio’s science advisory board, consults for TCG Labs-Soleil and Seranova Bio, and has received funding from AstraZeneca.
A version of this article first appeared on Medscape.com.
Baricitinib may be the superior choice to tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA) for whom conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) have failed, according to a new study.
After 12 weeks, patients taking baricitinib achieved a 50% improvement in RA symptoms according to American College of Rheumatology response criteria (ACR50) at twice the rate as in patients assigned to receive TNF inhibitors. In addition, 75% of the baricitinib group achieved a 28-joint Disease Activity Score with C-reactive protein under 2.6, compared with less than half of patients taking TNF inhibitors.
Putting Safety Into the Equation
However, safety concerns also need to be considered when prescribing medication, noted Andrew Wang, MD, PhD, a rheumatologist at Yale School of Medicine in New Haven, Connecticut. He was not involved with the study, called PERFECTRA.
“This category of drugs — JAK-STAT [inhibitors] — are much newer than TNF inhibitors, CTLAs, B-cell depleters, and the other tools we have,” he said, “with relatively less real-world experience and potential downsides in the future.”
Both the ACR and European Alliance of Associations for Rheumatology guidelines recommend that patients who have not achieved target disease activity with csDMARDs can be prescribed either a Janus kinase (JAK) inhibitor or a TNF inhibitor as a treatment option, yet many physicians favor TNF inhibitors because of extensive clinical experience with the drug class and other factors such as biosimilar availability and cost, Celine van de Laar, MSc, of Erasmus University in Rotterdam, the Netherlands, and coauthors explained.
There are also notable safety concerns for using JAK inhibitors: Results from a large postmarketing clinical trial of tofacitinib prompted the US Food and Drug Administration to issue a boxed warning for the medication due to an increased risk for cardiovascular events, cancer, blood clots, and death, in comparison with TNF inhibitors. That warning now includes two other medications in the same drug class: baricitinib and upadacitinib. The European Medicines Agency has also issued guidance to minimize the risk for side effects for these medications.
Some randomized controlled trials have demonstrated that baricitinib “showed significant clinical improvements” in patients with RA, compared with adalimumab and placebo, but these trials do not always reflect treatment in the real world, the study authors wrote. The results were published in RMD Open.
Study Details
In the study, researchers enrolled 199 patients with active RA for which previous use of at least one csDMARD had failed and randomly assigned 97 patients to receive baricitinib and the remainder to receive a TNF inhibitor: 64% started on adalimumab, 33% started on etanercept, and the rest used golimumab or infliximab.
For all patients, the suggested treatment allocation was provided via randomization lists, but physicians and patients ultimately decided treatment via shared decision-making.
Patients were diagnosed less than 5 years ago, had received no previous treatment with biologics or targeted synthetic DMARDs, and had no contraindications for TNF inhibitors or baricitinib. Researchers recruited patients from September 2019 through February 2022 across 15 health centers in the Netherlands and Belgium. The study was funded by Eli Lilly, which manufactures baricitinib, although the study was investigator initiated.
Patients were on average aged 55 years, and about two thirds were women. The average disease duration was 2 years.
At 12 weeks, 42% of the baricitinib group achieved ACR50, compared with 20% of the TNF inhibitor group. All patient-reported outcome measures showed improvement over the study period, favoring baricitinib. More patients receiving baricitinib remained on the medication overall than patients on a TNF inhibitor: At 48 weeks, 70% of patients receiving a TNF inhibitor and 80% of patients receiving baricitinib had continued taking their assigned treatment.
These results are not surprising, Wang noted, as “JAK inhibitors hit many arms of immune signaling, whereas TNF blockers just hit TNF.” However, there is a trade-off between potent, effective drugs and toxicity, he added.
“I would not be as bullish on starting baricitinib in a patient off the bat, in the same way that nobody would want to keep patients on glucocorticoids [any longer than is] minimally necessary.”
While the study was not powered to compare safety between the two drugs, there were no adverse events during the study that had not been previously reported.
“Prescribers have to be aware that cardiovascular and malignant [serious adverse events] are more frequently reported” with JAK inhibitors than with TNF inhibitors, the authors wrote. “Obviously, this has to be considered carefully in risk-benefit discussions with any individual patient.”
Dr. Wang noted that, in general, he and his colleagues would not start with a JAK inhibitor first except for special circumstances: For example, if a patient will not use an injectable medication, or for some reason, it’s impractical for the patient’s lifestyle to use medication that requires constant refrigeration.
“I think the take-home message here is these are, in general, lifelong diseases, and so a rheumatologist and their patients have to develop good relationships to monitor whether or not we’re hitting the sweet spot of keeping disease under control” while also avoiding overmedication and toxicity, he said.
One potential solution, which Dr. Wang has also done in his clinical practice, is to initiate a JAK inhibitor in patients who need it but then switch to a different modality after achieving disease control.
“You can imagine a scenario where you get them to a very low [Disease Activity Score] with baricitinib, for example, and then you switch them to a TNF inhibitor,” he said. “I can imagine that there would be ways that you could get the best of both worlds.”
PERFECTRA was financially supported by an unrestricted grant from Eli Lilly. The authors reported financial relationships with AbbVie, Eli Lilly, Galapagos, and Janssen-Cilag. Dr. Wang serves on NGM Bio’s science advisory board, consults for TCG Labs-Soleil and Seranova Bio, and has received funding from AstraZeneca.
A version of this article first appeared on Medscape.com.
Baricitinib may be the superior choice to tumor necrosis factor (TNF) inhibitors in patients with rheumatoid arthritis (RA) for whom conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) have failed, according to a new study.
After 12 weeks, patients taking baricitinib achieved a 50% improvement in RA symptoms according to American College of Rheumatology response criteria (ACR50) at twice the rate as in patients assigned to receive TNF inhibitors. In addition, 75% of the baricitinib group achieved a 28-joint Disease Activity Score with C-reactive protein under 2.6, compared with less than half of patients taking TNF inhibitors.
Putting Safety Into the Equation
However, safety concerns also need to be considered when prescribing medication, noted Andrew Wang, MD, PhD, a rheumatologist at Yale School of Medicine in New Haven, Connecticut. He was not involved with the study, called PERFECTRA.
“This category of drugs — JAK-STAT [inhibitors] — are much newer than TNF inhibitors, CTLAs, B-cell depleters, and the other tools we have,” he said, “with relatively less real-world experience and potential downsides in the future.”
Both the ACR and European Alliance of Associations for Rheumatology guidelines recommend that patients who have not achieved target disease activity with csDMARDs can be prescribed either a Janus kinase (JAK) inhibitor or a TNF inhibitor as a treatment option, yet many physicians favor TNF inhibitors because of extensive clinical experience with the drug class and other factors such as biosimilar availability and cost, Celine van de Laar, MSc, of Erasmus University in Rotterdam, the Netherlands, and coauthors explained.
There are also notable safety concerns for using JAK inhibitors: Results from a large postmarketing clinical trial of tofacitinib prompted the US Food and Drug Administration to issue a boxed warning for the medication due to an increased risk for cardiovascular events, cancer, blood clots, and death, in comparison with TNF inhibitors. That warning now includes two other medications in the same drug class: baricitinib and upadacitinib. The European Medicines Agency has also issued guidance to minimize the risk for side effects for these medications.
Some randomized controlled trials have demonstrated that baricitinib “showed significant clinical improvements” in patients with RA, compared with adalimumab and placebo, but these trials do not always reflect treatment in the real world, the study authors wrote. The results were published in RMD Open.
Study Details
In the study, researchers enrolled 199 patients with active RA for which previous use of at least one csDMARD had failed and randomly assigned 97 patients to receive baricitinib and the remainder to receive a TNF inhibitor: 64% started on adalimumab, 33% started on etanercept, and the rest used golimumab or infliximab.
For all patients, the suggested treatment allocation was provided via randomization lists, but physicians and patients ultimately decided treatment via shared decision-making.
Patients were diagnosed less than 5 years ago, had received no previous treatment with biologics or targeted synthetic DMARDs, and had no contraindications for TNF inhibitors or baricitinib. Researchers recruited patients from September 2019 through February 2022 across 15 health centers in the Netherlands and Belgium. The study was funded by Eli Lilly, which manufactures baricitinib, although the study was investigator initiated.
Patients were on average aged 55 years, and about two thirds were women. The average disease duration was 2 years.
At 12 weeks, 42% of the baricitinib group achieved ACR50, compared with 20% of the TNF inhibitor group. All patient-reported outcome measures showed improvement over the study period, favoring baricitinib. More patients receiving baricitinib remained on the medication overall than patients on a TNF inhibitor: At 48 weeks, 70% of patients receiving a TNF inhibitor and 80% of patients receiving baricitinib had continued taking their assigned treatment.
These results are not surprising, Wang noted, as “JAK inhibitors hit many arms of immune signaling, whereas TNF blockers just hit TNF.” However, there is a trade-off between potent, effective drugs and toxicity, he added.
“I would not be as bullish on starting baricitinib in a patient off the bat, in the same way that nobody would want to keep patients on glucocorticoids [any longer than is] minimally necessary.”
While the study was not powered to compare safety between the two drugs, there were no adverse events during the study that had not been previously reported.
“Prescribers have to be aware that cardiovascular and malignant [serious adverse events] are more frequently reported” with JAK inhibitors than with TNF inhibitors, the authors wrote. “Obviously, this has to be considered carefully in risk-benefit discussions with any individual patient.”
Dr. Wang noted that, in general, he and his colleagues would not start with a JAK inhibitor first except for special circumstances: For example, if a patient will not use an injectable medication, or for some reason, it’s impractical for the patient’s lifestyle to use medication that requires constant refrigeration.
“I think the take-home message here is these are, in general, lifelong diseases, and so a rheumatologist and their patients have to develop good relationships to monitor whether or not we’re hitting the sweet spot of keeping disease under control” while also avoiding overmedication and toxicity, he said.
One potential solution, which Dr. Wang has also done in his clinical practice, is to initiate a JAK inhibitor in patients who need it but then switch to a different modality after achieving disease control.
“You can imagine a scenario where you get them to a very low [Disease Activity Score] with baricitinib, for example, and then you switch them to a TNF inhibitor,” he said. “I can imagine that there would be ways that you could get the best of both worlds.”
PERFECTRA was financially supported by an unrestricted grant from Eli Lilly. The authors reported financial relationships with AbbVie, Eli Lilly, Galapagos, and Janssen-Cilag. Dr. Wang serves on NGM Bio’s science advisory board, consults for TCG Labs-Soleil and Seranova Bio, and has received funding from AstraZeneca.
A version of this article first appeared on Medscape.com.
FROM RMD OPEN
Patient-Driven Care Plus Telemonitoring Yields Promising Results for Spondyloarthritis
VIENNA — People with spondyloarthritis (SpA) who have low or stable disease activity can effectively and safely be managed using a model of patient-initiated care with or without remote monitoring, suggested the results of two separate trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting.
In the 18-month, single-center ReMonit study that included 243 people with axial SpA (axSpA), patient-initiated care was found to be noninferior for keeping them in a low-disease activity state, compared with both usual hospital follow-up and remote digital monitoring.
Meanwhile, in the 12-month, multicenter TeleSpA study, which included 200 patients with any type of SpA, the number of hospital visits needed by people who were randomly assigned to receive patient-initiated care together with asynchronous telemonitoring was significantly lower than for the usual-care group, with no detriment to the participants’ overall health outcomes or safety. Moreover, the strategy was deemed cost-effective from a healthcare provision perspective.
Time to Rationalize Healthcare Resources?
People with chronic rheumatic diseases such as axSpA require long-term follow-up in specialist healthcare centers, Inger Jorid Berg, MD, PhD, of Diakonhjemmet Hospital in Oslo, Norway, said when she presented the findings of the ReMonit study as a late-breaking abstract.
“Traditionally, this has been offered as prescheduled face-to-face consultations at an outpatient clinic, but remote monitoring and patient-initiated care may allow for more targeted and efficient uses of healthcare resources,” Dr. Berg said.
“The end goal of what you’re trying to do is increase the efficiency of outpatient care and provide more patient-tailored care,” Kasper Hermans, MD, said in an interview. He presented the results of the TeleSpA study.
Dr. Hermans, who is a rheumatology fellow and PhD candidate at Maastricht University, Maastricht, the Netherlands, observed during his presentation at EULAR 2024 that there is an increasing demand for rheumatology services but an expected shortfall in the future workforce. Thus, “sustainable alternative strategies are needed for optimizing the efficiency of care,” he said.
People need to have timely access to care, Dr. Hermans stressed, but perhaps alternatives to the traditional models of care where patients are seen routinely every 6 or 12 months are needed, particularly as prior work had suggested that around one-third of people who were seen by a rheumatologist perhaps did not need to be.
A strategy of patient-initiated care — which is where people are seen by a healthcare provider only if they feel that they need to and request a consultation — is therefore an attractive proposition, particularly if it is backed up with remote monitoring, which is what the TeleSpA study was testing.
Two Distinct Studies
ReMonit and TeleSpA were two distinct studies. While both were noninferiority trials and involved patient-initiated care and telemonitoring of outpatients with SpA, that is where the similarities generally end.
Notably, ReMonit included a very specific population of patients — all had a diagnosis of axSpA and were being treated with a tumor necrosis factor (TNF) inhibitor and had been on a stable dose for the last 6 months. For inclusion, they also had to have inactive disease or low disease activity, as indicated by an Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1.
ReMonit’s telemonitoring strategy involved participants completing monthly questionnaires using the Dignio smartphone app. Patients first completed the Patient Global Assessment (PGA) and noted whether they had experienced a flare in their disease. If they had a flare or their PGA score was 3 or higher, then they were asked to also complete the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI). If the BASDAI score was 4 or more, then the patient was called by a study nurse and offered a consultation.
“Patients in all three groups were recommended to take blood samples at the general practitioner’s or at the hospital every third month as a safety procedure when using TNF inhibitors,” Dr. Berg said.
The primary outcome was the proportion of people who remained with low disease activity (ASDAS < 2.1) at 6, 12, and 18 months in each of the three arms of the trial, which were patient-initiated care (n = 81), monthly remote monitoring (n = 80), or usual follow-up in the hospital every 6 months (n = 82).
TeleSpA on the other hand was a “much more pragmatic trial, much closer to actual care,” Dr. Hermans said. “We included axial spondyloarthritis, peripheral spondyloarthritis, or patients who had both axial and peripheral disease, including patients with psoriatic arthritis,” he said, adding that their inclusion was regardless of their baseline ASDAS based on C-reactive protein (ASDAS-CRP).
This means that patients who would otherwise have been classified at baseline as having high disease activity (by ASDAS-CRP or similar disease activity measures) could be included. The main proviso was that both the patient and their rheumatologist had to define the condition as being stable with an acceptable level of symptom control and no immediate plans to change treatment within the next 3 months.
TeleSpA’s remote monitoring strategy involved the use of SpA-Net, which Dr. Hermans and coinvestigators have described previously as “an ongoing, disease-specific, prospective, web-based registry for monitoring SpA in daily practice.” This captures a host of clinical and laboratory test information.
SpA-Net was used in both arms of the study. However, while the 100 participants in the standard-care arm completed questionnaires and had tests before every in-person visit that had been prescheduled with their rheumatologist, the 100 individuals in the patient-initiated care arm had no prescheduled in-person visits except for being seen at the start and end of the study. These patients were reminded via email to complete the necessary SpA-Net registry questionnaires at 6 months.
The primary outcome for TeleSpA was the total number of rheumatology visits, including both physical and telephone or video consultations, within a 1-year period.
ReMonit Results
Berg reported that similar percentages of patients remained in a low disease activity state at 6, 12, and 18 months, regardless of the group that they had been randomized into, and that there was little change seen within the individual groups.
For instance, at 6, 12, and 18 months, 92%, 91%, and 92% of individuals in the patient-initiated arm had an ASDAS of < 2.1. Corresponding percentages for the usual-care arm were 96%, 93%, and 90% and for the remote-monitoring arm were 96%, 96%, and 94%.
Both patient-initiated care and remote monitoring were noninferior to usual care, and patient-initiated care was also noninferior to remote monitoring. There were no differences between the trial arms in terms of disease activity, measured using either ASDAS or BASDAI, at 6, 12, or 18 months.
Dr. Berg stated that “patient satisfaction was high in all three follow-up strategies, and there was the lowest resource use with patient-initiated care.” She concluded that “remote monitoring and patient-initiated care could be implemented in the follow-up of patients with axial spondyloarthritis and low disease activity.”
TeleSpA Results
In TeleSpA, people in the patient-initiated care and telemonitoring arm were seen a mean of 1.9 times over the course of the 1-year follow-up vs 2.6 for people in the usual care arm. The reduction was caused in part by the decrease in physical visits (1.4 vs 2.0) as there were the same mean number of telephone visits in each group. Overall, there was a 25.4% reduction in consultations comparing the patient-initiated care and telemonitoring arm with the usual-care arm.
Importantly, the intervention was noninferior regarding all of the predefined health outcomes: ASDAS, BASDAI, pain assessed using a visual analog scale, patient global assessment, and physician global assessment.
And more than 90% of participants in both groups reported having an overall good experience with their care.
Dr. Hermans noted after his presentation that an additional study had been performed where “we actively engaged with patients in the intervention group as well as healthcare providers to ask them what their experiences were with the intervention, how we could possibly improve it, and whether or not they thought that it was a valid approach to follow-up after the end of the study. And results were very, very reassuring.”
In terms of safety, eight serious adverse events were reported, but none were related to the study intervention, Dr. Hermans said.
Dr. Hermans reported that there was “negligible difference” in the 1-year quality-adjusted life-years (+0.004, in favor of the intervention overall) and that, while healthcare costs were lower at €243/year for the entire intervention period, societal costs were higher, at €513/year vs usual care. The latter was thought to be “due to an unexpected rise in absenteeism that we think was most likely due to a small amount of outliers,” Dr. Hermans said.
Nonetheless, using at willingness-to-pay threshold of €20,000/ quality-adjusted life year, he reported that the added value of patient-initiated care with remote monitoring yielded a potential net monetary benefit of +€322 from a healthcare perspective for the entire intervention period.
“We believe that these results support the fast-paced adoption of remote care interventions,” Dr. Hermans said. “In the context that I described earlier, of decreasing healthcare personnel and rising costs, we believe that this could be a valuable approach for follow-up for patients with stable axSpA.”
ReMonit was sponsored by Diakonhjemmet Hospital, and TeleSpA was sponsored by Maastricht University Medical Center, with funding from the Dutch Arthritis Society. Dr. Berg and Dr. Hermans had no relevant conflicts of interest to report.
A version of this article first appeared on Medscape.com.
Editor’s Note: This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
VIENNA — People with spondyloarthritis (SpA) who have low or stable disease activity can effectively and safely be managed using a model of patient-initiated care with or without remote monitoring, suggested the results of two separate trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting.
In the 18-month, single-center ReMonit study that included 243 people with axial SpA (axSpA), patient-initiated care was found to be noninferior for keeping them in a low-disease activity state, compared with both usual hospital follow-up and remote digital monitoring.
Meanwhile, in the 12-month, multicenter TeleSpA study, which included 200 patients with any type of SpA, the number of hospital visits needed by people who were randomly assigned to receive patient-initiated care together with asynchronous telemonitoring was significantly lower than for the usual-care group, with no detriment to the participants’ overall health outcomes or safety. Moreover, the strategy was deemed cost-effective from a healthcare provision perspective.
Time to Rationalize Healthcare Resources?
People with chronic rheumatic diseases such as axSpA require long-term follow-up in specialist healthcare centers, Inger Jorid Berg, MD, PhD, of Diakonhjemmet Hospital in Oslo, Norway, said when she presented the findings of the ReMonit study as a late-breaking abstract.
“Traditionally, this has been offered as prescheduled face-to-face consultations at an outpatient clinic, but remote monitoring and patient-initiated care may allow for more targeted and efficient uses of healthcare resources,” Dr. Berg said.
“The end goal of what you’re trying to do is increase the efficiency of outpatient care and provide more patient-tailored care,” Kasper Hermans, MD, said in an interview. He presented the results of the TeleSpA study.
Dr. Hermans, who is a rheumatology fellow and PhD candidate at Maastricht University, Maastricht, the Netherlands, observed during his presentation at EULAR 2024 that there is an increasing demand for rheumatology services but an expected shortfall in the future workforce. Thus, “sustainable alternative strategies are needed for optimizing the efficiency of care,” he said.
People need to have timely access to care, Dr. Hermans stressed, but perhaps alternatives to the traditional models of care where patients are seen routinely every 6 or 12 months are needed, particularly as prior work had suggested that around one-third of people who were seen by a rheumatologist perhaps did not need to be.
A strategy of patient-initiated care — which is where people are seen by a healthcare provider only if they feel that they need to and request a consultation — is therefore an attractive proposition, particularly if it is backed up with remote monitoring, which is what the TeleSpA study was testing.
Two Distinct Studies
ReMonit and TeleSpA were two distinct studies. While both were noninferiority trials and involved patient-initiated care and telemonitoring of outpatients with SpA, that is where the similarities generally end.
Notably, ReMonit included a very specific population of patients — all had a diagnosis of axSpA and were being treated with a tumor necrosis factor (TNF) inhibitor and had been on a stable dose for the last 6 months. For inclusion, they also had to have inactive disease or low disease activity, as indicated by an Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1.
ReMonit’s telemonitoring strategy involved participants completing monthly questionnaires using the Dignio smartphone app. Patients first completed the Patient Global Assessment (PGA) and noted whether they had experienced a flare in their disease. If they had a flare or their PGA score was 3 or higher, then they were asked to also complete the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI). If the BASDAI score was 4 or more, then the patient was called by a study nurse and offered a consultation.
“Patients in all three groups were recommended to take blood samples at the general practitioner’s or at the hospital every third month as a safety procedure when using TNF inhibitors,” Dr. Berg said.
The primary outcome was the proportion of people who remained with low disease activity (ASDAS < 2.1) at 6, 12, and 18 months in each of the three arms of the trial, which were patient-initiated care (n = 81), monthly remote monitoring (n = 80), or usual follow-up in the hospital every 6 months (n = 82).
TeleSpA on the other hand was a “much more pragmatic trial, much closer to actual care,” Dr. Hermans said. “We included axial spondyloarthritis, peripheral spondyloarthritis, or patients who had both axial and peripheral disease, including patients with psoriatic arthritis,” he said, adding that their inclusion was regardless of their baseline ASDAS based on C-reactive protein (ASDAS-CRP).
This means that patients who would otherwise have been classified at baseline as having high disease activity (by ASDAS-CRP or similar disease activity measures) could be included. The main proviso was that both the patient and their rheumatologist had to define the condition as being stable with an acceptable level of symptom control and no immediate plans to change treatment within the next 3 months.
TeleSpA’s remote monitoring strategy involved the use of SpA-Net, which Dr. Hermans and coinvestigators have described previously as “an ongoing, disease-specific, prospective, web-based registry for monitoring SpA in daily practice.” This captures a host of clinical and laboratory test information.
SpA-Net was used in both arms of the study. However, while the 100 participants in the standard-care arm completed questionnaires and had tests before every in-person visit that had been prescheduled with their rheumatologist, the 100 individuals in the patient-initiated care arm had no prescheduled in-person visits except for being seen at the start and end of the study. These patients were reminded via email to complete the necessary SpA-Net registry questionnaires at 6 months.
The primary outcome for TeleSpA was the total number of rheumatology visits, including both physical and telephone or video consultations, within a 1-year period.
ReMonit Results
Berg reported that similar percentages of patients remained in a low disease activity state at 6, 12, and 18 months, regardless of the group that they had been randomized into, and that there was little change seen within the individual groups.
For instance, at 6, 12, and 18 months, 92%, 91%, and 92% of individuals in the patient-initiated arm had an ASDAS of < 2.1. Corresponding percentages for the usual-care arm were 96%, 93%, and 90% and for the remote-monitoring arm were 96%, 96%, and 94%.
Both patient-initiated care and remote monitoring were noninferior to usual care, and patient-initiated care was also noninferior to remote monitoring. There were no differences between the trial arms in terms of disease activity, measured using either ASDAS or BASDAI, at 6, 12, or 18 months.
Dr. Berg stated that “patient satisfaction was high in all three follow-up strategies, and there was the lowest resource use with patient-initiated care.” She concluded that “remote monitoring and patient-initiated care could be implemented in the follow-up of patients with axial spondyloarthritis and low disease activity.”
TeleSpA Results
In TeleSpA, people in the patient-initiated care and telemonitoring arm were seen a mean of 1.9 times over the course of the 1-year follow-up vs 2.6 for people in the usual care arm. The reduction was caused in part by the decrease in physical visits (1.4 vs 2.0) as there were the same mean number of telephone visits in each group. Overall, there was a 25.4% reduction in consultations comparing the patient-initiated care and telemonitoring arm with the usual-care arm.
Importantly, the intervention was noninferior regarding all of the predefined health outcomes: ASDAS, BASDAI, pain assessed using a visual analog scale, patient global assessment, and physician global assessment.
And more than 90% of participants in both groups reported having an overall good experience with their care.
Dr. Hermans noted after his presentation that an additional study had been performed where “we actively engaged with patients in the intervention group as well as healthcare providers to ask them what their experiences were with the intervention, how we could possibly improve it, and whether or not they thought that it was a valid approach to follow-up after the end of the study. And results were very, very reassuring.”
In terms of safety, eight serious adverse events were reported, but none were related to the study intervention, Dr. Hermans said.
Dr. Hermans reported that there was “negligible difference” in the 1-year quality-adjusted life-years (+0.004, in favor of the intervention overall) and that, while healthcare costs were lower at €243/year for the entire intervention period, societal costs were higher, at €513/year vs usual care. The latter was thought to be “due to an unexpected rise in absenteeism that we think was most likely due to a small amount of outliers,” Dr. Hermans said.
Nonetheless, using at willingness-to-pay threshold of €20,000/ quality-adjusted life year, he reported that the added value of patient-initiated care with remote monitoring yielded a potential net monetary benefit of +€322 from a healthcare perspective for the entire intervention period.
“We believe that these results support the fast-paced adoption of remote care interventions,” Dr. Hermans said. “In the context that I described earlier, of decreasing healthcare personnel and rising costs, we believe that this could be a valuable approach for follow-up for patients with stable axSpA.”
ReMonit was sponsored by Diakonhjemmet Hospital, and TeleSpA was sponsored by Maastricht University Medical Center, with funding from the Dutch Arthritis Society. Dr. Berg and Dr. Hermans had no relevant conflicts of interest to report.
A version of this article first appeared on Medscape.com.
Editor’s Note: This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
VIENNA — People with spondyloarthritis (SpA) who have low or stable disease activity can effectively and safely be managed using a model of patient-initiated care with or without remote monitoring, suggested the results of two separate trials presented at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting.
In the 18-month, single-center ReMonit study that included 243 people with axial SpA (axSpA), patient-initiated care was found to be noninferior for keeping them in a low-disease activity state, compared with both usual hospital follow-up and remote digital monitoring.
Meanwhile, in the 12-month, multicenter TeleSpA study, which included 200 patients with any type of SpA, the number of hospital visits needed by people who were randomly assigned to receive patient-initiated care together with asynchronous telemonitoring was significantly lower than for the usual-care group, with no detriment to the participants’ overall health outcomes or safety. Moreover, the strategy was deemed cost-effective from a healthcare provision perspective.
Time to Rationalize Healthcare Resources?
People with chronic rheumatic diseases such as axSpA require long-term follow-up in specialist healthcare centers, Inger Jorid Berg, MD, PhD, of Diakonhjemmet Hospital in Oslo, Norway, said when she presented the findings of the ReMonit study as a late-breaking abstract.
“Traditionally, this has been offered as prescheduled face-to-face consultations at an outpatient clinic, but remote monitoring and patient-initiated care may allow for more targeted and efficient uses of healthcare resources,” Dr. Berg said.
“The end goal of what you’re trying to do is increase the efficiency of outpatient care and provide more patient-tailored care,” Kasper Hermans, MD, said in an interview. He presented the results of the TeleSpA study.
Dr. Hermans, who is a rheumatology fellow and PhD candidate at Maastricht University, Maastricht, the Netherlands, observed during his presentation at EULAR 2024 that there is an increasing demand for rheumatology services but an expected shortfall in the future workforce. Thus, “sustainable alternative strategies are needed for optimizing the efficiency of care,” he said.
People need to have timely access to care, Dr. Hermans stressed, but perhaps alternatives to the traditional models of care where patients are seen routinely every 6 or 12 months are needed, particularly as prior work had suggested that around one-third of people who were seen by a rheumatologist perhaps did not need to be.
A strategy of patient-initiated care — which is where people are seen by a healthcare provider only if they feel that they need to and request a consultation — is therefore an attractive proposition, particularly if it is backed up with remote monitoring, which is what the TeleSpA study was testing.
Two Distinct Studies
ReMonit and TeleSpA were two distinct studies. While both were noninferiority trials and involved patient-initiated care and telemonitoring of outpatients with SpA, that is where the similarities generally end.
Notably, ReMonit included a very specific population of patients — all had a diagnosis of axSpA and were being treated with a tumor necrosis factor (TNF) inhibitor and had been on a stable dose for the last 6 months. For inclusion, they also had to have inactive disease or low disease activity, as indicated by an Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1.
ReMonit’s telemonitoring strategy involved participants completing monthly questionnaires using the Dignio smartphone app. Patients first completed the Patient Global Assessment (PGA) and noted whether they had experienced a flare in their disease. If they had a flare or their PGA score was 3 or higher, then they were asked to also complete the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI). If the BASDAI score was 4 or more, then the patient was called by a study nurse and offered a consultation.
“Patients in all three groups were recommended to take blood samples at the general practitioner’s or at the hospital every third month as a safety procedure when using TNF inhibitors,” Dr. Berg said.
The primary outcome was the proportion of people who remained with low disease activity (ASDAS < 2.1) at 6, 12, and 18 months in each of the three arms of the trial, which were patient-initiated care (n = 81), monthly remote monitoring (n = 80), or usual follow-up in the hospital every 6 months (n = 82).
TeleSpA on the other hand was a “much more pragmatic trial, much closer to actual care,” Dr. Hermans said. “We included axial spondyloarthritis, peripheral spondyloarthritis, or patients who had both axial and peripheral disease, including patients with psoriatic arthritis,” he said, adding that their inclusion was regardless of their baseline ASDAS based on C-reactive protein (ASDAS-CRP).
This means that patients who would otherwise have been classified at baseline as having high disease activity (by ASDAS-CRP or similar disease activity measures) could be included. The main proviso was that both the patient and their rheumatologist had to define the condition as being stable with an acceptable level of symptom control and no immediate plans to change treatment within the next 3 months.
TeleSpA’s remote monitoring strategy involved the use of SpA-Net, which Dr. Hermans and coinvestigators have described previously as “an ongoing, disease-specific, prospective, web-based registry for monitoring SpA in daily practice.” This captures a host of clinical and laboratory test information.
SpA-Net was used in both arms of the study. However, while the 100 participants in the standard-care arm completed questionnaires and had tests before every in-person visit that had been prescheduled with their rheumatologist, the 100 individuals in the patient-initiated care arm had no prescheduled in-person visits except for being seen at the start and end of the study. These patients were reminded via email to complete the necessary SpA-Net registry questionnaires at 6 months.
The primary outcome for TeleSpA was the total number of rheumatology visits, including both physical and telephone or video consultations, within a 1-year period.
ReMonit Results
Berg reported that similar percentages of patients remained in a low disease activity state at 6, 12, and 18 months, regardless of the group that they had been randomized into, and that there was little change seen within the individual groups.
For instance, at 6, 12, and 18 months, 92%, 91%, and 92% of individuals in the patient-initiated arm had an ASDAS of < 2.1. Corresponding percentages for the usual-care arm were 96%, 93%, and 90% and for the remote-monitoring arm were 96%, 96%, and 94%.
Both patient-initiated care and remote monitoring were noninferior to usual care, and patient-initiated care was also noninferior to remote monitoring. There were no differences between the trial arms in terms of disease activity, measured using either ASDAS or BASDAI, at 6, 12, or 18 months.
Dr. Berg stated that “patient satisfaction was high in all three follow-up strategies, and there was the lowest resource use with patient-initiated care.” She concluded that “remote monitoring and patient-initiated care could be implemented in the follow-up of patients with axial spondyloarthritis and low disease activity.”
TeleSpA Results
In TeleSpA, people in the patient-initiated care and telemonitoring arm were seen a mean of 1.9 times over the course of the 1-year follow-up vs 2.6 for people in the usual care arm. The reduction was caused in part by the decrease in physical visits (1.4 vs 2.0) as there were the same mean number of telephone visits in each group. Overall, there was a 25.4% reduction in consultations comparing the patient-initiated care and telemonitoring arm with the usual-care arm.
Importantly, the intervention was noninferior regarding all of the predefined health outcomes: ASDAS, BASDAI, pain assessed using a visual analog scale, patient global assessment, and physician global assessment.
And more than 90% of participants in both groups reported having an overall good experience with their care.
Dr. Hermans noted after his presentation that an additional study had been performed where “we actively engaged with patients in the intervention group as well as healthcare providers to ask them what their experiences were with the intervention, how we could possibly improve it, and whether or not they thought that it was a valid approach to follow-up after the end of the study. And results were very, very reassuring.”
In terms of safety, eight serious adverse events were reported, but none were related to the study intervention, Dr. Hermans said.
Dr. Hermans reported that there was “negligible difference” in the 1-year quality-adjusted life-years (+0.004, in favor of the intervention overall) and that, while healthcare costs were lower at €243/year for the entire intervention period, societal costs were higher, at €513/year vs usual care. The latter was thought to be “due to an unexpected rise in absenteeism that we think was most likely due to a small amount of outliers,” Dr. Hermans said.
Nonetheless, using at willingness-to-pay threshold of €20,000/ quality-adjusted life year, he reported that the added value of patient-initiated care with remote monitoring yielded a potential net monetary benefit of +€322 from a healthcare perspective for the entire intervention period.
“We believe that these results support the fast-paced adoption of remote care interventions,” Dr. Hermans said. “In the context that I described earlier, of decreasing healthcare personnel and rising costs, we believe that this could be a valuable approach for follow-up for patients with stable axSpA.”
ReMonit was sponsored by Diakonhjemmet Hospital, and TeleSpA was sponsored by Maastricht University Medical Center, with funding from the Dutch Arthritis Society. Dr. Berg and Dr. Hermans had no relevant conflicts of interest to report.
A version of this article first appeared on Medscape.com.
Editor’s Note: This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
FROM EULAR 2024
Commentary: Topical Treatments for AD and Possible Lifestyle Adjustments, July 2024
In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.
In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib.
Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.
Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.
In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib.
Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.
Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
In this real-life study, Patruno and colleagues found that dupilumab worked well but more slowly in patients with a higher body mass index (BMI). On the basis of these findings, if patients are not in a hurry, the standard dose of dupilumab should eventually work, regardless of BMI. If patients are in a hurry to see improvement, perhaps dose escalation could be considered for patients with a high BMI, or perhaps topical triamcinolone could be used to speed time-to–initial resolution in the high-BMI population.
In the very well-done study by Silverberg and colleagues, tapinarof was effective, well tolerated, and generally safe for atopic dermatitis in adults and children. Great! Topical tapinarof should soon be another good option for our patients with atopic dermatitis. How valuable will it be? We already have topical corticosteroids that are very effective for atopic dermatitis, and we have multiple other nonsteroidal topical agents, including topical calcineurin inhibitors and topical ruxolitinib.
Perhaps the biggest limitation of all these treatments is poor adherence to topical treatment. I'm not sure how effective even highly effective nonsteroidal topicals will be for patients who did not respond to topical steroids when the primary reason for topical steroid failure is poor treatment adherence. I'd love to see the development of a once-a-week or once-a-month topical therapy that would address the poor-adherence hurdle.
Abrocitinib is an effective treatment for improving atopic dermatitis. Although atopic dermatitis is a chronic condition requiring long-term management, we'd like to minimize exposure to the drug to avoid side effects. Thyssen and colleagues described the effectiveness of two maintenance treatment regimens: continuing 200 mg/d or reducing the dose to 100 mg/d. Both regimens prevented flares more than did placebo. This study also provided information on safety of the maintenance regimens. Rates of herpetic infections were low across all the groups, but unlike the two treatment groups, there were no cases of herpes simplex infection in the patients in the placebo arm.
Prostate Meds Tied to Reduced Risk for Lewy Body Dementia
Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease.
Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.
“These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”
The findings were published online in Neurology.
Increasing ATP Neuroprotective?
In recent years, investigators have speculated that improving metabolic activity in the brain may reduce the risk for Parkinson’s disease (PD).
In previous studies, the use of Tz/Dz/Az resulted in the activation of phosphoglycerate kinase-1 (PKG1), which increases the availability of adenosine triphosphate (ATP).
There have been case reports of PD being linked to mutations affecting PGK1. Researchers speculate that increased ATP availability in neurons resulting from the activation of PKG1 allows cells to better adapt to aging and synuclein aggregation.
To investigate whether glycolysis-enhancing drugs might be neuroprotective in those with DLB, investigators conducted a retrospective cohort study using a commercial health insurance claims database and a Medicare supplemental health claims database to follow a sample of men aged > 40 years taking Tz, Dz, or Az (n = 126,313), tamsulosin (n = 437,035), or a 5ARI (n = 80,158) for BPH.
Tamsulosin and 5ARI medications do not activate PKG1, so investigators used them as comparators to Tz/Dz/Az. Participants were followed from the medication initiation date until the end of enrollment in the claims databases.
After following claimants for an average of 3 years, 195 participants developed DLB who were taking Tz, Dz, or Az, a rate of 5.21 cases per 10,000 people per year.
During the follow-up period, 1286 participants taking tamsulosin developed DLB, a rate of 10.8 per 10,000 people per year, and among those taking 5ARIs, 193 cases of DLB were reported, a rate of 7.8 per 10,000 people per year.
After matching the groups by age and other health conditions that may explain differences in rates of DLB, men taking Tz/Dz/Az had a 60% lower risk than those taking tamsulosin (P < .001) and a 37% lower risk for developing DLB than those taking the 5ARI medications (P = .012).
“This emerging evidence of a protective association across a spectrum of diseases suggests a broad neuroprotective effect for Tz/Dz/Az, consistent with our hypothesized mechanism that activation of PGK1 increases brain ATP and mitigates neurodegeneration,” the authors wrote.
Study limitations include excluding women from the study, so the findings cannot be generalized to women. Claims analyses were limited to administrative data that could have been incorrect, and the analyses did not include medication dosages.
No study funding or author disclosures were reported.
A version of this article first appeared on Medscape.com.
Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease.
Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.
“These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”
The findings were published online in Neurology.
Increasing ATP Neuroprotective?
In recent years, investigators have speculated that improving metabolic activity in the brain may reduce the risk for Parkinson’s disease (PD).
In previous studies, the use of Tz/Dz/Az resulted in the activation of phosphoglycerate kinase-1 (PKG1), which increases the availability of adenosine triphosphate (ATP).
There have been case reports of PD being linked to mutations affecting PGK1. Researchers speculate that increased ATP availability in neurons resulting from the activation of PKG1 allows cells to better adapt to aging and synuclein aggregation.
To investigate whether glycolysis-enhancing drugs might be neuroprotective in those with DLB, investigators conducted a retrospective cohort study using a commercial health insurance claims database and a Medicare supplemental health claims database to follow a sample of men aged > 40 years taking Tz, Dz, or Az (n = 126,313), tamsulosin (n = 437,035), or a 5ARI (n = 80,158) for BPH.
Tamsulosin and 5ARI medications do not activate PKG1, so investigators used them as comparators to Tz/Dz/Az. Participants were followed from the medication initiation date until the end of enrollment in the claims databases.
After following claimants for an average of 3 years, 195 participants developed DLB who were taking Tz, Dz, or Az, a rate of 5.21 cases per 10,000 people per year.
During the follow-up period, 1286 participants taking tamsulosin developed DLB, a rate of 10.8 per 10,000 people per year, and among those taking 5ARIs, 193 cases of DLB were reported, a rate of 7.8 per 10,000 people per year.
After matching the groups by age and other health conditions that may explain differences in rates of DLB, men taking Tz/Dz/Az had a 60% lower risk than those taking tamsulosin (P < .001) and a 37% lower risk for developing DLB than those taking the 5ARI medications (P = .012).
“This emerging evidence of a protective association across a spectrum of diseases suggests a broad neuroprotective effect for Tz/Dz/Az, consistent with our hypothesized mechanism that activation of PGK1 increases brain ATP and mitigates neurodegeneration,” the authors wrote.
Study limitations include excluding women from the study, so the findings cannot be generalized to women. Claims analyses were limited to administrative data that could have been incorrect, and the analyses did not include medication dosages.
No study funding or author disclosures were reported.
A version of this article first appeared on Medscape.com.
Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease.
Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.
“These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”
The findings were published online in Neurology.
Increasing ATP Neuroprotective?
In recent years, investigators have speculated that improving metabolic activity in the brain may reduce the risk for Parkinson’s disease (PD).
In previous studies, the use of Tz/Dz/Az resulted in the activation of phosphoglycerate kinase-1 (PKG1), which increases the availability of adenosine triphosphate (ATP).
There have been case reports of PD being linked to mutations affecting PGK1. Researchers speculate that increased ATP availability in neurons resulting from the activation of PKG1 allows cells to better adapt to aging and synuclein aggregation.
To investigate whether glycolysis-enhancing drugs might be neuroprotective in those with DLB, investigators conducted a retrospective cohort study using a commercial health insurance claims database and a Medicare supplemental health claims database to follow a sample of men aged > 40 years taking Tz, Dz, or Az (n = 126,313), tamsulosin (n = 437,035), or a 5ARI (n = 80,158) for BPH.
Tamsulosin and 5ARI medications do not activate PKG1, so investigators used them as comparators to Tz/Dz/Az. Participants were followed from the medication initiation date until the end of enrollment in the claims databases.
After following claimants for an average of 3 years, 195 participants developed DLB who were taking Tz, Dz, or Az, a rate of 5.21 cases per 10,000 people per year.
During the follow-up period, 1286 participants taking tamsulosin developed DLB, a rate of 10.8 per 10,000 people per year, and among those taking 5ARIs, 193 cases of DLB were reported, a rate of 7.8 per 10,000 people per year.
After matching the groups by age and other health conditions that may explain differences in rates of DLB, men taking Tz/Dz/Az had a 60% lower risk than those taking tamsulosin (P < .001) and a 37% lower risk for developing DLB than those taking the 5ARI medications (P = .012).
“This emerging evidence of a protective association across a spectrum of diseases suggests a broad neuroprotective effect for Tz/Dz/Az, consistent with our hypothesized mechanism that activation of PGK1 increases brain ATP and mitigates neurodegeneration,” the authors wrote.
Study limitations include excluding women from the study, so the findings cannot be generalized to women. Claims analyses were limited to administrative data that could have been incorrect, and the analyses did not include medication dosages.
No study funding or author disclosures were reported.
A version of this article first appeared on Medscape.com.
Two-Drug Combo Promising for Methamphetamine Use Disorder
Extended-release injectable naltrexone combined with extended-release oral bupropion (NTX + BUPN) for moderate or severe methamphetamine use disorder was associated with a significant decrease in use of the drug, a new study showed.
Investigators leading the randomized clinical trial found a 27% increase in negative methamphetamine urine tests in the treatment group — indicating reduced use — compared with an 11% increase in negative urine tests in control participants.
“These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade,” lead author Michael Li, MD, assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA, Los Angeles, said in a news release.
The study was published online in Addiction.
Methamphetamine use has increased worldwide, from 33 million users in 2010 to 34 million in 2020, with overdose deaths rising fivefold in the United States over the past decade, the authors wrote.
A previous open-label study of NTX + BUPN showed efficacy for treating severe methamphetamine use disorder, and NTX and BUPN have each shown efficacy separately for this indication.
This new study is the second phase of the multicenter ADAPT-2 trial, conducted between 2017 and 2019 in 403 participants with methamphetamine use disorder. In the first stage, 109 people received NTX + BUPN and 294 received placebo.
The treatment group received extended-release NTX (380 mg) or placebo as an intramuscular injection on weeks 1, 4, 7, and 10. Extended-release BUPN or placebo tablets were administered weekly, with BUPN doses starting at 150 mg on day 1 and increasing to 450 mg by day 3. At week 13, participants received a tapering dose for 4 days before discontinuing.
As previously reported by this news organization, the two-drug combo was effective at reducing methamphetamine use at 6 weeks. The current analysis measured change in methamphetamine use during weeks 7-12 of the trial and in posttreatment weeks 13-16.
Participants in the intervention group during stage 1 showed an additional 9.2% increase (P = .038) during stage 2 in their probability of testing negative for methamphetamine. This represented a total increase of 27.1% in negative urine tests across the complete 12 weeks of treatment, compared with a total 11.4% increase in negative tests in the placebo group.
The 12-week increase in methamphetamine-negative urine tests in the intervention group was 15.8% greater (P = .006) than the increase in the placebo group.
There was no significant change in either group at posttreatment follow-up in weeks 13-16.
“Our findings suggest that ongoing NTX + BUPN treatment yields statistically significant reductions in methamphetamine use that continue from weeks 7 to 12,” the authors wrote. The lack of change in methamphetamine use from weeks 13-16 corresponds to the conclusion of treatment in week 12, they added.
It remains to be determined “whether continued use of NTX + BUPN treatment past 12 weeks would yield further reductions in use,” the authors wrote, noting that prior stimulant use disorder trials suggest that change in use is gradual and that sustained abstinence is unlikely in merely 12 weeks of a trial. Rather, it is dependent on treatment duration.
“This warrants future clinical trials to quantify changes in methamphetamine use beyond 12 weeks and to identify the optimal duration of treatment with this medication,” they concluded.
The study was funded by awards from the National Institute on Drug Abuse (NIDA), the US Department of Health and Human Services, the National Institute of Mental Health, and the O’Donnell Clinical Neuroscience Scholar Award from the University of Texas Southwestern Medical Center. Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free of charge for use in this trial under a written agreement with NIDA. Dr. Li reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
A version of this article first appeared on Medscape.com.
Extended-release injectable naltrexone combined with extended-release oral bupropion (NTX + BUPN) for moderate or severe methamphetamine use disorder was associated with a significant decrease in use of the drug, a new study showed.
Investigators leading the randomized clinical trial found a 27% increase in negative methamphetamine urine tests in the treatment group — indicating reduced use — compared with an 11% increase in negative urine tests in control participants.
“These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade,” lead author Michael Li, MD, assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA, Los Angeles, said in a news release.
The study was published online in Addiction.
Methamphetamine use has increased worldwide, from 33 million users in 2010 to 34 million in 2020, with overdose deaths rising fivefold in the United States over the past decade, the authors wrote.
A previous open-label study of NTX + BUPN showed efficacy for treating severe methamphetamine use disorder, and NTX and BUPN have each shown efficacy separately for this indication.
This new study is the second phase of the multicenter ADAPT-2 trial, conducted between 2017 and 2019 in 403 participants with methamphetamine use disorder. In the first stage, 109 people received NTX + BUPN and 294 received placebo.
The treatment group received extended-release NTX (380 mg) or placebo as an intramuscular injection on weeks 1, 4, 7, and 10. Extended-release BUPN or placebo tablets were administered weekly, with BUPN doses starting at 150 mg on day 1 and increasing to 450 mg by day 3. At week 13, participants received a tapering dose for 4 days before discontinuing.
As previously reported by this news organization, the two-drug combo was effective at reducing methamphetamine use at 6 weeks. The current analysis measured change in methamphetamine use during weeks 7-12 of the trial and in posttreatment weeks 13-16.
Participants in the intervention group during stage 1 showed an additional 9.2% increase (P = .038) during stage 2 in their probability of testing negative for methamphetamine. This represented a total increase of 27.1% in negative urine tests across the complete 12 weeks of treatment, compared with a total 11.4% increase in negative tests in the placebo group.
The 12-week increase in methamphetamine-negative urine tests in the intervention group was 15.8% greater (P = .006) than the increase in the placebo group.
There was no significant change in either group at posttreatment follow-up in weeks 13-16.
“Our findings suggest that ongoing NTX + BUPN treatment yields statistically significant reductions in methamphetamine use that continue from weeks 7 to 12,” the authors wrote. The lack of change in methamphetamine use from weeks 13-16 corresponds to the conclusion of treatment in week 12, they added.
It remains to be determined “whether continued use of NTX + BUPN treatment past 12 weeks would yield further reductions in use,” the authors wrote, noting that prior stimulant use disorder trials suggest that change in use is gradual and that sustained abstinence is unlikely in merely 12 weeks of a trial. Rather, it is dependent on treatment duration.
“This warrants future clinical trials to quantify changes in methamphetamine use beyond 12 weeks and to identify the optimal duration of treatment with this medication,” they concluded.
The study was funded by awards from the National Institute on Drug Abuse (NIDA), the US Department of Health and Human Services, the National Institute of Mental Health, and the O’Donnell Clinical Neuroscience Scholar Award from the University of Texas Southwestern Medical Center. Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free of charge for use in this trial under a written agreement with NIDA. Dr. Li reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
A version of this article first appeared on Medscape.com.
Extended-release injectable naltrexone combined with extended-release oral bupropion (NTX + BUPN) for moderate or severe methamphetamine use disorder was associated with a significant decrease in use of the drug, a new study showed.
Investigators leading the randomized clinical trial found a 27% increase in negative methamphetamine urine tests in the treatment group — indicating reduced use — compared with an 11% increase in negative urine tests in control participants.
“These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade,” lead author Michael Li, MD, assistant professor-in-residence of family medicine at the David Geffen School of Medicine at UCLA, Los Angeles, said in a news release.
The study was published online in Addiction.
Methamphetamine use has increased worldwide, from 33 million users in 2010 to 34 million in 2020, with overdose deaths rising fivefold in the United States over the past decade, the authors wrote.
A previous open-label study of NTX + BUPN showed efficacy for treating severe methamphetamine use disorder, and NTX and BUPN have each shown efficacy separately for this indication.
This new study is the second phase of the multicenter ADAPT-2 trial, conducted between 2017 and 2019 in 403 participants with methamphetamine use disorder. In the first stage, 109 people received NTX + BUPN and 294 received placebo.
The treatment group received extended-release NTX (380 mg) or placebo as an intramuscular injection on weeks 1, 4, 7, and 10. Extended-release BUPN or placebo tablets were administered weekly, with BUPN doses starting at 150 mg on day 1 and increasing to 450 mg by day 3. At week 13, participants received a tapering dose for 4 days before discontinuing.
As previously reported by this news organization, the two-drug combo was effective at reducing methamphetamine use at 6 weeks. The current analysis measured change in methamphetamine use during weeks 7-12 of the trial and in posttreatment weeks 13-16.
Participants in the intervention group during stage 1 showed an additional 9.2% increase (P = .038) during stage 2 in their probability of testing negative for methamphetamine. This represented a total increase of 27.1% in negative urine tests across the complete 12 weeks of treatment, compared with a total 11.4% increase in negative tests in the placebo group.
The 12-week increase in methamphetamine-negative urine tests in the intervention group was 15.8% greater (P = .006) than the increase in the placebo group.
There was no significant change in either group at posttreatment follow-up in weeks 13-16.
“Our findings suggest that ongoing NTX + BUPN treatment yields statistically significant reductions in methamphetamine use that continue from weeks 7 to 12,” the authors wrote. The lack of change in methamphetamine use from weeks 13-16 corresponds to the conclusion of treatment in week 12, they added.
It remains to be determined “whether continued use of NTX + BUPN treatment past 12 weeks would yield further reductions in use,” the authors wrote, noting that prior stimulant use disorder trials suggest that change in use is gradual and that sustained abstinence is unlikely in merely 12 weeks of a trial. Rather, it is dependent on treatment duration.
“This warrants future clinical trials to quantify changes in methamphetamine use beyond 12 weeks and to identify the optimal duration of treatment with this medication,” they concluded.
The study was funded by awards from the National Institute on Drug Abuse (NIDA), the US Department of Health and Human Services, the National Institute of Mental Health, and the O’Donnell Clinical Neuroscience Scholar Award from the University of Texas Southwestern Medical Center. Alkermes provided Vivitrol (naltrexone for extended-release injectable suspension) and matched placebo free of charge for use in this trial under a written agreement with NIDA. Dr. Li reports no relevant financial relationships. The other authors’ disclosures are listed on the original paper.
A version of this article first appeared on Medscape.com.
Sex Hormones Linked to Fatty Liver in Men With T2D
TOPLINE:
In men with type 2 diabetes (T2D), higher serum levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were associated with a lower risk for metabolic dysfunction–associated fatty liver disease (MAFLD), whereas higher progesterone levels were associated with a higher risk. In women with T2D, sex- or thyroid-related hormones were not independently associated with the risk for MAFLD.
METHODOLOGY:
- People with T2D may have FLD, and this study explored the link between sex-related and thyroid-related hormone levels and MAFLD to explore and confirm risk factors.
- The researchers used a 2020 definition of MAFLD, now defined in patients as both hepatic steatosis and the presence of overweight/obesity, T2D, or evidence of metabolic dysfunction in lean individuals.
- This cross-sectional study conducted in one hospital in China included 432 patients hospitalized because of T2D and its complications from January 2018 to April 2020 (median T2D duration, 6 years; mean age, 55.8 years; 247 men and 185 postmenopausal women).
- Researchers measured and later adjusted for potential confounding factors, including weight, height, waist circumference, arterial blood pressure, glycemic parameters, liver function, and lipid profiles.
- They assessed blood levels of sex and thyroid hormones by chemiluminescent immunoassays; MAFLD was diagnosed by either ultrasonography findings of hepatic steatosis or a high liver fat index score (fatty liver index > 60).
TAKEAWAY:
- Overall, 275 (63.7%) patients were diagnosed with MAFLD; after adjusting for potential confounding factors, none of the sex- and thyroid-related hormones were independently associated with the risk for MAFLD in all patients with T2D.
- In men with T2D, higher serum levels of FSH (adjusted odds ratio [aOR], 0.919; P = .019) and LH (aOR, 0.888; P = .022) were associated with a reduced risk for MAFLD.
- Higher serum levels of progesterone were associated with an increased risk for MAFLD in men with T2D (aOR, 8.069; P = .003).
- In women with T2D, sex hormones and thyroid hormones were not significantly linked to the risk of developing MAFLD.
IN PRACTICE:
“Our findings could be used to imply that screening for MAFLD and monitoring sex-related hormones are important for T2D patients, especially in men,” the authors wrote.
SOURCE:
This study was led by Weihong Lu, Xiamen Clinical Research Center for Cancer Therapy, Xiamen, China; Shangjian Li, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China; and Yuhua Li, China University of Mining & Technology-Beijing, Beijing, and was published online in BMC Endocrine Disorders.
LIMITATIONS:
Temporal sequences of the associations between sex-related and thyroid-related hormones and MAFLD were not evaluated because of the cross-sectional nature of the study. The small sample size from a single institution may have introduced selection bias. Serum levels of sex hormone-binding globulin and free testosterone were not assessed. The postmenopausal status of women in the study may have affected the ability to find sex-hormone related associations. The findings can only be limitedly extrapolated to similar patients with T2D but not the general population.
DISCLOSURES:
The study was supported by the Fujian Province Nature Science Foundations, China, and the Guiding Project on Medicine and Health in Xiamen, China. The authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
In men with type 2 diabetes (T2D), higher serum levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were associated with a lower risk for metabolic dysfunction–associated fatty liver disease (MAFLD), whereas higher progesterone levels were associated with a higher risk. In women with T2D, sex- or thyroid-related hormones were not independently associated with the risk for MAFLD.
METHODOLOGY:
- People with T2D may have FLD, and this study explored the link between sex-related and thyroid-related hormone levels and MAFLD to explore and confirm risk factors.
- The researchers used a 2020 definition of MAFLD, now defined in patients as both hepatic steatosis and the presence of overweight/obesity, T2D, or evidence of metabolic dysfunction in lean individuals.
- This cross-sectional study conducted in one hospital in China included 432 patients hospitalized because of T2D and its complications from January 2018 to April 2020 (median T2D duration, 6 years; mean age, 55.8 years; 247 men and 185 postmenopausal women).
- Researchers measured and later adjusted for potential confounding factors, including weight, height, waist circumference, arterial blood pressure, glycemic parameters, liver function, and lipid profiles.
- They assessed blood levels of sex and thyroid hormones by chemiluminescent immunoassays; MAFLD was diagnosed by either ultrasonography findings of hepatic steatosis or a high liver fat index score (fatty liver index > 60).
TAKEAWAY:
- Overall, 275 (63.7%) patients were diagnosed with MAFLD; after adjusting for potential confounding factors, none of the sex- and thyroid-related hormones were independently associated with the risk for MAFLD in all patients with T2D.
- In men with T2D, higher serum levels of FSH (adjusted odds ratio [aOR], 0.919; P = .019) and LH (aOR, 0.888; P = .022) were associated with a reduced risk for MAFLD.
- Higher serum levels of progesterone were associated with an increased risk for MAFLD in men with T2D (aOR, 8.069; P = .003).
- In women with T2D, sex hormones and thyroid hormones were not significantly linked to the risk of developing MAFLD.
IN PRACTICE:
“Our findings could be used to imply that screening for MAFLD and monitoring sex-related hormones are important for T2D patients, especially in men,” the authors wrote.
SOURCE:
This study was led by Weihong Lu, Xiamen Clinical Research Center for Cancer Therapy, Xiamen, China; Shangjian Li, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China; and Yuhua Li, China University of Mining & Technology-Beijing, Beijing, and was published online in BMC Endocrine Disorders.
LIMITATIONS:
Temporal sequences of the associations between sex-related and thyroid-related hormones and MAFLD were not evaluated because of the cross-sectional nature of the study. The small sample size from a single institution may have introduced selection bias. Serum levels of sex hormone-binding globulin and free testosterone were not assessed. The postmenopausal status of women in the study may have affected the ability to find sex-hormone related associations. The findings can only be limitedly extrapolated to similar patients with T2D but not the general population.
DISCLOSURES:
The study was supported by the Fujian Province Nature Science Foundations, China, and the Guiding Project on Medicine and Health in Xiamen, China. The authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
In men with type 2 diabetes (T2D), higher serum levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) were associated with a lower risk for metabolic dysfunction–associated fatty liver disease (MAFLD), whereas higher progesterone levels were associated with a higher risk. In women with T2D, sex- or thyroid-related hormones were not independently associated with the risk for MAFLD.
METHODOLOGY:
- People with T2D may have FLD, and this study explored the link between sex-related and thyroid-related hormone levels and MAFLD to explore and confirm risk factors.
- The researchers used a 2020 definition of MAFLD, now defined in patients as both hepatic steatosis and the presence of overweight/obesity, T2D, or evidence of metabolic dysfunction in lean individuals.
- This cross-sectional study conducted in one hospital in China included 432 patients hospitalized because of T2D and its complications from January 2018 to April 2020 (median T2D duration, 6 years; mean age, 55.8 years; 247 men and 185 postmenopausal women).
- Researchers measured and later adjusted for potential confounding factors, including weight, height, waist circumference, arterial blood pressure, glycemic parameters, liver function, and lipid profiles.
- They assessed blood levels of sex and thyroid hormones by chemiluminescent immunoassays; MAFLD was diagnosed by either ultrasonography findings of hepatic steatosis or a high liver fat index score (fatty liver index > 60).
TAKEAWAY:
- Overall, 275 (63.7%) patients were diagnosed with MAFLD; after adjusting for potential confounding factors, none of the sex- and thyroid-related hormones were independently associated with the risk for MAFLD in all patients with T2D.
- In men with T2D, higher serum levels of FSH (adjusted odds ratio [aOR], 0.919; P = .019) and LH (aOR, 0.888; P = .022) were associated with a reduced risk for MAFLD.
- Higher serum levels of progesterone were associated with an increased risk for MAFLD in men with T2D (aOR, 8.069; P = .003).
- In women with T2D, sex hormones and thyroid hormones were not significantly linked to the risk of developing MAFLD.
IN PRACTICE:
“Our findings could be used to imply that screening for MAFLD and monitoring sex-related hormones are important for T2D patients, especially in men,” the authors wrote.
SOURCE:
This study was led by Weihong Lu, Xiamen Clinical Research Center for Cancer Therapy, Xiamen, China; Shangjian Li, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China; and Yuhua Li, China University of Mining & Technology-Beijing, Beijing, and was published online in BMC Endocrine Disorders.
LIMITATIONS:
Temporal sequences of the associations between sex-related and thyroid-related hormones and MAFLD were not evaluated because of the cross-sectional nature of the study. The small sample size from a single institution may have introduced selection bias. Serum levels of sex hormone-binding globulin and free testosterone were not assessed. The postmenopausal status of women in the study may have affected the ability to find sex-hormone related associations. The findings can only be limitedly extrapolated to similar patients with T2D but not the general population.
DISCLOSURES:
The study was supported by the Fujian Province Nature Science Foundations, China, and the Guiding Project on Medicine and Health in Xiamen, China. The authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.