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Eptinezumab Inhibitor Fails Cluster Headache Test
SAN DIEGO — However, the drug met secondary outcomes of reduction in weekly attacks, mean change in baseline pain, and Patient Global Impression of Change (PGIC) score.
Eptinezumab is the latest of multiple anti–calcitonin gene-related peptide (CGRP) therapies to fail in the clinic against episodic cluster headache, all using weekly attacks as a primary endpoint, though therapies also scored positive results for secondary endpoints, according to Stewart Tepper, MD, who presented the study results at the annual meeting of the American Headache Society
Eptinezumab is already approved for migraine, and is fully bioavailable by the end of an infusion. “That was why we thought this might be a really interesting treatment for prevention of cluster headache,” said Dr. Tepper, who is VP of external research at the New England Institute for Neurology and Headache in Stamford, Connecticut.
Are We Looking at the Wrong Endpoint?
Secondary endpoints offered more encouragement. “For each week, the eptinezumab looked either numerically higher than the placebo or nominal statistical significance was achieved. By week 4, two-thirds of the patients had at least a 50% reduction in their number of weekly cluster attacks. Then the average pain intensity for the day and the patient global impression of change were all in favor of eptinezumab. That made us interested in whether we’re missing something, whether this is maybe not the correct endpoint to be looking at,” said Dr. Tepper.
He suggested that it may be time for the Food and Drug Administration (FDA) to reconsider the endpoints used in clinical trials for cluster headaches.
Study criteria included cluster periods that lasted at least 6 weeks, and at least 1 year since the diagnosis of episodic cluster headache. The study enrolled patients who were out of their cluster period, who underwent a second screening of 7-14 days after they entered a new cycle. After that, they were randomized to an injection of placebo or 400 mg eptinezumab, and followed for 4 weeks. After 4 weeks, all patients received an injection of 400 mg eptinezumab and placebo patients were crossed over to eptinezumab and followed out to 24 weeks.
The study population included 231 patients (78% male; mean age, 44 years), with a mean of 2.7 cluster headache attacks per day an average duration of 62 minutes per attack. The worst pain was reported as excruciating in 59% of participants.
The mean change in number of weekly attacks in weeks 1 and 2, compared with baseline, was not statistically significant (–4.6 with eptinezumab, –4.6 with placebo; P = .5048). More patients in the eptinezumab group had a 50% or greater reduction in attack frequency in weeks 3 (50.9% vs 37.3%; P < .05), week 3 (62.5% vs 43.8%; P < .01), and week 4 (66.7% vs 50.5%; P < .01). The difference in mean change in pain from baseline became statistically significant at week 3 and 4 (P < .01). There were also statistically significant differences in PGIC score at weeks 1, 2, and 4. The frequency of any treatment-emergent adverse event was similar in the eptinezumab and placebo groups (25.0% vs 26.5%), and only one led to treatment withdrawal in the eptinezumab group (0.9%).
Thoughts on Redesigning Cluster Headache Clinical Trials
During the Q&A session, Andrea Harriott, MD, PhD, a neurologist at Massachusetts General Hospital, Boston, and the session’s moderator, asked Dr. Tepper for his thoughts on how to design a good cluster headache trial. “I think we should go to the regulators and say we’re looking at the wrong outcome measure, and that we should use responder rate as the primary endpoint. That’s my guess. I think after four failed cluster studies for anti-CGRP therapies in terms of primary endpoint, all of which suggest some benefit, I think maybe we are looking at the wrong endpoint,” said Dr. Tepper.
Dr. Tepper was also asked about the potential for comparative efficacy trials testing anti-CGRP versus usual therapy, or usual therapy combined with antibodies against usual therapy. He noted that he had coauthored a recent commentary that responded to International Headache Society 2022 guidelines for randomized, placebo-controlled trials in cluster headache. “We actually did suggest comparative effectiveness [trials], both for recruitment and for compassion, but one of the problems is that verapamil is not even FDA approved for cluster headache in the US, and galcanezumab (Emgality, Eli Lilly) [is not approved] in the EU, so it becomes difficult from a regulatory standpoint to set that up, and you have to have buy in from regulatory authorities,” said Dr. Tepper.
Dr. Tepper has financial relationships with many pharmaceutical companies, including consulting for/advising Lundbeck, which funded the study. Dr. Harriott has served on the scientific advisory board of Theranica and has an authorship agreement with AbbVie.
SAN DIEGO — However, the drug met secondary outcomes of reduction in weekly attacks, mean change in baseline pain, and Patient Global Impression of Change (PGIC) score.
Eptinezumab is the latest of multiple anti–calcitonin gene-related peptide (CGRP) therapies to fail in the clinic against episodic cluster headache, all using weekly attacks as a primary endpoint, though therapies also scored positive results for secondary endpoints, according to Stewart Tepper, MD, who presented the study results at the annual meeting of the American Headache Society
Eptinezumab is already approved for migraine, and is fully bioavailable by the end of an infusion. “That was why we thought this might be a really interesting treatment for prevention of cluster headache,” said Dr. Tepper, who is VP of external research at the New England Institute for Neurology and Headache in Stamford, Connecticut.
Are We Looking at the Wrong Endpoint?
Secondary endpoints offered more encouragement. “For each week, the eptinezumab looked either numerically higher than the placebo or nominal statistical significance was achieved. By week 4, two-thirds of the patients had at least a 50% reduction in their number of weekly cluster attacks. Then the average pain intensity for the day and the patient global impression of change were all in favor of eptinezumab. That made us interested in whether we’re missing something, whether this is maybe not the correct endpoint to be looking at,” said Dr. Tepper.
He suggested that it may be time for the Food and Drug Administration (FDA) to reconsider the endpoints used in clinical trials for cluster headaches.
Study criteria included cluster periods that lasted at least 6 weeks, and at least 1 year since the diagnosis of episodic cluster headache. The study enrolled patients who were out of their cluster period, who underwent a second screening of 7-14 days after they entered a new cycle. After that, they were randomized to an injection of placebo or 400 mg eptinezumab, and followed for 4 weeks. After 4 weeks, all patients received an injection of 400 mg eptinezumab and placebo patients were crossed over to eptinezumab and followed out to 24 weeks.
The study population included 231 patients (78% male; mean age, 44 years), with a mean of 2.7 cluster headache attacks per day an average duration of 62 minutes per attack. The worst pain was reported as excruciating in 59% of participants.
The mean change in number of weekly attacks in weeks 1 and 2, compared with baseline, was not statistically significant (–4.6 with eptinezumab, –4.6 with placebo; P = .5048). More patients in the eptinezumab group had a 50% or greater reduction in attack frequency in weeks 3 (50.9% vs 37.3%; P < .05), week 3 (62.5% vs 43.8%; P < .01), and week 4 (66.7% vs 50.5%; P < .01). The difference in mean change in pain from baseline became statistically significant at week 3 and 4 (P < .01). There were also statistically significant differences in PGIC score at weeks 1, 2, and 4. The frequency of any treatment-emergent adverse event was similar in the eptinezumab and placebo groups (25.0% vs 26.5%), and only one led to treatment withdrawal in the eptinezumab group (0.9%).
Thoughts on Redesigning Cluster Headache Clinical Trials
During the Q&A session, Andrea Harriott, MD, PhD, a neurologist at Massachusetts General Hospital, Boston, and the session’s moderator, asked Dr. Tepper for his thoughts on how to design a good cluster headache trial. “I think we should go to the regulators and say we’re looking at the wrong outcome measure, and that we should use responder rate as the primary endpoint. That’s my guess. I think after four failed cluster studies for anti-CGRP therapies in terms of primary endpoint, all of which suggest some benefit, I think maybe we are looking at the wrong endpoint,” said Dr. Tepper.
Dr. Tepper was also asked about the potential for comparative efficacy trials testing anti-CGRP versus usual therapy, or usual therapy combined with antibodies against usual therapy. He noted that he had coauthored a recent commentary that responded to International Headache Society 2022 guidelines for randomized, placebo-controlled trials in cluster headache. “We actually did suggest comparative effectiveness [trials], both for recruitment and for compassion, but one of the problems is that verapamil is not even FDA approved for cluster headache in the US, and galcanezumab (Emgality, Eli Lilly) [is not approved] in the EU, so it becomes difficult from a regulatory standpoint to set that up, and you have to have buy in from regulatory authorities,” said Dr. Tepper.
Dr. Tepper has financial relationships with many pharmaceutical companies, including consulting for/advising Lundbeck, which funded the study. Dr. Harriott has served on the scientific advisory board of Theranica and has an authorship agreement with AbbVie.
SAN DIEGO — However, the drug met secondary outcomes of reduction in weekly attacks, mean change in baseline pain, and Patient Global Impression of Change (PGIC) score.
Eptinezumab is the latest of multiple anti–calcitonin gene-related peptide (CGRP) therapies to fail in the clinic against episodic cluster headache, all using weekly attacks as a primary endpoint, though therapies also scored positive results for secondary endpoints, according to Stewart Tepper, MD, who presented the study results at the annual meeting of the American Headache Society
Eptinezumab is already approved for migraine, and is fully bioavailable by the end of an infusion. “That was why we thought this might be a really interesting treatment for prevention of cluster headache,” said Dr. Tepper, who is VP of external research at the New England Institute for Neurology and Headache in Stamford, Connecticut.
Are We Looking at the Wrong Endpoint?
Secondary endpoints offered more encouragement. “For each week, the eptinezumab looked either numerically higher than the placebo or nominal statistical significance was achieved. By week 4, two-thirds of the patients had at least a 50% reduction in their number of weekly cluster attacks. Then the average pain intensity for the day and the patient global impression of change were all in favor of eptinezumab. That made us interested in whether we’re missing something, whether this is maybe not the correct endpoint to be looking at,” said Dr. Tepper.
He suggested that it may be time for the Food and Drug Administration (FDA) to reconsider the endpoints used in clinical trials for cluster headaches.
Study criteria included cluster periods that lasted at least 6 weeks, and at least 1 year since the diagnosis of episodic cluster headache. The study enrolled patients who were out of their cluster period, who underwent a second screening of 7-14 days after they entered a new cycle. After that, they were randomized to an injection of placebo or 400 mg eptinezumab, and followed for 4 weeks. After 4 weeks, all patients received an injection of 400 mg eptinezumab and placebo patients were crossed over to eptinezumab and followed out to 24 weeks.
The study population included 231 patients (78% male; mean age, 44 years), with a mean of 2.7 cluster headache attacks per day an average duration of 62 minutes per attack. The worst pain was reported as excruciating in 59% of participants.
The mean change in number of weekly attacks in weeks 1 and 2, compared with baseline, was not statistically significant (–4.6 with eptinezumab, –4.6 with placebo; P = .5048). More patients in the eptinezumab group had a 50% or greater reduction in attack frequency in weeks 3 (50.9% vs 37.3%; P < .05), week 3 (62.5% vs 43.8%; P < .01), and week 4 (66.7% vs 50.5%; P < .01). The difference in mean change in pain from baseline became statistically significant at week 3 and 4 (P < .01). There were also statistically significant differences in PGIC score at weeks 1, 2, and 4. The frequency of any treatment-emergent adverse event was similar in the eptinezumab and placebo groups (25.0% vs 26.5%), and only one led to treatment withdrawal in the eptinezumab group (0.9%).
Thoughts on Redesigning Cluster Headache Clinical Trials
During the Q&A session, Andrea Harriott, MD, PhD, a neurologist at Massachusetts General Hospital, Boston, and the session’s moderator, asked Dr. Tepper for his thoughts on how to design a good cluster headache trial. “I think we should go to the regulators and say we’re looking at the wrong outcome measure, and that we should use responder rate as the primary endpoint. That’s my guess. I think after four failed cluster studies for anti-CGRP therapies in terms of primary endpoint, all of which suggest some benefit, I think maybe we are looking at the wrong endpoint,” said Dr. Tepper.
Dr. Tepper was also asked about the potential for comparative efficacy trials testing anti-CGRP versus usual therapy, or usual therapy combined with antibodies against usual therapy. He noted that he had coauthored a recent commentary that responded to International Headache Society 2022 guidelines for randomized, placebo-controlled trials in cluster headache. “We actually did suggest comparative effectiveness [trials], both for recruitment and for compassion, but one of the problems is that verapamil is not even FDA approved for cluster headache in the US, and galcanezumab (Emgality, Eli Lilly) [is not approved] in the EU, so it becomes difficult from a regulatory standpoint to set that up, and you have to have buy in from regulatory authorities,” said Dr. Tepper.
Dr. Tepper has financial relationships with many pharmaceutical companies, including consulting for/advising Lundbeck, which funded the study. Dr. Harriott has served on the scientific advisory board of Theranica and has an authorship agreement with AbbVie.
FROM AHS 2024
GLP-1 Receptor Agonists in Endoscopy
Dear colleagues,
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are revolutionizing the field of obesity management and are now common medication in patients presenting for endoscopy. With their effect on gastric emptying, the American Society of Anesthesiologists has recommended cessation of such agents prior to endoscopy. However, is this necessary in patients who have been on a clear liquid diet in preparation for a colonoscopy or who are undergoing moderate sedation? Additionally, there are risks to holding GLP-1 RAs, especially for those taking them for glycemic control.
In this issue of Perspectives, Dr. Thomas Hickey and Dr. Ryan Pouliot discuss the nuances of pre-procedure cessation from an anesthesiologist’s perspective. Dr. Jana Al Hashash provides a gastroenterologist’s view, also highlighting the current paucity of evidence guiding management strategies. We hope these pieces will help your discussions in managing GLP-1 RAs prior to endoscopy in your own practice. We welcome your thoughts on this issue on X @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Connecticut, and chief of endoscopy at West Haven (Connecticut) VA Medical Center. He is an associate editor for GI & Hepatology News.
GLP-1 Receptor Agonists in Endoscopy
BY THOMAS R. HICKEY, MD; RYAN C. POULIOT, MD
In response to the recent dramatic increase in GLP-1 receptor agonist (GLP-1RA) prescribing and at the urging of its membership, the American Society of Anesthesiologists issued guidance on the preoperative management of these medications. The big takeaways were recommendations that patients on daily dosing should hold their dose on the day of a procedure, and that patients on weekly dosing should hold their dose a week prior.
The ASA guidance recognizes the sparse available evidence base and makes its recommendations in the spirit of patient safety, presuming that a more conservative approach will mitigate risk of rare but potentially devastating pulmonary aspiration, until prospective evidence informs the ideal approach. Until that approach is defined, whether more or less conservative, it is expected that anesthesiologists will adhere to their professional society’s recommendations.
Meanwhile, the American Gastroenterological Association Institute Rapid Clinical Practice Update (CPU) makes little distinction in the management of the endoscopy patient on GLP-1RA. A key refrain throughout the CPU is that there is no actionable data to justify the harms that may come to patients from stopping these medications (e.g., withdrawal of benefit to glycemic control and cardiovascular health) and in delaying or canceling procedures, which could lead to further stress on an overburdened workforce and add complexity to periprocedural processes.
Anesthesiologists should rightly consider themselves leaders in patient safety. As such, when a serious safety concern emerges they should be compelled to caution despite the possibility of other harms, until their concerns are mitigated by robust clinical evidence. Thankfully these questions are quite amenable to research, and prospective trials are already reporting compelling data that residual gastric contents, clearly a risk factor for aspiration, are increased in GLP-1RA groups compared to controls. This is evident even while following recommended fasting times and abstinences from these medications, and adjusting for confounders (e.g., age, diabetes, body mass index).1,2 It logically follows that large studies are likely to find an increased aspiration risk in GLP-1RA populations. Indeed, this increased risk has already been identified in a large retrospective study of endoscopy patients.3 These findings support the ASA’s caution. Additional data indicate that standard fasting guidelines in this patient population may be inadequate.4
The ASA guidance does not differentiate between patients undergoing surgery in the operating room and procedures in the endoscopy suite. Part of our task is to provide perspective on whether GLP-1RA management deserves different treatment for endoscopy patients. We can only speculate pending further data. For example, a prolonged fasting period including a full day of clears, with or without a bowel prep, intuitively protects against pulmonary aspiration. However, this is unlikely to mitigate an anesthesiologist’s concern that administration of propofol, frequently to a state of general anesthesia with an unsecured airway and resulting in a patient devoid of airway protection reflexes, is an inherently higher risk scenario for aspiration compared to surgery in the operating room with a secured airway. We also expect prospective trials will confirm retrospective findings that both propofol and procedures including upper endoscopy confer a higher risk for aspiration compared with conscious sedation and colonoscopy.3
We suggest a reasonable approach based on society guidance and existing evidence, pending additional data. Endoscopists and anesthesiologists should continue this important conversation with a specific focus on risks and benefits in order to decrease conflict and achieve consensus. If anesthesia care is desired, the patient instructions should be updated to reflect ASA guidance. Special attention should be paid to the “gray area,” for example those who did not hold the GLP-1 agonist as recommended.
This category of patients can be considered on a case-by-case basis by the anesthesiologist, proceduralist, and patient, with a range of options including: proceeding with endoscopist-directed sedation, proceeding with anesthesiology-administered conscious sedation, rescheduling the procedure, and proceeding with general anesthesia with rapid-sequence intubation. In addition to patient factors (e.g., GI symptoms, urgency of procedure), this consideration would vary based on local resources (e.g., presence or absence of anesthesia support staff, emergency airway equipment, nursing staff to comfort recovering patients after general endotracheal anesthesia), and aspiration risk inherent to the procedure (e.g., upper and or combination upper and lower endoscopy vs colonoscopy alone). Proficiency and availability of point-of-care ultrasound are rapidly increasing; adoption of a pre-procedure gastric ultrasound to assess for solids, thick liquids, or large volume of clear liquids may provide a less nuanced, more objective means to address this question.
While the question of periprocedural management of these medications has generated intense interest among anesthesiologists and endoscopists alike, it is worth noting the net positive health effects these drugs are likely to have on our patients, including improved glycemic control, significant weight loss, and decreased cardiovascular risk. We are eager to see whether these benefits translate into an overall improvement in periprocedural outcomes, including in our endoscopy patients.
Dr. Hickey is assistant professor of anesthesiology at the Yale University School of Medicine, New Haven, Connecticut, and the VA Connecticut Healthcare System. Dr. Pouliot is assistant professor of anesthesiology at the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
References
1. Sherwin M et al. Influence of semaglutide use on the presence of residual gastric solids on gastric ultrasound: A prospective observational study in volunteers without obesity recently started on semaglutide. Can J Anaesth. 2023 Aug. doi:10.1007/s12630-023-02549-5.
2. Wu F et al. Association of glucagon-like peptide receptor 1 agonist therapy with the presence of gastric contents in fasting patients undergoing endoscopy under anesthesia care: A historical cohort study. Can J Anaesth. 2024 Mar 14. doi:10.1007/s12630-024-02719-z.
3. Yeo YH et al. Increased risk of aspiration pneumonia associated with endoscopic procedures among patients with glucagon-like peptide 1 receptor agonist use. Gastroenterology. 2024 Mar 27. doi:10.1053/j.gastro.2024.03.015.
4. Sen S et al. Glucagon-like peptide-1 receptor agonist use and residual gastric content before anesthesia. JAMA Surg. 2024 Mar 6. doi:10.1001/jamasurg.2024.0111.
The Impact of GLP-1 Receptor Agonists On Endoscopy
BY JANA G. AL HASHASH, MD, MSc, AGAF
Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been approved for the treatment of type 2 diabetes mellitus since 2005. They have become more widely used over the last couple of years for weight loss in individuals who suffer from adiposity-based chronic disease.
The remarkable positive effects that GLP-1 RAs have had on weight loss as well as other medical conditions such as heart disease, hypertension, metabolic dysfunction–associated steatotic liver disease, among many others, have gained these drugs more traction. Even in situations when insurance companies deny coverage of GLP-1 RAs, many patients have been resorting to other routes to obtain these medications, commonly by purchasing them from online compounding pharmacies.
As such, more and more of our patients who present to endoscopy suites across the country are on one of the available GLP-1 RAs. This has necessitated endoscopists and anesthesiologists to become more familiar with the impact of GLP-1 RAs on patients undergoing endoscopic procedures.
Similar to narcotics, GLP-1 RAs affect gastrointestinal motility and delay gastric emptying. Common side effects of patients receiving GLP-1 RAs include nausea, vomiting, and increased satiety. Patients on GLP-1 RAs for weight loss may also have other contributing risk factors for gastroparesis such as diabetes mellitus which may further delay gastric emptying.
For endoscopists, our goals are to achieve the highest quality examination in the safest way possible. As such, being on a GLP-1 RAs could compromise both goals; but to date, the exact impact of these drugs on exam quality and patient safety is yet to be determined.
Studies have shown that patients on GLP-1 RAs have increased gastric residue on upper endoscopy compared with patients not on GLP-1 RAs. The effect of this increased residue on aspiration risk and clinically meaningful patient outcomes is being investigated, and the available published data are conflicting. Additionally, other published cases have shown that GLP-1 RAs are associated with increased solid gastric residue but not liquids, and that symptoms of dyspepsia and abdominal bloating are associated with an increased probability of residual gastric content.
Given the valid concern for increased gastric content residue, anesthesia specialists became more strict about which GLP-1 RA users they would agree to sedate, which ones they would intubate, and which procedures they would cancel. As one would imagine, cancellation and intubation rates have been increasing, and these have affected the schedules of patients, their families, and physicians.
The concern with GLP-1 RAs does not only apply to upper endoscopies, but also impacts colonoscopies. In addition to the concerns of aspiration and pneumonia, studies have shown that the use of GLP-1 RAs may be associated with a lower quality of bowel preparation and higher need for repeat colonoscopy. A study, which I believe is critical, showed that patients on GLP-1 RAs who were scheduled for upper endoscopy and colonoscopy were found to have less gastric residue and less risk of complications when compared with patients who were only having an upper endoscopy. This study sets the stage for a modified prep for patients on GLP-1 RAs prior to their procedures, since patients who received a modified/extended liquid diet on the day prior to their procedure (those preparing for a colonoscopy), had a protective effect against retained gastric content.
Clearly, there is a knowledge gap and a need for guidance. In our recently published AGA Rapid CPU, we advised an individualized approach to managing patients on GLP-1 RAs in the pre-endoscopic setting. Factors to consider are the indication for the GLP-1 RAs, the dose being used, duration of use, and indication and urgency of the procedure, as well as the presence of symptoms in the preoperative area (i.e., do patients have any nausea, vomiting, dyspepsia, etc.). Also an important factor is the facility in which the endoscopy will be taking place, as certain centers have the capacity to act fast and prevent complications or address them in a timely manner while other centers may not be prepared.
We proposed that a modified liquid diet be considered in patients prior to their endoscopies by advising patients to adhere to a clear liquid diet the day before the procedure, as this may help decrease gastric residue and be the safest and best approach for patients on GLP-1 RAs. Of course, it is important to note that more prospective studies are needed to inform clinical practice, and until then, we will have to individualize our approach and continue to put patient safety first.
Dr. Al Hashash is a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville, Florida.
Dear colleagues,
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are revolutionizing the field of obesity management and are now common medication in patients presenting for endoscopy. With their effect on gastric emptying, the American Society of Anesthesiologists has recommended cessation of such agents prior to endoscopy. However, is this necessary in patients who have been on a clear liquid diet in preparation for a colonoscopy or who are undergoing moderate sedation? Additionally, there are risks to holding GLP-1 RAs, especially for those taking them for glycemic control.
In this issue of Perspectives, Dr. Thomas Hickey and Dr. Ryan Pouliot discuss the nuances of pre-procedure cessation from an anesthesiologist’s perspective. Dr. Jana Al Hashash provides a gastroenterologist’s view, also highlighting the current paucity of evidence guiding management strategies. We hope these pieces will help your discussions in managing GLP-1 RAs prior to endoscopy in your own practice. We welcome your thoughts on this issue on X @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Connecticut, and chief of endoscopy at West Haven (Connecticut) VA Medical Center. He is an associate editor for GI & Hepatology News.
GLP-1 Receptor Agonists in Endoscopy
BY THOMAS R. HICKEY, MD; RYAN C. POULIOT, MD
In response to the recent dramatic increase in GLP-1 receptor agonist (GLP-1RA) prescribing and at the urging of its membership, the American Society of Anesthesiologists issued guidance on the preoperative management of these medications. The big takeaways were recommendations that patients on daily dosing should hold their dose on the day of a procedure, and that patients on weekly dosing should hold their dose a week prior.
The ASA guidance recognizes the sparse available evidence base and makes its recommendations in the spirit of patient safety, presuming that a more conservative approach will mitigate risk of rare but potentially devastating pulmonary aspiration, until prospective evidence informs the ideal approach. Until that approach is defined, whether more or less conservative, it is expected that anesthesiologists will adhere to their professional society’s recommendations.
Meanwhile, the American Gastroenterological Association Institute Rapid Clinical Practice Update (CPU) makes little distinction in the management of the endoscopy patient on GLP-1RA. A key refrain throughout the CPU is that there is no actionable data to justify the harms that may come to patients from stopping these medications (e.g., withdrawal of benefit to glycemic control and cardiovascular health) and in delaying or canceling procedures, which could lead to further stress on an overburdened workforce and add complexity to periprocedural processes.
Anesthesiologists should rightly consider themselves leaders in patient safety. As such, when a serious safety concern emerges they should be compelled to caution despite the possibility of other harms, until their concerns are mitigated by robust clinical evidence. Thankfully these questions are quite amenable to research, and prospective trials are already reporting compelling data that residual gastric contents, clearly a risk factor for aspiration, are increased in GLP-1RA groups compared to controls. This is evident even while following recommended fasting times and abstinences from these medications, and adjusting for confounders (e.g., age, diabetes, body mass index).1,2 It logically follows that large studies are likely to find an increased aspiration risk in GLP-1RA populations. Indeed, this increased risk has already been identified in a large retrospective study of endoscopy patients.3 These findings support the ASA’s caution. Additional data indicate that standard fasting guidelines in this patient population may be inadequate.4
The ASA guidance does not differentiate between patients undergoing surgery in the operating room and procedures in the endoscopy suite. Part of our task is to provide perspective on whether GLP-1RA management deserves different treatment for endoscopy patients. We can only speculate pending further data. For example, a prolonged fasting period including a full day of clears, with or without a bowel prep, intuitively protects against pulmonary aspiration. However, this is unlikely to mitigate an anesthesiologist’s concern that administration of propofol, frequently to a state of general anesthesia with an unsecured airway and resulting in a patient devoid of airway protection reflexes, is an inherently higher risk scenario for aspiration compared to surgery in the operating room with a secured airway. We also expect prospective trials will confirm retrospective findings that both propofol and procedures including upper endoscopy confer a higher risk for aspiration compared with conscious sedation and colonoscopy.3
We suggest a reasonable approach based on society guidance and existing evidence, pending additional data. Endoscopists and anesthesiologists should continue this important conversation with a specific focus on risks and benefits in order to decrease conflict and achieve consensus. If anesthesia care is desired, the patient instructions should be updated to reflect ASA guidance. Special attention should be paid to the “gray area,” for example those who did not hold the GLP-1 agonist as recommended.
This category of patients can be considered on a case-by-case basis by the anesthesiologist, proceduralist, and patient, with a range of options including: proceeding with endoscopist-directed sedation, proceeding with anesthesiology-administered conscious sedation, rescheduling the procedure, and proceeding with general anesthesia with rapid-sequence intubation. In addition to patient factors (e.g., GI symptoms, urgency of procedure), this consideration would vary based on local resources (e.g., presence or absence of anesthesia support staff, emergency airway equipment, nursing staff to comfort recovering patients after general endotracheal anesthesia), and aspiration risk inherent to the procedure (e.g., upper and or combination upper and lower endoscopy vs colonoscopy alone). Proficiency and availability of point-of-care ultrasound are rapidly increasing; adoption of a pre-procedure gastric ultrasound to assess for solids, thick liquids, or large volume of clear liquids may provide a less nuanced, more objective means to address this question.
While the question of periprocedural management of these medications has generated intense interest among anesthesiologists and endoscopists alike, it is worth noting the net positive health effects these drugs are likely to have on our patients, including improved glycemic control, significant weight loss, and decreased cardiovascular risk. We are eager to see whether these benefits translate into an overall improvement in periprocedural outcomes, including in our endoscopy patients.
Dr. Hickey is assistant professor of anesthesiology at the Yale University School of Medicine, New Haven, Connecticut, and the VA Connecticut Healthcare System. Dr. Pouliot is assistant professor of anesthesiology at the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
References
1. Sherwin M et al. Influence of semaglutide use on the presence of residual gastric solids on gastric ultrasound: A prospective observational study in volunteers without obesity recently started on semaglutide. Can J Anaesth. 2023 Aug. doi:10.1007/s12630-023-02549-5.
2. Wu F et al. Association of glucagon-like peptide receptor 1 agonist therapy with the presence of gastric contents in fasting patients undergoing endoscopy under anesthesia care: A historical cohort study. Can J Anaesth. 2024 Mar 14. doi:10.1007/s12630-024-02719-z.
3. Yeo YH et al. Increased risk of aspiration pneumonia associated with endoscopic procedures among patients with glucagon-like peptide 1 receptor agonist use. Gastroenterology. 2024 Mar 27. doi:10.1053/j.gastro.2024.03.015.
4. Sen S et al. Glucagon-like peptide-1 receptor agonist use and residual gastric content before anesthesia. JAMA Surg. 2024 Mar 6. doi:10.1001/jamasurg.2024.0111.
The Impact of GLP-1 Receptor Agonists On Endoscopy
BY JANA G. AL HASHASH, MD, MSc, AGAF
Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been approved for the treatment of type 2 diabetes mellitus since 2005. They have become more widely used over the last couple of years for weight loss in individuals who suffer from adiposity-based chronic disease.
The remarkable positive effects that GLP-1 RAs have had on weight loss as well as other medical conditions such as heart disease, hypertension, metabolic dysfunction–associated steatotic liver disease, among many others, have gained these drugs more traction. Even in situations when insurance companies deny coverage of GLP-1 RAs, many patients have been resorting to other routes to obtain these medications, commonly by purchasing them from online compounding pharmacies.
As such, more and more of our patients who present to endoscopy suites across the country are on one of the available GLP-1 RAs. This has necessitated endoscopists and anesthesiologists to become more familiar with the impact of GLP-1 RAs on patients undergoing endoscopic procedures.
Similar to narcotics, GLP-1 RAs affect gastrointestinal motility and delay gastric emptying. Common side effects of patients receiving GLP-1 RAs include nausea, vomiting, and increased satiety. Patients on GLP-1 RAs for weight loss may also have other contributing risk factors for gastroparesis such as diabetes mellitus which may further delay gastric emptying.
For endoscopists, our goals are to achieve the highest quality examination in the safest way possible. As such, being on a GLP-1 RAs could compromise both goals; but to date, the exact impact of these drugs on exam quality and patient safety is yet to be determined.
Studies have shown that patients on GLP-1 RAs have increased gastric residue on upper endoscopy compared with patients not on GLP-1 RAs. The effect of this increased residue on aspiration risk and clinically meaningful patient outcomes is being investigated, and the available published data are conflicting. Additionally, other published cases have shown that GLP-1 RAs are associated with increased solid gastric residue but not liquids, and that symptoms of dyspepsia and abdominal bloating are associated with an increased probability of residual gastric content.
Given the valid concern for increased gastric content residue, anesthesia specialists became more strict about which GLP-1 RA users they would agree to sedate, which ones they would intubate, and which procedures they would cancel. As one would imagine, cancellation and intubation rates have been increasing, and these have affected the schedules of patients, their families, and physicians.
The concern with GLP-1 RAs does not only apply to upper endoscopies, but also impacts colonoscopies. In addition to the concerns of aspiration and pneumonia, studies have shown that the use of GLP-1 RAs may be associated with a lower quality of bowel preparation and higher need for repeat colonoscopy. A study, which I believe is critical, showed that patients on GLP-1 RAs who were scheduled for upper endoscopy and colonoscopy were found to have less gastric residue and less risk of complications when compared with patients who were only having an upper endoscopy. This study sets the stage for a modified prep for patients on GLP-1 RAs prior to their procedures, since patients who received a modified/extended liquid diet on the day prior to their procedure (those preparing for a colonoscopy), had a protective effect against retained gastric content.
Clearly, there is a knowledge gap and a need for guidance. In our recently published AGA Rapid CPU, we advised an individualized approach to managing patients on GLP-1 RAs in the pre-endoscopic setting. Factors to consider are the indication for the GLP-1 RAs, the dose being used, duration of use, and indication and urgency of the procedure, as well as the presence of symptoms in the preoperative area (i.e., do patients have any nausea, vomiting, dyspepsia, etc.). Also an important factor is the facility in which the endoscopy will be taking place, as certain centers have the capacity to act fast and prevent complications or address them in a timely manner while other centers may not be prepared.
We proposed that a modified liquid diet be considered in patients prior to their endoscopies by advising patients to adhere to a clear liquid diet the day before the procedure, as this may help decrease gastric residue and be the safest and best approach for patients on GLP-1 RAs. Of course, it is important to note that more prospective studies are needed to inform clinical practice, and until then, we will have to individualize our approach and continue to put patient safety first.
Dr. Al Hashash is a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville, Florida.
Dear colleagues,
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are revolutionizing the field of obesity management and are now common medication in patients presenting for endoscopy. With their effect on gastric emptying, the American Society of Anesthesiologists has recommended cessation of such agents prior to endoscopy. However, is this necessary in patients who have been on a clear liquid diet in preparation for a colonoscopy or who are undergoing moderate sedation? Additionally, there are risks to holding GLP-1 RAs, especially for those taking them for glycemic control.
In this issue of Perspectives, Dr. Thomas Hickey and Dr. Ryan Pouliot discuss the nuances of pre-procedure cessation from an anesthesiologist’s perspective. Dr. Jana Al Hashash provides a gastroenterologist’s view, also highlighting the current paucity of evidence guiding management strategies. We hope these pieces will help your discussions in managing GLP-1 RAs prior to endoscopy in your own practice. We welcome your thoughts on this issue on X @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Connecticut, and chief of endoscopy at West Haven (Connecticut) VA Medical Center. He is an associate editor for GI & Hepatology News.
GLP-1 Receptor Agonists in Endoscopy
BY THOMAS R. HICKEY, MD; RYAN C. POULIOT, MD
In response to the recent dramatic increase in GLP-1 receptor agonist (GLP-1RA) prescribing and at the urging of its membership, the American Society of Anesthesiologists issued guidance on the preoperative management of these medications. The big takeaways were recommendations that patients on daily dosing should hold their dose on the day of a procedure, and that patients on weekly dosing should hold their dose a week prior.
The ASA guidance recognizes the sparse available evidence base and makes its recommendations in the spirit of patient safety, presuming that a more conservative approach will mitigate risk of rare but potentially devastating pulmonary aspiration, until prospective evidence informs the ideal approach. Until that approach is defined, whether more or less conservative, it is expected that anesthesiologists will adhere to their professional society’s recommendations.
Meanwhile, the American Gastroenterological Association Institute Rapid Clinical Practice Update (CPU) makes little distinction in the management of the endoscopy patient on GLP-1RA. A key refrain throughout the CPU is that there is no actionable data to justify the harms that may come to patients from stopping these medications (e.g., withdrawal of benefit to glycemic control and cardiovascular health) and in delaying or canceling procedures, which could lead to further stress on an overburdened workforce and add complexity to periprocedural processes.
Anesthesiologists should rightly consider themselves leaders in patient safety. As such, when a serious safety concern emerges they should be compelled to caution despite the possibility of other harms, until their concerns are mitigated by robust clinical evidence. Thankfully these questions are quite amenable to research, and prospective trials are already reporting compelling data that residual gastric contents, clearly a risk factor for aspiration, are increased in GLP-1RA groups compared to controls. This is evident even while following recommended fasting times and abstinences from these medications, and adjusting for confounders (e.g., age, diabetes, body mass index).1,2 It logically follows that large studies are likely to find an increased aspiration risk in GLP-1RA populations. Indeed, this increased risk has already been identified in a large retrospective study of endoscopy patients.3 These findings support the ASA’s caution. Additional data indicate that standard fasting guidelines in this patient population may be inadequate.4
The ASA guidance does not differentiate between patients undergoing surgery in the operating room and procedures in the endoscopy suite. Part of our task is to provide perspective on whether GLP-1RA management deserves different treatment for endoscopy patients. We can only speculate pending further data. For example, a prolonged fasting period including a full day of clears, with or without a bowel prep, intuitively protects against pulmonary aspiration. However, this is unlikely to mitigate an anesthesiologist’s concern that administration of propofol, frequently to a state of general anesthesia with an unsecured airway and resulting in a patient devoid of airway protection reflexes, is an inherently higher risk scenario for aspiration compared to surgery in the operating room with a secured airway. We also expect prospective trials will confirm retrospective findings that both propofol and procedures including upper endoscopy confer a higher risk for aspiration compared with conscious sedation and colonoscopy.3
We suggest a reasonable approach based on society guidance and existing evidence, pending additional data. Endoscopists and anesthesiologists should continue this important conversation with a specific focus on risks and benefits in order to decrease conflict and achieve consensus. If anesthesia care is desired, the patient instructions should be updated to reflect ASA guidance. Special attention should be paid to the “gray area,” for example those who did not hold the GLP-1 agonist as recommended.
This category of patients can be considered on a case-by-case basis by the anesthesiologist, proceduralist, and patient, with a range of options including: proceeding with endoscopist-directed sedation, proceeding with anesthesiology-administered conscious sedation, rescheduling the procedure, and proceeding with general anesthesia with rapid-sequence intubation. In addition to patient factors (e.g., GI symptoms, urgency of procedure), this consideration would vary based on local resources (e.g., presence or absence of anesthesia support staff, emergency airway equipment, nursing staff to comfort recovering patients after general endotracheal anesthesia), and aspiration risk inherent to the procedure (e.g., upper and or combination upper and lower endoscopy vs colonoscopy alone). Proficiency and availability of point-of-care ultrasound are rapidly increasing; adoption of a pre-procedure gastric ultrasound to assess for solids, thick liquids, or large volume of clear liquids may provide a less nuanced, more objective means to address this question.
While the question of periprocedural management of these medications has generated intense interest among anesthesiologists and endoscopists alike, it is worth noting the net positive health effects these drugs are likely to have on our patients, including improved glycemic control, significant weight loss, and decreased cardiovascular risk. We are eager to see whether these benefits translate into an overall improvement in periprocedural outcomes, including in our endoscopy patients.
Dr. Hickey is assistant professor of anesthesiology at the Yale University School of Medicine, New Haven, Connecticut, and the VA Connecticut Healthcare System. Dr. Pouliot is assistant professor of anesthesiology at the Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
References
1. Sherwin M et al. Influence of semaglutide use on the presence of residual gastric solids on gastric ultrasound: A prospective observational study in volunteers without obesity recently started on semaglutide. Can J Anaesth. 2023 Aug. doi:10.1007/s12630-023-02549-5.
2. Wu F et al. Association of glucagon-like peptide receptor 1 agonist therapy with the presence of gastric contents in fasting patients undergoing endoscopy under anesthesia care: A historical cohort study. Can J Anaesth. 2024 Mar 14. doi:10.1007/s12630-024-02719-z.
3. Yeo YH et al. Increased risk of aspiration pneumonia associated with endoscopic procedures among patients with glucagon-like peptide 1 receptor agonist use. Gastroenterology. 2024 Mar 27. doi:10.1053/j.gastro.2024.03.015.
4. Sen S et al. Glucagon-like peptide-1 receptor agonist use and residual gastric content before anesthesia. JAMA Surg. 2024 Mar 6. doi:10.1001/jamasurg.2024.0111.
The Impact of GLP-1 Receptor Agonists On Endoscopy
BY JANA G. AL HASHASH, MD, MSc, AGAF
Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been approved for the treatment of type 2 diabetes mellitus since 2005. They have become more widely used over the last couple of years for weight loss in individuals who suffer from adiposity-based chronic disease.
The remarkable positive effects that GLP-1 RAs have had on weight loss as well as other medical conditions such as heart disease, hypertension, metabolic dysfunction–associated steatotic liver disease, among many others, have gained these drugs more traction. Even in situations when insurance companies deny coverage of GLP-1 RAs, many patients have been resorting to other routes to obtain these medications, commonly by purchasing them from online compounding pharmacies.
As such, more and more of our patients who present to endoscopy suites across the country are on one of the available GLP-1 RAs. This has necessitated endoscopists and anesthesiologists to become more familiar with the impact of GLP-1 RAs on patients undergoing endoscopic procedures.
Similar to narcotics, GLP-1 RAs affect gastrointestinal motility and delay gastric emptying. Common side effects of patients receiving GLP-1 RAs include nausea, vomiting, and increased satiety. Patients on GLP-1 RAs for weight loss may also have other contributing risk factors for gastroparesis such as diabetes mellitus which may further delay gastric emptying.
For endoscopists, our goals are to achieve the highest quality examination in the safest way possible. As such, being on a GLP-1 RAs could compromise both goals; but to date, the exact impact of these drugs on exam quality and patient safety is yet to be determined.
Studies have shown that patients on GLP-1 RAs have increased gastric residue on upper endoscopy compared with patients not on GLP-1 RAs. The effect of this increased residue on aspiration risk and clinically meaningful patient outcomes is being investigated, and the available published data are conflicting. Additionally, other published cases have shown that GLP-1 RAs are associated with increased solid gastric residue but not liquids, and that symptoms of dyspepsia and abdominal bloating are associated with an increased probability of residual gastric content.
Given the valid concern for increased gastric content residue, anesthesia specialists became more strict about which GLP-1 RA users they would agree to sedate, which ones they would intubate, and which procedures they would cancel. As one would imagine, cancellation and intubation rates have been increasing, and these have affected the schedules of patients, their families, and physicians.
The concern with GLP-1 RAs does not only apply to upper endoscopies, but also impacts colonoscopies. In addition to the concerns of aspiration and pneumonia, studies have shown that the use of GLP-1 RAs may be associated with a lower quality of bowel preparation and higher need for repeat colonoscopy. A study, which I believe is critical, showed that patients on GLP-1 RAs who were scheduled for upper endoscopy and colonoscopy were found to have less gastric residue and less risk of complications when compared with patients who were only having an upper endoscopy. This study sets the stage for a modified prep for patients on GLP-1 RAs prior to their procedures, since patients who received a modified/extended liquid diet on the day prior to their procedure (those preparing for a colonoscopy), had a protective effect against retained gastric content.
Clearly, there is a knowledge gap and a need for guidance. In our recently published AGA Rapid CPU, we advised an individualized approach to managing patients on GLP-1 RAs in the pre-endoscopic setting. Factors to consider are the indication for the GLP-1 RAs, the dose being used, duration of use, and indication and urgency of the procedure, as well as the presence of symptoms in the preoperative area (i.e., do patients have any nausea, vomiting, dyspepsia, etc.). Also an important factor is the facility in which the endoscopy will be taking place, as certain centers have the capacity to act fast and prevent complications or address them in a timely manner while other centers may not be prepared.
We proposed that a modified liquid diet be considered in patients prior to their endoscopies by advising patients to adhere to a clear liquid diet the day before the procedure, as this may help decrease gastric residue and be the safest and best approach for patients on GLP-1 RAs. Of course, it is important to note that more prospective studies are needed to inform clinical practice, and until then, we will have to individualize our approach and continue to put patient safety first.
Dr. Al Hashash is a gastroenterologist and associate professor of medicine at Mayo Clinic, Jacksonville, Florida.
Dubious Medicine
Interest in and knowledge of the gut microbiome, and its role in health and disease, has increased exponentially in the past decade. Billions of dollars have been invested in gut microbiome research since release of the NIH Human Microbiome Project’s reference database in 2012, aimed not only at better understanding pathology and disease mechanisms, but also promoting development of novel diagnostic and therapeutic interventions. However, it is fair to say that gut microbiome research is still in its infancy, and there is still much to be learned.
Despite this, a global, and largely unregulated, industry of direct-to-consumer (DTC) microbiome tests has emerged. These (often costly) tests are now widely available to our patients via retail outlets and online — in exchange for a stool sample, consumers receive a detailed report comparing their microbiome to a “healthy” reference patient and recommending various interventions such as follow-up testing, special diets, or nutritional supplements. By now, we likely all have been handed one of these reports in clinic identifying a patient’s “abnormal” microbiome and asked to weigh in on its dubious results. A special feature article in this month’s issue outlines the controversies surrounding these DTC microbiome tests, which currently lack analytic and clinical validity, and highlights recent calls for increased regulation in this space.
Also We invite you to learn more about the exceptional Dr. Maria Abreu of the University of Miami, who recently assumed her new role as AGA President. Our quarterly Perspectives column tackles the issue of GLP-1 receptor agonists (GLP-1RAs) in GI endoscopy — gastroenterologist Dr. Jana Hashash and anesthesiologists Dr. Thomas Hickey and Dr. Ryan Pouliot offer contrasting perspectives on this topic drawn from AGA and American Society of Anesthesiologists guidance. Finally, our July Member Spotlight features Dr. Lisa Mathew of South Denver Gastroenterology who shares her perspectives on hosting a GI podcast, why private practice is a fantastic laboratory for clinical innovation, and how she found her “tribe” in the field of gastroenterology.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Interest in and knowledge of the gut microbiome, and its role in health and disease, has increased exponentially in the past decade. Billions of dollars have been invested in gut microbiome research since release of the NIH Human Microbiome Project’s reference database in 2012, aimed not only at better understanding pathology and disease mechanisms, but also promoting development of novel diagnostic and therapeutic interventions. However, it is fair to say that gut microbiome research is still in its infancy, and there is still much to be learned.
Despite this, a global, and largely unregulated, industry of direct-to-consumer (DTC) microbiome tests has emerged. These (often costly) tests are now widely available to our patients via retail outlets and online — in exchange for a stool sample, consumers receive a detailed report comparing their microbiome to a “healthy” reference patient and recommending various interventions such as follow-up testing, special diets, or nutritional supplements. By now, we likely all have been handed one of these reports in clinic identifying a patient’s “abnormal” microbiome and asked to weigh in on its dubious results. A special feature article in this month’s issue outlines the controversies surrounding these DTC microbiome tests, which currently lack analytic and clinical validity, and highlights recent calls for increased regulation in this space.
Also We invite you to learn more about the exceptional Dr. Maria Abreu of the University of Miami, who recently assumed her new role as AGA President. Our quarterly Perspectives column tackles the issue of GLP-1 receptor agonists (GLP-1RAs) in GI endoscopy — gastroenterologist Dr. Jana Hashash and anesthesiologists Dr. Thomas Hickey and Dr. Ryan Pouliot offer contrasting perspectives on this topic drawn from AGA and American Society of Anesthesiologists guidance. Finally, our July Member Spotlight features Dr. Lisa Mathew of South Denver Gastroenterology who shares her perspectives on hosting a GI podcast, why private practice is a fantastic laboratory for clinical innovation, and how she found her “tribe” in the field of gastroenterology.
Megan A. Adams, MD, JD, MSc
Editor in Chief
Interest in and knowledge of the gut microbiome, and its role in health and disease, has increased exponentially in the past decade. Billions of dollars have been invested in gut microbiome research since release of the NIH Human Microbiome Project’s reference database in 2012, aimed not only at better understanding pathology and disease mechanisms, but also promoting development of novel diagnostic and therapeutic interventions. However, it is fair to say that gut microbiome research is still in its infancy, and there is still much to be learned.
Despite this, a global, and largely unregulated, industry of direct-to-consumer (DTC) microbiome tests has emerged. These (often costly) tests are now widely available to our patients via retail outlets and online — in exchange for a stool sample, consumers receive a detailed report comparing their microbiome to a “healthy” reference patient and recommending various interventions such as follow-up testing, special diets, or nutritional supplements. By now, we likely all have been handed one of these reports in clinic identifying a patient’s “abnormal” microbiome and asked to weigh in on its dubious results. A special feature article in this month’s issue outlines the controversies surrounding these DTC microbiome tests, which currently lack analytic and clinical validity, and highlights recent calls for increased regulation in this space.
Also We invite you to learn more about the exceptional Dr. Maria Abreu of the University of Miami, who recently assumed her new role as AGA President. Our quarterly Perspectives column tackles the issue of GLP-1 receptor agonists (GLP-1RAs) in GI endoscopy — gastroenterologist Dr. Jana Hashash and anesthesiologists Dr. Thomas Hickey and Dr. Ryan Pouliot offer contrasting perspectives on this topic drawn from AGA and American Society of Anesthesiologists guidance. Finally, our July Member Spotlight features Dr. Lisa Mathew of South Denver Gastroenterology who shares her perspectives on hosting a GI podcast, why private practice is a fantastic laboratory for clinical innovation, and how she found her “tribe” in the field of gastroenterology.
Megan A. Adams, MD, JD, MSc
Editor in Chief
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.