Etrasimod can be safely used alongside opioids, antidepressants in ulcerative colitis
Key takeaways:
- The incidence of adverse events potentially related to serotonin syndrome was low and similar across all subgroups of patients.
- No adverse events were serious or led to treatment discontinuation.
Using etrasimod with opioids or antidepressants did not increase risk for serotonin syndrome-associated adverse events among patients with ulcerative colitis, according to a study published in United European Gastroenterology Journal.
“Several UC therapies have known recommendations against concomitant use with commonly prescribed medications,” Anita Afzali, MD, executive vice chair for clinical operations in the department of internal medicine and professor in the division of digestive diseases at University of Cincinnati College of Medicine, and colleagues wrote.
“Unlike ozanimod, etrasimod and its metabolites do not have the structure to inhibit monoamine oxidase; however, the risk of adverse events with concomitant opioids or antidepressants has not been analyzed in a clinical setting,” they added.
To better define potential drug-drug interactions with etrasimod, Afzali and colleagues conducted a post-hoc analysis of 527 patients with moderately to severely active UC who received once-daily etrasimod (Velsipity, Pfizer) 2 mg with or without concomitant opioids or antidepressants in the phase 3 ELEVATE UC 52 and ELEVATE UC 12 placebo-controlled randomized trials.
The researchers analyzed safety data pooled from both trials and reported the proportions of patients who had at least one concurrent adverse event potentially associated with serotonin syndrome, including pyrexia and tachycardia.
Overall, 14.6% of patients (n = 77; mean age, 38.9 years; 88.3% white) were taking concomitant opioids and 6.6% (n = 35; mean age, 40.7 years; 80% white) were taking concomitant antidepressants.
Based on 265.6 patient-years of exposure, the researchers observed that pyrexia occurred among 2.6% of patients on concomitant opioids and 8.6% of those on concomitant antidepressants. Similarly, tachycardia occurred among 2.6% of those on concomitant opioids and 2.9% of those on concomitant antidepressants.
Additionally, they found that no reported adverse events were serious or led to treatment discontinuation among patients on concomitant opioids or antidepressants.
“These findings, in combination with etrasimod and its metabolites not having the structure to inhibit monoamine oxidase, are in alignment with the current labelling of etrasimod, which does not include restrictive recommendations on concomitant use of antidepressants or opioids,” the researchers wrote.
Afzali and colleagues acknowledged several limitations to their analysis, including its post-hoc and descriptive nature, as well as the relatively small sample size of patients using concomitant antidepressants or opioids.
“Five-year follow-up data from the ongoing ELEVATE UC open-label extension study and real-world studies will hopefully provide greater insights into this important topic for clinicians,” they wrote.
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