Itramod can be safely used with opioids, antidepressants in ulcerative colitis
Etrasimod is a new type of drug that has attracted widespread attention in the treatment of ulcerative colitis (UC) in recent years. Itramod can be used safely with opioids and antidepressants without significantly increasing the risk of adverse events related to serotonin syndrome, according to a published study. This finding provides an important reference for clinicians when dealing with concomitant medications.
Although some treatments for ulcerative colitis recommend against concurrent use with commonly prescribed medications such as opioids and antidepressants, itramod has structural characteristics that differ from ozanimod and has not been shown to inhibit monoamine oxidase (MAO). Therefore, in clinical practice, it is particularly important to explore the safety of these two types of drugs combined with itrimod.
To gain insight into this issue, a retrospective analysis was conducted on 527 patients with moderately to severely active UC. These patients were treated with itrimod (Velsipity, Pfizer Inc.) in the Phase 3 ELEVATE UC 52 and ELEVATE UC12 placebo-controlled randomized trials. Patients took 2 mg of itrimod daily and were divided into two groups: receiving or not receiving opioids and antidepressants. By analyzing safety data from both trials, the researchers assessed the incidence of adverse events potentially related to serotonin syndrome, focusing specifically on symptoms such as fever and tachycardia.
Results of the study showed that overall14.6% of patients (77 people, mean age 38.9 years old, 88.3% white) were also taking opioids, while 6.6% of patients (35 people, mean age 40.7 years, 80% white) were taking antidepressants. Based on 265.6 patient-years of exposure, the study found that only 2.6% of patients concurrently taking opioids and 8.6% of those concurrently taking antidepressants developed fever, while the incidence of tachycardia was relatively low at 2.6% and 2.9%.
More importantly, no serious adverse events were observed in patients taking concurrent opioids or antidepressants, and no cases resulted in treatment discontinuation, indicating that the combination of istrimod with these drugs is relatively safe. The researchers stated that the structural characteristics of itrimod and its metabolites are consistent with its clinical application label, and the label does not make restrictive recommendations on the combined use of antidepressants or opioids.
Although this study has certain clinical implications, it has several limitations, such as its retrospective and descriptive nature and the relatively small sample size of patients taking combination antidepressants or opioids. This means that future research will still require larger clinical trials to verify these results. Meanwhile, five-year follow-up data from the ongoing ELEVATE UC open-label extension study and real-world study will provide clinicians with additional insights in this important area.
In summary, itridimod is a new option for the treatment of ulcerative colitis, and its safety when used in combination with opioids and antidepressants is gradually recognized. This provides clinicians with more basis for formulating personalized treatment plans, and also brings hope for improved treatment effects and quality of life for patients.
References:https://www.healio.com/news/gastroenterology/20250318/etrasimod-can-be-safely-used-alongside-opioids-antidepressants-in-ulcerative-colitis
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