Reuters Health – 27/01/2021 – New data support the long-term safety and sustained clinical effects of etrasimod in patients with moderately to severely active ulcerative colitis (UC).
Etrasimod is a next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator being developed by Arena Pharmaceuticals for treatment of immune and inflammatory-mediated diseases.
In the phase-2 OASIS trial, funded by the drugmaker, etrasimod (2 mg once daily) provided significant benefit compared with placebo and was generally well tolerated over 12 weeks in adults with moderately to severely active UC and previous inadequate response, loss of response or intolerance to conventional or biologic therapy.
Now, in the Journal of Crohn’s and Colitis, researchers report results of an open-label extension study in evaluating 112 patients who continued to take the drug for up to an additional 34 to 40 weeks (46 to 52 weeks total).
“At end of treatment, 64% of patients met the criteria for clinical response, 33% for clinical remission, and 43% for endoscopic improvement,” Dr. Severine Vermeire of University Hospitals Leuven, in Belgium, and colleagues report.
“Week 12 clinical response, clinical remission, or endoscopic improvement was maintained to end of treatment in 85%, 60%, or 69% of patients, respectively. Steroid-free clinical remission occurred in 22% of overall patients,” they add.
Treatment-emergent adverse events occurred in 67 patients (60%) receiving etrasimod 2 mg at any time, most commonly worsening UC and anemia; 94% of adverse events were mild to moderate.
In December 2020, Arena Pharmaceuticals announced that it had achieved its targeted enrollment goal of 372 participants in the phase-3 ELEVATE UC 52 trial evaluating the safety and efficacy of etrasimod in adults with moderately to severely active ulcerative colitis.
The company funded medical-writing support for the new report. Several authors have disclosed financial relationships with the drugmaker.
SOURCE: https://bit.ly/39hYjJ1 Journal of Crohn’s and Colitis, online January 21, 2021.
By Reuters Staff
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