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Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.
Patients in the open-label extension of the OASIS study saw increases in Inflammatory Bowel Disease Questionnaire (IBDQ) scores.
In data presented at the 2021 American College of Gastroenterology (ACG) Annual Meeting, investigators found etrasimod 2 mg results in improvements in quality of life for patients with moderate-to-severe ulcerative colitis.
A team, led by Michael V. Chiorean, MD, Swedish Medical Center, examined the effect of etrasimod on quality of life metrics.
Etrasimod is an oral, selective sphingosine 1-phosphate receptor 1, 4, and 5 modulatory that has shown promise inducing response and remission in the OASIS phase 2 trial of patients with moderate-to-severe ulcerative colitis.
Next, patients were offered to option to continue treatment in the open-label extension, where they received etrasimod 2 mg for up to an additional 34 weeks.
The OASIS study enrolled 109 adult patients with moderate-to-severe ulcerative colitis between 18-80 years. Each patient was randomized to receive either once-daily etrasimod 2 mg (n = 30), etrasimod 1 mg (n = 38), or placebo (n = 41).
The investigators evaluated quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ), which contains 32 items across 4 dimensions—bowel/systemic symptoms; social/emotional function. Each item is assessed on a 7 point scale.
The investigators collected data at baseline, week 12, and at the conclusion of treatment. They also evaluated changes from baseline in IBDQ scores based on the randomized treatment in the OASIS trial. At the final analysis there were 29 patients treated with etrasimod 2 mg, 38 patients in the 1 mg group, and 40 individuals in the placebo arm.
The IBDQ scores increased by 37.2 ± 40.4 points in the etrasimod 2mg group (P=0.07 vs placebo) and 30.9 ± 34.4 points in the etrasimod 1mg group (P=0.63 vs placebo) vs 24.4 ± 26.2 points in the placebo group at the week 12 mark.
Then at the conclusion of treatment the increases in scores in the etrasimod 2 mg group was maintained at 37.8 ± 44.9. On the other hand, IBDQ scores increased further in both the etrasimod 1 mg and placebo groups after the patients transitioned to etrasimod 2 mg (40.3 ± 43.5 and 41.7 ± 50.3, respectively).
At week 12, 73% of participants in the etrasimod 2 mg group achieved clinically meaningful improvements in IBDQ scores, compared to 61% in the etrasimod 1 mg group and 56% in the placebo group. At the conclusion of treatment, 71% of patients achieved clinically meaningful improvement.
“These data suggest a trend toward improved quality of life among adults with UC treated with etrasimod 2 mg,” the authors wrote. “Greater sample size is needed to confirm these results.”
The study, “Etrasimod Improves Quality of Life in Adults With Moderate-to-Severe Ulcerative Colitis: Results From the Phase 2 OASIS Trial and Open-Label Extension,” was published online by ACG.