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Eluxadoline safe, effective for patients with IBS-D in phase 2 study
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Patients with irritable bowel syndrome with diarrhea treated with eluxadoline had better rates of clinical response and indicated more symptom improvement than placebo recipients in a recent study.
In a phase 2, multicenter, double blind study, researchers randomly assigned 807 adult patients with IBS with diarrhea (IBS-D) to 5 mg, 25 mg, 100 mg or 200 mg eluxadoline or placebo orally twice a day for 12 weeks. Patients were evaluated at 2, 4, 8, 12 and 14 weeks, and reported daily symptoms via interactive voice response system (IVRS), and also responded to monthly questionnaires. The primary endpoint was clinical response at week 4 of treatment.
More patients who received 25 mg (12% of cases) or 200 mg (13.8%) experienced clinical response at 4 weeks compared with placebo (5.7%) (P=.041 for 25 mg; P=.015 for 200 mg). Clinical response at 12 weeks was more common among 100-mg recipients than placebo recipients (20.2% vs. 11.3%; P=.03).
Compared with placebo recipients, 100-mg patients experienced improved global symptom relief at weeks 8 and 12 (P<.001 for both) and greater symptom improvement as indicated by IBS-Symptom Severity Score at 4, 8 and 12 weeks (P=.011 at 4 weeks; P<.001 at 8 and 12 weeks). IBS-Quality-of-Life scores also were significantly improved compared with placebo at 4 (P=.012), 8 and 12 weeks (P<.001 for both).
Similar results were observed in the 200-mg group, though investigators said severe adverse events occurred more frequently. Adverse event rates overall were not significantly different across doses. Common gastrointestinal events included abdominal pain, constipation, nausea and vomiting, which occurred most often among 200-mg recipients.
“Overall, the results from the current study confirm the effectiveness of eluxadoline to manage IBS-D based on a composite response of abdominal pain and stool consistency without significant risk of constipation,” the researchers concluded. “These results also suggest that additional clinical development of eluxadoline is warranted.”
Disclosure: See the study for a full list of relevant financial disclosures.
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