Effectiveness, safety, and clinical outcomes of treatment with the oral α4-integrin antagonist carotegrast methyl in patients with active ulcerative colitis: a multicenter observational study (CANAL study).

Abstract

Background: Carotegrast methyl is an oral α4-integrin antagonist used to induce remission in patients with ulcerative colitis with an inadequate response to 5-aminosalicylate (5-ASA). This multicenter, retrospective observational study evaluated the clinical usefulness of carotegrast methyl in real-world practice.

Methods: Patients with an inadequate response to 5-ASA who received carotegrast methyl were included. Clinical data were collected during and after treatment for up to 52 weeks. The primary endpoint was the response rate at week 8. The remission rate at week 8, response/remission rate at end of treatment, cumulative response/remission rate, and adverse drug reactions were also assessed. Effectiveness was evaluated using the patient reported outcomes-2 measure (sum of Mayo subscores for stool frequency and rectal bleeding).

Results: Data were collected from 196 patients, of whom 180 were evaluable for effectiveness. The PRO-2-defined response and remission rates at week 8 were 57.8% and 43.3%, respectively, and the rates at the end of treatment (median treatment duration: 83.5 days) were 58.9% and 50.0%, respectively. The cumulative PRO-2-defined response/remission rates increased until week 16, followed by a slight further increase. Adverse drug reactions occurred in 31 of 196 patients (15.8%, 43 events), with no serious events.

Conclusions: In terms of patient-reported symptom improvement, carotegrast methyl is an effective and well-tolerated treatment for patients with ulcerative colitis who have an inadequate response to 5-ASA. A substantial proportion of patients responded to 8 weeks of treatment. Continued treatment for up to 16 weeks may improve symptoms, even in patients with insufficient response at week 8.