Efficacy and safety of carotegrast methyl in active ulcerative colitis: a real-world prospective cohort study.

BACKGROUND/AIMS: Carotegrast methyl, an oral α4-integrin inhibitor, was recently approved for the treatment of active ulcerative colitis (UC). However, real-world data regarding its efficacy and safety remain scarce. This study aimed to assess the clinical effectiveness and safety profile of carotegrast methyl in patients with active UC.

METHODS

Patients with active UC received carotegrast methyl at a dosage of 960 mg three times daily. Treatment was discontinued at 8 weeks for patients who achieved endoscopic remission. For those not achieving endoscopic remission, treatment was continued for up to 24 weeks. Clinical and endoscopic assessments were performed at 8 and 24 weeks to evaluate treatment progress.

RESULTS

Among 50 UC patients, 45% achieved clinical remission, and 22% achieved endoscopic remission by week 8. Of those who discontinued treatment after reaching endoscopic remission, 55% experienced relapse during a median follow-up period of 30 weeks. For patients who continued treatment through 24 weeks, 52% achieved clinical remission, with a cumulative remission maintenance rate of 74.2%. Mild adverse events were reported in 6% of patients, including hyperamylasemia, hepatic dysfunction, and elevated biliary enzymes, all of which resolved after discontinuation of treatment. In 8 patients who relapsed and were re-administered carotegrast methyl, 62.5% achieved clinical remission, demonstrating the drug's effectiveness and safety in re-treatment.

CONCLUSIONS

Carotegrast methyl effectively induces both clinical and endoscopic remission in patients with active UC and has a favorable safety profile. Re-administration is safe and effective for patients experiencing relapse.