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Budesonide MMX safe, effective for ulcerative colitis
Patients with mild-to-moderate ulcerative colitis who were treated with budesonide MMX experienced clinical and endoscopic remission more frequently than placebo recipients in a recent study.
Researchers randomly assigned 509 patients with mild-to-moderate ulcerative colitis (UC) to receive either 6 mg (n=128) or 9 mg (n=126) budesonide MMX once daily, 3 mg Entocort EC three times a day (n=126), or placebo (n=129) for 8 weeks. Incidence of clinical and endoscopic remission was recorded within each group. All participants had a UC Disease Activity Index score between 4 and 10.
Safety analysis included two additional 9-mg budesonide recipients who were not randomly assigned, but 410 participated in efficacy analysis after exclusions for normal histopathology at baseline and Good Clinical Practice violations. The modified intention-to-treat group included 89 placebo recipients, 109 patients in each budesonide group and 103 Entocort patients.
Among evaluable participants, 17.4% of cases in the 9-mg and 8.3% in the 6-mg budesonide group experienced endoscopic and clinical remission, compared with 12.6% of Entocort and 4.5% of placebo recipients. Participants in the 9-mg budesonide group were significantly more likely than placebo recipients to achieve remission (OR=4.49; 95% CI, 1.47-13.72). Sensitivity analysis classifying randomly assigned patients excluded from efficacy analysis as treatment failures yielded similar remission results (15.1% for 9 mg budesonide vs. 3.1% placebo; P=.0008).
Incidence of clinical and endoscopic improvement was numerically but not significantly higher in the 9-mg budesonide group than placebo (42.2% of cases vs. 33.7% and 42.2% vs. 31.5%, respectively). Histological healing (16.5% compared with 6.7%; P=.0361) and complete symptom resolution (23.9% vs. 11.2%; P=.022) were more common in this group than placebo recipients.
Adverse events occurred at similar rates for all groups, with UC relapse (15.3% of all participants) and headache (11.4%) being the most common events.
“Budesonide MMX 9 mg daily was safe and effective for the induction of remission of active, mild-to-moderate UC,” the researchers concluded. “Colonic-release budesonide may therefore be an alternative to conventional corticosteroid therapy.”
Disclosure: See the study for a full list of relevant disclosures.