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Aim

Assess efficacy and safety of adalimumab for induction and maintenance of clinical remission in patients with moderate-to-severe ulcerative colitis (UC). MATERIALS AND METHODS: Adult patients with UC (Mayo score: 6-12 points; endoscopy subscore: 2-3 points despite concurrent treatment with oral corticosteroids/immunosuppressants) were randomized 1:1 to placebo or adalimumab (160 mg, Week 0; 80 mg, Week 2; 40 mg every other week [eow] starting Week 4). Patients were allowed previous anti-TNF agent use. Co-primary endpoints were proportion of patients with (1) clinical remission at Week 8; (2) clinical remission at Week 52. Major secondary endpoints included sustained clinical remission at both Week 8 and 52, clinical response and mucosal healing at Week 8, Week 52, and both Week 8 and 52. At/after Week 8 patients were permitted corticosteroid tapering. Patients demonstrating inadequate response1 could switch to openlabel (OL) 40 mg eow at Week 12. Dose escalation to 40 mg weekly was permitted for patients demonstrating inadequate response on OL administration. Efficacy analyses were conducted on the ITT population; using NRI for missing/incomplete data. Safety analyses were conducted on the safety population

Results

248 (of 494) ITT patients received adalimumab. Significantly more adalimumab-treated patients achieved clinical remission, clinical response, and mucosal healing at Week 8, Week 52, and both Week 8 and 52, compared with placebo. Among patients with corticosteroid use at baseline, significantly more adalimumab-treated patients discontinued corticosteroids before Week 52 and achieved clinical remission at Week 52, compared with placebo (13.3% vs. 5.7%, P = 0.035). Among patients with prior anti-TNF agent use (40.3% of ITT patients), significantly more adalimumab-treated patients achieved clinical remission at Week 52, clinical response at Week 52, and sustained clinical response at both Week 8 and 52, compared with placebo. No deaths, tuberculosis or lymphomas were reported. Incidence rates of serious and infectious AEs were similar between placebo and adalimumab groups.

Conclusion

Adalimumab was efficacious in inducing and maintaining clinical remission in patients with moderate-to-severe UC who did not adequately respond to conventional therapy with oral corticosteroids/immunosuppressants. The safety profile in UC was consistent with the known safety profile of adalimumab.

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Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.
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