Long-term safety and efficacy of adalimumab in Japanese patients with moderate to severe Crohn's disease

Background and aimsAdalimumab has been shown to be effective and well tolerated in patients with Crohn's disease. This analysis reports the results of a cohort of Japanese patients with moderate to severe Crohn's disease who were evaluated for up to 3 years to assess the long-term use of adalimumab.MethodsThe study consisted of a double-blind part and an open-label part. Patients were included either in the 52-week double-blind, placebo-controlled part of the study followed by a 96-week open-label extension or in the open-label part from the beginning or in the event of a flare. Patients were treated with adalimumab and evaluated for up to 148 weeks as 3 data cohorts: the all-adalimumab cohort (patients receiving ≥ 1 injection of adalimumab), the 148-week follow-up subcohort (patients who completed 148 weeks of follow-up after the first adalimumab dose), and the dose-escalation subcohort (patients receiving adalimumab doses that increased to 80 mg every other week).ResultsIn the all-adalimumab cohort (n = 79), clinical remission rates were approximately 30% after 36 weeks of exposure to adalimumab and for the remainder of the study (35%, 33%, and 28% for weeks 48, 108, and 144, respectively). An improvement in quality of life was also maintained over the same period. In the dose-escalation subcohort (n = 40), the clinical remission rate was 75% (6/8) 48 weeks after dose escalation. Adalimumab was tolerated, and no deaths were reported.ConclusionsAdalimumab is effective for maintaining long-term clinical remission in Japanese patients with moderate to severe Crohn's disease (NCT00445432).