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Summary   Background  Therapies that maintain remission for patients with Crohn's disease are essential. Stable remission rates have been demonstrated for up to 2 years in adalimumab‐treated patients with moderately to severely active Crohn's disease enrolled in the  CHARM  and  ADHERE  clinical trials.    Aim  To present the long‐term efficacy and safety of adalimumab therapy through 4 years of treatment.    Methods  Remission (CDAI <150), response (CR‐100) and corticosteroid‐free remission over 4 years, and maintenance of these endpoints beyond 1 year were assessed in CHARM early responders randomised to adalimumab. Corticosteroid‐free remission was also assessed in all adalimumab‐randomised patients using corticosteroids at baseline. Fistula healing was assessed in adalimumab‐randomised patients with fistula at baseline. As observed, last observation carried forward and a hybrid nonresponder imputation analysis for year 4 ( hNRI ) were used to report efficacy. Adverse events were reported for any patient receiving at least one dose of adalimumab.    Results  Of 329 early responders randomised to adalimumab induction therapy, at least 30% achieved remission (99/329) or CR‐100 (116/329) at year 4 of treatment ( hNRI ). The majority of patients (54%) with remission at year 1 maintained this endpoint at year 4 ( hNRI ). At year 4, 16% of patients taking corticosteroids at baseline were in corticosteroid‐free remission and 24% of patients with fistulae at baseline had healed fistulae. The incidence rates of adverse events remained stable over time.    Conclusions  Prolonged adalimumab therapy maintained clinical remission and response in patients with moderately to severely active Crohn's disease for up to 4 years. No increased risk of adverse events or new safety signals were identified with long‐term maintenance therapy. ( clinicaltrials.gov  number: NCT00077779).

Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE