Long-Term Adalimumab Treatment Is Associated with Sustained Fistula Healing in Patients with Moderate to Severe Crohnʼs Disease

Abstract

Purpose: Adalimumab (ADA), a fully human monoclonal antibody that targets tumor necrosis factor, is approved for the induction and maintenance of remission in adults with moderate to severe Crohn's disease (CD). Fistulizing disease complicates the course of CD in 20–40% of patients (pts). The efficacy of ADA in complete fistula closure for up to 12 months has been demonstrated previously in the CHARM study. Methods: To assess the long-term efficacy of ADA in fistula healing, we followed pts in the CHARM trial for an additional 2 years of treatment in an open-label extension (OLE) study. Pts with draining fistulas at baseline of CHARM were evaluated after 3 years of ADA treatment. Following a 4-week, open-label induction period, pts in CHARM were randomized to placebo, ADA 40 mg every other week (eow), or ADA 40 mg every week (ew). At/after Week 12, pts with flare or nonresponse could receive open-label ADA. At the end of CHARM (56 weeks), pts were allowed to enroll in an OLE, in which they received ADA (eow) and could change from eow to ew for flares or nonresponse, or, if receiving OL ADA ew, continued on this dose. All ADA patients were analyzed as a single group using observed cases. Results: The percentages of pts with healed fistulas at 6 and 12 months in the blinded study and through an additional 2 years of ADA exposure in the OLE is summarized in the table. Month 12 in CHARM and Weeks 60 and 108 in the OLE represent approximately 1, 2, and 3 years of ADA therapy, respectively. Conclusion: Rates of fistula healing were sustained after 3 years of ADA therapy. ADA therapy resulted in sustained fistula closure in more than 60% of the ADA-treated pts in the OLE who had fistulas at baseline of CHARM. This research was funded by Abbott Laboratories, Abbott Park, IL.Table: Long-Term Efficacy of Fistula Healing With 3 Years of ADA Therapy.