Sustainability of Adalimumab in Fistula Healing and Response: 2-Year Data from CHARM and 12-Month Open-Label Extension Follow-Up Study

Abstract

Purpose: Adalimumab (ADA), a fully human monoclonal antibody that targets tumor necrosis factor, has been shown to be efficacious in the induction and maintenance of remission in patients (pts) with Crohn's disease (CD). Fistulizing disease complicates the course of CD in 20–30% of pts, in many cases leading to surgical resection. The CHARM study has previously shown efficacy of ADA in fistula closure and response. We assessed long-term efficacy of ADA in fistula healing and response in CD pts from the CHARM trial in an open-label extension (OLE) follow-up study. Methods: Pts in CHARM were randomized to placebo (PBO), 40 mg every other week (EOW) or 40 mg weekly (EW). Pts with flare or non-response could receive OL ADA at/after Week 12. At the end of CHARM (56 weeks), pts were allowed to enroll into an open-label extension (OLE). In the OLE, pts received EOW OL or remained on EW OL, and could change from EOW to OL EW for flares or non-response. In this analysis, pts with fistulas at baseline (BL) of CHARM were studied, pooling the 2 doses, using an ITT, non-responder imputation analysis. Pts were analyzed for the percentage (%) of healed fistulas and% with ≥50% fistula response at 6 and 12 months in the blinded study and at 6 and 12 months of the OLE follow-up study (for a total of 24 months of therapy). Results: Results are in the table below.Table: Long-Term Efficacy of Fistula Healing and Response with ADA Through 2 YearsConclusion: Sustainable efficacy of ADA in fistula healing and response is evident after 2 years. ADA has shown sustained response in almost two-thirds of the patients in the OLE who had fistulas at baseline of CHARM and sustained closure in more than half of the ADA-treated patients.