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101

SUSTAINABLE FISTULA HEALING AND RESPONSE WITH ADALIMUMAB: 2-YEAR DATA FROM CHARM AND 12-MONTH OPEN-LABEL EXTENSION FOLLOW-UP STUDY

JF Colombel1, MA Kamm2, D Schwartz3, WJ Sandborn4, J Li5,
KG Lomax5, PF Pollack5

1CHU Lille, Lille, France; 2St. Mark’s Hospital, Harrow, United Kingdom; 3Vanderbilt University Medical Center, Nashville, TN, USA; 4Mayo Clinic, Rochester, MN, USA; 5Abbott, Parsippany, NJ, USA
Aims: To assess the long-term efficacy of adalimumab (ADA) in fistula healing and response in Crohn’s disease (CD) patients (pts) from the CHARM trial in an open-label extension (OLE) follow-up study. Fistulas complicate the course of CD in 20%-30% of pts and often lead to surgical resection. ADA, a fully human monoclonal antibody targeting tumor necrosis factor, is effective in the induction and maintenance of remission in pts with CD and has demonstrated efficacy in fistula closure and response in CHARM.
METHODS: Pts in CHARM were randomized to placebo (PBO), ADA 40 mg every other week (EOW), or ADA 40 mg every week (EW). After flare or non-response, pts could receive open-label (OL) ADA at/after Week 12. At the end of CHARM (56 weeks), pts could enroll in an OLE in which they 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. Data were pooled from the 2 ADA dosing groups and analyzed with both non-responder imputation (data not shown) and last observation carried forward (LOCF) analyses. The percentage (%) of pts with 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 (24 total months of therapy) were evaluated.
RESULTS: Results are in the table below.
Table: Long-term Fistula Healing and Response With Adalimumab Therapy
Months since BL of CHARM Fistula healing* n (%) =>50% Fistula response* n (%)
635 (50)45 (64)
1235 (50)41 (59)
1839 (56)50 (71)
2442 (60)50 (71)

*Includes all ADA pts, EOW + EW (N=70), with fistulas at baseline of CHARM. Endpoints defined as complete healing, or =>50% reduction, of draining fistulas at time point since baseline of CHARM. Months 18 and 24 represent 6 and 12 months in OLE after up to 12 months of blinded therapy in the CHARM study. LOCF analysis.
CONCLUSIONS: ADA has demonstrated sustainable efficacy in fistula healing and response through 2 years of therapy. Almost two-thirds of the pts in the OLE who had fistulas at baseline of CHARM showed sustained response with ADA therapy, and more than half showed sustained fistula closure.
Funded by Abbott Laboratories

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