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219 INDUCTION, MAINTENANCE, AND SUSTAINABILITY OF THE HEALING OF DRAINING FISTULAS IN PATIENTS WITH CROHN'S DISEASE TREATED WITH ADALIMUMAB: RESULTS OF THE CHARM STUDY R Panaccione1, RA Enns2, JF Colombel3, WJ Sandborn4, SB Hanauer5, PF Pollack6 AIM: To evaluate the efficacy of adalimumab (ADA), a self-injectable, fully human monoclonal antibody that targets TNF, in the healing of draining fistulas in patients (pts) with active Crohn's disease (CD).
1University of Calgary, Calgary, Alberta, 2University of British Columbia, Vancouver, British Columbia; 3CHU Lille, Lille, France; 4Mayo Clinic, Rochester, Minnesota, 5University of Chicago, Illinois, 6Abbott Laboratories, Parsippany, New Jersey, USA
METHODS: In CHARM, a Phase III, double-blind, placebo-controlled study of the long-term maintenance of clinical remission and safety of ADA in pts with active moderate to severe CD (CDAI 220-450), all pts received open-label induction dosages of ADA sc, 80 mg at Wk 0 (BL) and 40 mg at Wk 2. At Wk 4, all pts were randomized to receive placebo (PBO) or ADA 40 mg sc every other week (EOW) or 40 mg weekly (W), through Wk 56. Complete healing was defined as no draining with gentle compression of all fistulas present at BL. Pts with draining fistulas at both screening and BL visits were evaluated for healing at Wks 26 and 56 and at their last 2 blinded study visits. Based on a pre-specified analysis plan, data from both ADA treatment arms were combined to obtain a more robust sample size and statistical power.
RESULTS: Clinical characteristics at BL were similar across treatment arms: mean age, 37 yrs; female, 62%; Caucasian, 93%; mean CDAI, 313; median CRP, 0.9 mg/dL; and immunosuppressant use, 47%. Of 854 patients enrolled, 778 were randomized at Wk 4. Of these, 499 were stratified as randomized responders (RR [CR-70 at Wk 4]). Results for patients with draining fistulas are shown, ADA EOW and W arms combined (Table).
Complete Fistula Healing in CHARM: Patients With Draining Fistulas, n/N (%)
Randomized pts
PBO
ADA
All
Wk 26
6/47 (13)
21/70 (30) *
Wk 56
6/47 (13)
23/70 (33) *
Last 2 visits
6/47 (13)
23/70 (33) *
Wks 26 and 56
6/47 (13)
21/70 (33) *
RR (CR-70)
Wk 26
4/28 (14)
14/36 (39) *
Wk 56
4/28 (14)
15/36 (42) *
* p<0.05 vs. PBO
CONCLUSIONS: In patients with active Crohn's disease, adalimumab therapy was significantly superior to placebo in maintaining complete fistula healing. In patients with fistula healing at Wk 26, healing was sustained at Wk 56.
Funded by Abbott Laboratories