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P560. Comparison of efficacy and tolerance of two maintenance regimens with adalimumab in patients with moderate to severe Crohn's disease

J. Filippi1, D. Agrefilo2, E. Fontas3, X. Hébuterne2, 1University of Nice Sophia Antipolis, Gastroenterology Department, Nice, France, 2University of Nice Sophia Antipolis, Gastroenterology Department, Archet 2 Hospital, Nice, France, 3University of Nice Sophia Antipolis, Clinical Research Department, Nice, France

Background

In adult patients with Crohn's disease (CD), the induction regimen commonly used with adalimumab (ADA) is 160 mg at week 0 (w0) and 80 mg at w2, followed by a maintenance regimen of 40 mg every other week (eow). In situations of partial response or loss of response, the interval between injections can be shortened to one week, or the dose can be increased to 80 mg eow. The aim of this study was to assess the efficacy and safety of a systematic maintenance optimization of the dose (80 mg eow), in comparison with the classical regimen (40 mg eow).

Methods

This monocentric, retrospective study was based on the ADA prescribing practices of two physicians implicated in the management of CD patients: one using the classical (CLA) dose (160 mg w0, 80 mg w2 and 40 mg eow), the other using the systematic optimized (OPT) dose (160 mg w0 and 80 eow). Outpatients with moderate to severe CD, treated with ADA and followed every three months between 2007 and 2011, were studied. Baseline characteristics, efficacy and tolerance of the two regimens were assessed. Results are expressed as percentage and median. Comparisons were performed using Chi-square tests for qualitative parameters, exact Fisher tests (for small sample size) and Mann–Whitney tests for quantitative parameters.

Results

A total of 84 patients (39 CLA and 45 OPT) were analyzed. Baseline characteristics were similar between the two groups. In the CLA and OPT groups, 30.8% and 28.9% of patients had concomitant immunosuppressive drugs, 33.3% and 46.7% of patients were on second line of anti TNF alpha therapy and at baseline, the median Harvey Bradshaw Index (HBI) was 11.6 and 10.7, respectively (NS).

At 3, 6, 9 and 12 months, the steroid-free remission (HBI <4) rates were 66.7%, 65.8%, 59% and 40.7% in the CLA group and 84.4%, 84.2%, 82% and 81.3% in the OPT group respectively (p = 0.05 at months 3 and 6, p = 0.01 at month 9 and p = 0.001 at month 12). During follow-up, treatment optimization was required in 64.1% of CLA patients versus 13.3% of OPT patients (p < 0.0001); in 31.1% of patients in the OPT group it was possible to taper the maintenance regimen to 40 mg eow. There was no significant difference concerning the occurrence of side effects (tumor, dermatological, infectious, and rheumatic) between groups.

Conclusion

In moderate to severe CD patients, maintenance treatment with ADA systematically optimized at 80 mg eow appears to be more effective than the standard regimen, with a similar tolerance.