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P516. Efficacy of adalimumab in refractory ulcerative colitis in clinical practice

M. Lequoy1, P. Seksik2, Y. Bouhnik3, M. Allez4, F. Carbonnel5, A. Bourrier1, H. Sokol2, L. Beaugerie2, J. Cosnes2, 1Hôpital Saint Antoine, 75012, Paris, France, 2Hôpital Saint Antoine, Gastro-Entérologie, Paris, France, 3Hôpital Beaujon, 92, Clichy, France, 4Hôpital Saint Louis, 75010, Paris, France, 5CHU de Bicêtre, 94, Le Kremlin-Bicêtre, France

Background

Controlled trials have demonstrated the efficacy of anti-TNF in ulcerative colitis (UC). Unlike infliximab (IFX), there are limited data with regard to the efficacy of adalimumab (ADA) in clinical practice. The aim of this study was to evaluate the efficacy of ADA for inducing and maintaining remission in patients with refractory UC.

Methods

This retrospective and multicentre study included 68 consecutive patients with refractory UC (n = 62) or unclassified colitis (n = 6) treated with ADA between 2006 and 2012 as rescue therapy. 36 of those had lost response to IFX, 14 had developed intolerance, 13 were primary failures, and 13 patients had refused IFX. Study endpoints were achievement of clinical remission (clinical Mayo score [without endoscopy] ≤2), time-to-clinical recurrence (Kaplan–Meier) and time-to-colectomy (Kaplan–Meier). In addition, we compared disease course through semesters between 56 patients treated with ADA and 56 patients treated with IFX matched for sex and duration of prior anti-TNF treatment.

Results

Among the 63 patients who were active when starting ADA, 40 (63%) achieved clinical remission after a median period of 1 month. Among the 45 patients in clinical remission after induction with ADA (n = 40) or switched from IFX while inactive (n = 5), 32 (71%) were still in remission at 1 year and 26 (58%) at 2 years. Among the total of 68 patients, 14 (21%) underwent colectomy (cumulative rate 34% at 4 years). Predictive factors of colectomy were early disease (p < 0.05), deep ulcerations (p = 0.04), thrombocytosis (p < 0.05) and anemia (p < 0.02). No patient died during the survey. Six (9%) had non serious adverse events. Overall, ADA showed complete efficacy (achievement and/or maintenance of clinical remission along follow-up) in 31 patients (46%). Comparison with patients maintained under IFX showed no significant differences regarding time-to-clinical recurrence, time-to-colectomy, and median values of clinical Mayo score, CRP and hemoglobin. However steroids were used more often in the ADA group (18 on 119 semesters (15%) versus 5 on 197 (3%) in the IFX group; p = 0.03).

Conclusion

In clinical practice, ADA is well tolerated and effective as it is able to achieve and maintain clinical remission in about half patients with refractory ulcerative colitis, in particular in those who had lost response or had developed intolerance to IFX.