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P442. Infliximab versus combination infliximab and immunosuppressant therapy for patients with active ulcerative colitis: a meta-analysis

D. Christophorou1, N. Funakoshi1, Y. Duny2, J.-C. Valats1, M. Bismuth1, J.-P. Daures2, P. Blanc1, 1University Hospital Saint Eloi, Department of Hepatology and Gastroenterology, Montpellier, France, 2CHU Nimes, Departement d' Information Medicale, Nimes, France

Background

The SUCCESS trial demonstrated the superiority of combined infliximab (IFX) and azathioprine therapy over IFX therapy alone at 16 weeks for immunosuppressant (IS) naïve patients with moderate to severe ulcerative colitis (UC). Nevertheless, the benefit of combination therapy remains debated for all UC patients regardless of prior IS use. The aim of this meta-analysis was to determine whether combination IFX and IS therapy is more effective than infliximab alone for patients with moderate to severe active UC regardless of prior IS use.

Methods

We identified all published controlled trials including patients with moderate to severe active UC, treated by either IFX alone or combined IFX-IS therapy (azathioprine, 6-mercaptopurine ou methotrexate), by using the bibliographic database of the National Library of Medecine and the abstract books of international congresses. The main outcome was clinical remission at 6 months, defined as a Mayo score inferior or equal to 3. Two statistical methods were used, Mantel-Haenszel and Der-Simonian and Laird. Intertrial heterogeneity was taken into account and publication bias was assessed.

Results

Three controlled trials were analyzed and included in the meta-analysis: two were published as original articles and one in an abstract form. These three trials included 522 patients, 271 treated with IFX alone and 251 treated with IFX and IS. The clinical remission rate was significantly higher in the combination therapy group (IFX-IS) OR 0.48, 95% CI [0.33–0.69], P < 0.0001, (P-heterogeneity=0.36). The Harbord test for small study effects did not show evidence of publication bias (p = 0.29). Calculation of an adjusted OR using the Duval and Tweedie method did not modify results (OR 0.63, 95% CI [0.47–0.85]). This result can be considered as robust, as according to Orwin's formula, four additional medium-sized non-significant studies would be necessary to reduce the effect size to a non-significant value.

Conclusion

Combination therapy with IFX-IS is significantly more effective than IFX alone for the obtention and maintenance of clincal remission at 6 months' for patients with moderate to severe ulcerative colitis, regardless of prior IS use.