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P217. The efficacy of anti-TNF‑α antibody infliximab in refractory ulcerative colitis: Its positioning among the variety of treatment options

N. Inoue1, K. Matsuoka2, T. Hisamatsu2, J. Miyoshi2, Y. Mikami2, T. Sujino2, S. Okamoto2, T. Kanai2, H. Ogata1, Y. Iwao1, T. Hibi2

1Keio University School of Medicine, Center for Diagnostic and Therapeutic Endoscopy, Tokyo, Japan; 2Keio University School of Medicine, Division of Gastroenterology & Hepatology, Department of Internal Medicine, Tokyo, Japan

Background: Anti-TNF (tumor necrosis factor)-α antibody (infliximab: IFX) is one of rescue options for acute severe steroid-refractory ulcerative colitis (UC). In addition to tacrolimus which was already approved in Japan, IFX was recently approved for clinical use in patients with UC in Japan. In the present study, we evaluate the efficacy and safety of IFX in patients with intractable UC retrospectively.

Methods: We analysed 28 patients who were treated with infliximab at Keio University Hospital from June, 2010 through July, 2011. Infliximab (5 mg/kg body weight) was administered at 0, 2, 6 weeks and every 8 weeks thereafter. Indications for IFX were as follows; tacrolimus-failure (tacrolimus-refractory and relapse after tacrolimus therapy), steroid-refractory, steroid-dependent, others (intractable, extra-intestinal manifestations). Evaluation of the clinical response was based on a modified Truelove-Witts clinical activity index (CAI). Short-term clinical response was determined at 6 weeks after the start of IFX therapy. Efficacy of maintenance therapy and safety were also evaluated.

Results: Overall efficacy of induction therapy was 63.0% (remission: 37.0%, improvement; 26.0%). When looking at indications for infliximab administration, efficacies including remission and improvement were 40.0%, 85.7%, 57.1% and 100% for tacrolimus-failure, steroid-refractory, steroid-dependent and the others, respectively. Efficacy of IFX in patients with history of tacrolimus therapy was 41.7%, which was much lower than in those without tacrolimus (80.0%). Among patients who were administered infliximab as maintenance therapy, 6 of 8 patients who achieved remission with induction therapy remained remission. The rest 2 patients, who had relapsed, achieved remission with re-induction therapy or adjustment of administration schedule. As for safety issue, only one patient developed infusion reaction which required discontinuation of the therapy.

Conclusions: Our results suggested that infliximab therapy was safe and effective for induction and maintaining remission of ulcerative colitis refractory to conventional medical treatment, however, its efficacy might be lowered after tacrolimus therapy.