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Benefit–risk assessment of golimumab in the treatment of refractory ulcerative colitis

Authors Pugliese D, Felice C, Landi R, Papa A, Guidi L, Armuzzi A

Received 29 July 2015

Accepted for publication 10 November 2015

Published 3 February 2016 Volume 2016:8 Pages 1—7


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Professor Chul Ahn

Daniela Pugliese, Carla Felice, Rosario Landi, Alfredo Papa, Luisa Guidi, Alessandro Armuzzi

Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy

Abstract: Significant advances in the management of patients with ulcerative colitis (UC) have been made since the introduction of anti-tumor necrosis factor (TNF)-alpha agents, especially for those who fail or do not tolerate conventional therapies. Two drugs, infliximab first, then adalimumab afterward, showed effectiveness in inducing and maintaining long-term remission both in pivotal trials as well as in clinical practice. However, approximately 25% of patients with UC, who fail or do not tolerate all available therapies, require a colectomy for refractory disease. The therapeutic scenario of UC has been recently upgraded by the introduction of golimumab, the latest anti TNF-alpha agent to be approved. Golimumab is a totally humanized monoclonal antibody, administered by a subcutaneous injection every 4 weeks. Treatment with golimumab has shown to be effective to induce sustained clinical benefit in tough-to-treat patients with UC, including steroid and/or immunosuppressive refractory and steroid-dependent patients. In this review, we summarize all available efficacy and safety data of golimumab in UC, analyzing the potential therapeutic position for the treatment of refractory patients with UC.

Keywords: ulcerative colitis, refractoriness, anti-TNF-alpha, golimumab

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