title: Benefit-risk assessment of golimumab in the treatment of refractory ulcerative colitis.
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.
authors.affiliation: Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Pugliese
authors.affiliation: Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Felice
authors.affiliation: Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
authors.forename: Rosario
authors.initials: R
authors.lastname: Landi
authors.affiliation: Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Papa
authors.affiliation: Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
authors.forename: Luisa
authors.initials: L
authors.lastname: Guidi
authors.affiliation: Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Armuzzi
keywords: anti-TNF-alpha; golimumab; refractoriness; ulcerative colitis