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ABSTRACT Biosimilars are not generic drugs. These are more complex medications than small molecules, with identical chemical structures of monoclonal antibodies that lost their patency over time. Besides identical to the original product at the end, the process of achieving its final forms differs from the one used in the reference products. These differences in the formulation process can alter final outcomes such as safety and efficacy of the drugs. Recently, a biosimilar of Infliximab was approved in some countries, even to the management of inflammatory bowel diseases. However, this decision was based on studies performed in rheumatologic conditions such as rheumatoid arthritis and ankylosing spondylitis. Extrapolation of the indications from rheumatologic conditions was done for Crohn’s disease and ulcerative colitis based on these studies. In this article, the authors explain possible different mechanisms in the pathogenesis between rheumatologic conditions and inflammatory bowel diseases, that can lead to different actions of the medications in different diseases. The authors also alert the gastroenterological community for the problem of extrapolation of indications, and explain in full details the reasons for being care with the use of biosimilars in inflammatory bowel diseases without specific data from trials performed in this scenario.

ABSTRACT BACKGROUND: Adalimumab is a monoclonal antibody, tumor necrosis factor-alpha (TNFα) inhibitor that has efficacy for inducing and maintaining remission in moderate-to-severe ulcerative colitis. Real world studies with adalimumab in Latin American ulcerative colitis patients are scarce. OBJECTIVE: To assess the clinical remission rates in induction and maintenance with adalimumab therapy in ulcerative colitis. METHODS: Observational, multicenter and retrospective study on a case series of patients with moderate-to-severe ulcerative colitis under adalimumab therapy. The variables analyzed were: demographic data, previous infliximab status, concomitant drugs, the Montreal Classification, disease activity (Mayo score) at weeks 0, 8, 26 and 52, or until the last follow-up. Clinical remission was defined as a partial Mayo score ≤2 and Last observation carried forward (LOCF) and Non responder imputation (NRI) analysis were used. RESULTS: Thirty-six patients were included in the study. With LOCF analysis, remission rates at weeks 8, 26 e 52 were of 41.7%, 47.2% and 47.2%, respectively. With NRI analysis, remission rates at weeks 8, 26 and 52 were of 41.7%, 41.7% and 27.8%, respectively. CONCLUSION: Adalimumab was effective in the treatment of moderate-to-severe ulcerative colitis. Clinical remission was observed in approximately 40% of the patients at weeks 8 and 26, and in almost a quarter of the patients after 1 year of follow up.

Ulcerative colitis treatment intends to induce remission, and its maintenance. Biological drugs, such as infliximab, have been indicated in moderate and severe cases of the disease, which are unresponsive to conventional medication. Randomized controlled trials proved the efficacy of biological treatment with high rates of sustained disease remission and mucosal healing. Recently, the concept of mucosal healing has been inversely associated with surgical treatment. Patients treated with infliximab have lower colectomy rates than those receiving conventional therapies. We suppose that earlier use of biological drugs in disease's course would lead to better clinical control and mucosal healing, with a consequent reduction in colectomy rates. To support this hypothesis, a literature review from January, 1996 to April, 2011 was performed.O tratamento da colite ulcerativa tem como objetivo induzir a remissão, além da manutenção da remissão da doença. Agentes biológicos como o infliximabe têm sido indicados em casos moderados e graves da doença, os quais não respondem à medicação convencional. Ensaios clínicos randomizados comprovaram a eficácia do tratamento biológico com altas taxas de remissão da doença e cicatrização sustentada da mucosa. Recentemente, o conceito de cicatrização da mucosa tem sido inversamente associado com o tratamento cirúrgico. Pacientes tratados com infliximabe têm taxas mais baixas de colectomia se comparados com aqueles que receberam terapias convencionais. Supõe-se que quanto mais cedo for introduzida a terapia biológica no curso da doença, melhor seriam o controle clínico e a cicatrização da mucosa, com consequente redução nas taxas de colectomia. Para apoiar esta hipótese, foi realizada uma revisão da literatura entre janeiro de 1996 e abril de 2011.