Efficacy and safety of tofacitinib for moderate and severe ulcerative colitis in real clinical practice: an open observational prospective study


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Background. Tofacitinib (TOFA) is the first synthetic selective Janus kinases (JAK) inhibitor used in the treatment of ulcerative colitis, which contributes to the rapid induction of clinical remission, reduces the risk of immunogenicity and has the fewest side effects. Objective. Evaluation of the efficacy and safety of therapy with tofacitinib in patients with moderate and severe UC in real clinical practice; identification of the frequency and reasons for the need to prolong the induction course of tofacitinib in UC patients. Methods. The study included 35 patients with exacerbation of UC (mean age - 40.6±11.8 years, mean disease duration - 6.1±2.2 years). There were 23 (65.6%) patients with moderate UC, 12 (34.4%) - with severe UC; primary inefficiency or loss of response to GIBD was detected in 25 (71.4%) patients, extraintestinal manifestations - in 22 (62.8%). Patients were prescribed TOFA at induction dose of 10 mg twice a day for 8 weeks, followed by a maintenance dose of 5 mg twice a day. The dynamics of clinical symptoms and inflammatory activity measures were assessed at the 12th week of treatment. Results. Quick clinical response on the 3rd day of treatment was detected in 18 (51.4%) patients. At the 8th week of therapy, 26 (74.3%) patients showed clinical remission according to the Mayo scale, 8 (22.8%) patients achieved clinical response indicators, and 1 (2.8%) did not respond to therapy. At the 12th week, 26 (74.3%) patients maintained the achieved clinical remission, 7 (20%) had a clinical effect, and 2 (10%) had no improvement. In respect to extraintestinal manifestations, at the 8th week of treatment, a decrease in articular syndrome was noted in 10 (71.4%) of 14 patients, regression of skin and mucous lesions - in 4 (57.1%) of 7 patients. There were no cases of AEs that could cause drug withdrawal. Conclusion. Tofacitinib has been shown to be highly effective in induction and maintenance therapy in a cohort of patients with severe and moderate UC who do not respond to the treatment with disease-modifying agents and GIBD. The drug is characterized by good tolerance and a sufficient safety profile. Further studies are required to study the long-term efficacy and safety of tofacitinib in real clinical practice.

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作者简介

O. Knyazev

A.S. Loginov Moscow Clinical Scientific and Practical Center; Research Institute for Healthcare Organization and Medical Management

Moscow, Russia

T. Shkurko

A.S. Loginov Moscow Clinical Scientific and Practical Center; Research Institute for Healthcare Organization and Medical Management

Moscow, Russia

A. Kagramanova

A.S. Loginov Moscow Clinical Scientific and Practical Center

Moscow, Russia

Albina Lishchinskaya

A.S. Loginov Moscow Clinical Scientific and Practical Center

Email: lalbina@inbox.ru
Cand. Sci. (Med.), Senior Researcher at the Department of Treatment of Inflammatory Bowel Diseases Moscow, Russia

D. Bordin

A.S. Loginov Moscow Clinical Scientific and Practical Center; Tver State Medical University; A.I. Yevdokimov Moscow State University of Medicine and Dentistry

Moscow, Russia; Tver, Russia

A. Parfenov

A.S. Loginov Moscow Clinical Scientific and Practical Center

Moscow, Russia

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