Efficacy and safety of tofacitinib in moderate and severe ulcerative colitis in real clinical practice: three years of observation

Abstract

Introduction. Tofacitinib is the first member of a new class of targeted synthetic anti-inflammatory drugs for the treatment of ulcerative colitis (UC). The article presents a three-year Russian experience of tofacitinib use for the treatment of moderate and severe UC.Aim of the study. To evaluate the efficacy and safety of tofacitinib therapy in real clinical practice in moderate to severe UC patients during three years of follow-up.  Methods. The study included 56 patients with UC who had moderate (60.7%) and severe (35.8%) states of disease, the total lesion was diagnosed in 67.8%, and extraintestinal manifestations in 57.1% of patients. Early achievement of clinical response, clinical and endoscopic, corticosteroid-free remission, and safety were evaluated.Results. Early response to tofacitinib therapy was obtained in 47 (83.9%) patients. Clinical remission was achieved in 36 (64.3%) at week 8 of therapy and clinical response was achieved in 13 (23.2%) patients. The majority of patients who achieved clinical remission at weeks 8 and 12 achieved healing of colon mucosa at week 24. Clinical and endoscopic remission rates after 24 weeks – 44 (78.6%) patients, clinical response in 7 (12.5%) patients, 5 (8.9%) did not respond to TFCB therapy. Corticosteroidfree remission was 77.6%. After 2 years of tofacitinib therapy, remission of UC was maintained in 46 (82.1%). After 36 months, remission of UC was maintained in 45 (80.3%) of the 56 patients who had been started on tofacitinib therapy. The cumulative effect of survival in the treatment of tofacitinib in UC was 87.5% after 6 months and persisted for one year, 82.1% after 2 years, and 80.3% after 3 years.Conclusions. The administration of tofacitinib in UC is effective in achieving rapid clinical response, clinical remission, and mucosal healing in patients who do not respond well to biological therapy.