EXPERIENCE OF TOFACITINIB USING IN THERAPY OF ULCERATIVE COLITIS IN REAL CLINICAL PRACTICE

Abstract

AIM: to demonstrate the first Russian experience with the use of tofaciminib (TOFA) for the treatment of moderate and severe UC in real clinical practice. PATIENTS AND METHODS: eighty-five patients with UC (aged 41.38±14.69 years, average disease duration 9.55±5.27 years, mild UC – 3.5%, moderate UC – 41.2%, severe – 52.9%, acute severe UC – 2.6%), resistant to corticosteroid therapy (36.5%) and biological agents (61.2%), were prescribed with TOFA at an induction dose of 10 mg 2 times a day, followed by a decrease in the dose to a maintenance dose (5 mg 2 times a day). Early clinical response, clinical and endoscopic remission, prevalence and dynamic of extraintestinal manifestations were assessed at 8 and 12 weeks of treatment, as well as safety and tolerability. RESULTS: Sixty-eight (80.0%) patients completed induction treatment with TOFA for 8 weeks, other patients continue to receive TOFA. A quick response within one week was detected in 41 (50.6%) patients, on average, on the 5th day of therapy. At the end of induction, 52 (76.5%) patients achieved clinical remission, 3 (4.4%) achieved a clinical response, 13 (19.1%) patients showed no positive changes. Of the 53 patients observed over 12 weeks, 41 (77.4%) had clinical remission, 6 (11.3%) had clinical improvement, and 6 (11.3%) patients had no response to the treatment. The changes of extraintestinal manifestations were positive: 55.2% of patients at week 8 and 77.8% of patients at week 12 showed clinical improvement, mainly in relation to the joint syndrome. One episode of herpes zoster infection, one case of anemia, were identified dur-ing 12 weeks of follow-up. CONCLUSION: TOFA in UC is effective in achieving a rapid clinical response, clinical remission and mucosal healing in patients who do not adequately respond to therapy with basic as well as biological drugs. Tofacitinib is an effective and safe therapeutic option for this challenging patient population.