P002  Frequency and causes of prolongation of the induction course of tofacitinib in patients with ulcerative colitis.

Knyazev Oleg1, Kagramanova Anna1, Lishchinskaya Albina1, Shkurko Tatyana2, Zvyaglova Mariya1, Kulakov Dmitriy1, Demchenko Alexandra1
1 Moscow Clinical Scientific Center named after A. S. Loginov, Moscow, Russia, 2 Research Institute of Health Organization and Medical Management, Moscow, Russia

BACKGROUND: Tofacitinib is a selective immunosuppressant, the first representative of the Janus kinase family inhibitors, which has a high selectivity against other kinases of the human genome. According to the results of the study, tofacitinib inhibits JAK-1, JAK-2 and in high concentrations-JAK-3 and tyrosine kinase-2. The drug is registered in Russia for the treatment of patients with ulcerative colitis. According to the instructions for medical use, in patients with incomplete response to the induction course, it is possible to conduct an additional 8 weeks of therapy at an induction dose of 10 mg 2 times a day.  Aim: to identify the frequency and reasons for the need to prolong the induction course of tofacitinib in patients with ulcerative colitis.

METHODS: 35 patients with ulcerative colitis (UC) who received tofacitinib were observed in the Department of inflammatory bowel diseases. Patients were divided into two groups. Group 1 (n=10) of patients were bio naive. The 2nd group of patients (n=25) had previous experience of treatment with one or more anti-TNF-α drugs. The necessity of prolongation up to 16 weeks of induction course of tofacitinib was assessed in patients with insufficient clinical response at week 8 of therapy (reduction of partial index of Mayo less than 30%) and lack of normalization of laboratory parameters (CRP, hemoglobin, FCP). The comparative analysis was carried out by the method of four-field tables using nonparametric statistical criteria.

RESULTS: In the follow-up period among group 1 UC patients (n=10) who had not previously received anti-TNF-α drugs, the need for a prolonged induction course of tofacitinib was not required in any patient (0%). In the 2-nd group of patients (n=25), previously treated with anti-TNF-α drugs, a prolonged induction course of tofacitinib was required in 9 (36%) patients (x2-4.484; p= 0.028).

CONCLUSION(S): The need for prolongation up to 16 weeks of the induction course of tofacitinib in patients with ulcerative colitis b is significantly higher in patients who have previously received one or more anti-TNF-α drugs.