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• W3208492892 abstract "Introduction: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. Patients (pts) with UC are susceptible to C. difficile infection (CDI).1,2 In the tofacitinib UC clinical program, previous analyses showed CDI rates to be similar/numerically lower among tofacitinib-treated than PBO-treated pts.3 Here, we present an updated analysis of CDI in the tofacitinib UC clinical program, incl. final data from the completed open-label, long-term extension (OLE) study (as of Aug 24, 2020). Methods: CDI events were evaluated from 4 randomized, PBO-controlled studies (1 Phase (P)2 & 2 P3 induction studies [NCT00787202;NCT01465763;NCT01458951]; 1 maintenance P3 study [NCT01458574]) and 1 OLE study (NCT01470612), as 3 cohorts: Induction (P2/P3 induction), Maintenance (P3 maintenance), and Overall (pts receiving ≥ 1 dose of tofacitinib 5 or 10 mg BID in P2/P3/OLE studies). Pts in the Overall Cohort were analyzed by predominant dose (PD; 5 or 10 mg BID based on average daily dose < 15 mg or ≥ 15 mg, respectively). Proportions and incidence rates (IRs; unique pts with events per 100 pt-years [PY] of exposure) of CDI were evaluated. All pts had CDI screening; a positive test excluded pts from program entry. Results: The Overall Cohort comprised 1,157 pts who received ≥ 1 dose of tofacitinib 5 or 10 mg BID, representing 776.4 PY and 2,038.0 PY, respectively, of tofacitinib exposure and ≤ 7.8 years of treatment. 82.6% of pts received PD 10 mg BID. Induction and Maintenance Cohort CDI IRs were reported previously (Table 1). In the Overall Cohort, 9 pts had CDI (all PD 10 mg BID; Table 1); events were mild in 4 pts and moderate in 5. 6 pts continued study treatment without interruption; 3 discontinued (1 temporarily; 2 permanently). CDI resolved with treatment in 8 pts and was still present in 1 at the time of study discontinuation. 2 events were reported as serious AEs due to hospitalization. 8 pts with CDI had no prior history of CDI. 5 pts were receiving 5-ASA and 1 was receiving 5-ASA/corticosteroids when the CDI occurred. Conclusion: In the UC clinical program, CDI IRs among pts receiving tofacitinib were low and generally similar to those reported for vedolizumab in UC,2 similar to/lower than among all pts with IBD,4 and in this analysis remained stable since the previous data cut.3Table 1.: IRs of CDI Among Pts in the Induction, Maintenance, and Overall Cohorts" @default.
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• W3208492892 date "2021-10-01" @default.
• W3208492892 modified "2023-10-03" @default.
• W3208492892 title "S923 Clostridium difficile Infection in Patients Treated With Tofacitinib in the Ulcerative Colitis Clinical Program" @default.
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• W3208492892 doi "https://doi.org/10.14309/01.ajg.0000777224.78256.d2" @default.
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