Tofacitinib for the Treatment of Ulcerative Colitis: Analysis of Infection Rates from the Ulcerative Colitis Clinical Programme
| Autor: | Leonardo Salese, Rajiv Mundayat, Chinyu Su, Gary S. Friedman, Nervin Lawendy, Kevin L. Winthrop, Gary Chan, Walter Reinisch, Chudy I. Nduaka, Edward V. Loftus, Andrew John Thorpe, Daniel C. Baumgart |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Medication Therapy Management Opportunistic Infections Infections Placebo Herpes Zoster Risk Assessment Severity of Illness Index Gastroenterology Immunocompromised Host Eccojc/1040 Piperidines Internal medicine Humans Janus Kinase Inhibitors Medicine Herpes zoster disease AcademicSubjects/MED00260 ulcerative colitis tofacitinib Tofacitinib Dose-Response Relationship Drug business.industry Incidence Original Articles General Medicine medicine.disease Ulcerative colitis Confidence interval Pyrimidines Cohort Colitis Ulcerative Female business |
| Zdroj: | Journal of Crohn's & Colitis |
| ISSN: | 1876-4479 1873-9946 |
| DOI: | 10.1093/ecco-jcc/jjaa233 |
| Popis: | Background and Aims Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis. We report integrated analyses of infections in the Phase [P]2 and P3 OCTAVE programmes. Methods Three cohorts were analysed: Induction [P2/3 induction studies]; Maintenance [P3 maintenance study]; and Overall [all tofacitinib-treated patients in induction, maintenance, or ongoing, open-label, long-term extension studies; as of May 2019]. Proportions and incidence rates [IRs; unique patients with events/100 patient-years] of serious infections [SIs], herpes zoster [HZ] [non-serious and serious], and opportunistic infections [OIs] are reported [censored at time of event]. Results In the Induction Cohort [N = 1220], no patients receiving placebo and eight [0.9%] receiving tofacitinib 10 mg twice daily [BID] developed SIs. Maintenance Cohort [N = 592] SI IRs (95% confidence interval [CI]) were 1.94 [0.23–7.00] for placebo and 1.35 [0.16–4.87] and 0.64 [0.02–3.54] for tofacitinib 5 and 10 mg BID, respectively; HZ IRs were 0.97 [0.02–5.42], 2.05 [0.42–6.00], and 6.64 [3.19–12.22], respectively. In the Overall Cohort [N = 1157; 82.9% predominantly received tofacitinib 10 mg BID], SI, HZ, and non-HZ OI IRs were 1.70 [1.24–2.27], 3.48 [2.79–4.30], and 0.15 [0.04–0.38], respectively. No SIs resulted in death. Conclusions During induction, SIs were more frequent with tofacitinib versus placebo. SIs were generally infrequent in the Maintenance and Overall Cohorts, with rates comparable between treatment groups. Maintenance Cohort HZ IR was numerically higher with tofacitinib 10 mg BID versus 5 mg BID. Overall Cohort HZ IRs remained stable over time. Non-HZ OIs and viral infections were rare. |
| Databáze: | OpenAIRE |
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