Tofacitinib for the Treatment of Ulcerative Colitis: Up to 6.8 Years of Safety Data From Global Clinical Trials
Refereed conference paper presented and published in conference proceedings

香港中文大學研究人員

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摘要INTRODUCTION:
Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. Efficacy and safety of tofacitinib were evaluated in randomized, placebo-controlled Phase (P)2 (NCT00787202) and P3 (NCT01465763; NCT01458951; NCT01458574) studies, and in an ongoing, open-label, long-term extension (OLE) study (NCT01470612) (1–3). We report updated tofacitinib safety analyses from the tofacitinib UC clinical program, with exposure up to 6.8 years.

METHODS:
Two cohorts were analyzed: P3 Maintenance (N = 592; patients [pts] receiving placebo, tofacitinib 5 or 10 mg twice daily [BID]) and Overall (N = 1,157; pts receiving tofacitinib 5 or 10 mg BID in P2/P3/OLE studies; data as of May 2019, database not locked). Proportions and incidence rates (IRs; unique pts with events per 100 pt-years [PY] of exposure) were evaluated for adverse events (AEs) of special interest. Opportunistic infections (OIs), malignancies, major adverse cardiovascular events (MACE), and gastrointestinal (GI) perforations were reviewed by independent adjudication committees.

RESULTS:
Demographics, clinical characteristics, and safety data are shown in the table. In the Overall Cohort, 1,157 pts received ≥ 1 dose of tofacitinib 5 or 10 mg BID; most pts (N = 959, 83%) received an average dose of 10 mg BID. Median treatment duration was 623 (range 1–2,494) days (2,581.3 PY of exposure). IRs (95% confidence interval) for AEs of special interest were: deaths, 0.19 (0.06, 0.44); serious infections, 1.70 (1.24, 2.27); herpes zoster (non-serious and serious), 3.48 (2.79, 4.30); OIs, 1.07 (0.71, 1.55); malignancies (excl. non-melanoma skin cancer [NMSC]), 0.75 (0.46, 1.16); NMSC, 0.73 (0.44, 1.13); MACE, 0.26 (0.11, 0.54); deep vein thrombosis, 0.04 (0.00, 0.21); pulmonary embolism, 0.15 (0.04, 0.38); GI perforations, 0.11 (0.02, 0.33). Results in the Overall Cohort as per the previous Nov 2017 data cut are presented for context (4).

CONCLUSION:
The safety profile of tofacitinib in pts with UC was manageable and consistent with that of other UC therapies incl. biologics. Overall, IRs for AEs of interest have generally remained stable in the tofacitinib UC clinical program over an extended period of time (up to 6.8 years).
著者Sandborn WJ, Panes J, D'Haens GR, Sands BE, Panaccione R, Ng SC, Jones TV, Lawendy N, Kulisek N, Mundayat R, Su CY
會議名稱2020 ACG Annual Meeting
會議開始日23.10.2020
會議完結日28.10.2020
會議地點Virtual
會議國家/地區Others
會議論文集題名The American Journal of Gastroenterology
出版作品名稱AMERICAN JOURNAL OF GASTROENTEROLOGY
出版年份2020
月份10
卷號115
期次Supplement
出版社LIPPINCOTT WILLIAMS & WILKINS
頁次S353 - S354
國際標準期刊號0002-9270
語言英式英語
Web of Science 學科類別Gastroenterology & Hepatology;Gastroenterology & Hepatology

上次更新時間 2022-12-01 於 23:39