PMID- 37977068 OWN - NLM STAT- MEDLINE DCOM- 20231228 LR - 20240207 IS - 1878-1705 (Electronic) IS - 1567-5769 (Linking) VI - 126 DP - 2024 Jan 5 TI - Effectiveness and safety of upadacitinib for inflammatory bowel disease: A systematic review and meta-analysis of RCT and real-world observational studies. PG - 111229 LID - S1567-5769(23)01556-4 [pii] LID - 10.1016/j.intimp.2023.111229 [doi] AB - BACKGROUND: Upadacitinib, a novel and selective inhibitor of Janus kinase 1, has demonstrated promising efficacy in managing inflammatory bowel disease (IBD). In this systematic review and meta-analysis, our primary aim was to comprehensively assess the therapeutic effectiveness and safety profile of upadacitinib in the treatment of patients with IBD. METHODS: We conducted an extensive literature search across prominent databases, including Medline, Embase, Web of Science, and Cochrane Central, to identify pertinent studies providing insights into the efficacy and safety of upadacitinib in IBD. The primary endpoint was the achievement of clinical remission, while secondary endpoints encompassed clinical response, endoscopic response, endoscopic remission, and the evaluation of adverse events (AEs). RESULTS: In this meta-analysis of nine studies, we categorized results by study type. Clinical remission rates were: RCTs 36 % (95 % CI = 30-42 %), real-world studies 25 % (95 % CI = 1-49 %), retrospective studies 40 % (95 % CI = 24-56 %), cohort studies 55 % (95 % CI = 25-85 %). Clinical response rates were: RCTs 61 % (95 % CI = 55-67 %), real-world studies 42 % (95 % CI = 14-70 %), cohort studies 65 % (95 % CI = 57-73 %). Endoscopic remission rates were: RCTs 19 % (95 % CI = 15-24 %), cohort studies 29 % (95 % CI = 5-52 %). Endoscopic response rates were: RCTs 41 % (95 % CI = 36-47 %), cohort studies 57 % (95 % CI = 31-83 %). Incidence rate for any AEs: IBD 69 % (95 % CI = 63-76 %), UC 65 % (95 % CI = 57-74 %), CD 75 % (95 % CI = 67-82 %). CONCLUSION: Cumulative data from real-world studies and trials confirm the efficacy of upadacitinib in IBD induction and maintenance, with consistent safety. However, further long-term studies are needed to understand its sustained effectiveness and safety. CI - Copyright (c) 2023 Elsevier B.V. All rights reserved. FAU - Zheng, Dian-Yu AU - Zheng DY AD - Department of Gastroenterology, First Hospital of China Medical University, Shenyang City, Liaoning Province, China. FAU - Wang, Yi-Nuo AU - Wang YN AD - Department of Gastroenterology, First Hospital of China Medical University, Shenyang City, Liaoning Province, China. FAU - Huang, Yu-Hong AU - Huang YH AD - Department of Gastroenterology, First Hospital of China Medical University, Shenyang City, Liaoning Province, China. FAU - Jiang, Min AU - Jiang M AD - Department of Gastroenterology, First Hospital of China Medical University, Shenyang City, Liaoning Province, China. FAU - Dai, Cong AU - Dai C AD - Department of Gastroenterology, First Hospital of China Medical University, Shenyang City, Liaoning Province, China. Electronic address: congdai2006@sohu.com. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20231116 PL - Netherlands TA - Int Immunopharmacol JT - International immunopharmacology JID - 100965259 RN - 4RA0KN46E0 (upadacitinib) SB - IM MH - Humans MH - *Crohn Disease/drug therapy MH - Retrospective Studies MH - Remission Induction MH - *Inflammatory Bowel Diseases/drug therapy MH - *Colitis, Ulcerative/drug therapy MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - Adverse events OT - Crohn's disease OT - Inflammatory bowel disease OT - Remission OT - Ulcerative colitis OT - Upadacitinib COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2023/11/18 11:42 MHDA- 2023/12/28 06:42 CRDT- 2023/11/17 18:19 PHST- 2023/08/19 00:00 [received] PHST- 2023/10/23 00:00 [revised] PHST- 2023/11/11 00:00 [accepted] PHST- 2023/12/28 06:42 [medline] PHST- 2023/11/18 11:42 [pubmed] PHST- 2023/11/17 18:19 [entrez] AID - S1567-5769(23)01556-4 [pii] AID - 10.1016/j.intimp.2023.111229 [doi] PST - ppublish SO - Int Immunopharmacol. 2024 Jan 5;126:111229. doi: 10.1016/j.intimp.2023.111229. Epub 2023 Nov 16.