PMID- 30982208 OWN - NLM STAT- MEDLINE DCOM- 20200507 LR - 20200507 IS - 1573-2568 (Electronic) IS - 0163-2116 (Linking) VI - 64 IP - 10 DP - 2019 Oct TI - Therapeutic Efficacy and Adverse Events of Tacrolimus in Patients with Crohn's Disease: Systematic Review and Meta-Analysis. PG - 2945-2954 LID - 10.1007/s10620-019-05619-1 [doi] AB - BACKGROUND: Only a few randomized controlled trials (RCTs) and some uncontrolled trials have reported the efficacy and adverse events (AEs) of tacrolimus (Tac) in patients with refractory Crohn's disease (CD). The aim of this study was to undertake a systematic review and meta-analysis of the therapeutic efficacy and AEs of Tac in patients with CD. METHODS: We investigated studies reporting the therapeutic efficacy of Tac in patients with CD from 1950 until December 2017. Study subjects were categorized into three groups: systemic administration of Tac for patients with luminal CD (Group 1); systemic administration of Tac for patients with perianal CD (Group 2); and topical administration of Tac for patients with localized CD (Group 3). The primary endpoint of this study was the remission rate. Secondary endpoints were partial response rate, factors related to remission, and the incidence of AEs. RESULTS: The remission rate of Group 1, 2, and 3 was 37.1, 32.0, and 22.7%, respectively. The partial response rate of those was 42.3, 42.9, and 44.3%, respectively. In addition, the incidence of AEs of those was 50.9, 65.5, and 40.0%, respectively. No life-threatening AEs were observed in any study. CONCLUSION: This systematic review and meta-analysis demonstrated that Tac therapy was effective for subpopulation of CD patients and that the incidence of AEs was tolerable. Therefore, Tac therapy should be considered an option for patients with CD. However, there have been few well-designed RCTs on this subject and further studies are required. FAU - Iida, Tomoya AU - Iida T AUID- ORCID: 0000-0003-2842-8052 AD - Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. FAU - Nojima, Masanori AU - Nojima M AD - Center for Translational Research, The Institute of Medical Science Hospital, The University of Tokyo, Tokyo, 108-8639, Japan. FAU - Nakase, Hiroshi AU - Nakase H AD - Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. hiropynakase@gmail.com. LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Systematic Review DEP - 20190413 PL - United States TA - Dig Dis Sci JT - Digestive diseases and sciences JID - 7902782 RN - 0 (Immunosuppressive Agents) RN - WM0HAQ4WNM (Tacrolimus) SB - IM MH - Crohn Disease/*drug therapy MH - Humans MH - Immunosuppressive Agents/administration & dosage/adverse effects MH - Remission Induction MH - *Tacrolimus/administration & dosage/adverse effects MH - Treatment Outcome OTO - NOTNLM OT - Crohn's disease OT - Meta-analysis OT - Systematic review OT - Tacrolimus EDAT- 2019/04/15 06:00 MHDA- 2020/05/08 06:00 CRDT- 2019/04/15 06:00 PHST- 2018/11/05 00:00 [received] PHST- 2019/04/08 00:00 [accepted] PHST- 2019/04/15 06:00 [pubmed] PHST- 2020/05/08 06:00 [medline] PHST- 2019/04/15 06:00 [entrez] AID - 10.1007/s10620-019-05619-1 [pii] AID - 10.1007/s10620-019-05619-1 [doi] PST - ppublish SO - Dig Dis Sci. 2019 Oct;64(10):2945-2954. doi: 10.1007/s10620-019-05619-1. Epub 2019 Apr 13.