Tacrolimus for the treatment of active rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials
- Authors
- Lee, Y. H.; Woo, J-H; Choi, S. J.; Ji, J. D.; Bae, S-C; Song, G. G.
- Issue Date
- 8월-2010
- Publisher
- TAYLOR & FRANCIS LTD
- Citation
- SCANDINAVIAN JOURNAL OF RHEUMATOLOGY, v.39, no.4, pp.271 - 278
- Indexed
- SCIE
SCOPUS
- Journal Title
- SCANDINAVIAN JOURNAL OF RHEUMATOLOGY
- Volume
- 39
- Number
- 4
- Start Page
- 271
- End Page
- 278
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/115957
- DOI
- 10.3109/03009740903501642
- ISSN
- 0300-9742
- Abstract
- Objective. The aim of this study was to assess the efficacy and safety of tacrolimus in patients with active rheumatoid arthritis (RA). Methods. We surveyed randomized controlled trials (RCTs) and open-label studies that examined the efficacy and toxicity of tacrolimus in disease-modifying anti-rheumatic drug (DMARD) - and methotrexate (MTX)-resistant or intolerant patients with active RA patients using Medline, the Cochrane Controlled Trials Register, and by performing manual searches. Meta-analysis of RCTs was performed to determine treatment efficacy and safety outcomes. The results are presented as risk ratios (RRs), weighted mean differences (WMDs), or standardized mean differences (SMDs). Open-label studies were included in the systematic review. Results. The four RCTs included 1014 DMARD-resistant or -intolerant patients with DMARD-resistant or -intolerant RA. Median follow-up duration was 6 (range 4-6) months. American College of Rheumatology 20, 50, and 70% (ACR20, ACR50, and ACR70) response rates were significantly higher in the tacrolimus 3 mg/day group (n = 390) than in the controls (n = 402) [primary efficacy outcome, ACR50; risk ratio (RR) 2.583, 95% confidence interval (CI) 1.095-6.092, p = 0.030], and efficacies in the tacrolimus 1.5-2 mg/day group showed a similar pattern. Patients treated with tacrolimus withdrew from treatment because of adverse events (n = 222) (primary safety outcome, withdrawals due to adverse events; RR 1.475, 95% CI 0.895-2.187, p = 0.053) more frequently than controls (n = 231), although this was not significant. All four open-label studies found that tacrolimus was safe, well-tolerated, and provided clinical benefits. Conclusions. Tacrolimus, at dosages of 1.5-3 mg/day, was found to be effective in DMARD-resistant or -intolerant patients with active RA.
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