TY - JOUR
T1 - Tacrolimus for the treatment of active rheumatoid arthritis
T2 - A systematic review and meta-analysis of randomized controlled trials
AU - Lee, Y. H.
AU - Woo, J. H.
AU - Choi, S. J.
AU - Ji, J. D.
AU - Bae, S. C.
AU - Song, G. G.
N1 - Funding Information:
This study was supported by a grant from the Korea Healthcare Technology R&D Project, Ministry for Health, Welfare and Family Affairs, Republic of Korea (A084794).
PY - 2010/8
Y1 - 2010/8
N2 - 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 46) months. American College of Rheumatology 20, 50, and 70 (ACR20, ACR50, and ACR70) response rates were significantly higher in the tacrolimus 3 mgday group (n 390) than in the controls (n 402) [primary efficacy outcome, ACR50; risk ratio (RR) 2.583, 95 confidence interval (CI) 1.0956.092, p 0.030], and efficacies in the tacrolimus 1.52 mgday 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 0.8952.187, 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 1.53 mgday, was found to be effective in DMARD-resistant or -intolerant patients with active RA.
AB - 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 46) months. American College of Rheumatology 20, 50, and 70 (ACR20, ACR50, and ACR70) response rates were significantly higher in the tacrolimus 3 mgday group (n 390) than in the controls (n 402) [primary efficacy outcome, ACR50; risk ratio (RR) 2.583, 95 confidence interval (CI) 1.0956.092, p 0.030], and efficacies in the tacrolimus 1.52 mgday 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 0.8952.187, 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 1.53 mgday, was found to be effective in DMARD-resistant or -intolerant patients with active RA.
UR - http://www.scopus.com/inward/record.url?scp=77954879792&partnerID=8YFLogxK
U2 - 10.3109/03009740903501642
DO - 10.3109/03009740903501642
M3 - Article
C2 - 20476867
AN - SCOPUS:77954879792
VL - 39
SP - 271
EP - 278
JO - Scandinavian Journal of Rheumatology
JF - Scandinavian Journal of Rheumatology
SN - 0300-9742
IS - 4
ER -