RT Journal Article
SR Electronic
T1 Safety and Effectiveness of 6 Months’ Etanercept Monotherapy and Combination Therapy in Japanese Patients with Rheumatoid Arthritis: Effect of Concomitant Disease-modifying Antirheumatic Drugs
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1658
OP 1668
DO 10.3899/jrheum.120490
VO 40
IS 10
A1 Takao Koike
A1 Masayoshi Harigai
A1 Shigeko Inokuma
A1 Naoki Ishiguro
A1 Junnosuke Ryu
A1 Tsutomu Takeuchi
A1 Yoshiya Tanaka
A1 Hisashi Yamanaka
A1 Tomohiro Hirose
A1 Takunari Yoshinaga
A1 Michio Suzukawa
YR 2013
UL http://www.jrheum.org/content/40/10/1658.abstract
AB Objective. To assess real-world safety, tolerability, and effectiveness of etanercept monotherapy, etanercept plus methotrexate (MTX), or etanercept plus other disease-modifying antirheumatic drugs (DMARD) in Japanese patients with active rheumatoid arthritis (RA) despite previous treatment with DMARD. Methods. In this 24-week, all-cases postmarketing surveillance study, adverse events (AE) were coded using the Medical Dictionary for Regulatory Activities. Effectiveness was assessed every 4 weeks using the 28-joint Disease Activity Score and the European League Against Rheumatism response criteria. Results. Of 13,861 patients (81% women) in the analysis, 3616, 2506, and 7739, respectively, were classified into etanercept monotherapy (ETN-mono), etanercept plus DMARD other than MTX (ETN + DMARD), and etanercept plus MTX (ETN + MTX) groups. Rates of AE and serious AE (SAE) in the ETN + MTX group were lower than in other groups. Risk of SAE or serious infections was not significantly increased with higher versus lower MTX doses at baseline or with concomitant use of salazosulfapyridine or bucillamine in ETN + DMARD versus ETN-mono groups. A greater likelihood of achieving clinical remission was seen with ETN + MTX versus ETN-mono (OR 1.36; 95% CI, 1.16–1.60; p < 0.001). Higher MTX dose at baseline was associated with a higher remission rate (> 8 mg vs 0 to ≤ 4 mg, OR 1.47, 95% CI 1.07–2.00, p = 0.016; 6 to ≤ 8 mg vs 0 to ≤ 4 mg, OR 1.27, 95% CI 1.01–1.60, p = 0.038). Conclusion. Combination therapies with etanercept plus MTX or other DMARD were reasonably well tolerated, and ETN + MTX at higher doses was more effective than ETN-mono in Japanese patients with RA.