• Yukiko Komano, Michi Tanaka, Toshihiro Nanki, Ryuji Koike, Ryoko Sakai, Hideto Kameda, Atsuo Nakajima, Kazuyoshi Saito, Mitsuhiro Takeno, Tatsuya Atsumi, Shigeto Tohma, Satoshi Ito, Naoto Tamura, Takao Fujii, Tetsuji Sawada, Hiroaki Ida, Akira Hashiramoto, Takao Koike, Yoshiaki Ishigatsubo, Katsumi Eguchi, Yoshiya Tanaka, Tsutomu Takeuchi, Nobuyuki Miyasaka, Masayoshi Harigai, and REAL Study Group.
• Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, and the Clinical Research Center, Tokyo Medical and Dental University, Tokyo, Japan.
• J Rheumatol. 2011 Jul 1; 38 (7): 1258-64.

ObjectiveTo compare tumor necrosis factor-α (TNF-α) inhibitors to nonbiological disease-modifying antirheumatic drugs (DMARD) for the risk of serious infection in Japanese patients with rheumatoid arthritis (RA).MethodsSerious infections occurring within the first year of the observation period were examined using the records for patients recruited to the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety (REAL), a hospital-based prospective cohort of patients with RA. The analysis included 1144 patients, 646 of whom were treated with either infliximab or etanercept [exposed group: 592.4 patient-years (PY)]. The remaining 498 patients received nonbiological DMARD with no biologics (unexposed group: 454.7 PY).ResultsIn the unexposed group, the incidence rate for all serious adverse events (SAE) was 9.02/100 PY and for serious infections, 2.64/100 PY. In the exposed group, SAE occurred in 16.04/100 PY and serious infections in 6.42/100 PY. The crude incidence rate ratio comparing serious infections in the exposed group with the unexposed group was 2.43 (95% CI 1.27-4.65), a significant increase. A multivariate analysis revealed that the use of TNF inhibitors is a significant independent risk factor for serious infection (relative risk 2.37, 95% CI 1.11-5.05, p = 0.026).ConclusionOur study has provided the first epidemiological data on Japanese patients with RA for the safety of TNF inhibitors compared to nonbiological DMARD for up to 1 year of treatment. Anti-TNF therapy was associated with a significantly increased risk for serious infections, compared to treatment with nonbiological DMARD.

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