TY - JOUR T1 - Incidence and Risk Factors for Serious Infection in Patients with Rheumatoid Arthritis Treated with Tumor Necrosis Factor Inhibitors: A Report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety JF - The Journal of Rheumatology JO - J Rheumatol SP - 1258 LP - 1264 DO - 10.3899/jrheum.101009 VL - 38 IS - 7 AU - YUKIKO KOMANO AU - MICHI TANAKA AU - TOSHIHIRO NANKI AU - RYUJI KOIKE AU - RYOKO SAKAI AU - HIDETO KAMEDA AU - ATSUO NAKAJIMA AU - KAZUYOSHI SAITO AU - MITSUHIRO TAKENO AU - TATSUYA ATSUMI AU - SHIGETO TOHMA AU - SATOSHI ITO AU - NAOTO TAMURA AU - TAKAO FUJII AU - TETSUJI SAWADA AU - HIROAKI IDA AU - AKIRA HASHIRAMOTO AU - TAKAO KOIKE AU - YOSHIAKI ISHIGATSUBO AU - KATSUMI EGUCHI AU - YOSHIYA TANAKA AU - TSUTOMU TAKEUCHI AU - NOBUYUKI MIYASAKA AU - MASAYOSHI HARIGAI Y1 - 2011/07/01 UR - http://www.jrheum.org/content/38/7/1258.abstract N2 - Objective. To 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). Methods. Serious 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). Results. In 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). Conclusion. Our 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. ER -