TY - JOUR
T1 - Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors
T2 - A report from the registry of Japanese rheumatoid arthritis patients for longterm safety
AU - Komano, Yukiko
AU - Tanaka, Michi
AU - Nanki, Toshihiro
AU - Koike, Ryuji
AU - Sakai, Ryoko
AU - Kameda, Hideto
AU - Nakajima, Atsuo
AU - Saito, Kazuyoshi
AU - Takeno, Mitsuhiro
AU - Atsumi, Tatsuya
AU - Tohma, Shigeto
AU - Ito, Satoshi
AU - Tamura, Naoto
AU - Fujii, Takao
AU - Sawada, Tetsuji
AU - Ida, Hiroaki
AU - Hashiramoto, Akira
AU - Koike, Takao
AU - Ishigatsubo, Yoshiaki
AU - Eguchi, Katsumi
AU - Tanaka, Yoshiya
AU - Takeuchi, Tsutomu
AU - Miyasaka, Nobuyuki
AU - Harigai, Masayoshi
PY - 2011/7
Y1 - 2011/7
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 multi variate 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.
AB - 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 multi variate 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.
KW - Antirheumatic agents
KW - Drug toxicity
KW - Rheumatoid arthritis
KW - Tumor necrosis factor-α
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U2 - 10.3899/jrheum.101009
DO - 10.3899/jrheum.101009
M3 - Article
C2 - 21498482
AN - SCOPUS:79959994678
VL - 38
SP - 1258
EP - 1264
JO - Journal of Rheumatology
JF - Journal of Rheumatology
SN - 0315-162X
IS - 7
ER -