Document Detail

Time-dependent increased risk for serious infection from continuous use of TNF antagonists during three years in rheumatoid arthritis patients.
MedLine Citation:
PMID:  22422487     Owner:  NLM     Status:  Publisher    
OBJECTIVE: To investigate associations between continuous treatments with tumor necrosis factor (TNF) antagonists and risk for developing serious infections (SIs) during three years in Japanese patients with Rheumatoid Arthritis (RA) enrolled in the Registry of Japanese RA Patients for Long-Term Safety (REAL) database. METHODS: We analyzed 727 RA patients who had started either infliximab (IFX) or etanercept (ETN) [the anti-TNF group, 1480.1 patient-years (PY)] and 571 RA patients who had started conventional non-biological DMARDs (the unexposed group, 1104.1 PY) at the time of enrollment in REAL. We assessed the occurrence of SIs within a three-year observation period, including the period after switching to other TNF antagonists and all SIs, unlimited to the first one in each patient as reported in other studies, to evaluate the real safety of TNF antagonists in daily practice. RESULTS: he incidence rate of SIs per 100 PY was 5.54 (95% confidence interval [95% CI] 4.44-6.84) in the anti-TNF group and 2.72 (95% CI, 1.87-3.83) in the unexposed group. Poisson regression analysis revealed that the relative risk (RR; 95% CI) of continuous use of TNF antagonists for SIs after adjusting for baseline and time-dependent covariates was significantly elevated both for overall [1.97(1.25-3.19)] and for the first year [2.40 (1.20-5.03)], but not for the second and third years combined [1.38 (0.80-2.43)].The adjusted RR for SIs of ETN compared to IFX was not significantly elevated. CONCLUSIONS: Continuous anti-TNF therapy was significantly associated with increased risks for developing SIs during, but not after, the first year. © 2012 by the American College of Rheumatology.
Ryoko Sakai; Yukiko Komano; Michi Tanaka; Toshihiro Nanki; Ryuji Koike; Hayato Nagasawa; Koichi Amano; Atsuo Nakajima; Tatsuya Atsumi; Takao Koike; Atsushi Ihata; Yoshiaki Ishigatubo; Kazuyoshi Saito; Yoshiya Tanaka; Satoshi Ito; Takayuki Sumida; Shigeto Tohma; Naoto Tamura; Takao Fujii; Takahiko Sugihara; Atsushi Kawakami; Noboru Hagino; Yukitaka Ueki; Akira Hashiramoto; Kenji Nagasaka; Nobuyuki Miyasaka; Masayoshi Harigai;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-15
Journal Detail:
Title:  Arthritis care & research     Volume:  -     ISSN:  2151-4658     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101518086     Medline TA:  Arthritis Care Res (Hoboken)     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 by the American College of Rheumatology.
Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan; Department of Medicine and Rheumatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.
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