Abstract | OBJECTIVE: METHODS: We analyzed 727 RA patients who had started either infliximab or etanercept (the anti-TNF group; 1,480.1 patient-years [PY]) and 571 RA patients who had started conventional nonbiologic disease-modifying antirheumatic drugs (the unexposed group; 1,104.1 PY) at the time of enrollment in the REAL. We assessed the occurrence of SIs within a 3-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: The 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) of continuous use of TNF antagonists for SIs after adjusting for baseline and time-dependent covariates was significantly elevated both overall (1.97, 95% CI 1.25-3.19) and for the first year (2.40, 95% CI 1.20-5.03), but not for the second and third years combined (1.38, 95% CI 0.80-2.43). The adjusted RR for SIs of etanercept compared to infliximab was not significantly elevated. CONCLUSION: Continuous anti-TNF therapy was significantly associated with increased risks for developing SIs during, but not after, the first year.
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Authors | Ryoko Sakai, Yukiko Komano, Michi Tanaka, Toshihiro Nanki, Ryuji Koike, Hayato Nagasawa, Koichi Amano, Atsuo Nakajima, Tatsuya Atsumi, Takao Koike, Atsushi Ihata, Yoshiaki Ishigatsubo, 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, Real Study Group |
Journal | Arthritis care & research
(Arthritis Care Res (Hoboken))
Vol. 64
Issue 8
Pg. 1125-34
(Aug 2012)
ISSN: 2151-4658 [Electronic] United States |
PMID | 22422487
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2012 by the American College of Rheumatology. |
Chemical References |
- Antibodies, Monoclonal
- Immunoglobulin G
- Receptors, Tumor Necrosis Factor
- Tumor Necrosis Factor-alpha
- Infliximab
- Etanercept
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Topics |
- Adult
- Aged
- Antibodies, Monoclonal
(adverse effects)
- Arthritis, Rheumatoid
(drug therapy, epidemiology)
- Cohort Studies
- Communicable Diseases
(chemically induced, epidemiology)
- Etanercept
- Female
- Follow-Up Studies
- Humans
- Immunoglobulin G
(adverse effects)
- Infliximab
- Japan
(epidemiology)
- Male
- Middle Aged
- Prospective Studies
- Receptors, Tumor Necrosis Factor
- Risk Factors
- Severity of Illness Index
- Time Factors
- Tumor Necrosis Factor-alpha
(antagonists & inhibitors)
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