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Abstract
Background In Japan, the treatments for the patients with rheumatoid arthritis using etanercept (ETN) started since 2005. We should carefully treat especially in elderly patients, who have relatively high risk associated with the treatment. Now, mid, and long term follow up data for the efficacy and safety of the treatment of RA with ETN in clinical practice should be needed.
Objectives The aims of this study are to investigate the trends and safety of ETN treatment especially in elderly patients.
Methods We collected the data from the patients who started ETN treatment as first-biologics since 2005 and registered in the multicenter, large cohort of RA patients (Tsurumai Biologics Communication Registry; TBCR). We surveyed the following information: demographic data, disease activity (DAS28-CRP) at the initiation of ETN, current treatment status (discontinuation of treatment with ETN and its reason). Drug survival rate was determined by Kaplan-Meier method, comparing by age (tertile values), MTX use, and by DAS28-CRP (tertile values) at the initiation of ETN. Cumulative incidence rate of adverse events was determined in the same way.
Results We analyzed 683 ETN cases of 1574 cases registered in TBCR until 2010. The mean follow up time was 26.8 months. Mean of age and disease duration was 55.9 years old and 11.0 years, respectively. The rate of concomitant MTX use was 79.6%, 69.5%, 50.0% (young age:≤51, middle age: 52-64, old age: 65≤, respectively). Drug survival rate was significantly lower in old age and no MTX use group (p<0.001, Fig. 1 and 2). In old age group, disease activity at baseline had no significant effect on drug survival rate (Fig. 3). The cumulative incidence rate of adverse events was significantly higher in old age and no MTX use group (p<0.001, Fig. 4).
Conclusions In clinical practice, some elderly patients may not use MTX because of complications. We showed that incidence rate of adverse events was high in those patients. We should treat more carefully the elderly patients who don’t use concomitant MTX.
Disclosure of Interest H. Matsubara: None Declared, T. Kojima Speakers Bureau: Abbott Japan, Chugai,Pharmaceutical, Daiichi Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer Japan, Takeda Pharmaceutical, N. Takahashi: None Declared, K. Funahashi: None Declared, D. Kato: None Declared, Y. Hattori: None Declared, N. Ishiguro Speakers Bureau: Abbott Japan, Chugai,Pharmaceutical, Daiichi Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer Japan, Takeda Pharmaceutical