Background In Japan, the aggressive therapy using biologics (Bio) started just 8 years ago. Now, mid, and long-term follow up data for efficacy and safety of the treatment of RA with Bio in real clinical practice should be needed. We set up the multicenter, large cohort study, or registry of RA patients treated using Bio (Tsurumai Biologics Communication Registry; TBCR). Now at 2011, 2073 patients were registered in TBCR.
Objectives The aims of this study are to elucidate the trends and safety of Bio treatment for over two years in TBCR, especially in elderly patients, who have relatively high risk associated with the treatment.
Methods We collected the data from the patients, who were started treatment with Bio from 2003 to 2008 and registered in TBCR.We surveyed the following information: demographic data,disease activity (DAS28-CRP)at the initiation of biologics, initial Bio, current treatment status (discontinuation of treatment with biologics and its reason).Adverse events were categorized based on ICD-10 classification. In this study, the patients were followed up until August 31, 2010 or until they withdrew from treatment with 1st Bio, whichever came first.Cumulativeincidence rate of those events was determined by Kaplan-Meier method, comparing by age (tertile values) and by starting year of treatment with Bio.
Results We analyzed 894 cases. The mean follow up time was 28.5 months. Mean of age and disease duration was 56.3 years old and 11.4 years, respectively. As for changes in baseline characteristics by starting year, patients in young and middle age groups had significant improving in disease activity, and Steinblocker Stage but not those in old age. 124 adverse events were occurred in this study. Most likely events were related to respiratory system (R-AD), 53 cases (43%). About 80% of total AD as well as R-AD were occurred until 24 months. The cumulative incidence rate of R-AD was significant higher in old age group, comparing to young age group (p=0.02). The rate of R-AD in old age group was almost same as that in middle age group after 3 years (Fig 1). In old age group, the cumulative incidence rate of R-AD was improving to same level of younger groups during these 7 years (p=0.04, Fig 2) while there was no significant difference in younger groups (Fig 3 and 4).
Conclusions We can treat the patients with RA more aggressively to target “remission” in younger patients, who have relatively lower risk for the treatment with Bio. However, the decision for older age patients in clinical practice is often difficult in point of safety. We clearly showed that incidence rate of most likely serious R-AD significantly decreased especially in older age patients during 7 years-experience. Safety of the Bio treatment can be improved by evidences and experiences during this decade. Further studies should be needed for long term prognosis of RA.
Disclosure of Interest T. Kojima Speakers Bureau: Abbott Japan, Chugai Pharmaceutical, Daiichi Sankyo Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, Pfizer Japan, Takeda Pharmaceutical, K. Funahashi: None Declared, N. Takahashi: None Declared, D. Kato: None Declared, H. Matsubara: 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