Background The 2010 EULAR Recommendations have been updated last year, abatacept (ABT) has become available as the first biologic agent for patients with RA (1). The long term efficacy and safety of ABT in patients with or without previous biologic therapy has been reported in clinical trials, but still uncertain in clinical routine practice.
Objectives The aim of this study was to assess the 2-year outcomes of ABT therapy in biologic naïve patients (Naïve group) and patients failed to prior biologics (Switch group) in clinical routine practice.
Methods All RA patients who were initiated ABT therapy from October 2010 through to October 2011 (n=152) at Nagoya University Hospital and 12 other institutes (Tsurumai Biologics Communications Registry: TBCR group) were enrolled in this study. We compared disease activities using DAS28 CRP between Naïve group (n=66) and Switch group (n=86). Furthermore, discontinuation due to inadequate responses (IRs) and adverse events (AEs) were evaluated.
Results In the baseline characteristics data, there was no significant difference between Naïve and Switch group, except for age (64.9 vs. 61.9 years old), disease duration (10.4 vs. 14.1 years) and swollen joint count (4.1 vs. 6.5). Disease activities were significantly decreased at week 12 in both groups, and further decreasing were observed continuously (Fig. 1). However, DAS28 CRP values were significantly lower in Naïve group (p<0.01) at all-time points after week12. The percentage of the patients who achieved low disease activity (DAS28 CRP<2.7) in Naïve group was apparently higher than that in Switch group (58.5% vs. 34.4% at week 52 and 75.0% vs. 41.1% at week 104, Fig. 2). Drug retention rate at 104 weeks was 77.3% in Naïve group and 59.3% in Switch group. Discontinuation rate due to IRs in Naïve group was lower than that in Switch group (16.2% vs. 28.2%), whereas discontinuation rate due to AEs were quite similar (3.0% vs. 5.6%, Fig. 3).
Conclusions This study demonstrated that the long term efficacy and safety of ABT in clinical routine practice was comparable to that in clinical trials. Interestingly, no adverse event leading to discontinuation was observed after week 24 except one patient. Safety as well as efficacy is an important consideration when initiating intensive treatment, especially in patients with serious comorbidity. Our results suggest that ABT would be beneficial for patients who have complications with careful treatment.
Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2013.
Disclosure of Interest M. Hanabayashi: None declared, T. Kojima Speakers bureau: Mitsubishi Tanabe Pharma Corporation, Takeda Pharma Corporation, Eisai Pharma Corporation, Chugai Pharma Corporation, Abbott, Bristol-Myers Squibb and Pfizer., N. Takahashi: None declared, D. Kida: None declared, K. Funahashi: None declared, S. Hirabara: None declared, S. Asai: None declared, Y. Yoshioka: None declared, N. Ishiguro Speakers bureau: Mitsubishi Tanabe Pharma Corporation, Takeda Pharma Corporation, Eisai Pharma Corporation, Chugai Pharma Corporation, Abbott, Bristol-Myers Squibb and Pfizer.