Background In recent years, abatacept (ABT) has become used as the first biologic agent for patients with RA. The long term efficacy and safety of ABT in patients without previous biologic therapy has been reported in clinical trials, but still uncertain in clinical routine practice.
Objectives In this paper, we studied the 3-year outcomes of ABT therapy in biologic naïve patients (Naïve group) and patients failed to prior biologics (Switch group) to demonstrate the “real-world” data using our registry system.
Methods All RA patients who were initiated ABT therapy from October 2010 through to October 2011 (n=134) at Nagoya University Hospital and 18 other institutes (Tsurumai Biologics Communications Registry: TBCR group) were enrolled in this study. We compared disease activities using DAS28 CRP between Naïve group (n=57) and Switch group (n=77). Furthermore, discontinuation due to inadequate responses (IRs) and adverse events (AEs) were evaluated.
Results In the baseline characteristics data, there were several differences between Naïve and Switch group, such as age (66.5 vs. 61.2 years old), disease duration (8.5 vs. 13.3 years), distribution of Steinbrocker classification stage, tacrolims user (3.6 vs. 15.8%) and prednisolone user (44.6 vs. 65.8%). However, disease activity data such as DAS28 components were similar. Mean DAS28 CRP values were significantly decreased at week 12 in both groups, and further decreasing were observed continuously (Fig. 1). However, disease activities 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 (64.6% vs. 37.9% at week 156, Fig.2). Drug retention rate at 156 weeks was 69.2% in Naïve group and 45.5% in Switch group. Discontinuation rate due to IRs in Naïve group was lower than that in Switch group (17.5% vs. 35.1%), whereas discontinuation rate due to AEs were quite similar (8.0% vs. 7.8%, Fig.3).
Conclusions This study demonstrated that the long term outcome of ABT therapy in clinical routine practice were comparable to that in clinical trials and useful as the first biologic agent for RA patients. It was the important data that adverse event leading to discontinuation was very low over three years in both group. 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.
Disclosure of Interest M. Hanabayashi: None declared, N. Takahashi: None declared, H. Miyake: None declared, Y. Yokota: None declared, T. Kojima Speakers bureau: Mitsubishi Tanabe Pharma Corporation, Takeda Pharma Corporation, Eisai Pharma Corporation, Chugai Pharma Corporation, abbvie, Bristol-Myers Squibb, Pfizer, Janssen Pharmaceutical K.K. and UCB Japan Co. Ltd., N. Ishiguro Speakers bureau: Mitsubishi Tanabe Pharma Corporation, Takeda Pharma Corporation, Eisai Pharma Corporation, Chugai Pharma Corporation, abbvie, Bristol-Myers Squibb, Pfizer, Janssen Pharmaceutical K.K. and UCB Japan Co. Ltd.