Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry.

Marie-Elise Truchetet,Thomas Barnetche,Bernard Bannwarth,Christophe Richez,Emilie Shipley,Jacques-Eric Gottenberg,Nicolas Poursac,Thierry Schaeverbeke

doi:10.1186/s13075-016-0956-7

Abstract

BackgroundRetention rate, efficacy, and safety of abatacept (ABA) was compared between patients with rheumatoid arthritis receiving ABA as monotherapy to those in combination ABA + conventional synthetic DMARD (csDMARD).MethodsThe patients were obtained from the ORA registry. The retention rate was analysed in two ways: (1) therapeutic strategy retention, in which the addition of a csDMARD was considered to indicate failure of the monotherapy strategy; and (2) ABA retention, which was assessed by the discontinuation of ABA regardless of other treatment modifications. Efficacy and safety were compared between ABA initiated alone and ABA used in combination with a csDMARD.ResultsThe retention rate at month 6 (M6) was evaluated in 569 patients. A significant difference was identified in the retention rate between the ABA monotherapy strategy and the ABA + csDMARD strategy (58.5 % [110/188] vs. 68 % [258/381], respectively, p = 0.031). No significant difference was identified in the ABA retention rate initiated either as a monotherapy or in combination with csDMARDs (75 % [142/188] vs. 76 % [291/381], respectively, p = 0.824). Data regarding ABA efficacy were available for 444 patients. There was no significant difference in the responder proportion after 6 months of treatment between ABA monotherapy and ABA + csDMARD treatment (60.2 % [88/146] vs. 60 % [179/298], respectively, p = 0.967).ConclusionsThis “real-life” analysis, which is relevant for bedside practice, emphasised the satisfactory efficacy and safety of ABA used in monotherapy, which provides an acceptable alternative when csDMARDs are undesirable.

Highlights

Retention rate, efficacy, and safety of abatacept (ABA) was compared between patients with rheumatoid arthritis receiving ABA as monotherapy to those in combination ABA + conventional synthetic Disease-modifying anti-rheumatic drug (DMARD)
Since the earliest studies conducted with tumour necrosis factor alpha (TNF-α) inhibitors, it has been demonstrated that the therapeutic response to biological agents was improved by the addition of a conventional synthetic DMARD (csDMARD), primarily MTX [5, 6]
This study provides the first evaluation of the efficacy and safety of the ABA monotherapy strategy in Orencia and Rheumatoid Arthritis (ORA) patients

Summary

Introduction

Efficacy, and safety of abatacept (ABA) was compared between patients with rheumatoid arthritis receiving ABA as monotherapy to those in combination ABA + conventional synthetic DMARD (csDMARD). In parallel with the discovery of new pathways and drugs in the pathogenesis of rheumatoid arthritis (RA), the development of new therapeutic strategies has been a key component in the improvement of RA care [1]. These strategies include the early introduction of diseasemodifying anti-rheumatic drugs (DMARDs), treat to target and tight control [2, 3]. The combination of methotrexate (MTX) and a biologic agent is considered as the standard strategy for RA that is responding poorly to conventional synthetic DMARDs (csDMARDs) alone. The AMBITION and ACT-RAY studies discussed the equivalence of tocilizumab when used in monotherapy or in combination with MTX [8, 9]

Methods

Results

Discussion

Conclusion