Longterm Safety and Efficacy of Abatacept Through 5 Years of Treatment in Patients with Rheumatoid Arthritis and an Inadequate Response to Tumor Necrosis Factor Inhibitor Therapy
The Journal of Rheumatology, 07/17/2012
Genovese MC et al. – Safety remained consistent, and abatacept efficacy was maintained from 6 months to 5 years, demonstrating the benefits of switching to abatacept in this difficult–to–treat population of patients with rheumatoid arthritis (RA) previously failing anti–TNF therapy.Methods
- Patients completing the 6–month, double–blind (DB) placebo–controlled period were eligible to enter the longterm extension (LTE), where all patients received abatacept every 4 weeks (~10 mg/kg, according to weight range).
- Safety, efficacy, physical function, and health–related quality of life were monitored throughout.
- In total, 317 patients (218 DB abatacept, 99 DB placebo) entered the LTE; 150 (47.3%) completed it.
- Overall incidences of serious adverse events, infections, serious infections, malignant neoplasms, and autoimmune events did not increase during the LTE versus the DB period.
- American College of Rheumatology responses with abatacept at Month 6 were maintained over 5 years.
- At Year 5, among patients who received abatacept for 5 years and had available data, 38/103 (36.9%) achieved low disease activity as defined by the 28–joint Disease Activity Score (DAS28)/C–reactive protein (CRP); 23/103 (22.3%) achieved DAS28/CRP–defined remission.
- Health Assessment Questionnaire response was achieved by 62.5% of patients remaining on treatment at Year 5; mean improvements from baseline in physical component summary and mental component summary scores were 7.34 and 6.42, respectively.
- High proportions of patients maintained efficacy and physical function benefits or improved their disease state at each timepoint throughout the LTE, if remaining on abatacept treatment.