Objective: To evaluate the safety and efficacy of abatacept following 2 years of the ATTAIN (Abatacept Trial in Treatment of Anti-TNF INadequate responders) trial in rheumatoid arthritis (RA) patients.
Methods: Patients completing the 6-month, double-blind (DB) period were eligible to enter the long-term extension (LTE); patients received abatacept ~10 mg/kg, plus DMARDs. Safety and efficacy (ACR responses, DAS28 [CRP], HAQ-DI, SF-36, MOS-sleep, fatigue VAS) were assessed through 2 years.
Results: 317 patients (218 from the abatacept and 99 from the placebo group) entered and 222 (70%) completed 18 months of LTE treatment. The incidence and type of adverse events (AEs) were consistent between the DB and cumulative (DB plus LTE) periods. Rates of serious AEs were 25.6 and 23.4 /100 pt–yrs in the DB versus cumulative period. At 6 months and 2 years, using non-responder analyses, ACR responses in abatacept-treated patients were: ACR 20, 59.4% and 56.2%; ACR 50, 23.5% and 33.2%; ACR 70, 11.5% and 16.1%; HAQ-DI responses were 54.4% and 47.9%. At 6 months and 2 years, using post-hoc as-observed analyses, the percentage of patients (95% CI) achieving DAS28 (CRP) low disease activity score (≤3.2) and DAS28 (CRP)-defined remission (<2.6) increased from 18.3% (13.0, 23.5) to 32.0% (24.6, 39.4) and 11.1% (6.8, 15.3) to 20.3% (13.9, 26.6). Clinically meaningful improvements in SF- 36, pain, fatigue, and sleep problems were also maintained through 2 years of abatacept treatment.
Conclusion: No unique safety observations were reported during open-label exposure. Improvements in the signs and symptoms of RA, physical function and health-related quality of life observed after 6 months, were maintained through 2 years in this population with difficult-to-treat disease.
- T cell
- rheumatoid arthritis