SAN DIEGO, CA—Year 1 results from the AMPLE study regarding improvements in patient-reported outcomes (PROs), productivity, and independence with subcutaneous (SC) abatacept + methotrexate and adalimumab + methotrexate are maintained up to Year 2, according to recent head-to-head study results presented at the 2013 ACR/ARHP Annual Meeting.
The AMPLE study is a Phase 3b, randomized, investigator-blinded, 2-year study that randomized 646 biologic-naïve patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate to abatacept 125mg weekly (n=318) or adalimumab 40mg biweekly (n=328), with background methotrexate.
Year 1 data showed comparable improvements in health-related quality of life (HRQoL) and similar onset of response with SC abatacept and adalimumab on background methotrexate for multiple PROs. To assess maintenance of response over time, R Fleischmann, MD, of University of Texas Southwestern Medical Center, Dallas, TX, and colleagues presented PRO data from the two years of the AMPLE study.
Pain, fatigue, and patient global assessment (PtGA) were measured by 100mm visual analog scales. Physical function was evaluated using the Health Assessment Questionnaire-Disability Index (HAQ-DI), and HRQoL was assessed using the Short Form-36 (SF-36). The Activity Limitation Questionnaire (ALQ) measured the number of days patients were unable to perform usual activities during the past 30 days. Psychosocial independence was assessed using the ALQ plus the Role Emotional, Social Functioning and Role Physical subscale items from the SF-36 survey. Physical independence was evaluated using 15 items from the HAQ-DI, and The Work Productivity and Activity Impairment questionnaire assessed work productivity.
A similar proportion of abatacept- vs. adalimumab-treated patients (54.1% vs. 48.8%, respectively) achieved a HAQ-DI response (improvement of ≥0.3 units from baseline) at 2 years. Improvements in PtGA at 2 years were 43.5% vs. 40.6% for abatacept and adalimumab, respectively. Comparable improvements in activity limitation, independence, and work productivity were observed between the two treatments.
Dr. Fleischmann noted, “Improvements in all domains of the SF-36 observed at 1 year were maintained at 2 years. Comparable improvements in activity limitation, independence, and work productivity were observed between the two treatments.”
“These data demonstrate that, despite different mechanisms of action, these biologic agents lead to comparable clinical and patient-reported benefits in this population,” he concluded.