Bristol-Myers Squibb Company (NYSE: BMY) today announced new clinical trial results showing the subcutaneous (SC) formulation of Orencia ® (abatacept) on a background of methotrexate (MTX) was similar to Humira ® (adalimumab) plus MTX in demonstrating clinical improvements in Patient Reported Outcomes (PROs) in adults with moderate to severe rheumatoid arthritis (RA), including patient pain, patient global assessment, fatigue, physical function and health related quality of life (HRQoL) that were sustained for one year.
At one year, Orencia SC plus MTX was similar to Humira plus MTX in improving patient pain (53.0% and 39.2%), improving patient global assessment (46.1% and 41.2%) and decreasing fatigue (-23.2% and -21.4%). A normal physical function (measured by the Health Assessment Questionnaire Disability Index, HAQ-DI) was achieved by 60.4% of patients in the Orencia SC treatment group and 57.0% in the Humira treatment group, and the measure of Health Related Quality of Life (HRQoL) assessed using SF-36 was also similar between the two groups.
The data comes from analysis of one-year results from AMPLE ( A batacept Versus Adali m umab Com p arison in Bio l ogic-Naiv e RA Subjects With Background Methotrexate), an ongoing, investigator-blinded randomized, Phase IIIb, controlled study comparing the efficacy of Orencia SC vs. Humira on a background of MTX in adult, biologic naïve patients with moderate to severe RA. AMPLE is a two year study with a one year efficacy primary endpoint (non-inferiority for ACR20).
“The AMPLE PRO data provides important information about Orencia and Humira in combination with MTX in RA,” said Roy Fleischmann, M.D., University of Texas Southwestern Medical Center, AMPLE study investigator. “By exploring patient reported outcomes, which are associated with pain, fatigue, disability and functional loss that can significantly impact a patient’s health-related quality of life, we have advanced our understanding of an important area of focus for RA patients.”About the Study AMPLE included 646 adult biologic-naïve patients with active moderate to severe RA and inadequate response to MTX; 318 in the Orencia SC ® (abatacept) plus MTX group and 328 in the Humira ® plus MTX group. Patients were stratified by disease activity and randomized to either 125 mg Orencia SC weekly (without an IV load) or 40 mg Humira every other week, both on background MTX. The primary endpoint was to determine non-inferiority of Orencia SC plus MTX to Humira plus MTX by a difference in ACR20 response at 12 months. Secondary endpoints included injection site reactions, radiographic non-progression as assessed using the van der Heijde modified total Sharp score (mTSS) method, safety and retention. PROs assessed were patient pain, patient global assessment and fatigue. Physical function was evaluated with the HAQ-DI. HRQoL was assessed using the SF-36. The Routine Assessment of Patient Index Data (RAPID3), an index of three patient reported core dataset measures, was also assessed.