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New Head-to-Head Patient Reported Outcomes Data for Orencia


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 (Abatacept Versus Adalimumab Comparison in Biologic-Naive 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.”

Posted-In: News FDA


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