Bristol-Myers Squibb Company 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.”
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