Bristol-Myers Squibb Co. (BMY) Tuesday announced results of year two data from AMPLE study, a first-of-its-kind trial comparing the subcutaneous formulation of ORENCIA vs. Humira, each on a background of MTX, in biologic naïve patients with moderate to severe Rheumatoid Arthritis, or RA.
AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis (RA) Subjects With Background Methotrexate), met its primary endpoint as measured by non-inferiority of ACR20 (American College of Rheumatology 20 percent improvement) at year one.
The ORENCIA regimen achieved comparable rates of efficacy vs. the Humira regimen (64.8% vs. 63.4%, respectively). Onset of response was also generally similar for the two groups.
Year two of the study remained investigator-blinded. At year two, the ORENCIA regimen achieved the same rate of efficacy (60%) as the Humira regimen based on ACR20.
Radiographic progression was also assessed at two years with 85% of patients on the ORENCIA regimen and 84% of patients on the Humira regimen achieving radiographic non-progression.
At 24 months, overall safety data were similar for both groups, including frequency of adverse events, serious adverse events, and malignancies for the ORENCIA regimen and the Humira regimen, respectively.
Zero of the 12 patients who experienced serious infections in the ORENCIA group discontinued, while nine of the 19 patients who experienced serious infections in the Humira group discontinued.
Autoimmune events, of mild or moderate severity, were reported in 3.8% of patients in the ORENCIA group and 1.8% of patients in the Humira group. Injection site reactions were reported in 4.1% of patients taking the ORENCIA regimen and 10.4% of patients taking the Humira regimen.
AMPLE is a phase IIIb randomized, investigator-blinded multinational study of 24 months duration with a 12 month efficacy primary endpoint (non-inferiority for ACR20).
The study included 646 adult biologic-naïve patients with active moderate to severe RA and inadequate response to MTX; 318 in the ORENCIA 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 or 40 mg Humira every other week, both on background MTX. The primary endpoint was to determine non-inferiority of ORENCIA plus MTX to Humira plus MTX based on ACR20 response at 12 months.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.