New Phase III data on Orencia for Rheumatoid Arthritis-BMS

BMS announced results of new sub-analyses of the Phase IIIb AVERT trial investigating Orencia (abatacept) plus methotrexate (MTX) in biologic and MTX-naïve citrullinated protein (CCP)-positive early moderate to severe Rheumatoid Arthritis (RA) patients. One analysis assessed the development of anti-CCP antibodies in patients with early rapidly progressing RA by measuring isotypes and the number of epitopes recognized after treatment with Orencia plus MTX, Orencia alone, or MTX alone. Results demonstrated Orencia plus MTX numerically reduced the concentrations of all CCP isotypes and the average number of epitopes recognized over one year of treatment more than Orencia alone or MTX alone. Over 12 months of treatment, 6.7 percent, 12.1 percent, and 7.8 percent of patients on Orencia plus MTX, Orencia alone, and MTX alone, respectively, experienced a serious adverse event and 1.7 percent, 4.3 percent and 2.6 percent led to discontinuation. Serious infections were observed in 0.8 percent of patients in the combination arm and 3.4 percent in the Orencia monotherapy arm.

In addition, significantly more patients on Orencia plus MTX achieved the stringent clinical endpoint of Boolean-defined remission at 12 months (37 percent Orencia plus MTX; 26.7 percent Orencia alone; 22.4 percent MTX alone). Higher remission rates as compared to MTX or Orencia alone were consistent across other clinically stringent measures, including CDAI remission (42 percent Orencia plus MTX; 31 percent Orencia alone; 27.6 percent MTX alone) and SDAI remission (42 percent Orencia plus MTX; 29.3 percent Orencia alone; 25 percent MTX alone). A small but significantly higher number of patients treated with Orencia plus MTX were able to maintain drug-free remission up to month 18 and six months after drug withdrawal, according to the remission threshold of DAS28-CRP <2.4 (13 percent Orencia plus MTX; vs. 3.5 percent MTX alone).

Finally sustained improvements on MRI endpoints were also observed at six months after stopping combination therapy with Orencia plus MTX vs. MTX alone. These data were presented at the American College of Rheumatology 2014 annual meeting.