Bristol-Myers’ Orencia shows sustained benefit in post-market RA study

Bristol-Myers Squibb (NYSE:BMY) announces positive results from the open-label switch period of a Phase IV exploratory biomarker study, Early AMPLE, comparing the effects on disease progression of Orencia (abatacept) and adalimumab [branded version is AbbVie (NYSE:ABBV) and Johnson & Johnson’s (NYSE:JNJ) Humira] in patients with moderate-to-severe early rheumatoid arthritis (RA) who tested positive for certain autoantibodies.

Results showed that seropositive RA patients treated with Orencia showed “substantial clinical improvements” at week 48 sustaining responses observed at week 24 compared to adalimumab. The results are being virtually presented at EULAR 2020.

76 seropositive RA patients entered the open-label switch period. At week 48, the ACR 20/50/70 (20 – 70% improvement in RA symptoms) response rates were 78%, 63% and 50%, respectively, compared to 83%, 73% and 50%, respectively, at week 24. By comparison, the week 24 response rates for adalimumab were 63%, 45% and 30%, respectively.

RA patients with a genetic marker called Shared Epitope (SE) who continued on Orencia showed “numerically higher responses” than the broader seropositive population at week 48, suggesting the potential value of SE as a predictor of response to Orencia.

No new safety signals were observed.

The FDA first approved the T cell costimulation modulator for RA in December 2005.

https://seekingalpha.com/news/3579984-bristol-myers-orencia-shows-sustained-benefit-in-post-market-ra-study