Presentation of the first U.S. observational study exploring the impact of biomarkers on treatment response for Orencia and TNF-inhibitors in moderate to severe rheumatoid arthritis
In this study, patients who tested positive via a common blood test for certain biomarkers of poor prognosis (anti-CCP or RF) were more likely to have a greater response with Orencia treatment than patients testing negative for the biomarkers
Other data being presented: More than 20 abstracts, including new pediatric study findings demonstrating equivalent efficacy and safety of subcutaneous Orencia to intravenous Orencia in pediatric juvenile idiopathic arthritis patients and the first data disclosure of Phase 1 data showing investigational BTK inhibitor, BMS-986142, for the treatment of rheumatoid arthritis and other inflammatory disease was well tolerated
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that it will present new data – offering insights into the field of rheumatoid arthritis (RA) – at the Annual European Congress of Rheumatology (EULAR 2016), to be held June 8-11, in London, UK.
Among the studies that Bristol-Myers Squibb will present are findings from the first U.S. observational study exploring patients’ response to treatment based on their baseline status for two biomarkers of poor prognosis, anti-cyclic citrullinated peptide (anti-CCP, also known as ACPA) and rheumatoid factor (RF). Both anti-CCP and RF are biomarkers of poor prognosis which may be associated with more severe disease progression and joint damage. This new study and its results will be featured in an Annual European Congress of Rheumatology (EULAR 2016) press release and in an oral presentation on Thursday, June 9, 10:50 CET.
The study analyzed data from the Corrona, LLC RA registry, the largest RA cohort prospectively followed in North America. The analysis included patients with RA who had been tested for both anti-CCP and RF, and received Orencia, a T cell co-stimulation blocker (n=566), or another class of RA biologic medicines, TNF-inhibitors (n=1715), between June 2002 and January 2015. The primary outcome measured in the analysis was mean change from baseline in Clinical Disease Activity Index (CDAI) at six months and secondary outcomes were achievement of low disease activity (LDA) at six months (LDA; CDAI =10 among those with moderate or high disease activity at baseline) and achievement of remission at six months (CDAI =2.8 among those with low, moderate or high disease activity at baseline). Response rates for Orencia and TNF-inhibitors were evaluated based on serologic status: double positive (anti-CCP+/RF+); single positive (anti-CCP+/RF– or anti-CCP–/RF+); and double negative (anti-CCP–/RF–).
Topline results from the real-world data analysis showed that in patients who initiated Orencia, double positive status was associated with a significantly greater response compared with double negative status on all outcomes (CDAI –8.9 vs. –4.5, p=0.002; LDA 43% vs. 26%, p=0.002; remission 15% vs. 5%, p=0.001). In addition, single positive status was associated with a greater likelihood of remission as compared with double negative status for those administered Orencia (12% vs. 5%, p=0.018). The study did not show significant differences in responses between anti-CCP/RF status in those administered TNF-inhibitors (double positive vs. double negative: CDAI –7.5 vs. –6.8, p=0.46; LDA 39% vs. 35%, p=0.20; remission 16% vs. 14%, p=0.38).
“The Corrona RA registry offers an unrivaled source of real-world observational data collected from U.S. patients with RA,” said Leslie Harrold, M.D., M.P.H., the study’s Principal Investigator and an Associate Professor of Medicine and Orthopedics and Physical Rehabilitation at the University of Massachusetts Medical School as well as Senior Medical Director of Pharmacoepidemiology and Outcomes research at Corrona. “We believe our findings provide new insights on RA for the rheumatology community.”
The Corrona RA registry is a real-world observational study that has collected data from 662 participating rheumatologists in 168 rheumatology practices across 40 states in the U.S. It currently includes data from more than 40,000 patients with RA.
“As a leader in the field of immunoscience, Bristol-Myers Squibb is dedicated to the research of disease biomarkers and finding transformative ways that may help reduce the impact of autoimmune diseases like RA,” said Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers Squibb. “The real-world data from the Corrona RA registry study showed patients who are seropositive for anti-CCP or RF, and particularly those who are double seropositive, were more likely to have incremental improvements in response to Orencia than if they were negative for these biomarkers as compared to those who initiated TNF-inhibitors. In addition, there was differential response to Orencia but not with TNF-inhibitors in patients who were CCP+ vs. CCP-. These findings and scientific insights underscore our decade-long commitment to ongoing Orencia research.”
Other key data Bristol-Myers Squibb is presenting at the Annual European Congress of Rheumatology (EULAR 2016) includes:
- Phase 3 data from the AVERT (Assessing Very Early Rheumatoid Arthritis Treatment) study, which evaluated the efficacy and safety of re-treating patients with early, active RA (tested positive for anti-CCP) with Orencia plus methotrexate after a period of treatment withdrawal. The full analysis of the data will be featured in a poster presentation on Saturday, June 11, 10:20 CET.
- A Phase 3 juvenile idiopathic arthritis (pJIA) study demonstrating subcutaneous (SC) Orencia has equivalent efficacy and comparable safety to intravenous (IV) Orencia for pJIA patients. SC Orencia showed efficacy after four months with greater than 80% of patients achieving an ACR30 response with few clinically relevant adverse events. The data will be featured in an oral presentation on Friday, June 10, 10:20 CET.
- The first data disclosure for Bristol-Myers Squibb’s investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, BMS-986142, targeted for RA and other inflammatory diseases. Researchers will report on Phase 1 data which showed that BMS-986142 was well tolerated, warranting further development of the agent. The data will be featured in a poster presentation on Thursday, June 9, 11:45 CET.
The full listing of abstracts Bristol-Myers Squibb will present at the Annual European Congress of Rheumatology (EULAR 2016) follows. Complete abstracts can be accessed online via the Annual European Congress of Rheumatology (EULAR 2016) program planner at https://b-com.mci-group.com/AbstractList/EULAR2016.aspx.
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