26 Jun Real World Study of Subcutaneous Abatacept (ORENCIA®) For Rheumatoid Arthritis
MedicalResearch.com Interview with:
Sean Connolly, Ph.D.
Director of Non-Registrational Data Generation
Study Director for ASCORE
MedicalResearch.com: What is the background for this study?
Response: ASCORE is a two-year, prospective multicenter study to observe retention and response rates of moderate-to-severe rheumatoid arthritis (RA) patients receiving ORENCIA® (abatacept), administered subcutaneously via a pre-filled syringe, in routine clinical practice. Findings shared at the Annual European Congress of Rheumatology (EULAR 2019) are the results from the first 12 months.
An important objective of our development program is to understand how well we can replicate findings from our clinical trials among a real-world patient population. In the case of ASCORE, which looked at approximately 3,000 patients, both bio-naïve and patients receiving later-line therapies, these data add to the body of research that may help inform physicians treating patients with RA.
Patients participating in ASCORE were divided into two distinct cohorts at the outset of the study: bio-naïve and patients previously administered one or more biologic agents. The primary endpoint is to estimate the rentention rate of patients in each cohort over a 24-month period. Furthermore, ASCORE examines the patient populations across ten countries to understand factors including: how ORENCIA is prescribed, characteristics of patients from each country (socio-demographic data, medical history, co-morbidities, etc.), and population health statistics within each country. This sub-analysis is factored into patient response to treatment across both cohorts, which may help physicians better understand how and why certain populations demonstrate a specific retention rate.
MedicalResearch.com: What are the main findings?
Response: One year into the study, we found that overall retention of subcutaneous abatacept was approximately 65% and comparable to that of IV abatacept. Among patients continuing abatacept at one year, good/moderate response rates were consistently more than 65%, irrespective of previous exposure to biologics. Higher retention and clinical response rates were achieved with abatacept earlier in treatment history.
MedicalResearch.com: What should readers take away from your report?
Response: While we cannot yet make the comparison of IV versus subcutaneous administration within one-year results from ASCORE, we’re seeing that in real-world patients, retention and response rates are approximately 65% and higher, particularly within the cohort of biologic-naïve patients..
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We’re always looking for ways to better understand our patient population and add to the body of research that enables us to connect the right patients to the right therapies at the right time. In the case of ASCORE, we’d like to better understand the predictors of retention. The 3,000 patients included in the analysis are all-comers across ten countries and with countless patient journeys.If we can understand the baseline characteristics of the patient population, perhaps we can use these data to suggest which patients will benefit most from abatacept treatment.
MedicalResearch.com: Is there anything else you would like to add?
Response: Our mission at Bristol-Myers Squibb is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. ASCORE is just one example of the type of research we’re pursuing to better understand the individuals comprising a patient population, as well as the journey that leads them to us.
EULAR 2019 ABSTRACT
ASCORE, A 2-YEAR, OBSERVATIONAL, PROSPECTIVE MULTICENTRE STUDY OF SUBCUTANEOUS ABATACEPT FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE: 1-YEAR INTERIM ANALYSIS,
Rieke Alten, Xavier Mariette, Maya Buch, Roberto Caporali, Rene-Marc Flipo, Adrian Forster, Michael Nurmohamed, Yusuf Patel, Peter Peichl, Raimon Sanmarti, Melanie Chartier, Julia Heitzmann, Christiane Rauch, Sean Connolly
Meeting: 2018 ACR/ARHP Annual Meeting
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