Ab0546 design of anifrolumab study of treatment effectiveness in the real world (aster): a multi-national, observational, post-launch study to describe the clinical effectiveness of anifrolumab in routine clinical practice in patients with sle

Background Real-world evidence (RWE) on prescription medication use for systemic lupus erythematosus (SLE) is limited, and no real-world studies to date have investigated medication use post-launch with anifrolumab, a type I interferon receptor inhibitor. ASTER is the first multi-national, real-world study to examine patients with SLE receiving standard therapy who initiate anifrolumab treatment as an add-on biologic. Objectives To describe the study design of ASTER. Methods ASTER ( NCT05637112 ) is a longitudinal, observational cohort study with 1 year of retrospective baseline data and 3 years of follow-up after first anifrolumab initiation until patient discontinuation, death, loss to follow-up or end of study (whichever occurs first). Adults with an SLE diagnosis per the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria for SLE who start anifrolumab per the approved country-specific label are eligible. Patients who are anifrolumab experienced, currently in anifrolumab early access/compassionate use programs, or in a clinical trial with an investigational product are excluded. Eligible patients will be enrolled at a routine clinical visit before the first anifrolumab infusion. Key study measures and data collection methods are presented in the Table 1. Patient-reported outcomes (PROs) and diaries are selected and designed based on patient feedback. Key endpoints of disease activity and the proportion of patients attaining a Lupus Low Disease Activity State will be assessed. For patients who discontinue anifrolumab, data collection will continue for the entire follow-up period, unless they withdraw consent. Results About 500 patients are expected to be enrolled from Austria, Canada, Denmark, France, Germany, Israel, Italy, Norway, Spain, and Sweden, with 15–200 patients per country. The study will be open for enrollment in 2023 and data collection is expected to finish in 2029. Data will be collected at baseline and at quarterly (Year 1) or biannual visits (Years 2 and 3). Electronic case report forms will be used to record patient information using the Medidata RAVE system. MyReco ® software will be used to record PROs via a mobile application and collect physician-completed assessments via a web platform. Results will primarily be descriptive. Conclusion ASTER will provide physicians with valuable insights into the effectiveness of anifrolumab in patients with SLE in routine clinical practice. ASTER will generate comprehensive RWE of anifrolumab to inform patients about its impact on disease activity and health-related quality of life outcomes in global real-world settings. Table 1. Key study measures Demographics (age, sex, ethnicity, insurance type) a Clinical characteristics (comorbidities, medical history, adverse events/drug reactions b , lab results) a SLE treatment history (steroids, antimalarials, immunosuppressants, NSAIDs, biologics) a SLE flares a Healthcare resource use a Clinical assessments c Physician’s Global Assessment d SLE Disease Activity Index 2000 d Cutaneous Lupus Erythematosus Disease Area and Severity Index Systemic Lupus International Collaborating Clinics/ACR Damage Index a Low Lupus Disease Activity State d PROs c Functional Assessment of Chronic Illness Therapy–Fatigue Lupus Quality of Life Patient Global Assessment European Quality of Life 5-Dimension Health Questionnaire 5 Level Work Productivity and Activity Impairment: Lupus Pain Numerical Rating Scale Diaries (e.g, medication use, pain, fatigue, sleep quality) e ACR, American College of Rheumatology; NSAIDs, non-steroidal anti-inflammatory drugs; PRO, patient-reported outcome; SLE, systemic lupus erythematosus. a Collected at baseline and biannually in Years 1–3. b Collected throughout the study. c Collected at baseline, quarterly in Year 1, and biannually in Years 2–3. d Primary objective. e Collected at baseline, weekly in Year 1 only. Acknowledgements Writing assistance by Sheila Longo, PhD, of JK Associates Inc., part of Fishawack Health. This study was sponsored by AstraZeneca. Disclosure of Interests Marta Mosca Speakers bureau: AstraZeneca, GSK, Janssen, Lilly, Consultant of: AstraZeneca, AbbVie, GSK, UCB, Lilly, Cathy Emmas Shareholder of: AstraZeneca, Employee of: AstraZeneca, Cassandra Nan Shareholder of: AstraZeneca, GSK, Employee of: AstraZeneca, Heide Stirnadel-Farrant Shareholder of: AstraZeneca, GSK, Employee of: AstraZeneca, Samuel Chen Shareholder of: AstraZeneca, Employee of: AstraZeneca, Lucy Carty Employee of: Currently employed by AstraZeneca as a contractor, Barnabas Desta Shareholder of: AstraZeneca, Employee of: AstraZeneca, Caroline Seo Shareholder of: AstraZeneca, Consultant of: HEOR consulting firm (Pharmerit-an OPEN Health Company), Employee of: AstraZeneca, Stephanie Chen Shareholder of: AstraZeneca, Employee of: AstraZeneca, Alessandro Sorrentino Shareholder of: Abbott Laboratories, Galapagos, Gilead, Kontigo Care, Moderna, Employee of: AstraZeneca; Before: Janssen and Sanofi.