ANIFROLUMAB FOR PATIENTS WITH MODERATE TO SEVERE SYSTEMIC LUPUS ERYTHEMATOSUS: INTERIM ANALYSIS OF A RETROSPECTIVE COHORT STUDY

Background: Anifrolumab, a human IgG1κ monoclonal antibody that blocks signaling from the type I interferon (IFN) receptor, is approved and recommended for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), despite standard therapy. Real-world effectiveness data of anifrolumab are limited to small case series. ERYTHRO is an ongoing multi-country, multi-site retrospective medical chart review study of adult patients with moderate to severe SLE who participated in the early access program (EAP) with anifrolumab. Objectives: To investigate effectiveness of anifrolumab treatment for up to 6 months in patients with moderate to severe SLE in an interim analysis of the ERYTHRO study. Methods: Patients in the ERYTHRO study received anifrolumab treatment in France, Germany, Greece, Israel, Italy, Portugal, Spain, and the United Kingdom, and had their first anifrolumab infusion between 14 December 2020 and the end of February 2023. Data extraction for the ERYTHRO study commenced in October 2023 and is expected to end in the second quarter of 2024; these interim results include data extracted by 5 December 2023. Baseline data were defined as the data collected at the date nearest to the first anifrolumab infusion, within the preceding 180 days. The primary endpoints were change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and Physician’s Global Assessment (PGA) scores at 6 months. As this study used retrospective medical chart data, the timing of clinical assessments may not have been at regular intervals in all patients. Therefore, 6 months was defined as 6 months (± 2.5 months), ie, Day 105 to Day 255 post-first infusion of anifrolumab. Safety data were already collected and reported according to the EAP’s regulatory requirements; as such, the ERYTHRO study did not independently collect safety data. Results: These interim results included 13 enrolled patients (of 14 screened) from France (n=10) and the United Kingdom (n=3). Most patients were female (n=12, 92%) and the median age was 38 years (interquartile range [IQR]: 34–47). Overall, 2 (15%) patients had a family history of autoimmune diseases. The median Charlson Comorbidity Index score was 0 (IQR: 0–1) and the most common comorbidity was renal disease, reported in 3 (23%) of patients. Median (IQR) time from first SLE symptom manifestation to first SLE diagnosis was 18 (1–36) months, and from SLE diagnosis to first anifrolumab infusion was 139 (77–251) months. For patients with available SLEDAI-2K data at both the baseline and 6-month visits (n=9), median (IQR) SLEDAI-2K score at baseline was 8.0 (6.0–10.0) and improved to 4.0 (4.0–4.0) after six months of anifrolumab treatment (median [IQR] change from baseline −4.0 [−6.0 to −4.0]) ( Figure 1 ). Similarly, among the patients with available PGA data at both visits (n=6), the median PGA score at baseline was 2.2 (2.0–2.5) and decreased by 1.3 (-2.0 to -1.0) points after 6 months of anifrolumab treatment. Conclusion: This is the first multi-country retrospective real-world cohort study analyzing the effectiveness of anifrolumab treatment for adult patients with moderate to severe SLE. These interim data suggest a promising trend of improvement after 6 months of anifrolumab treatment in SLE disease activity, measured by both SLEDAI-2K and PGA, in support of other single-country real-world findings. A larger sample size will allow further analyses of the real-world effects of anifrolumab. REFERENCES: [1] SAPHNELO (anifrolumab) Prescribing Information. AstraZeneca; 2023. [2] Fanouriakis A, et al. Annals Rheum Dis . 2024;83:15–29. [3] Miyazaki Y, et al. Rheumatology (Oxford ). 2023. Acknowledgements: This study was sponsored by AstraZeneca. Writing assistance was provided by Sofia Fernandes, PhD, and Heather Hultzapple, PharmD, of JK Associates Inc., part of Avalere Health, and funded by AstraZeneca. Disclosure of Interests: Edward M. Vital Speakers bureau: AstraZeneca, Lilly, Novartis, Otsuka, UCB, Consultant of: Abbvie, AstraZeneca, Lilly, Merck, Novartis, Pfizer, Roche, UCB, Grant/research support from: AstraZeneca and Sandoz, François Chasset Speakers bureau: Amgen, AstraZeneca, BMS, GlaxoSmithKline, Consultant of: AstraZeneca, GlaxoSmithKline, Lilly, Merck, PrincipaBio, Grant/research support from: AstraZeneca, BMS, GlaxoSmithKline, Raquel Faria Speakers bureau: AstraZeneca, GlaxoSmithKline, Novartis, SOBI, Consultant of: AstraZeneca, GlaxoSmithKline, Novartis, SOBI, Lucy M. Carter Paid instructor at: Alumis Inc, Consultant of: UCB, Danuta Kielar Shareholder of: AstraZeneca, Employee of: AstraZeneca, Stephanie Y Chen Shareholder of: AstraZeneca, Employee of: AstraZeneca, Lucy Carty Employee of: AstraZeneca, Jonatan Natman Employee of: AstraZeneca, Miina Waratani Employee of: AstraZeneca. DOI: 10.1136/annrheumdis-2024-eular.747 Keywords: Real-world evidence, Biological DMARD Citation: , volume 83, supplement 1, year 2024, page 1832Session: Systemic lupus erythematosus (Publication Only)

Real-world evidence, Biological DMARD