BE-EARLY: A PHASE 4, PROSPECTIVE, OPEN-LABEL STUDY TO EVALUATE THE IMPACT OF BELIMUMAB ON EARLY (≤ 2 YEARS) SYSTEMIC LUPUS ERYTHMETOSUS IN ADULTS

PV251 / #283 Poster Topic: AS24 - SLE-Treatment Background/Purpose Approximately 40% of patients with systemic lupus erythematosus (SLE) develop organ damage within the first 5 years of diagnosis due to uncontrolled disease activity and cumulative steroid exposure, impacting quality of life and increasing early mortality risk.[1] Intervention with a disease-modifying biologic such as belimumab (BEL) in the early disease stages might modify the disease course and prevent irreversible organ damage while minimizing the need for glucocorticoids (GCs) or exposure to immunosuppressants (IS). Evidence suggests that BEL induces better responses compared with standard therapy (ST) when used earlier in SLE, especially in patients with minimal or no organ damage or within 2 years of classification.[2,3] However, the use of BEL early in the disease course has been limited in clinical practice, mostly following the failure of ≥ 2 IS. Here, we present the BE-EARLY (BEL in Early SLE) study design, which will evaluate the efficacy and safety of BEL in adult SLE patients with early disease. Methods This Phase 4, prospective, open-label, single-arm, 3-year clinical study (GSK Study 219240; NCT06411249 ) will include approximately 350 participants from 11 countries with active, autoantibody-positive, early SLE (≤ 2 years since diagnosis) with no organ damage and inadequate response to initial ST (with/without a first conventional IS). Key eligibility criteria are shown in Table 1. Participants will receive BEL 200 mg/week subcutaneously as an add-on to initial ST for 52 weeks (Part A), with a long-term extension up to 104 weeks (end of study is the safety follow-up visit after Week 156; Part B). Key primary and secondary endpoints are shown in Table 2. Participants will be required to taper the average oral GC (oGC; prednisone equivalent) dose starting at Week 12 to ≤ 7.5 mg/day by Week 26, and to ≤ 5 mg/day by Week 48 (if the investigator considers the disease is stable and under control on ≤ 7.5 mg/day). No changes in oGC dose are allowed between Weeks 48 and 52. An optional concomitant IS taper may be attempted after the Week 52 visit if the patient maintains Definition Of Remission in SLE (DORIS) criteria for ≥ 6 months. Descriptive summaries will be performed for all endpoints. Table 1. Key eligibility criteria Table 2. Key primary and secondary endpoints Results Currently, 22% of sites are active; the first patient was included in July 2024. The primary endpoint data are expected in 2027. Conclusions This clinical study will investigate the efficacy and safety of BEL in adults with early, active SLE, using relevant disease activity endpoints. The open-label design was selected as several other treatment options are available, and BEL is an approved biological therapy in the population of this study. It is expected that early BEL administration will benefit participants’ short-term outcomes, such as improvements in disease activity, quality of life, and reduction in oGC use, as well as long-term outcomes, including attainment of remission and prevention of organ damage. References: [1.] Urowitz MB. Arthritis Care Res 2012;64:132-7. [2.] Gatto M. Arthritis Rheumatol 2020;72(8):1314-24. [3.] Petri M. Ann Rheum Dis 2022;81:323. Funding: Funded by GSK. Accepted (abstract-only publication): EULAR European Congress of Rheumatology, 12–15 June 2024. Reused with permission. Petri M. Ann Rheum Dis 2024;83:1837. Presented: 26 th Asia Pacific League of Associations for Rheumatology Congress, 21–25 August 2024.

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