PO:11:300 Evaluating DORIS remission attainment with anifrolumab in immunosuppressant- and biologic-naïve patients with SLE: design of SUNFLOWER, a phase 3b prospective study

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Objectives DORIS remission is protective against organ damage in patients with SLE. 1 Treatment recommendations prioritize a treat-to-target approach aiming for prompt remission, including adding targeted therapies early to minimize glucocorticoid use.1 Anifrolumab treatment has demonstrated remission attainment and glucocorticoid-sparing effects2 3; however, in practice, anifrolumab is often reserved for nonresponders to standard therapy including conventional immunosuppressants. Here, we describe the design of a novel phase 3b study to investigate DORIS remission attainment following subcutaneous anifrolumab initiation among patients with SLE who are naïve to conventional immunosuppressants/other biologics.Methods SUNFLOWER is a multinational, single-arm study with a 52-week open-label anifrolumab (120 mg subcutaneously, QW) administration phase and a 12-week safety follow-up ( figure 1). Eligible patients are 18–70 years with rheumatologist-confirmed SLE. First-line treatment with an antimalarial (alone or with glucocorticoids) is obligatory, alongside no history of conventional immunosuppressants/other biologics. Patients not in LLDAS are eligible (either baseline clinical SLEDAI-2K >/=4 regardless of glucocorticoid dose/disease duration, or clinical SLEDAI-2K <4 with glucocorticoid dose >/=7.5 mg/day prednisone equivalent [PE] for >5 weeks). Patients taking >5 mg/day PE at study entry will attempt a protocolized taper to 5 mg/day, per modified Delphi consensus guidance.4Patients achieving DORIS remission for 2 consecutive visits will attempt complete glucocorticoid withdrawal following a 12-week regimen (figure 1).The primary endpoint is DORIS remission attainment at Week 52. Non-protocol-permitted changes to standard therapy, including immunosuppressant use, are intercurrent events. Secondary endpoints include the time spent in DORIS remission and LLDAS, and DORIS remission attainment with 0 mg/day PE. Safety endpoints include AEs and AESIs. Descriptive statistics will be used for all endpoints.Results Approximately 275 patients will be enrolled from 2026.Abstract PO:11:300 Figure 1SUNFLOWER study designConclusions The SUNFLOWER study will describe clinical outcomes following earlier initiation of anifrolumab than is typically seen in routine practice. Use in a less treatment-resistant population may enable higher DORIS remission rates. The study will also inform an approach to minimize cumulative glucocorticoid exposure. 4 Targeting rapid DORIS remission and glucocorticoid tapering with earlier biologic use may prevent organ damage and improve outcomes.1 References Fanouriakis. ARD. 2024;83:15–29. Morand. ARD. 2025;84:777–88. Mosca. ARD. 2025;84:168–9. Vital. ARD. 2025;84:1284–5.Study sponsor: AstraZeneca. Medical writing: Adam Creasey, MSc; Mark Lawrence, PhD (Avalere Health).

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