{
  "abstract": "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).",
  "authors": [
    {
      "affiliations": [
        "Schroeder Arthritis Institute, Krembil Research Institute, Univ. Health Network, Toronto, ON, Canada",
        "Univ. of Toronto Lupus Clinic, Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada"
      ],
      "name": "Zahi Touma"
    },
    {
      "affiliations": [
        "AstraZeneca, Wilmington, DE, USA"
      ],
      "name": "Gelareh Atefi"
    },
    {
      "affiliations": [
        "AstraZeneca, Wilmington, DE, USA"
      ],
      "name": "John P Bell"
    },
    {
      "affiliations": [
        "AstraZeneca, Medical and Scientific Affairs, RandI, Mississauga, ON, Canada"
      ],
      "name": "Shelly Chandran"
    },
    {
      "affiliations": [
        "French National Reference Center for SLE, Hôpital La Pitié-Salpêtrière, Sorbonne Univ., Paris, France"
      ],
      "name": "Zahir Amoura"
    },
    {
      "affiliations": [
        "Div. of Rheumatology, Univ. of California, San Francisco, USA"
      ],
      "name": "Maria Dall Era"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit, Attikon Univ. Hospital, National and Kapodistrian Univ. of Athens Medical School, Athens, Greece"
      ],
      "name": "Antonis Fanouriakis"
    },
    {
      "affiliations": [
        "Institute of Metabolic Science, Univ. of Cambridge, Cambridge, UK",
        "NIHR Cambridge Biomedical Research Centre, Addenbrookes Hospital, Cambridge, UK"
      ],
      "name": "Mark Gurnell"
    },
    {
      "affiliations": [
        "Centre for Inflammatory Diseases, Monash Univ., Melbourne, VIC, Australia"
      ],
      "name": "Eric Morand"
    },
    {
      "affiliations": [
        "Dept. of Clinical and Experimental Medicine, Univ. of Pisa, Pisa, Italy"
      ],
      "name": "Marta Mosca"
    },
    {
      "affiliations": [
        "Rheumazentrum Ruhrgebiet Herne, Ruhr-Univ. Bochum, Bochum, Germany"
      ],
      "name": "Johanna Mucke"
    },
    {
      "affiliations": [
        "Thurston Arthritis Research Center, Univ. of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA",
        "Dept. of Medicine, Div. of Rheumatology, Allergy and Immunology, Univ. of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA"
      ],
      "name": "Saira Sheikh"
    },
    {
      "affiliations": [
        "Biopharmaceuticals Medical, AstraZeneca, Cambridge, UK"
      ],
      "name": "Soram Patel"
    }
  ],
  "title": "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",
  "uid": "5de801c7-391e-5daf-a0ca-5626941c464f"
}