{
  "abstract": "Objectives Low disease activity (Lupus Low Disease Activity State [LLDAS]) and remission (Definition of Remission in SLE [DORIS]) are recommended treatment targets associated with reduced organ damage and improved outcomes. We report LLDAS and remission, including sustained outcomes, from the phase 3 PHOENYCS GO trial ( NCT04294667) of dapirolizumab pegol (DZP).DZP is a novel CD40L inhibitor with broad modulatory effects on SLE immunopathology; it consists of a polyethylene glycol (PEG)-conjugated antigen-binding fragment (Fab’), which lacks an Fc domain. In PHOENYCS GO, the primary endpoint was met; DZP plus standard of care (DZP+SOC) resulted in a significantly higher rate of BICLA response versus placebo (PBO)+SOC at Week 48 (49.5% versus 34.6%; p=0.0110).Methods In the 48-week PHOENYCS GO trial, patients were randomised 2:1 to intravenous DZP 24 mg/kg+SOC or PBO+SOC every 4 weeks. Investigators were required to taper glucocorticoid dose, starting by Week 8, for patients with baseline dose >7.5 mg/day prednisone equivalent.The pre-specified LLDAS definition required glucocorticoid dose <=7.5 mg/day; an alternative definition requiring <=5 mg/day (LLDAS-5) was explored post hoc, aligning with current treatment guidelines. Achievement of LLDAS and remission (DORIS) by visit, sustained (>=3 consecutive) visits in LLDAS and remission, and LLDAS in >=50% of visits (LLDAS-50) are reported, using both LLDAS definitions.Results Baseline characteristics reflected a moderate-to-severe SLE population ( table 1). To Week 48, greater proportions of patients receiving DZP+SOC versus PBO+SOC achieved LLDAS and LLDAS-5 (nominal p<0.0001; nominal p=0.0002; figure 1A–1B). By Week 48, greater proportions of patients receiving DZP+SOC versus PBO+SOC sustained LLDAS and LLDAS-5 across >=3 consecutive visits (nominal p=0.0023; nominal p=0.0007; figure 1C). 23.6% versus 15.9% of patients receiving DZP+SOC versus PBO+SOC achieved pre-specified LLDAS-50 (nominal p=0.1042); per the alternative definition 12.5% versus 4.7% achieved LLDAS-5-50 (nominal p=0.0103; figure 1C). A higher proportion of patients receiving DZP+SOC versus PBO+SOC achieved remission at Week 48 (nominal p=0.0056; figure 1D) and sustained remission across >=3 consecutive visits (nominal p=0.0208; figure 1C).Abstract PT4:04 Table 1Baseline demographics and disease characteristicsAbstract PT4:04 Figure 1Achievement of LLDAS, LLDAS-5 and remission outcomes through week 48Conclusions DZP+SOC resulted in higher rates of achievement and time in LLDAS and remission versus PBO+SOC. This remained true with a more stringent definition of LLDAS (glucocorticoid dose <=5 mg/day), aligning with current treatment guidelines.",
  "authors": [
    {
      "affiliations": [
        "Monash University, Centre for Inflammatory Diseases, Melbourne, Australia"
      ],
      "name": "Eric F Morand"
    },
    {
      "affiliations": [
        "University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK"
      ],
      "name": "Lucy M Carter"
    },
    {
      "affiliations": [
        "University of California, Division of Rheumatology, San Francisco, USA"
      ],
      "name": "Maria Dall’Era"
    },
    {
      "affiliations": [
        "Johns Hopkins University School of Medicine, Baltimore, USA"
      ],
      "name": "Michelle Petri"
    },
    {
      "affiliations": [
        "University of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK",
        "Leeds Teaching Hospitals NHS Trust, NIHR Leeds Biomedical Research Centre, Leeds, UK"
      ],
      "name": "Edward Vital"
    },
    {
      "affiliations": [
        "UCB, Raleigh, USA"
      ],
      "name": "Teri Jimenez"
    },
    {
      "affiliations": [
        "Biogen, Cambridge, USA"
      ],
      "name": "Janine Gaiha-Rorhbach"
    },
    {
      "affiliations": [
        "UCB, Brussels, Belgium"
      ],
      "name": "Bernard Lauwerys"
    },
    {
      "affiliations": [
        "Biogen, Baar, Switzerland"
      ],
      "name": "Annette Nelde"
    },
    {
      "affiliations": [
        "UCB, Monheim am Rhein, Germany"
      ],
      "name": "Christian Stach"
    },
    {
      "affiliations": [
        "Amsterdam University Medical Centre, Department of Rheumatology, Amsterdam, The Netherlands"
      ],
      "name": "Ronald Van Vollenhoven"
    }
  ],
  "title": "PT4:04 Achievement of low disease activity and remission in patients with SLE treated with dapirolizumab pegol: updated 48-week analyses from a phase 3 trial including lower glucocorticoid dose criteria",
  "uid": "0a27e0f7-13f1-5068-879c-59142c01d1ad"
}