{
  "abstract": "Objectives This 1-year long-term extension (LTE) study ( NCT04451772) followed the 48-week phase 2 SLEek study (NCT03978520) that evaluated upadacitinib (a Janus kinase inhibitor) alone or combined with elsubrutinib (a Bruton’s tyrosine kinase inhibitor) in adults with moderately to severely active systemic lupus erythematosus (SLE). The objective was to evaluate the efficacy and safety of an additional 56 weeks of treatment.Methods Patients randomised to upadacitinib 30 mg one time per day (QD) or upadacitinib 30 mg/elsubrutinib 60 mg QD (upadacitinib/elsubrutinib) in the SLEek study continued their assigned treatment during the LTE. Patients originally receiving placebo switched to upadacitinib/elsubrutinib in the LTE. Assessments through week 104 included SLE Responder Index-4 (SRI-4), British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA), Lupus Low Disease Activity State (LLDAS), change from baseline in glucocorticoid dose, flare events and adverse events.Results This LTE analysis included 127 patients. Efficacy responses for the groups receiving upadacitinib, upadacitinib/elsubrutinib and placebo to upadacitinib/elsubrutinib were maintained or increased from weeks 48 to 104 (week 104: SRI-4: 82.1%, 85.4% and 61.3%; BICLA: 69.2%, 78.0% and 54.8%; LLDAS: 60.0%, 78.0% and 34.4%). From weeks 48 through 104, the mean daily glucocorticoid dose was reduced, and the incidence of flares was maintained or further reduced in all treatment groups. Safety profiles were similar to those observed in the primary SLEek study.Conclusions In this LTE study, upadacitinib monotherapy and upadacitinib/elsubrutinib combined were well tolerated and continued to demonstrate beneficial effects on SLE disease activity, glucocorticoid dose and flares through 104 weeks.",
  "authors": [
    {
      "affiliations": [
        "Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA"
      ],
      "name": "Joan T Merrill"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Department of Medicine, NYU Langone Health, New York, New York, USA"
      ],
      "name": "Amit Saxena"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Department of Medicine III, University Medical Center and Faculty of Medicine, TU Dresden, Dresden, Germany"
      ],
      "name": "Martin Aringer"
    },
    {
      "affiliations": [
        "First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Fukuoka, Japan"
      ],
      "name": "Yoshiya Tanaka"
    },
    {
      "affiliations": [
        "Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China"
      ],
      "name": "Xiaofeng Zeng"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Ling Cheng"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Thao T Doan"
    },
    {
      "affiliations": [
        "The Louise Coote Lupus Unit, Guy's and St Thomas’ Hospitals NHS Foundation Trust, London, UK"
      ],
      "name": "David D’Cruz"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Karim R Masri"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Kristin M D’Silva"
    }
  ],
  "title": "Efficacy and safety of upadacitinib as monotherapy or combined with elsubrutinib for the treatment of systemic lupus erythematosus: results through 104 weeks in a long-term extension study",
  "uid": "b0e44058-2890-5612-ae09-89d482631aa8"
}