{
  "abstract": "Introduction Here, we evaluate the long-term efficacy and safety of up to 3 years of total upadacitinib (UPA) maintenance therapy in patients with moderately to severely active Crohn’s disease (CD) in the ongoing U-ENDURE LTE study.Methods Patients who completed the U-ENDURE 52-week (wk) maintenance study were eligible for the subsequent LTE study and continued their previously assigned treatment (UPA 15 mg [UPA15] once-daily [QD] or UPA 30 mg [UPA30] QD). This analysis included patients who completed 52 wks of maintenance treatment and an additional 96 wks in the LTE study (total 3 years), with efficacy assessed from LTE wk 0-96. Inadequate responders were eligible to receive rescue therapy (open-label UPA30 or protocol-approved CD-related medications); patients who received rescue therapy were analysed separately. Clinical and endoscopic endpoints were evaluated using both as-observed (AO) and nonresponder imputation (NRI) methods; mean change from baseline of induction in high-sensitivity C-reactive protein (hs-CRP) and faecal calprotectin (FCP) were evaluated using AO analysis. Safety was assessed from maintenance wk 0, with up to 292 wks of cumulative maintenance and LTE treatment exposure (cut-off date: 19 Nov 2024).Results Baseline (wk 0 of induction) demographics and clinical characteristics were generally well-balanced among UPA15- or UPA30-treated patients enrolled in the LTE. From LTE wk 0 to wk 96, AO efficacy rates remained stable in each treatment group for clinical remission per stool frequency (SF)/abdominal pain score (APS) (UPA15: 78.3% to 83.1%; UPA30: 84.7% to 84.3%) or Crohn’s Disease Activity Index (CDAI) (UPA15: 81.3% to 83.1%; UPA30: 86.1% to 88.6%); similar results were observed in corticosteroid-free clinical remission. From LTE wk 0 to wk 96, efficacy rates remained stable for endoscopic response (UPA15: 59.6% to 70.8%; UPA30: 71.2% to 70.1%), and endoscopic remission (UPA15: 42.4% to 50.8%; UPA30: 53.0% to 56.7%). Clinical or endoscopic remission was sustained through LTE wk 96. Mean change from induction baseline was stable from LTE wk 0 through wk 96 for inflammatory markers, hs-CRP (UPA15: -12.4, -12.0; UPA30: -12.7, -10.1) and FCP (UPA15: -2752, -3263; UPA30: -1850, -2055) (AO). Across efficacy endpoints, similar results were found per NRI. No new safety signals were identified in this safety analysis among UPA15- or UPA30-treated patients. 1 The safety profile was consistent with the known safety profile of UPA in CD.2Conclusions Sustained efficacy for clinical, endoscopic, and inflammatory markers was observed in patients who completed up to 3 years of UPA maintenance therapy, with no new safety signals identified. 2References D’Haens G, et al. J Crohn’s Colitis. (Abstract). 2024;18:i17–i18.Loftus EV Jr., Panés J, et al. N Engl J Med. 2023;88:1966–80.",
  "authors": [
    {
      "affiliations": [
        "Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, USA"
      ],
      "name": "Edward V Loftus"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands"
      ],
      "name": "Geert D’Haens"
    },
    {
      "affiliations": [
        "Department of Hepato-Gastroenterology and Digestive Oncology, University Hospital CHU of Liège, Liège, Belgium"
      ],
      "name": "Edouard Louis"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Cleveland Clinic Foundation, Cleveland, USA"
      ],
      "name": "Miguel Regueiro"
    },
    {
      "affiliations": [
        "Department of Medicine, Western University, London, Canada"
      ],
      "name": "Vipul Jairath"
    },
    {
      "affiliations": [
        "Unit of Pharmacology and Therapeutics, Department of Biomedicine, Faculty of Medicine, University of Porto, Porto, Portugal",
        "Department of Gastroenterology, São João University Hospital Center, Porto, Portugal",
        "CINTESIS@RISE, Faculty of Medicine, University of Porto, Porto, Portugal"
      ],
      "name": "Fernando Magro"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan"
      ],
      "name": "Hiroshi Nakase"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Elena Dubcenco"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Irina Fish"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Kimmie Kim"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Yibo Wang"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Samuel I Anyanwu"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Fernando Aponte"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Sina Ogholikhan"
    },
    {
      "affiliations": [
        "AbbVie Ltd., Maidenhead, UK"
      ],
      "name": "Christina Coll"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Goethe-University Hospital, Frankfurt, Germany"
      ],
      "name": "Irina Blumenstein"
    }
  ],
  "title": "P189 Efficacy and safety of upadacitinib maintenance treatment in patients with moderately to severely active crohn’s disease: 3-year results from U-ENDURE",
  "uid": "25843f63-b7e3-58bf-b4b8-425ea8b93272"
}