{
  "abstract": "Introduction Guselkumab (GUS) is a dual-acting IL-23p19 subunit inhibitor that potently neutralizes IL-23 and binds to CD64, a receptor on cells that produce IL-23. In the QUASAR studies, GUS intravenous (IV) induction and subcutaneous (SC) maintenance demonstrated symptomatic, endoscopic, and histologic efficacy through 2 years. 1 2 Here, we describe maintenance of endoscopic and histologic efficacy in the long-term extension (LTE).Methods At maintenance week (W) 0, GUS IV induction responders were randomized 1:1:1 to GUS 100 mg SC every 8 weeks (q8w), GUS 200 mg SC q4w or placebo (GUS withdrawal). Participants (pts) completing the W44 visit could enter the LTE and continue the treatment regimen they were receiving at W44. Placebo pts discontinued after study unblinding. Efficacy data for randomized pts who continued to receive their GUS regimen assigned at W0 in the LTE were analyzed using 2 Methods 1) nonresponder imputation (NRI) accounting for pts with treatment failure or missing data, and 2) ‘as observed.’Results Overall, 303 randomized pts (155 for 100 mg q8w and 148 for 200 mg q4w) continued their GUS treatment assigned at W0 in the LTE. Of pts who achieved endoscopic improvement at W44, 87.2% of GUS 100 mg q8w pts and 80.2% GUS 200 mg q4w pts maintained endoscopic improvement through W92 (NRI analysis). Of pts who achieved histologic improvement at W44, 77.9% and 75.2%, respectively, maintained histologic improvement at W92. Of pts who achieved histo-endoscopic mucosal improvement (HEMI) at W44, 73.5% and 75.5%, respectively, maintained HEMI through W92. Of pts who were in histologic remission at W44, 71.2% maintained histologic remission at W92 in both GUS groups. Results of the as-observed analysis were consistent with the NRI analysis; the dropout rate was low among GUS-treated pts in the LTE.Conclusions High rates of long-term sustained endoscopic and histologic endpoints were observed at W92 of the LTE with both GUS dose regimens.Study Support Johnson & Johnson.References Rubin DT, et al. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025;405(10472):33–49.Lichtenstein GR, et al. Efficacy and safety of guselkumab for ulcerative colitis through week 92 of the QUASAR long-term extension study. Presented at: Digestive Disease Week (DDW); 2025; San Diego, CA.",
  "authors": [
    {
      "affiliations": [
        "Inflammatory Bowel Disease Unit, Guy’s and St Thomas’ NHS Foundation Trust, London, UK"
      ],
      "name": "Mark A Samaan"
    },
    {
      "affiliations": [
        "Kyorin University School of Medicine, Tokyo, Japan"
      ],
      "name": "Tadakazu Hisamatsu"
    },
    {
      "affiliations": [
        "Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain"
      ],
      "name": "Julián Panés"
    },
    {
      "affiliations": [
        "University of Porto, Porto, Portugal"
      ],
      "name": "Fernando Magro"
    },
    {
      "affiliations": [
        "University of Pennsylvania, Philadelphia, USA"
      ],
      "name": "Gary R Lichtenstein"
    },
    {
      "affiliations": [
        "Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Harvard Medical School, Boston, USA"
      ],
      "name": "Jessica R Allegretti"
    },
    {
      "affiliations": [
        "University of British Columbia, Vancouver, Canada"
      ],
      "name": "Brian Bressler"
    },
    {
      "affiliations": [
        "Division of Gastroenterology, McGill University Health Care, Montréal, Canada"
      ],
      "name": "Waqqas Afif"
    },
    {
      "affiliations": [
        "University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea"
      ],
      "name": "Byong Duk Ye"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Spring House, USA"
      ],
      "name": "Shadi Yarandi"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Spring House, USA"
      ],
      "name": "Matthew Germinaro"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Spring House, USA"
      ],
      "name": "Nicole Shipitofsky"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Spring House, USA"
      ],
      "name": "Dwiti Pandya"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Spring House, USA"
      ],
      "name": "Ye Miao"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Spring House, USA"
      ],
      "name": "Hongyan Zhang"
    },
    {
      "affiliations": [
        "Department of Medicine, Agaplesion Markus Hospital, Goethe University, Frankfurt, Germany"
      ],
      "name": "Axel Dignass"
    },
    {
      "affiliations": [
        "University of Chicago Medicine Inflammatory Bowel Disease Centre, Chicago, USA"
      ],
      "name": "David T Rubin"
    },
    {
      "affiliations": [
        "Icahn School of Medicine at Mount Sinai, New York, USA"
      ],
      "name": "Bruce E Sands"
    }
  ],
  "title": "P217 Maintenance of endoscopic and histologic efficacy with guselkumab for ulcerative colitis at week 92 of the QUASAR long-term extension study",
  "uid": "949d9ef7-d861-5535-b229-e09ddc6264e4"
}