{
  "abstract": "Introduction The on-going VIVID-2 ( NCT04232553) open-label extension study evaluates the long-term efficacy and safety of mirikizumab (MIRI), a selective IL-23p19 monoclonal antibody, in patients with moderately to severely active Crohn’s disease (CD). We present results from patients randomised to MIRI in the Phase 3 VIVID-1 study (NCT03926130) who attained endoscopic response at week 52 (W52) and continued to receive MIRI maintenance dosing through to W152in VIVID-2.Methods In VIVID-1, the MIRI group received induction with 900 mg intravenously (IV) at weeks (W) 0, 4, and 8, then 300 mg subcutaneously (SC) every 4W. W52 endoscopic responders (≥50% reduction from baseline in Simple Endoscopic Score for CD [SES-CD]) continued the same MIRI SC dosing in VIVID-2. Outcomes were assessed at W152 of MIRI treatment. Safety was assessed from the first dose in VIVID-2 through W152. Discontinuations or missing data were handled using observed cases (OCs) and modified nonresponder imputation (mNRI).Results Among MIRI W52 endoscopic responders (N=251) (OC%/mNRI%), 87.9%/76.8% achieved Crohn’s Disease Activity Index (CDAI) remission, 86.8%/75.7% achieved Corticosteroid-free (CSF) CDAI remission, 75.0%/66.1% achieved bowel urgency (BU) clinically meaningful improvement (CMI), and 53.8%/47.2% achieved BU remission at W152 ( figure 1a). Of patients who achieved the specified endpoint at W52, 92.4%/82.8% maintained CDAI remission, 91.2%/81.1% maintained CSF CDAI remission, 82.1%/72.7% maintained BU CMI, and 71.7%/64.0% maintained BU remission at W152 (figure 1b). Of patients who did not achieve the specified endpoint at W52, 72.5%/58.4% gained CDAI remission, 73.9%/62.1% gained CSF CDAI remission, 53.8%/46.4% gained BU CMI, and 28.1%/24.8% gained BU remission at W152 (figure 1c).Further decreases were observed in median concentrations of C-reactive protein (CRP) and fecal calprotectin (FCP) in MIRI W52 endoscopic responders from W52 to W152 (CRP 1.7mg/L to 1.2mg/L; FCP 119µg/g to 65 µg/g). The overall safety profile remained consistent with no increase from year one of treatment in exposure-adjusted incidence rates of long-latency events such as MACE, malignancies, overall infections, or serious infections.Conclusions MIRI treatment in W52 endoscopic responders demonstrated sustained and durable long-term clinical efficacy through to W152in patients with moderately-to-severely active CD. The safety data was consistent with the known safety profile of MIRI.Data shown includes only participants randomized to MIRI in VIVID-1, who achieved endoscopic response at W52 and continued with MIRI SC dosing in VIVID-2, with baseline SES-CD ≥7 (or ≥4 for isolated ileal disease).Endpoint definitions:CDAI remission: CDAI Total Score <150CSF CDAI remission: CDAI score <150 at the designated timepoint with no CS use for 12 weeks priorBU CMI: ≥3-point improvement in the Urgency NRS from baseline at Week 152 in patients with a baseline Urgency NRS ≥3BU Remission: Urgency NRS ≤2 in patients with a baseline Urgency NRS ≥3Abbreviations CDAI=Crohn’s Disease Activity Index; CSF=corticosteroid free; MIRI=Mirikizumab; mNRI=Modified Nonresponder Imputation; N=Number of Patients in the ­Analysis Population; Nx=Number of Patients with Non-missing Values; OC=Observed Case; SC=Subcutaneous; SES-CD=Simple Endoscopic Score for Crohn’s Disease; W=week.Abstract P169 Figure 1W152 outcomes after 3 years of continuous MIRI treatment in W52 endoscopic responders",
  "authors": [
    {
      "affiliations": [
        "CHU de Bordeaux, Hôpital Haut-Lévêque, Service d’Hépato-gastroentérologie et Oncologie Digestive, Université de Bordeaux, Bordeaux, France"
      ],
      "name": "David Laharie"
    },
    {
      "affiliations": [
        "Eli Lilly and Company, Indianapolis, USA"
      ],
      "name": "David Clemow"
    },
    {
      "affiliations": [
        "Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, USA"
      ],
      "name": "Bruce E Sands"
    },
    {
      "affiliations": [
        "Eli Lilly and Company, Indianapolis, USA"
      ],
      "name": "Rebecca R Hozak"
    },
    {
      "affiliations": [
        "Department of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, USA"
      ],
      "name": "Edward L Barnes"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, the Netherlands"
      ],
      "name": "Geert D’Haens"
    },
    {
      "affiliations": [
        "Eli Lilly and Company, Indianapolis, USA"
      ],
      "name": "Prashant Gupta"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan"
      ],
      "name": "Tadakazu Hisamatsu"
    },
    {
      "affiliations": [
        "Eli Lilly and Company, Indianapolis, USA"
      ],
      "name": "Arul Gandhi R"
    },
    {
      "affiliations": [
        "Department of Medicine, Brigham and Women’s Hospital, Boston, USA"
      ],
      "name": "Colleen Kelly"
    },
    {
      "affiliations": [
        "Eli Lilly and Company, Indianapolis, USA"
      ],
      "name": "Michelle U Lopes"
    },
    {
      "affiliations": [
        "Eli Lilly and Company, Indianapolis, USA"
      ],
      "name": "Richard Moses"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, USA"
      ],
      "name": "Miguel Regueiro"
    },
    {
      "affiliations": [
        "Eli Lilly and Company Limited, Basingstoke, UK"
      ],
      "name": "Endip Dhesi"
    }
  ],
  "title": "P169 Efficacy and safety of mirikizumab in week 52 endoscopic responders with crohn’s disease: 3-year vivid-2 open-label extension interim results",
  "uid": "6ade3785-58a9-5339-b64c-9c60f95833a0"
}