{
  "abstract": "Introduction Risankizumab (RZB), a high-affinity humanised IgG1 monoclonal antibody targeting interleukin-23 p19, has shown sustained efficacy and an acceptable safety profile for patients (pts) with ulcerative colitis (UC). 1 This interim analysis reports efficacy data at week (wk) 0 and wk 96, as well as safety data of the COMMAND (NCT03398135) open-label extension (OLE).Methods The COMMAND OLE enrolled pts who completed 52-wks maintenance dosing in the COMMAND substudies or entered directly from the induction study. 1 All pts received RZB 180mg (RZB180) subcutaneous (SC) starting at OLE wk 0, except pts who had prior rescue therapy (single RZB 1200 mg intravenous [IV] dose then RZB 360mg [RZB360] Q8w) who continued RZB360 in the OLE. The OLE was not designed to compare RZB180 and RZB360 groups. The data cut-off date for this interim analysis was as of June 30, 2024. Efficacy endpoints assessed were clinical remission (CR) per Adapted Mayo Score (AMS), clinical response per AMS, endoscopic improvement, endoscopic remission, and corticosteroid-free CR per Partial AMS up to wk 96. Data are reported as observed prior to RZB rescue therapy during OLE. The safety analysis also includes pts who directly entered the OLE from induction; presented as events/100 pt years (E/100 PY).Results Of the pts who entered the OLE (RZB180, N = 701; RZB360, N = 302), approximately 40% of pts had the opportunity to reach OLE wk 96 as of the cut-off date. At OLE wk 0 and 96, a similar proportion of patients in the RZB180 group achieved clinical and endoscopic outcomes. In the RZB360 group, the percent of pts achieving clinical and endoscopic endpoints increased from OLE wk 0 through OLE wk 96. Similar rates of serious AEs, severe AEs, and AEs leading to discontinuation of study drug were reported in the RZB180 group and the RZB360 group with no new safety risks identified.Conclusions In this interim analysis of the OLE, a sustained benefit was observed with long-term RZB treatment up to 96 wks. The long-term safety profile for RZB remains consistent and supports the long-term use.Reference Louis E, et al. JAMA. 2024;332(11):881–897.",
  "authors": [
    {
      "affiliations": [
        "First Department of Medicine, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany"
      ],
      "name": "Raja Atreya"
    },
    {
      "affiliations": [
        "Hepato-Gastroenterology and Digestive Oncology Department, University Hospital CHU of Liège, Liège, Belgium"
      ],
      "name": "Edouard Louis"
    },
    {
      "affiliations": [
        "Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, USA"
      ],
      "name": "Edward V Loftus"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, USA"
      ],
      "name": "David T Rubin"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Inflammatory Bowel Disease Center, Icahn School of Medicine at Mount Sinai, New York, USA"
      ],
      "name": "Marla Dubinsky"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan"
      ],
      "name": "Tadakazu Hisamatsu"
    },
    {
      "affiliations": [
        "AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany"
      ],
      "name": "Jasmina Kalabic"
    },
    {
      "affiliations": [
        "AbbVie Spain, Madrid, Spain"
      ],
      "name": "Paloma Mendez"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Su Chen"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Saajan Shah"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "Pierre Morisset"
    },
    {
      "affiliations": [
        "AbbVie Inc., North Chicago, USA"
      ],
      "name": "W Rachel Duan"
    },
    {
      "affiliations": [
        "AbbVie Ltd., Maidenhead, UK"
      ],
      "name": "Christina Coll"
    },
    {
      "affiliations": [
        "Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Canada"
      ],
      "name": "Remo Panaccione"
    }
  ],
  "title": "P257 Efficacy and safety up to 3 years of risankizumab in moderately to severely active ulcerative colitis patients: COMMAND interim results",
  "uid": "c3b34ad3-3b95-5ffe-9928-00a4aa6a5c3c"
}