{
  "abstract": "Introduction The comparable efficacy and safety of both IV and SC induction with guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, in pts with moderately to severely active CD has been established in the phase 3 GALAXI and GRAVITI studies. To determine whether pts with higher baseline disease severity respond differently to IV or SC induction, we compared the efficacy of GUS IV and SC induction in subgroups based on baseline disease characteristics.Methods Pts had moderately to severely active CD (CDAI 220-450 and SES-CD≥6 or if ileal disease only, SES-CD≥4), and a history of inadequate response/intolerance to oral corticosteroids, AZA/6-MP/MTX, or biologics. GUS induction regimen was 200mg IV q4w in GALAXI 2 & 3 (N=582) and 400mg SC q4w in GRAVITI (N=230), while matching IV/SC PBO q4w (N=148 and N=117, respectively) was the comparator regimen. Clinical remission (CDAI<150) and endoscopic response (≥50% improvement from baseline SES-CD) were evaluated at Wk12 for predefined subgroups based on baseline involved disease location, CDAI, SES-CD, C-reactive protein (CRP), and fecal calprotectin (FeCal). Abnormal CRP was defined as >3 mg/L and >5 mg/L for GALAXI and GRAVITI, respectively.Results GALAXI and GRAVITI had similar entry criteria, and baseline disease characteristics of the randomized study ­populations were also similar. Pts treated with IV or SC GUS induction achieved clinical remission at Wk12 in greater proportions than those who received PBO across subgroups of disease location (ileal only [IV: GUS=44%, PBO=13%; SC: GUS=56%, PBO=27%], colon only [IV: GUS=44% vs PBO=18%; SC: GUS=56% vs PBO=18%], and both ileum and colon [IV: GUS=52% vs PBO=24%; SC: GUS=57% vs PBO=22%]), baseline CDAI (≤300 [IV: GUS=52%, PBO=25%; SC: GUS=66%, PBO=26%] and >300 [IV: GUS=40% vs PBO=10%; SC: GUS=41% vs PBO=14%]), baseline SES-CD (≤12 [IV: GUS=43%, PBO=21%; SC: GUS=52%, PBO=24%] and >12 [IV: GUS=53% vs PBO=16%; SC: GUS=62% vs PBO=18%]), baseline CRP (≤3mg/L or ≤5mg/L in GALAXI and GRAVITI, respectively, [IV: GUS=45%, PBO=17%; SC: GUS=53%, PBO=28%] and >3mg/L or >5mg/L [IV: GUS=48% vs PBO=20%; SC: GUS=59% vs PBO=17%]), and baseline FeCal (≤250μg/g [IV: GUS=49%, PBO=25%; SC: GUS=60%, PBO=26%] and >250μg/g [IV: GUS=46% vs PBO=16%; SC: GUS=54% vs PBO=20%]). Endoscopic response at Wk12 was also achieved by greater proportions of GUS- than PBO-induced pts across all subgroups with either IV or SC induction.Conclusions Both IV and SC induction with GUS were similarly effective in pts with moderately to severely active CD across predefined subgroups of disease location and baseline clinical, endoscopic, and inflammatory biomarker disease activity. The treatment effects were consistent in the subgroups following IV and SC induction, particularly in those that represent high disease severity.",
  "authors": [
    {
      "affiliations": [
        "London North-West University Healthcare NHS Trust, London, UK"
      ],
      "name": "Ailsa Hart"
    },
    {
      "affiliations": [
        "Icahn School of Medicine at Mount Sinai, New York, USA"
      ],
      "name": "Bruce E Sands"
    },
    {
      "affiliations": [
        "Kyorin University, Tokyo, Japan"
      ],
      "name": "Tadakazu Hisamatsu"
    },
    {
      "affiliations": [
        "Division of Digestive Diseases, University of Cincinnati, College of Medicine Ohio, Cincinnati, USA"
      ],
      "name": "Anita Afzali"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Spring House, USA"
      ],
      "name": "Natalie A Terry"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Spring House, USA"
      ],
      "name": "Mobolaji Olurinde"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Antwerp, Belgium"
      ],
      "name": "Rian Van Rampelbergh"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Raritan, USA"
      ],
      "name": "Jacqueline Yee"
    },
    {
      "affiliations": [
        "Johnson & Johnson, Antwerp, Belgium"
      ],
      "name": "Wilbert van Duijnhoven"
    },
    {
      "affiliations": [
        "IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milano, Italy"
      ],
      "name": "Silvio Danese"
    },
    {
      "affiliations": [
        "University of Calgary, Calgary, Canada"
      ],
      "name": "Remo Panaccione"
    }
  ],
  "title": "P191 Intravenous and subcutaneous guselkumab induction are efficacious in crohn’s disease patients with high baseline disease severity: GALAXI and GRAVITI results",
  "uid": "b2a1be6b-d855-55ba-a4e1-cf1ead5327a8"
}