{
  "abstract": "Introduction Systemic sclerosis (SSc) is a systemic autoimmune disease with important role of B-cells in the pathogenesis. The aim of LIBERIUS study ( NCT05726630) was to evaluate the efficacy and safety of Divozilimab (DIV), a novel anti-CD20 monoclonal antibody, versus placebo (PBO) in SSc patients.Material and Methods 151 patients (>18 years) diagnosed with SSc according to the ACR/EULAR 2013 criteria, with a modified Rodnan skin score (mRSS) 10-20 were randomized (Tab 1). Participants received infusions of DIV 250 mg on Week (W) 0 and W2, followed by DIV 500 mg on W24, or the respective volume of placebo (PBO) at the same timepoints. The subsequent use in open mode, starting from W48, included infusions of DIV 500 mg every 6 months. This analysis presents 48-week results from the placebo-controlled period (before the DIV infusion at W48). The primary endpoint was the change in mRSS from baseline at W48, with safety evaluated through adverse events (AEs) and adverse reactions (ARs). Subanalysis included the changes in mRSS from baseline at W48 in subgroups of male and female, with and without concomitant mycophenolate mofetil (MMF), and with initial forced vital capacity (FVC) >80% or <80%. Least Squares Means Difference (LSMD) with 95% of Confidence Interval (CI) was used to estimate the difference between groups.Results Baseline mRSS was 14 and 13 points in DIV and PBO groups, respectively. The mRSS changes from baseline at W48 in the overall population were -5.8 (1.1) in DIV and -2.7 (1.0) in PBO, LSMD (95% CI) between DIV and PBO groups was -3.1 (-4.5; -1.7), p<0.0001. The mRSS changes from baseline at W48 in the subgroups is presented in Fig 1. In analysis of DIV+MMF vs PBO+MMF or DIV alone vs PBO, DIV treatment was superior to both PBO and MMF+PBO. Also, DIV+MMF demonstrated almost the same changes of mRSS as DIV alone, suggesting advantage of DIV over MMF in SSc treatment. In all subgroups by gender and initial FVC (%), DIV demonstrated superior efficacy over PBO. At least one AE was recorded in 53.9% (41/76) and 62.2% (46/74) of patients in DIV and PBO groups respectively (p>0.05). The most frequent treatment-related ARs were infusion reactions and a decrease number of lymphocytes. There were no severe and serious ARs in DIV group.Conclusions Divozilimab treatment leads to significant decrease of skin fibrosis comparing to standard treatment with favorable safety profile, which allows to consider DIV as an actual therapeutic option for SSc.Abstract P.261 Figure 1Changes in modified Rodnan skin score from baseline at W48Abstract P.261 Table 1Demographic and clinical characteristics at baseline",
  "authors": [
    {
      "affiliations": [
        "V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia"
      ],
      "name": "Lidia Ananyeva"
    },
    {
      "affiliations": [
        "V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia"
      ],
      "name": "Liudmila Garzanova"
    },
    {
      "affiliations": [
        "North-Western State Medical University named after I.I. Mechnikov, Saint-Petersburg, Russia",
        "St. Petersburg Clinical Rheumatology Hospital No. 25, Saint-Petersburg, Russia"
      ],
      "name": "Inna Gaydukova"
    },
    {
      "affiliations": [
        "V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia"
      ],
      "name": "Mayya Starovoytova"
    },
    {
      "affiliations": [
        "A.S Loginov Moscow Clinical Scientific Center, Moscow, Russia"
      ],
      "name": "Galina Lukina"
    },
    {
      "affiliations": [
        "Kazan State Medical University, Kazan, Russia"
      ],
      "name": "Diana Abdulganieva"
    },
    {
      "affiliations": [
        "Novosibirsk State Medical University, Novosibirsk, Russia"
      ],
      "name": "Elena Zonova"
    },
    {
      "affiliations": [
        "Siberian State Medical University, Tomsk, Russia"
      ],
      "name": "Larisa Eliseeva"
    },
    {
      "affiliations": [
        "G.G. Kuvatov Republican Clinical Hospital, Ufa, Russia"
      ],
      "name": "Gulshat Fatkhullina"
    },
    {
      "affiliations": [
        "JSC BIOCAD, Saint-Petersburg, Russia"
      ],
      "name": "Anton Lutsky"
    },
    {
      "affiliations": [
        "JSC BIOCAD, Saint-Petersburg, Russia"
      ],
      "name": "Arina Zinkina-Orikhan"
    },
    {
      "affiliations": [
        "JSC BIOCAD, Saint-Petersburg, Russia"
      ],
      "name": "Yulia Linkova"
    },
    {
      "affiliations": [
        "JSC BIOCAD, Saint-Petersburg, Russia"
      ],
      "name": "Ekaterina Fokina"
    },
    {
      "affiliations": [
        "JSC BIOCAD, Saint-Petersburg, Russia"
      ],
      "name": "Anastasia Porozova"
    },
    {
      "affiliations": [
        "JSC BIOCAD, Saint-Petersburg, Russia"
      ],
      "name": "Anna Eremeeva"
    },
    {
      "affiliations": [
        "JSC BIOCAD, Saint-Petersburg, Russia"
      ],
      "name": "Polina Pukhtinskaia"
    }
  ],
  "title": "P.261 The efficacy and safety of divozilimab, anti-CD20 monoclonal antibody in patients with systemic sclerosis",
  "uid": "06454f34-ff6b-5792-8b72-74cd8a185f0f"
}