{
  "abstract": "Rationale The randomised, double-blind, placebo-controlled Phase IIb ALIENTO trial ( NCT05037929) evaluated efficacy and safety of astegolimab (anti-ST2) in COPD.Methods Participants (current/former smokers, aged 40–90 years, history of frequent exacerbations) were randomised 1:1:1 to astegolimab SC 476 mg Q2W or Q4W, or placebo, for 52 weeks. Efficacy and safety endpoints were evaluated.Results 1301 participants were treated (Q2W, n=433; Q4W, n=437; placebo, n=431; 79% on ICS/LABA/LAMA at baseline). Annualised rate of moderate/severe COPD exacerbations (primary endpoint) was significantly lower with astegolimab Q2W vs placebo (adjusted rate reduction 15%; P=0.0494), but not Q4W vs placebo (figure 1). There were numerical decreases with astegolimab Q2W in moderate/severe COPD exacerbation rate in participants with baseline EOS <300 cells/µL (RR 0.87 [95% CI 0.73, 1.04]; P=0.1210), severe exacerbation rate (RR 0.71 [95% CI 0.49, 1.05]; P=0.0883), and change from baseline to Week 52 in SGRQ-C (difference in adjusted mean –1.87 [95% CI –4.01, 0.26]; P=0.0857). No differences were seen in other secondary endpoints (Week 52). Adverse events were balanced between treatment arms.Abstract S1 Figure 1Conclusions Astegolimab Q2W decreased annualised COPD exacerbation rate by 15% ( P=0.0494) vs placebo in the overall ALIENTO population (irrespective of smoking status or EOS level), with trends for improvement in some other clinical outcomes.",
  "authors": [
    {
      "affiliations": [
        "Department of Respiratory Sciences, Institute for Lung Health, University of Leicester, Leicester, UK"
      ],
      "name": "N Greening"
    },
    {
      "affiliations": [
        "Department of Respiratory Sciences, Institute for Lung Health, University of Leicester, Leicester, UK"
      ],
      "name": "CE Brightling"
    },
    {
      "affiliations": [
        "Global Allergy and Airways Patient Platform, Vienna, Austria"
      ],
      "name": "R Tal-Singer"
    },
    {
      "affiliations": [
        "Mass General Brigham Hospital, Harvard University Medical School, Boston, MA, USA"
      ],
      "name": "B Celli"
    },
    {
      "affiliations": [
        "University of Barcelona, Barcelona, Spain",
        "Respiratory Institute, Hospital Clinic Barcelona, Barcelona, Spain",
        "FCRB-IDIBAPS, Barcelona, Spain",
        "CIBER Enfermedades Respiratorias, ISCIII, Spain"
      ],
      "name": "A Agusti"
    },
    {
      "affiliations": [
        "IKF Pneumologie Mainz, Mainz, Germany",
        "Thoraxklinik Heidelberg, Hedelberg, Germany"
      ],
      "name": "S Korn"
    },
    {
      "affiliations": [
        "Department of Medicine, McMaster University, Hamilton, ON, Canada",
        "Research Institute of St. Joes Hamilton, Hamilton, ON, Canada"
      ],
      "name": "P Nair"
    },
    {
      "affiliations": [
        "University of Notre Dame Australia, Fremantle, WA, Australia"
      ],
      "name": "P Bremner"
    },
    {
      "affiliations": [
        "Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA"
      ],
      "name": "NA Hanania"
    },
    {
      "affiliations": [
        "Department of Chronic Diseases and Metabolism (CHROMETA), University Hospital Leuven, Leuven, Belgium"
      ],
      "name": "W Janssens"
    },
    {
      "affiliations": [
        "Genentech, Inc, South San Francisco, CA, USA"
      ],
      "name": "DS Cheung"
    },
    {
      "affiliations": [
        "Genentech, Inc, South San Francisco, CA, USA"
      ],
      "name": "MA Grimbaldeston"
    },
    {
      "affiliations": [
        "Genentech, Inc, South San Francisco, CA, USA"
      ],
      "name": "J Ng"
    },
    {
      "affiliations": [
        "Genentech, Inc, South San Francisco, CA, USA"
      ],
      "name": "X Yang"
    },
    {
      "affiliations": [
        "Genentech, Inc, South San Francisco, CA, USA"
      ],
      "name": "D Mohan"
    },
    {
      "affiliations": [
        "Department of Medicine, Pulmonary, Critical Care and Sleep Medicine, Philipps University of Marburg (UMR), German Center for Lung Research, Marburg, Germany"
      ],
      "name": "CF Vogelmeier"
    }
  ],
  "title": "S1 Randomised, placebo-controlled trial of astegolimab for COPD with frequent exacerbations: ALIENTO",
  "uid": "49621eb8-cb62-5778-9aee-f7d92ad4a8c3"
}