{
  "abstract": "Introduction Background and Aim: Resmetirom is approved for treatment of F2-F3 metabolic dysfunction- associated steatohepatitis (MASH) in the United States. Our aim was to assess health-related quality of life (HRQL) in metabolic dysfunction steatotic liver disease (MASLD) patients without and with cirrhosis treated with resmetirom.Methods MASLD patients with cirrhosis (CP-A) or without cirrhosis were enrolled in a 52-week, Phase 3 double-blind placebo-controlled study of resmetirom (Period 1 of MAESTRO-NAFLD) and upon treatment completion, were offered to enroll in a 52-week open-label extension study of resmetirom (Period 2). HRQL was assessed using LDQOL, CLDQ-NAFLD and WPAI throughout treatment Period 1 (baseline, week 24, week 52) and treatment Period 2 (day 1, week 12, week 28, week 52). For non-cirrhotic MASLD, PDFF response was defined as a decrease in MRI-PDFF ≥30% from baseline while for cirrhotic MASLD, it was defined as ≥20% decrease in MRI-PDFF (if baseline MRI-PDFF >5%).Results MAESTRO NAFLD included 1307 MASLD patients (combined double-blind placebo-controlled mITT and open-label groups). Of these, 1114 were without cirrhosis (baseline MRI-PDFF≥8%) and 193 with cirrhosis (23% with baseline MRI-PDFF≤5%). At baseline, HRQL scores of patients with cirrhosis were significantly lower (up to -15% of score range) for all 6 domains of CLDQ-NAFLD, 14/17 domains of LDQOL, Activity Impairment of WPAI (p<0.05). Among patients with cirrhosis, there was no significant difference in baseline HRQL scores between those with MRI-PDFF ≤5% and >5% (all p>0.05). By weeks 24 and 52 of treatment, non-cirrhotic patients receiving placebo experienced worsening of HRQL in some physical health-related domains of LDQOL (mean decrease up to -5%; p<0.05) while no decreases were observed in non-cirrhotic patients treated with resmetirom. In addition, non-cirrhotic patients receiving resmetirom experienced improvement in Abdominal and Worry domains of CLDQ-NAFLD and Health Distress of LDQOL (mean increase up to +5% of score range size); no similar improvements were observed in placebo (all p>0.05). Non-cirrhotic patients with PDFF response experienced improvements in Abdominal and Worry scores (up to +7%) which were greater than those seen in placebo or non-responders.In patients with cirrhosis, by week 24 of treatment with resmetirom during Period 1, there were improvements in Worry (CLDQ-NAFLD) and Health Distress (LDQOL) up to +5% of score range (p≤0.05) which became more pronounced by treatment week 52 and were sustained throughout Period 2 (day 1, week 12, week 28) (all p<0.05). In cirrhotic subjects with MRI-PDFF >5%, PDFF response by Period 1 week 52, there was an improvement in Stigma score (LDQOL): mean change (+3.4 vs. -4.6 (p=0.046).Conclusion Patients without or with cirrhosis due to MASLD treated with resmetirom experience sustained improvement in select disease-specific HRQL scores.",
  "authors": [
    {
      "affiliations": [
        "Madrigal Pharmaceuticals, London, United Kingdom"
      ],
      "name": "Daniel Abeles"
    },
    {
      "affiliations": [
        "Madrigal Pharmaceuticals, London, United Kingdom"
      ],
      "name": "Ron Basuroy"
    },
    {
      "affiliations": [
        "The Global NASH/MASH Council, Washington, DC, USA, Washington, USA",
        "Beatty Liver and Obesity Research Program, Inova Health Systems, Falls Church, USA"
      ],
      "name": "Zobair Younossi"
    },
    {
      "affiliations": [
        "The Global NASH/MASH Council, Washington, DC, USA, Washington, USA",
        "Beatty Liver and Obesity Research Program, Inova Health Systems, Falls Church, USA"
      ],
      "name": "Fatema Nader"
    },
    {
      "affiliations": [
        "Madrigal Pharmaceuticals, London, United Kingdom"
      ],
      "name": "Dominic Labriola"
    },
    {
      "affiliations": [
        "Madrigal Pharmaceuticals, London, United Kingdom"
      ],
      "name": "Rebecca Taub"
    },
    {
      "affiliations": [
        "The Global NASH/MASH Council, Washington, DC, USA, Washington, USA",
        "Beatty Liver and Obesity Research Program, Inova Health Systems, Falls Church, USA",
        "Center for Outcomes Research in Liver Diseases, Washington, USA"
      ],
      "name": "Andrei Racila"
    }
  ],
  "title": "O14 Improvement in health-related quality of life in non-cirrhotic and cirrhotic patients with MASLD treated with resmetirom: data from MAESTRO-NAFLD",
  "uid": "66b30562-6a6a-5b95-9c66-880e36e5faae"
}