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Allanore, Yannick; Khanna, Dinesh; Smith, Vanessa; Aringer, Martin; Hoffmann-Vold, Anna-Maria; Kuwana, Masataka; Merkel, Peter A; Stock, Christian; Sambevski, Steven; Denton, Christopher P; Bergna, M; Casado, G; Mannucci Walter, P; Proudman, S; Stevens, W; Thakkar, V; Troy, L; Loeffler-Ragg, J; Olschewski, H; André, B; Bondue, B; Houssiau, F; Smith, V; Wuyts, W; [...]

Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease

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  • Medientyp: E-Artikel
  • Titel: Effects of nintedanib in patients with limited cutaneous systemic sclerosis and interstitial lung disease
  • Beteiligte: Allanore, Yannick; Khanna, Dinesh; Smith, Vanessa; Aringer, Martin; Hoffmann-Vold, Anna-Maria; Kuwana, Masataka; Merkel, Peter A; Stock, Christian; Sambevski, Steven; Denton, Christopher P; Bergna, M; Casado, G; Mannucci Walter, P; Proudman, S; Stevens, W; Thakkar, V; Troy, L; Loeffler-Ragg, J; Olschewski, H; André, B; Bondue, B; Houssiau, F; Smith, V; Wuyts, W; [...]
  • Erschienen: Oxford University Press (OUP), 2024
  • Erschienen in: Rheumatology
  • Sprache: Englisch
  • DOI: 10.1093/rheumatology/kead280
  • ISSN: 1462-0324; 1462-0332
  • Schlagwörter: Pharmacology (medical) ; Rheumatology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Objectives</jats:title> <jats:p>To investigate the course of interstitial lung disease (ILD) and the effects of nintedanib in patients with limited cutaneous systemic sclerosis (lcSSc).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>In the SENSCIS trial, patients with SSc-ILD were randomized to receive nintedanib or placebo. Patients who completed the SENSCIS trial were eligible to enter SENSCIS-ON, in which all patients received open-label nintedanib.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Among 277 patients with lcSSc treated in the SENSCIS trial, the rate (s.e.) of decline in forced vital capacity (FVC; ml/year) over 52 weeks was −74.5 (19.2) in the placebo group and −49.1 (19.8) in the nintedanib group (difference: 25.3 [95% CI −28.9, 79.6]). Among 249 patients with data at week 52, mean (s.e.) change in FVC at week 52 was −86.4 (21.1) ml in the placebo group and −39.1 (22.2) ml in the nintedanib group. Among 183 patients with lcSSc who participated in SENSCIS-ON and had data at week 52, mean (s.e.) change in FVC from baseline to week 52 of SENSCIS-ON was −41.5 (24.0) ml in patients who took placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON and −45.1 (19.1) ml in patients who took nintedanib in the SENSCIS trial and continued it in SENSCIS-ON.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>Patients with lcSSc may develop progressive fibrosing ILD. By targeting pulmonary fibrosis, nintedanib slows decline in lung function in patients with lcSSc and ILD.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial registration</jats:title> <jats:p>ClinicalTrials.gov (https://clinicaltrials.gov), NCT02597933 and NCT03313180</jats:p> </jats:sec>