"EFFECTIVE LUNG AGE" IN SUBJECTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD) IN THE SENSCIS TRIAL

BackgroundFVC declines gradually with aging. The loss of lung function in patients with progressive SSc-ILD mimics an accelerated ageing process.ObjectivesUsing reference equations, we estimated the “effective lung age” of subjects in the SENSCIS trial (i.e. the age of healthy individuals with the same FVC) and compared these estimates to their real age.MethodsThe SENSCIS trial enrolled subjects with SSc-ILD with first non-Raynaud symptom within the prior ≤7 years, extent of fibrotic ILD on HRCT ≥10%, FVC ≥40% predicted, DLco 30–89% predicted. Evidence of recent decline in FVC was not an inclusion criterion. Subjects were randomised to receive nintedanib or placebo. Using reference equations published by the European Respiratory Society Global Lung Function Initiative, based on FVC data from over 70,000 healthy individuals aged 3–95 years from 26 countries, [Quanjer et al. Eur Respir J 2012;40:1324–1343], we estimated the effective lung age of subjects at baseline and at week 52 based on their FVC, sex, ethnicity and height, and compared these effective lung ages with the subjects’ real ages. Three subjects aged <25 years were excluded. The upper limit of effective lung age was considered to be 95 years.ResultsMean time since onset of first non-Raynaud symptom was 3.5 years in both the nintedanib and placebo groups. At baseline, mean (SD) effective lung age was 83.1 (14.4) years in the nintedanib group (n=287) and 82.9 (14.8) years in the placebo group (n=286). In these groups, respectively, the mean (SD) difference between effective lung age and real age was 28.4 (17.7) and 29.3 (18.5) years and the difference was >20 years in 71.4% and 72.4% of subjects. In the nintedanib and placebo groups, respectively, median (Q1, Q3) effective lung age was 88.4 (74.6, 95.0) and 88.5 (74.7, 95.0) years at baseline and 91.0 (75.2, 95.0) and 95.0 (75.9, 95.0) years at week 52.ConclusionAt entry into the SENSCIS trial, subjects with SSc-ILD had an effective lung age that was much higher than their real age. Over 52 weeks, the increase in effective lung age was numerically lower in subjects treated with nintedanib than placebo. These data show that marked loss of lung function that can occur in the few years following onset of SSc-ILD and support a benefit of nintedanib in slowing the progression of SSc-ILD.AcknowledgementsThe SENSCIS trial was funded by Boehringer Ingelheim. Toby M Maher and Oliver Distler were members of the SENSCIS trial Steering Committee.Disclosure of InterestsToby Maher Speakers bureau: Boehringer Ingelheim, Galapagos, Genentech, Consultant of: AstraZeneca, Bayer, Blade Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Galapagos, Galecto, GlaxoSmithKline R&D, IQVIA, Pliant, Respivant, Roche, Theravance and Veracyte, Grant/research support from: AstraZeneca, GlaxoSmithKline, Arnaud Bourdin Speakers bureau: Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Regeneron, Sanofi, Paid instructor for: Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Regeneron, Sanofi, Consultant of: Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Regeneron, Sanofi, Grant/research support from: AstraZeneca and Boehringer Ingelheim, Elizabeth Volkmann Speakers bureau: Boehringer Ingelheim, Consultant of: Boehringer Ingelheim, Grant/research support from: Boehringer Ingelheim, Corbus, Forbius, Horizon, Kadmon, Serena Vettori Consultant of: Boehringer Ingelheim, Jörg H.W. Distler Shareholder of: 4D Science, Speakers bureau: Boehringer Ingelheim, Inventiva, Janssen, and UCB, Consultant of: AbbVie, Active Biotech, Anamar, ARXX, AstraZeneca, Bayer Pharma, Boehringer Ingelheim, Celgene, Galapagos, GlaxoSmithKline, Inventiva, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: Anamar, ARXX, Bristol-Myers Squibb, Bayer Pharma, Boehringer Ingelheim, Cantargia, Celgene, CSL Behring, Galapagos, GlaxoSmithKline, Inventiva, Kiniksa, Sanofi-Aventis, RedX, UCB, Margarida Alves Employee of: Margarida Alves is an employee of Boehringer Ingelheim, Christian Stock Employee of: Christian Stock is an employee of Boehringer Ingelheim, Oliver Distler Speakers bureau: OD has/had relationships with the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years:Speaker fee: Bayer, Boehringer Ingelheim, Janssen, Medscape, Consultant of: OD has/had relationships with the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years:Consultancy fee: Abbvie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, 4P Science, Galapagos, Glenmark, Horizon, Inventiva, Kymera, Lupin, Miltenyi Biotec, Mitsubishi Tanabe, MSD, Novartis, Prometheus, Roivant, Sanofi and TopadurOD has/had relationships with the following companies in the area of potential treatments for arthritides in the last three calendar years:Consultancy fee: Abbvie, Grant/research support from: OD has/had relationships with the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years:Research Grants: Boehringer Ingelheim, Kymera, Mitsubishi Tanabe