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POS0835 DECLINE IN FORCED VITAL CAPACITY (FVC) IN SUBJECTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD) IN THE SENSCIS TRIAL VERSUS HYPOTHETICAL REFERENCE SUBJECTS WITHOUT LUNG DISEASE

T. Maher, A. Bourdin, E. Volkmann, S. Vettori, J. H. W. Distler, M. Alves, C. Stock, O. Distler
Published: 19 May 2021
 by  BMJ

Abstract: Background: In the randomized SENSCIS trial in subjects with SSc-ILD, nintedanib reduced the rate of decline in FVC over 52 weeks (mL/year) by 44% compared to placebo. Healthy individuals have varied FVC depending on age, sex, ethnicity and height; expected values can be determined using internationally recognised reference equations.Objectives: To provide further context to the FVC declines observed in the SENSCIS trial, we compared the decline in FVC observed in subjects with SSc-ILD in the SENSCIS trial with the decline in FVC that would be expected in hypothetical subjects without ILD matched for age, sex, ethnicity and height.Methods: The SENSCIS trial enrolled subjects with SSc-ILD aged ≥18 years with first non-Raynaud symptom ≤7 years before screening, extent of fibrotic ILD ≥10% on HRCT, FVC ≥40% predicted and DLco 30–89% predicted. Baseline FVC (mL) and changes in FVC (mL) at week 52 were assessed in the nintedanib and placebo groups, with missing values at week 52 imputed using predictions from the primary analysis model (random slope and intercept model). Changes in FVC in the SENSCIS trial were compared to values in hypothetical healthy reference subjects matched to the SENSCIS subjects for age, sex, ethnicity and height. FVC values in these healthy reference subjects were derived from the equations published by the European Respiratory Society Global Lung Function Initiative in 2012, which were derived from data from over 70,000 subjects.1Results: In the nintedanib and placebo groups of the SENSCIS trial, respectively, mean (SD) time since onset of first non-Raynaud symptom was 3.5 (1.6) and 3.5 (1.8) years. In the nintedanib group, mean (SD) FVC at baseline was 2460 (737) mL, compared with 3403 (787) mL in the healthy reference subjects. In the placebo group, mean (SD) FVC at baseline was 2544 (817) mL compared with 3516 (887) mL in the healthy reference subjects. The difference in the change from baseline in FVC at week 52 between the nintedanib-treated subjects in the SENSCIS trial (n=287) and the healthy reference subjects was 26.6 mL ([95% CI: 1.2, 52.0]; p=0.04). The difference in the change from baseline in FVC at week 52 between the placebo-treated subjects in the SENSCIS trial (n=286) and the reference subjects was 77.5 mL ([95% CI: 51.4, 103.7]; p<0.001) (Figure 1).Conclusion: Subjects with SSc-ILD who participated in the SENSCIS trial had marked lung function impairment at baseline compared with healthy matched reference subjects, despite a mean duration of SSc of 3.5 years. Over 52 weeks, the decline in FVC in subjects with SSc-ILD who received placebo was 4-fold greater than in healthy reference subjects. Subjects with SSc-ILD who were treated with nintedanib had a decline in FVC that was only slightly greater than the decline observed in the matched healthy subjects. These data support the clinical relevance of the reduction in the rate of FVC decline provided by nintedanib in patients with SSc-ILD.References: [1]Quanjer et al. Eur Respir J 2012;40:1324−43. Acknowledgements: The SENSCIS trial was funded by Boehringer Ingelheim. Medical writing support was provided by FleishmanHillard Fishburn, London, UK. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE).Disclosure of Interests: Toby Maher Speakers bureau: Boehringer Ingelheim and Roche/Genentech, Consultant of: Acelleron Pharma, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline and Roche/Genentech, Arnaud Bourdin Speakers bureau: Actelion/Janssen (personal fees and other), AstraZeneca (personal fees and other), Boeringher Ingelheim (personal fees and other), Chiesi (personal fees and other), GlaxoSmithKline (personal fees and other), Novartis (personal fees and other), Pulsar Therapeutics (other), Roche (personal fees and other), Sanofi Regeneron (personal fees and other), Teva (other) and United Therapeutics (other), Consultant of: Actelion/Janssen (personal fees and other), AstraZeneca (personal fees and other), Boeringher Ingelheim (personal fees and other), Chiesi (personal fees and other), GlaxoSmithKline (personal fees and other), Novartis (personal fees and other), Pulsar Therapeutics (other), Roche (personal fees and other), Sanofi Regeneron (personal fees and other), Teva (other) and United Therapeutics (other), Grant/research support from: Actelion/Janssen (grants and other), AstraZeneca (grants and other), Boeringher Ingelheim (grants and other), Chiesi (other), GlaxoSmithKline (grants and other), Novartis (other), Pulsar Therapeutics (other), Roche (other), Sanofi Regeneron (other), Teva (other) and United Therapeutics (other), Elizabeth Volkmann Consultant of: Boehringer Ingelheim, Grant/research support from: Corbus and Forbius, Serena Vettori Paid instructor for: Boehringer Ingelheim, Consultant of: Boehringer Ingelheim, Jörg H.W. Distler Speakers bureau: Actelion, Active Biotech, AnaMar, Arxx Therapeutics, Bayer, Boehringer Ingelheim, Celgene, Galapagos NV, GlaxoSmithKline, Inventiva, JB Therapeutics, Medac, Pfizer, RuiYi and UCB, Consultant of: AnaMar, Arxx Therapeutics, Bayer, Boehringer Ingelheim, Galapagos NV, Inventiva, JB Therapeutics and UCB, Grant/research support from: Active Biotech, AnaMar, Array BioPharma, Arxx Therapeutics, aTyr, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Galapagos NV, GlaxoSmithKline, Inventiva, Novartis, Sanofi-Aventis, Redx and UCB, Margarida Alves Employee of: Currently an employee of Boehringer Ingelheim, Christian Stock Employee of: Currently an employee of Boehringer Ingelheim, Oliver Distler Consultant of: AbbVie, Acceleron Pharma, Amgen, AnaMar, Arxx Therapeutics, Baecon Discovery, Bayer, Blade Therapeutics, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos NV, GlaxoSmithKline, Glenmark Pharmaceuticals, Horizon (Curzion) Pharmaceuticals, Inventiva, IQVIA, Italfarmaco, iQone, Kymera Therapeutics, Lilly, Medac, Medscape, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Roche, Sanofi, Serodapharm, Target Bioscience, Topadur Pharma and UCB, Grant/research support from: Kymera Therapeutics and Mitsubishi Tanabe Pharma
Keywords: FVC / fees / Boehringer Ingelheim / decline observed / Pharma / LUNG / reference / Function / model

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