Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial

Elizabeth R. Volkmann*, Michael Kreuter, Anna M. Hoffmann-Vold, Marlies Wijsenbeek, Vanessa Smith, Dinesh Khanna, Christopher P. Denton, Wim A. Wuyts, Corinna Miede, Margarida Alves, Steven Sambevski, Yannick Allanore

*Corresponding author for this work

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Abstract

OBJECTIVE: The aim of these analyses was to investigate the rate of decline in forced vital capacity (FVC) in patients with SSc-associated interstitial lung disease (SSc-ILD) with and without cough or dyspnoea in the SENSCIS trial. METHODS: Patients in the SENSCIS trial were randomized to receive nintedanib or placebo. Subgroups with and without cough or dyspnoea at baseline were defined by responses to the St George's Respiratory Questionnaire. RESULTS: At baseline, 114/575 patients (19.8%) did not have cough and 172/574 patients (30.0%) did not have dyspnoea. In the placebo group, the rate of FVC decline over 52 weeks was similar in patients with and without cough (-95.6 and -83.4 mL/year, respectively) or dyspnoea (-95.8 and -87.7 mL/year, respectively). The effect of nintedanib vs placebo on reducing the rate of FVC decline was numerically more pronounced in patients without than with cough [difference: 74.4 (95% CI -11.1, 159.8) vs 31.5 (-11.1, 74.1)] and without than with dyspnoea [79.8 (9.8, 149.7) vs 25.7 (-19.9, 71.3)], but interaction P-values did not indicate heterogeneity in the treatment effect between these subgroups (P = 0.38 and P = 0.20, respectively). CONCLUSION: In the placebo group of the SENSCIS trial, the rate of FVC decline was similar irrespective of the presence of cough or dyspnoea at baseline. The effect of nintedanib on reducing the rate of FVC decline was numerically more pronounced in patients without than with cough or dyspnoea at baseline, but no statistically significant heterogeneity was observed between the subgroups. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02597933.

Original languageEnglish
Pages (from-to)4397-4408
Number of pages12
JournalRheumatology (Oxford, England)
Volume61
Issue number11
Early online date12 Feb 2022
DOIs
Publication statusPublished - Nov 2022

Bibliographical note

Publisher Copyright:
© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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