Decline in forced vital capacity (FVC) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) with and without cough: data from the SENSCIS trial*

Rationale Patients with SSc-ILD often have cough due to the SSc-ILD itself, comorbidities, or medication use. It is unclear whether the course of SSc-ILD or response to therapy is associated with cough. We investigated the rate of FVC decline in subgroups by patient-reported cough at baseline in the SENSCIS trial.

Methods The SENSCIS trial enrolled patients with SSc-ILD with first non-Raynaud symptom within ≤7 years, extent of fibrotic ILD ≥10% on HRCT and FVC ≥40% predicted. Patients were randomized to nintedanib or placebo until the last patient reached week 52. In post-hoc analyses, we analysed the rate of decline in FVC (mL/year) over 52 weeks in patients with and without cough at baseline based on the St. George’s Respiratory Questionnaire (SGRQ). Patients who reported having cough “most days a week”, “several days a week” or “a few days a month” (rather than “only with chest infection” or “not at all”) over the last month were considered to have cough at baseline. A random slope and intercept model was used to assess the rate of decline in FVC (mL/year) and an interaction test to assess potential heterogeneity in the treatment effect of nintedanib between subgroups.

Results Of 576 patients, 80.0% had cough at baseline. At baseline, in patients with and without cough, respectively, mean (SD) extent of fibrotic ILD on HRCT was 37.2 (21.3)% and 30.7 (20.3)%; mean (SD) FVC 71.5 (16.1) and 76.7 (18.3) % predicted; 48.4% and 49.1% were taking mycophenolate; 80.3% and 77.2% drugs for gastric acid-related disorders and 50.1% and 49.1% corticosteroids. In placebo, the rate of decline in FVC (mL/year) was similar in patients with and without cough at baseline (Figure). The effect of nintedanib versus placebo on reducing the rate of decline in FVC (mL/year) was numerically more pronounced in patients without cough (difference: 74.4 [95% CI: -11.1, 159.8]) than with cough (31.5 [-11.1, 74.1]), but the exploratory interaction p-value did not indicate heterogeneity in the treatment effect between subgroups (p=0.38).

Conclusion In SENSCIS, patients with SSc-ILD who had cough had numerically lower FVC % predicted at baseline. The rate of decline in FVC in placebo was similar in patients with and without cough at baseline. In both subgroups, the rate of decline in FVC was numerically lower in patients treated with nintedanib than placebo.

Presented at ATS 2021

Fig. 1 This abstract is funded by: The SENSCIS trial was funded by Boehringer Ingelheim*presented at ATS 2021, Am J Respir Crit Care Med 2021;203:A1805, presenting on beha

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Artikel online veröffentlicht:
11. Mai 2022