Effects of nintedanib in patients with idiopathic pulmonary fibrosis and varying severities of cough* 

Rationale Cough can be a major problem for patients with IPF and may be related to disease progression. The cough symptoms and impact domains of the Cough and Sputum Assessment Questionnaire (CASA-Q) assess the frequency and impact of cough on usual activities. We assessed the effect of nintedanib on FVC decline and changes in cough scores in patients with IPF in subgroups by baseline cough scores.

Methods In the INPULSIS trials, patients with IPF were randomised to nintedanib or placebo. We assessed the effects of nintedanib on the rate of FVC decline (mL/year) and change from baseline in CASA-Q cough symptoms and impact scores over 52 weeks in subgroups by median CASA-Q cough symptoms and impact scores at baseline. CASA-Q scores range from 0 to 100, with lower scores indicating worse cough.

Results 634 patients received nintedanib, 421 placebo. Baseline median CASA-Q cough symptoms and impact scores were 58.3 and 81.3. The rate of decline in FVC was numerically greater in patients with lower CASA-Q cough scores at baseline (Figure). Nintedanib reduced the rate of decline in FVC versus placebo in both subgroups, with a more pronounced effect in patients with a cough symptom score ≤58.3. In patients with baseline CASA-Q cough symptoms score ≤58.3, the adjusted mean change in CASA-Q cough symptoms score at week 52 was 0.67 with nintedanib and −1.87 with placebo (difference: 2.54 [95% CI: −1.59, 6.67]), while in patients with a score >58.3, it was −1.48 with nintedanib and −1.28 with placebo (difference: −0.20 [95% CI: −3.49 3.08]). In patients with CASA-Q cough impact score ≤81.3, the adjusted mean change at week 52 was −4.27 with nintedanib and −6.03 with placebo (difference: 1.76 [95% CI: −1.74, 5.26]), while in patients with an impact score >81.3, it was −0.99 with nintedanib and −2.43 with placebo (difference: 1.44 [95% CI: −2.08, 4.95]). There was no heterogeneity in the effect of nintedanib on CASA-Q cough symptoms (p=0.31) or impact (p=0.90) score between the subgroups with lower versus higher scores at baseline.

Conclusions In the INPULSIS trials, patients who had a greater frequency of cough at baseline had a numerically faster rate of decline in FVC and more pronounced treatment effect of nintedanib on decline in FVC over 52 weeks. No clinically meaningful effect of nintedanib on CASA-Q cough scores was observed over 52 weeks.

Presented at ATS2021

This abstract is funded by: The INPULSID trials were funded by Boehringer Ingelheim.

Abb. 1 This abstract is funded by: The INPULSIS trials were funded by Boehringer Ingelheim *presented at ATS 2021; presenting on behalf of the authors.

 

MissingLinkText

Publication History

Article published online:
11 May 2022