Effects of nintedanib on dyspnoe, cough and quality of life in patients with progressive fibrosing interstitial lung diseases: findings from the INBUILD trial*

Rationale: The efficacy and safety of nintedanib (NIN) in patients with fibrosing ILDs and a progressive phenotype (PF-ILD) were investigated in the INBUILD trial. NIN slowed the FVC decline, with adverse events manageable for most patients. We assessed the effects of NIN on symptoms and health-related quality of life (HRQL) using two patient-reported outcome measures developed for use in ILDs: the Living with Pulmonary Fibrosis (L-PF) questionnaire and the Pulmonary Fibrosis Impact on Quality of Life Scale (PF-IQOLS).

Methods: A total of 663 patients with an ILD other than IPF, features of diffuse fibrosing lung disease of > 10% extent on HRCT, FVC ≥ 45% predicted and DLco ≥ 30%–<80% predicted, who had shown progression of ILD within the 24 months before screening were randomized to receive NIN or placebo. Patients completed the L-PF (range from 0 – 100) and PF-IQOLS (ranges from 1 – 5) at baseline and week 52 (higher scores represent worse health status, minimal clinically important differences have not been established). Changes from baseline at week 52 in the L-PF symptoms dyspnea-, symptoms cough-, symptoms fatigue domain score, symptoms-, impacts- and total score, and in the PF-IQOLS summary score, were assessed in pre-specified analyses.

Results: Baseline mean (SD) FVC was 69.0 (15.6) % predicted. Baseline mean (SD) L-PF symptoms dyspnea-, symptoms cough-, symptoms fatigue domain score, symptoms-, impacts-, and total score, and PF-IQOLS summary score, were 21.7 (18.0), 39.5 (26.5), 51.9 (15.3), 37.6 (13.8), 45.6 (17.8), 41.6 (14.4) and 1.83 (0.73), respectively. Statistically significant differences between NIN and placebo were observed in change from baseline at week 52 in the L-PF symptoms dyspnea-, symptoms cough-, symptoms-, impacts- and total score ([Fig. 1]). Adjusted mean (SE) changes from baseline at week 52 in PF-IQOLS summary score were 0.08 (0.04) with NIN and 0.20 (0.04) with placebo (difference − 0.12 [95% CI: − 0.23, − 0.01]; p = 0.0355).

Abb. 1 Changes in L-PF (Living with Pulmonary Fibrosis) scores in the INBUILD trial.

Conclusions: In the INBUILD trial in patients with PF-ILDs, results using the L-PF questionnaire suggested that NIN may prevent worsening of cough and reduced worsening of dyspnea, while results using the PF-IQOLS suggested that NIN may reduce worsening of HRQL.

Publication History

Article published online:
30 April 2021