Effect of nintedanib in patients with limited and extensive systemic sclerosis-associated interstitial lung disease (SSc-ILD): data from the SENSCIS trial^[*]

Rationale: In the SENSCIS trial with SSc-ILD, nintedanib reduced the rate of decline in forced vital capacity (FVC) (mL/year) over 52 weeks by 44% versus placebo. Previous studies have shown that patients with SSc-ILD and more extensive lung disease on HRCT have worse prognosis than patients with less extensive disease. We assessed the effect of nintedanib in patients with extensive and limited SSc-ILD in SENSCIS.

Methods: Patients with first non-Raynaud symptom < 7 years before screening, extent of fibrotic ILD ≥ 10% on HRCT (assessed in the whole lung to the nearest 5%) performed ≤ 12 months before screening, and FVC ≥ 40% predicted were randomized to nintedanib or placebo. The annual rate of decline in FVC (mL/year) and the proportion of patients with an absolute decline in FVC > 5% predicted over 52 weeks were assessed in subgroups by extensive ILD (extent of fibrotic ILD on HRCT > 30%, or > 10% to ≤ 30% with FVC < 70% predicted) or limited ILD (> 10% to ≤ 30% with FVC ≥ 70% predicted) at baseline.

Results: Extensive ILD was present in 180 (62.5%) and 178 (61.8%) of patients in the nintedanib and placebo groups, respectively. Mean (SD) FVC was 2325 (752) mL and 66.1% predicted in patients with extensive ILD and 2787 (732) mL and 83.1% predicted in patients with limited ILD. The effect of nintedanib versus placebo on the annual FVC decline was numerically greater in patients with extensive than limited ILD, but statistical testing did not indicate a heterogenous treatment effect between subgroups ([Fig. 1]). In both subgroups, smaller proportions of patients treated with nintedanib than placebo had an absolute decline in FVC > 5% predicted at week 52 (extensive ILD: 21.2% versus 27.0%; limited ILD: 19.4% versus 30.9%). The effect of nintedanib versus placebo on the annual FVC decline was numerically greater in patients with fibrotic ILD ≥ 30% than < 30%, but statistical testing did not indicate a heterogenous treatment effect between subgroups ([Fig. 1]). The effect of nintedanib versus placebo was consistent in subjects with FVC < 70% and ≥ 70% predicted ([Fig. 1]).

Abb. 1 

Conclusion: Nintedanib reduced the rate of ILD progression in patients with SSc-ILD. Nintedanib had a numerically greater treatment effect in patients with extensive than limited lung disease, but statistical testing did not indicate a heterogenous treatment effect between subgroups.

^* Presented at ATS2020.

Publication History

Article published online:
30 April 2021