medwireNews: Nintedanib slows lung function decline in a variety of patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD), suggests a subgroup analysis of data from the SENSCIS trial.
In the primary analysis from this trial, published in May 2019, the tyrosine kinase inhibitor reduced the annual rate of decline in forced vital capacity (FVC) relative to placebo among 576 people with SSc-ILD, but did not improve other clinical endpoints.
Presenting the subgroup analyses at the EULAR 2019 congress in Madrid, Spain, Oliver Distler (University Hospital Zurich, Switzerland) said that nintedanib consistently reduced the rate of FVC decline across various prespecified groups, including when patients were categorized by age, sex, ethnicity, and geographic region.
The magnitude of reduction in FVC decline with nintedanib relative to placebo appeared to be numerically greater in some subgroups than others. For example, the relative reduction was 51% for patients with diffuse cutaneous SSc and 34% for those with limited cutaneous SSc, but Distler said that there was no significant interaction between any of the subgroups and nintedanib efficacy.
He also pointed out that the lack of efficacy of nintedanib for other clinical endpoints including skin fibrosis and health-related quality of life was “consistent across subgroups,” supporting the main trial findings demonstrating “significant efficacy in the lung but nothing really in the skin.”
In light of these results, Distler noted that the regulatory submission for nintedanib “is for scleroderma–ILD and not for scleroderma.”
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Ann Rheum Dis 2019; 78: 75 (abstract)
European Congress of Rheumatology 2019; Madrid, Spain: 12–15 June
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