Nintedanib showed long-term safety and sustained effectiveness by slowing lung function decline in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) involved in the SENSCIS-ON trial, announced Boehringer Ingelheim.
Nintedanib is a tyrosine kinase inhibitor that targets receptors involved in signalling pathways that lead to pulmonary fibrosis. Systemic sclerosis or scleroderma is a rare autoimmune disease characterised by the thickening and scarring of connective tissue in the body.
The open-label SENSCIS-ON trial is an extension study evaluating the long-term safety of nintedanib in patients with SSc-ILD who have already completed the phase III SENSCIS trial.
The trial is assessing the absolute and relative change from baseline in the forced vital capacity (FVC) as a measure of lung function over a period of 52 weeks.
According to the new interim analysis data, the safety profile of nintedanib was consistent with the SENSCIS trial. An adverse event of diarrhoea was observed in the trial. 347 patients who received nintedanib showed a decrease in FVC over 52 weeks as did the participants in the SENSCIS study. In all patients treated in SENSCIS-ON, the average change in FVC from baseline to week 52 was −51.3mL, while it was −42.7mL in the SENSCIS trial.
Boehringer, in August, initiated patient enrolment for the phase III trial InPedILD of nintedanib in children and adolescents aged six to 17 with fibrosing interstitial lung disease.