Highland KB, et al. Understanding and treating autoimmune lung disease. Presented at: American Thoracic Society International Conference; May 14-19, 2021 (virtual meeting).
The research was funded by Boehringer Ingelheim. Highland reports she received grants and fees from Actelion, Boehringer Ingelheim and United Therapeutics, fees from Bayer, and grants from Eiger, Genentech and Reata.
In the SENSCIS-ON trial, two-thirds of patients with systemic sclerosis-associated interstitial lung disease who continued nintedanib after completion of the SENSCIS trial maintained stable lung function or had improvement in lung function.
“The SENSCIS-ON trial provides important new evidence about the longer-term use of nintedanib in people living with systemic sclerosis-associated ILD, showing a sustained reduction in lung function decline with a manageable safety profile,” Kristin B. Highland, MD, director of the Rheumatic Lung Disease Program at the Cleveland Clinic, said in a press release issued by Boehringer Ingelheim. “These new data build on the data already available on the use of nintedanib in systemic sclerosis-associated ILD patients and should provide physicians with important information that will help them as they treat this serious, often life-threatening lung disease.”
SENSCIS-ON is an open-label extension study to assess the safety and efficacy of nintedanib (Ofev, Boehringer Ingelheim) treatment over the longer term in patients with systemic sclerosis-associated ILD (SSc-ILD). Patients in SENSCIS-ON came from two parent trials, Highland said while presenting the results at the American Thoracic Society International Conference. The first was the SENSCIS trial in which patients were randomly assigned to nintedanib or placebo until the last patient had reached week 52, but for no longer than 100 weeks. The second was an open-label drug-drug interaction study of nintedanib and oral contraceptives in women with SSc-ILD, in which patients received nintedanib for 14 to 28 days.
Patients in SENSCIS-ON were divided into two groups: patients who received nintedanib in the SENSCIS trial and continued nintedanib in SENSCIS-ON, who served as the “continued nintedanib” group (n = 197; mean age, 55 years; mean FVC at baseline, 2,379 mL and 70.4% predicted) , and patients who received placebo in the SENSCIS trial and initiated nintedanib in SENSCIS-ON or who took only nintedanib for a short period in the drug-drug interaction study, who served as the “initiated nintedanib” group (n = 247; mean age, 54 years; mean FVC at baseline, 2,443 mL and 70.8% predicted), she said.
The researchers then analyzed changes in FVC, adverse events and other outcomes over 52 weeks in SENSCIS-ON.
Mean change in FVC over 52 weeks was –58.3 mL in the continued nintedanib group and –44 mL in the initiated nintedanib group. This was similar to the change in FVC from baseline to 52 weeks in the patients assigned nintedanib in the original SENSCIS trial (–42.7 mL). The decline in FVC in patients treated with nintedanib was much smaller than in the patients assigned placebo in SENSCIS, Highland said during the presentation.
The adverse event profile of nintedanib in SENSCIS-ON was consistent with events reported in the SENSCIS trial. Diarrhea was the most frequent adverse event in patients assigned nintedanib.
Dose reduction and treatment interruption were permitted to manage adverse events. Over 52 weeks, 18% of patients in the continued nintedanib group had at least one dose reduction, 28% had at least one treatment interruption and 6.6% permanently discontinued treatment, according to the presentation.
“These findings support a clinically meaningful benefit of nintedanib in slowing the progression of systemic sclerosis-associated ILD with a safety profile that could be managed by dose adjustments,” Highland said.