medwireNews: Nintedanib’s safety and tolerability profile is similar in patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD) and those with idiopathic pulmonary fibrosis (IPF), according to a comparison of data from the SENSCIS and INPULSIS trials.
The receptor tyrosine kinase inhibitor has been shown to reduce lung function decline in both patient populations, but “patients in the [SSc]–ILD and IPF studies differ in age, sex, disease characteristics, and comorbidities, so we wanted to compare the safety and tolerability of nintedanib” in the two trials, said Kristin Highland (Cleveland Clinic, Ohio, USA) at the EULAR 2019 congress in Madrid, Spain.
She reported that 98.3% of 288 nintedanib-treated patients with SSc–ILD experienced adverse events (AEs) in the SENSCIS trial, as did 95.5% of the 638 IPF patients treated with nintedanib in the two INPULSIS trials. The corresponding rates in the placebo groups were 95.8% and 89.6%.
The proportion of patients who experienced serious AEs and AEs leading to treatment discontinuation in the nintedanib treatment arms were also similar in the two studies.
Highland noted that rates of gastrointestinal events were higher in people with SSc–ILD than those with IPF, with 75.7% versus 62.4% of patients in the nintedanib groups having diarrhea and 31.6% versus 24.5% having nausea, which she said was “expected based on the underlying disease.”
Nintedanib is currently approved for the treatment of IPF in the USA and Europe, and has been submitted for regulatory approval for SSc–ILD.
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Ann Rheum Dis 2019; 78: 200 (abstract)
European Congress of Rheumatology 2019; Madrid, Spain: 12–15 June
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