FRI0301 GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD) TREATED WITH NINTEDANIB: DATA FROM THE SENSCIS TRIAL

Abstract

Background: In patients with idiopathic pulmonary fibrosis (IPF), ninteda‐nib has a manageable adverse event (AE) profile characterised predominantly by gastrointestinal (GI) events. The efficacy and safety OF nintedanib versus placebo in patients with SSc‐ILD were investigated in the SENSCIS trial (NCT02597933). Objectives: To characterise GI AEs associated with nintedanib therapy in the SENSCIS trial. Methods: Patients with SSc‐ILD with onset of first non‐Raynaud symptom <7 years were randomised to receive nintedanib 150 mg bid or placebo double‐blind. Dose reductions to 100 mg bid and treatment interruptions were allowed to manage adverse events. AEs reported over 52 weeks of treatment were coded using preferred terms in the Medical Dictionary for Regulatory Activities and analysed descriptively. A questionnaire was used to collect additional information on diarrhoea AEs. Results: A total of 576 patients (288 per group) received >1 dose of nintedanib or placebo. Over 52 weeks, 13.9% and 7.3% of patients treated with nintedanib and placebo discontinued study treatment due to AEs. The most frequent AEs in patients treated with nintedanib were diarrhoea (75.7% vs 31.6%), nausea (31.6% vs 13.5%) and vomiting (24.7% vs 10.4%). Serious diarrhoea AEs were reported in 2 patients (0.7%) in each group, and serious vomiting AEs were reported in 2 patients (0.7%) in the placebo group and none in the nintedanib group. Of the 218 nintedanib‐treated patients who experienced a diarrhoea AE, most experienced events that were at worst of mild (49.5%) or moderate (45.0%) intensity, most (70.2%) experienced 1 or 2 events, and the duration of diarrhoea AEs was <9 days for 50% of the events reported over 52 weeks. Among nintedanib‐treated patients who experienced >1 diarrhoea AE, 26.1% had a permanent dose reduction and 9.2% discontinued study drug due to the AE. Among the 91 patients in the placebo group who experienced >1 diarrhoea AE, the duration of diarrhoea AEs was <3 days for 50% of the events reported over 52 weeks, 2.2% had a permanent dose reduction and 1.1% discontinued study drug due to the AE. Conclusion: In patients with SSc‐ILD, the gastrointestinal AEs associated with nintedanib were manageable for most patients and consistent with its known safety and tolerability profile in patients with IPF.