OP0017 NINTEDANIB REDUCED DECLINE IN FORCED VITAL CAPACITY ACROSS SUBGROUPS OF PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE: DATA FROM THE SENSCIS TRIAL
In the SENSCIS trial, nintedanib reduced the progression of interstitial lung disease associated with systemic sclerosis (SSc-ILD) compared with placebo, as demonstrated by a significantly lower rate of decline in forced vital capacity (FVC) over 52 weeks (primary endpoint). Objectives: To assess the effect of nintedanib on the rate of decline in FVC in the SENSCIS trial across pre-specified subgroups defined by baseline characteristics. Methods: Patients with SSc-ILD with onset of first
... set of first non-Raynaud symptom <7 years before screening and !10% fibrosis of the lungs on a high-resolution computed tomography scan were randomised to receive nintedanib 150 mg bid or placebo double-blind. The annual rate of decline in FVC (ml/year) assessed over 52 weeks (primary endpoint) was analysed in the overall population using a random coefficient regression model (with random slopes and intercepts) including antitopoisomerase I antibody (ATA) status, age, height, gender and baseline FVC as covariates. Analyses in subgroups by baseline characteristics included additional terms for treatment-by-subgroup and treatment-by-subgroup-by-time interaction. Results: A total of 576 patients were treated (288 in each group). Most (75.2%) of patients were female, 51.9% had diffuse cutaneous SSc, and 48.4% were taking mycophenolate at baseline. Mean ± SD age was 54.0 ± 12.2 years and 21.4% of patients were aged !65 years. Nintedanib had a consistent effect on reducing the rate of FVC decline across pre-specified subgroups defined by baseline characteristics (p>0.05 for all treatment-by-time-by-subgroup interactions) (figure). Conclusion: Nintedanib is effective at reducing ILD progression in a broad range of patients with SSc-ILD.