Category: Professional Posters
Purpose: 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). The purpose of this analysis was 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 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 anti-topoisomerase 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 the patients were female, 51.9% had diffuse cutaneous SSc, and 48.4% were taking mycophenolate at baseline. Mean ± standard deviation 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). For example, the adjusted difference (95% confidence interval) between nintedanib and placebo in rate of decline in FVC was 34.6 (-9.3, 78.4) mL/year in female patients and 58.6 (-18.0, 135.1) mL/year in male patients (p=0.59). The corresponding age-related data were: 44.4 (1.4, 87.4) mL/year in patients aged < 65 years and 28.1 (-54.2, 110.4) in those aged ≥65 years (p=0.73). In patients with diffuse cutaneous SSc, the difference between nintedanib and placebo was 56.6 (3.2, 110.0) mL/year, compared with 25.3 (-28.9, 79.6) mL/year in limited cutaneous SSc (p=0.42).
Conclusion: Nintedanib is effective at reducing ILD progression in a broad range of patients with SSc-ILD.