Session Information
Date: Monday, November 11, 2019
Session Title: Systemic Sclerosis & Related Disorders – Clinical Poster II
Session Type: Poster Session (Monday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Interstitial lung disease (ILD) is a common and usually early manifestation of systemic sclerosis (SSc). Decline in lung function in patients with SSc-ILD is generally believed to be most rapid early in the course of the disease. In the SENSCIS trial, nintedanib reduced the annual rate of decline in forced vital capacity (FVC) vs placebo in patients with SSc-ILD. We analyzed outcomes in the SENSCIS trial in subgroups based on time since onset of first non-Raynaud symptom.
Methods: Subjects with SSc-ILD with onset of first non-Raynaud symptom < 7 years before screening, ≥10% fibrosis of the lungs on high-resolution computed tomography (HRCT) and FVC ≥40% predicted were randomized to receive nintedanib 150 mg bid or placebo. We analyzed outcomes in subgroups based on time (at randomization) since onset of the first non-Raynaud symptom (≤3 vs >3 years).
Results: Among 576 patients who received ≥1 dose of trial drug, the time since onset of first non-Raynaud symptom was ≤3 years in 118 (40.9%) and 127 (44.1%) of patients in the nintedanib and placebo groups, respectively. At baseline, in patients with onset of first non-Raynaud symptom ≤3 years and >3 years, respectively, 41% and 60% had diffuse cutaneous SSc, 59% and 62% were positive for anti-topoisomerase I antibody, mean (SD) modified Rodnan skin score (mRSS) was 9.8 (8.8) and 12.1 (9.0), C-reactive protein level (mg/dL) was 7.1 (20.1) and 5.8 (10.7), extent of fibrosis on HRCT (%) was 34.8 (21.0) and 36.9 (21.4), FVC (mL) was 2549 (819) and 2463 (744), and FVC % predicted was 73.1 (16.1) and 72.1 (17.1). In both the nintedanib and placebo groups, the rate of decline in FVC (mL/year) was numerically greater in patients with onset of first non-Raynaud symptom ≤3 than >3 years (Figure). Nintedanib reduced the rate of decline in FVC compared with placebo both in patients with onset of first non-Raynaud symptom ≤3 and >3 years, with a similar effect between subgroups (Figure). In the nintedanib and placebo groups, respectively, absolute declines in FVC >5% predicted were seen in 21.2% and 33.1% of patients with onset of first non-Raynaud symptom ≤3 years (OR 0.55 [95% CI 0.31, 0.98) and 20.1% and 24.8% with onset >3 years (OR 0.76 [0.45, 1.28]) (treatment-by-subgroup interaction p=0.41). The adverse event profile of nintedanib was consistent between the subgroups by time since onset of first non-Raynaud symptom.
Conclusion: In patients with SSc-ILD in the SENSCIS trial, the rate of FVC decline over 52 weeks was numerically greater in patients whose onset of first non-Raynaud symptom was ≤3 years than >3 years before randomization. The effect of nintedanib on reducing decline in FVC was consistent between subgroups of patients by time since first non-Raynaud symptom.
To cite this abstract in AMA style:
Fischer A, Distler O, Khanna D, Allanore Y, Hoffmann-Vold A, Valentini G, Maher T, Aringer M, Meng L, Alves M, Gahlemann M, Quaresma M, Kuwana M. Lung Function Decline in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease in the SENSCIS Trial: Subgroup Analysis by Time Since First Non-Raynaud Symptom [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/lung-function-decline-in-patients-with-systemic-sclerosis-associated-interstitial-lung-disease-in-the-senscis-trial-subgroup-analysis-by-time-since-first-non-raynaud-symptom/. Accessed November 30, 2020.« Back to 2019 ACR/ARP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/lung-function-decline-in-patients-with-systemic-sclerosis-associated-interstitial-lung-disease-in-the-senscis-trial-subgroup-analysis-by-time-since-first-non-raynaud-symptom/