Date: Friday, November 6, 2020
Session Title: Systemic Sclerosis & Related Disorders – Clinical Poster I
Session Type: Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: The progression of SSc-ILD is variable and unpredictable. However, observational studies have identified patient characteristics that may be prognostic of a greater rate of decline in forced vital capacity (FVC) in patients with SSc-ILD. We used data from the placebo group of the SENSCIS trial to conduct a preliminary analysis of whether baseline variables were prognostic of a greater rate of decline in FVC over 52 weeks.
Methods: Patients with SSc-ILD with onset of first non-Raynaud symptom ≤7 years before screening, extent of fibrotic ILD ≥10% on HRCT and FVC ≥40% predicted were enrolled in the SENSCIS trial. Patients on prednisone ≤10 mg/day (or equivalent) and/or stable therapy with mycophenolate or methotrexate for ≥6 months prior to randomization were allowed to participate. Patients were randomized to receive nintedanib or placebo until the last patient had reached week 52 but for ≤100 weeks. We used data from the placebo group to investigate baseline characteristics as prognostic factors for a greater rate of decline in FVC (mL/year) over 52 weeks (Table). Our analyses were based on a random coefficient regression model with effects of anti-topoisomerase I antibody status, sex, time, baseline FVC (mL), age and height, and subgroup-by-time and baseline-by-time interactions.
Results: A total of 288 patients received placebo, of whom 73.6% were female, 61.5% were ATA-positive, and 50.7% had diffuse cutaneous SSc. At baseline, mean (SD) age was 53.4 (12.6) years, FVC was 72.7 (16.6) % predicted and modified Rodnan skin score was 10.9 (8.8); median time since onset of first non-Raynaud’s symptom was 3.5 years. Almost half (48.6%) of patients were taking mycophenolate at baseline. In the primary analysis, the adjusted rate (SE) of decline in FVC in the placebo group was -93.3 (13.5) mL/year. None of the baseline factors investigated in this patient population was prognostic (p< 0.05) of a greater rate of decline in FVC (mL/year) over 52 weeks, but baseline FVC ≤70% predicted and not taking mycophenolate at baseline showed trends toward being prognostic factors (Table).
Conclusion: Among patients with SSc-ILD who received placebo in the SENSCIS trial, no baseline characteristic was found to be prognostic of a greater rate of decline in FVC over 52 weeks, although baseline FVC ≤70% predicted and not taking mycophenolate at baseline showed trends toward being prognostic factors. These findings support previous studies suggesting that the course of SSc-ILD is difficult to predict, that prognostic factors identified in certain populations may not apply to all populations of patients with SSc-ILD, and that new parameters or a combination of factors from different disease domains might be needed to predict the course of SSc-ILD.
To cite this abstract in AMA style:Kuwana M, Assassi S, Avouac J, Hoyles R, Pope J, Smith V, Miede C, Clerisme-Beaty E, Alves M, Distler O. Factors Prognostic of Greater Decline in Forced Vital Capacity in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Data from the Placebo Group of the SENSCIS Trial [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/factors-prognostic-of-greater-decline-in-forced-vital-capacity-in-patients-with-systemic-sclerosis-associated-interstitial-lung-disease-ssc-ild-data-from-the-placebo-group-of-the-senscis-trial/. Accessed August 3, 2021.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/factors-prognostic-of-greater-decline-in-forced-vital-capacity-in-patients-with-systemic-sclerosis-associated-interstitial-lung-disease-ssc-ild-data-from-the-placebo-group-of-the-senscis-trial/