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*

Introduction SSc-ILD progression is variable and unpredictable, but observational studies have identified patient characteristics that may be prognostic of a greater FVC decline in SSc-ILD. We used placebo data of the SENSCIS trial to conduct a preliminary analysis of whether baseline variables were prognostic of a greater FVC decline over 52 weeks. Methods SENSCIS enrolled SSc-ILD patients with onset of first non-Raynaud symptom ≤7 years before screening, fibrotic ILD ≥10% on HRCT and FVC ≥40% predicted. Prednisone ≤10 mg/day (or equivalent) and/or stable therapy with mycophenolate or methotrexate for ≥6 months prior to randomization were allowed. Patients were randomized to nintedanib or placebo until the last patient had reached week 52 but for ≤100 weeks. We used data from placebo to investigate baseline characteristics as prognostic factors for a greater FVC decline (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, height and subgroup-by-time and baseline-by-time interactions. Results 288 patients received placebo, 73.6% were female, 61.5% ATA-positive, and 50.7% had diffuse cutaneous SSc. At baseline, mean (SD) age was 53.4 (12.6) years, FVC 72.7 (16.6) % predicted and modified Rodnan skin score 10.9 (8.8); median time since first non-Raynaud’s symptom was 3.5 years; almost half (48.6%) were taking mycophenolate. In the primary analysis, the adjusted rate (SE) of FVC decline in placebo group was -93.3 (13.5) mL/year. None of the baseline factors was prognostic (p<0.05) of a greater FVC decline (mL/year) over 52 weeks, but baseline FVC ≤70% predicted and not taking mycophenolate showed trends toward being prognostic factors (Table). Conclusion Among SSc-ILD patients who received placebo in SENSCIS, no baseline characteristic was found to be prognostic of a greater FVC decline over 52 weeks, although baseline FVC ≤70% predicted and not taking mycophenolate showed trends. This supports 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 with SSc-ILD, and that new parameters or a combination of factors from different disease domains might be needed. Previously presented at ACR 202,

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