POS0837 SEX DIFFERENCES IN FVC DECLINE AND IN CIRCULATING BIOMARKERS IN PATIENTS WITH SSc-ILD
Authors: E. Volkmann, J. Varga, Z. Mcmahan, C. Miede, C. Diefenbach, M. Alves, S. Assassi
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> There is some evidence that the progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD) is faster in male than female patients. <h3>Objectives:</h3> To assess differences between sexes in the rate of progression of SSc-ILD and in circulating biomarkers of inflammation and fibrosis at baseline in patients with SSc-ILD in the SENSCIS trial. <h3>Methods:</h3> The SENSCIS trial enrolled patients with SSc with first non-Raynaud symptom in the prior ≤7 years and an extent of fibrotic ILD on high-resolution computed tomography (HRCT) ≥10%. Patients were randomised to receive nintedanib or placebo stratified by anti-topoisomerase I antibody (ATA) status. Using data from the placebo group, we assessed differences between male and female patients in the rate of decline in forced vital capacity (FVC) (mL and % predicted) over 52 weeks using random coefficient regression models. We also evaluated clinical characteristics and circulating biomarkers at baseline in male and female patients. <h3>Results:</h3> Of 288 patients in the placebo group, 73.6% were female. In a model that adjusted for sex, the difference in the rate of decline in FVC (mL/year) over 52 weeks between female and male patients was 78.7 mL/year (p=0.02). In a model that adjusted for sex and baseline FVC (mL), the difference was 24.2 mL/year and did not reach statistical significance (p=0.54) (Table 1). Differences between female and male patients in the rate of decline in FVC % predicted were small and did not reach statistical significance (Table 1). At baseline, compared with female patients, male patients had a numerically lower diffusing capacity for carbon monoxide (DLco) and a higher (worse) score on the composite physiologic index (CPI); a numerically greater proportion of males than females had honeycombing on HRCT and were using mycophenolate; a numerically smaller proportion of males than females had diffuse cutaneous SSc or were ATA positive (Table 2). Some numerical differences were observed between male and female patients in biomarkers of inflammation and fibrosis (Table 2). <h3>Conclusion:</h3> In the SENSCIS trial in patients with SSc-ILD, the higher rate of decline in FVC (mL/year) over 52 weeks in male versus female patients was largely accounted for by the difference in baseline FVC. There were some numerical differences between male and female patients in clinical characteristics and circulating biomarkers at baseline. <h3>REFERENCES: NIL. Acknowledgements:</h3> The SENSCIS trial was supported by Boehringer Ingelheim International GmbH. <h3>Disclosure of Interests:</h3> Elizabeth Volkmann Professor Volkmann reports consulting fees from Boehringer Ingelheim and GSK., Professor Volkmann reports grant/research support from Boehringer Ingelheim, Horizon and Prometheus., John Varga Professor Varga reports grant/research support from Boehringer Ingelheim., Zsuzsanna McMahan: None declared, Corinna Miede Corinna Miede is an employee of mainanalytics GmbH, Sulzbach (Taunus), Germany, which was contracted by Boehringer Ingelheim to assist with these analyses., Claudia Diefenbach Claudia Diefenbach is an employee of Boehringer Ingelheim., Margarida Alves Margarida Alves is an employee of Boehringer Ingelheim., Shervin Assassi Professor Assassi reports consulting fees from AstraZeneca, aTyr Pharma, Boehringer Ingelheim, CSL Behring, Merck and Teneofour., Professor Assassi reports grant/research support from aTyr Pharma, Boehringer Ingelheim and Janssen.