Outcomes in Systemic Sclerosis-Associated Interstitial Lung Disease Based on Serological Profiles: Focus on Anti-Centromere and Anti-RNA Polymerase III Antibodies.

Abstract

OBJECTIVE Compare the progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD) based on serological status. METHODS In a post-hoc analysis of the SENSCIS trial (nintedanib vs placebo in SSc-ILD; NCT02597933), we analyzed the rate of decline in forced vital capacity (FVC) over 52 weeks in 3 subsets: positive for anti-centromere antibody (ACA), positive for anti-RNA polymerase III antibody (ARA), negative for ACA, ARA and anti-topoisomerase I antibody (ATA). RESULTS Among study participants who underwent baseline serological evaluation, 32/549 (5.8%) were ACA positive, 98/528 (18.6%) were ARA positive, and 127/526 (24.1%) were negative for ACA, ARA and ATA. Among the serological subsets of interest, in the placebo arm, the adjusted rate (SE) of decline in FVC (mL/year) was -31.2 (41.5) among participants who were positive for ACA and -64.7 (35.1) among participants who were positive for ARA, numerically lower than in the overall SENSCIS trial population (-93.3 [13.5]). However, participants who were negative for ACA, ARA and ATA experienced a numerically greater rate of decline in FVC (mL/year) than the overall trial population, both in those randomized to placebo (-115.6 [35.4] vs. -93.3 [13.5], respectively) and those randomized to nintedanib (-91.8 [34.3] vs. -52.4 [13.8]). CONCLUSION These analyses of data from the SENSCIS trial suggest that patients with SSc-ILD who are ACA positive or ARA positive can experience progression of SSc-ILD. Patients negative for ACA, ARA and ATA had a higher rate of progression than the overall trial population and should be monitored closely.