Faculty, Staff and Student Publications
Language
English
Publication Date
9-1-2025
Journal
The Journal of Rheumatology
DOI
10.3899/jrheum.2024-1063
PMID
40233987
Abstract
Objective: We aimed to compare the progression of systemic sclerosis-associated interstitial lung disease (SSc-ILD) based on serological status.
Methods: In a posthoc analysis of the SENSCIS trial (nintedanib vs placebo in SSc-ILD; ClinicalTrials.gov: NCT02597933), we analyzed the rate of decline in forced vital capacity (FVC) over 52 weeks in 3 subsets: (1) positive for anticentromere antibody (ACA), (2) positive for anti-RNA polymerase III antibody (ARA), and (3) negative for ACA, ARA, and antitopoisomerase 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 (standard error) of decline in FVC was -31.2 (41.5) mL/year among participants who were positive for ACA and -64.7 (35.1) mL/year among participants who were positive for ARA, numerically lower than in the overall SENSCIS trial population (-93.3 [13.5] mL/yr). However, participants who were negative for ACA, ARA, and ATA experienced a numerically greater rate of decline in FVC than the overall trial population, both in those randomized to placebo (-115.6 [35.4] mL/yr vs -93.3 [13.5] mL/yr) and those randomized to nintedanib (-91.8 [34.3] mL/yr vs -52.4 [13.8] mL/yr).
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.
Keywords
Adult, Aged, Female, Humans, Male, Middle Aged, Antibodies, Antinuclear, Autoantibodies, Disease Progression, Indoles, Lung Diseases, Interstitial, RNA Polymerase III, Scleroderma, Systemic, Treatment Outcome, Vital Capacity, autoantibodies, connective tissue diseases, systemic sclerosis
Published Open-Access
yes
Recommended Citation
Volkmann, Elizabeth R; Assassi, Shervin; Denton, Christopher P; et al., "Outcomes in Systemic Sclerosis-Associated Interstitial Lung Disease Based on Serological Profiles With a Focus on Anticentromere and Anti-RNA Polymerase III Antibodies" (2025). Faculty, Staff and Student Publications. 3569.
https://digitalcommons.library.tmc.edu/uthmed_docs/3569