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NCT07662265

Tocilizumab in Refractory ASS-ILD

Sponsor: Hu Yinan

View on ClinicalTrials.gov

Summary

Refractory anti-synthetase syndrome-associated interstitial lung disease (ASyS-ILD) lacks targeted therapy. Interleukin-6 drives both inflammation and fibrosis. We evaluated the real-world efficacy and safety of tocilizumab, an IL-6 receptor antagonist. This single-center retrospective cohort study included patients with refractory ASyS-ILD treated between January 2020 and July 2025. Tocilizumab recipients were compared with those receiving standard of care (SOC) immunosuppressants. Overlap weighting based on propensity scores was used to balance 11 baseline variables. The primary outcome was improvement in symptoms and HRCT findings at ≥3 months. Secondary outcomes included changes in biomarkers and pulmonary function, progression-free survival (PFS), and adverse events. Cox regression identified independent predictors of symptom progression. Generalized additive models (GAM) explored nonlinear relationships, and XGBoost-SHAP machine learning assessed variable importance.

Official title: Tocilizumab for Refractory Anti-Synthetase Syndrome-Associated Interstitial Lung Disease: A Real-World Retrospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

111

Start Date

2022-01-01

Completion Date

2025-10-31

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DRUG

Tociliuzumab

Tocilizumab, a humanized monoclonal antibody against the IL-6 receptor, is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, and giant cell arteritis. In patients with rheumatoid arthritis-associated ILD, tocilizumab has been shown to reduce KL-6 levels, a biomarker of alveolar epithelial injury. However, evidence for tocilizumab in ASyS-ILD is limited to isolated case reports, and no systematic evaluation of its efficacy and safety in this specific population has been published.

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China