Enrichment Strategies for Systemic Sclerosis-Interstitial Lung Disease Trials

• Published in: American journal of respiratory and critical care medicine Vol. 209; no. 9; pp. 1067 - 1068
• Main Authors: Volkmann, Elizabeth R, Tashkin, Donald P
• Format: Journal Article
• Language: English
• Published: United States American Thoracic Society 01.05.2024
• Subjects: Clinical trials; Clinical Trials as Topic; Drug therapy; Female; Humans; Lung diseases; Lung Diseases, Interstitial - therapy; Male; Scleroderma; Scleroderma, Systemic - therapy
• ISSN: 1073-449X; 1535-4970; 1535-4970
• DOI: 10.1164/rccm.202401-0246ED

Volkmann and Tashkin discuss enrichment strategies for systemic sclerosis-associated interstitial lung disease (SScILD) trials which have evolved in recent years, with the approval of two drugs, nintedanib and tocilizumab, for the treatment of SScILD. However, current eligibility criteria for these trials may limit patient accrual and the generalizability of trial data. For example, excluding patients with limited cutaneous disease, which is the more prevalent subtype of SSc, may hinder the investigation of certain therapies. Additionally, the use of strict inclusion criteria may not maximize trial enrollment or provide data that accurately reflects real-world populations. To address these issues, modernized and practical clinical protocols, such as adaptive designs, should be considered for SScILD trials. Furthermore, fostering partnerships with academia and industry can help create research registries that provide data for modeling placebo arms in trials. By broadening eligibility criteria and utilizing innovative trial designs, they can improve trial enrollment, generate more representative data, and enhance the development of therapies for SScILD.