Comparative Efficacy of Immunosuppressive Therapies in the Treatment of Diffuse Cutaneous Systemic Sclerosis
Open Access
- 10 March 2025
- journal article
- Published by Wiley in ACR Open Rheumatology
- Vol. 7 (3) , e70004
Abstract
Objectives: The RESOLVE‐1 trial of lenabasum in diffuse cutaneous systemic sclerosis (dcSSc) allowed background immunosuppressive therapy (IST) at the discretion of individual investigators, and no significant differences were observed between treatment arms. This provides a powerful opportunity to compare the relative efficacy of different ISTs in a well‐defined large cohort of patients with dcSSc.Methods: Prespecified IST categories, efficacy end points, baseline disease characteristics likely to influence efficacy outcomes, the definition of interstitial lung disease, definitions of IST use, and categories of IST use by which efficacy outcomes were evaluated were. Descriptive statistics are used to present results.Results: For skin, change in modified Rodnan skin score (mRSS) was numerically greatest with mycophenolate mofetil (MMF) treatment in patients with the earliest disease, reaching −10.8 points in the MMF group versus −4.8 points in the no IST group in patients with a disease duration ≤2 years. Other ISTs had improvements intermediate between that seen in the MMF and no IST groups. Forced vital capacity (mL) was stable over 52 weeks in patients in the MMF group compared to an around 160‐mL decline over 52 weeks in no IST group. Differences in outcome were observed between antinuclear antibody subgroups, with greater difference in favor of MMF for skin and lungs being observed in anti–topoisomerase 1 autoantibody–positive patients. In contrast, anti–RNA polymerase III autoantibody–positive patients in both the no IST and MMF groups improved rapidly, with a decrease in mRSS.Conclusion: Taken together, our findings robustly support routine use of MMF in dcSSc and show benefit especially in early‐stage disease. Those patients with high‐risk antibodies for lung fibrosis might be especially suitable for MMF treatment.Keywords
This publication has 29 references indexed in Scilit:
- Treatment outcome in early diffuse cutaneous systemic sclerosis: the European Scleroderma Observational Study (ESOS)Annals of the Rheumatic Diseases, 2017
- Efficacy of Mycophenolate Mofetil and Oral Cyclophosphamide on Skin Thickness: Post Hoc Analyses From Two Randomized Placebo‐Controlled TrialsArthritis Care & Research, 2017
- Mycophenolate Mofetil Versus Placebo for Systemic Sclerosis–Related Interstitial Lung Disease: An Analysis of Scleroderma Lung Studies I and IIArthritis & Rheumatology, 2017
- Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trialThe Lancet Respiratory Medicine, 2016
- Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trialThe Lancet, 2016
- The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic SclerosisArthritis & Rheumatology, 2016
- Systemic sclerosisNature Reviews Disease Primers, 2015
- Performance of American Thoracic Society-Recommended Spirometry Reference Values in a Multiethnic Sample of AdultsChest, 2010
- Observational Study of Treatment Outcome in Early Diffuse Cutaneous Systemic SclerosisThe Journal of Rheumatology, 2009
- Cyclophosphamide versus Placebo in Scleroderma Lung DiseaseNew England Journal of Medicine, 2006