Treatment of Skin Fibrosis in Systemic Sclerosis — Not Early Inflammatory Diffuse Cutaneous

This protocol applies to patients with systemic sclerosis who have established skin fibrosis but are not classified as early inflammatory diffuse cutaneous SSc. The clinical goal is a measurable reduction in skin involvement.

Clinical Scenario

Skin fibrosis in systemic sclerosis, in patients who do not meet the criteria for early inflammatory diffuse cutaneous SSc. This distinction matters: the therapeutic approach is guided by the presence of established fibrotic skin disease rather than an early, actively inflamed phase.

Treatment Target

The primary outcome measure is improvement in the modified Rodnan skin score (mRSS), the validated clinical index used to quantify skin thickness and fibrosis in SSc and to track therapeutic response over time.

Approach (Partial)

Evidence-based recommendations support the use of immunomodulatory agents for SSc-related skin fibrosis; both conventional disease-modifying agents and biologics figure in the evidence base.

The complete agent selection, clinical context for each option, and treatment parameters are available in the full protocol below.

Instant Access to Structured Evidence-Based Regimens

References

DOI: 10.1136/ard-2024-226430

Methotrexate (1B), mycophenolate mofetil (MMF) (1B) and/or rituximab (1A) should be considered for treatment of SSc skin fibrosis.
Post hoc analyses of SLS-II identified modified Rodnan skin score (mRSS) improvements from baseline to 24 months for both MMF and cyclophosphamide.
The absolute improvement in mRSS at 24 weeks was significantly higher in the rituximab group than in the placebo group.

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