This protocol addresses patients with skin fibrosis in early, inflammatory diffuse cutaneous systemic sclerosis (dcSSc) in whom first-line immunosuppressive treatment has failed to produce meaningful improvement in skin involvement, as measured by the modified Rodnan skin score (mRSS).
Patients in this scenario have received one or more first-line agents — methotrexate, mycophenolate mofetil, or rituximab — without achieving the target of improved mRSS. This documented insufficient response to first-line therapy defines the indication for the next treatment step described in this protocol.
The protocol applies to patients with active, early-phase inflammatory diffuse cutaneous systemic sclerosis presenting with skin fibrosis, in whom initial therapy has proven insufficient to reduce skin thickening as assessed by the modified Rodnan skin score.
The primary clinical target is measurable improvement in the modified Rodnan skin score (mRSS) at 48 weeks — a validated composite measure of skin thickening across body areas used in systemic sclerosis trials.
DOI: 10.1136/ard-2024-226430
Tocilizumab may be considered for the treatment of skin fibrosis in patients with early, inflammatory dcSSc.
Although these data do not support the use of tocilizumab as first-line therapy for skin involvement in early dcSSc, a trend in benefit was observed together with a satisfactory safety profile, so the task force agreed to considering tocilizumab for the treatment of skin fibrosis in patients with early, inflammatory dcSSc.
The least squares mean (LSM) change in mRSS at 48 weeks was -6.33 in the tocilizumab group and -2.77 in the placebo group.
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