Brentuximab vedotin for skin involvement in refractory diffuse cutaneous systemic sclerosis, an open-label trial.

ABSTRACT:

Objective

We explored the efficacy and safety of brentuximab vedotin, a chimeric anti-CD30 antibody drug conjugate, in patients with severe active diffuse cutaneous systemic sclerosis (dcSSc).

Methods

This phase II proof-of-concept, single centre, open-label, single arm, investigator-initiated trial included patients ≥18 years, with dcSSc, modified Rodnan skin score (mRSS) ≥15 with <5 years since the first non-Raynaud's symptom and/or skin worsening despite immunosuppression who were treated with intravenous brentuximab vedotin 0.6 mg/kg q3 weeks for 45 weeks. The primary end point was a decrease in mRSS of ≥8 points at 48 weeks.

Results

Eleven patients were treated with brentuximab vedotin, with nine completing the study. The mean mRSS reduction at week 48 was 11.3 (

SUBMITTER: Fernandez-Codina A 

PROVIDER: S-EPMC11879290 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature