Systemic sclerosis & Raynaud's
Brentuximab vedotin for skin involvement in refractory diffuse cutaneous systemic sclerosis, an open-label trial
Authors' conclusion
In dcSSc, brentuximab vedotin improved skin and FVC without safety concerns.
Study context
- Population
- Adults ≥18 years with diffuse cutaneous systemic sclerosis (dcSSc), modified Rodnan skin score (mRSS) ≥15, <5 years since first non-Raynaud's symptom and/or skin worsening despite immunosuppression9 completed
- Participants
- 11 adults
- Outcome
- Decrease in mRSS of ≥8 points
- Follow-up
- 48 weeks
Methodological detailsproof-of-concept, single centre, open-label, investigator-initiated
- Proof-of-concept
- Single centre
- Open-label
- Investigator-initiated
Main finding
As reported in the abstract
mRSS reduction · week 48
Mean mRSS reduction
11.3
95% CI 6.9, 15.8P = 0.001
Decrease in mRSS ≥8, primary end point met
7 of 11
Further findings
% FVC increase (spread as printed in parentheses)
- % FVC increase
- 7.8% (12.5)
CRISS ≥0.6
- Patients with CRISS ≥0.6, suggesting a beneficial treatment effect
- 86%
Safety
- Most adverse events were mild
- No SAEs attributed to brentuximab vedotin
Original publication
Brentuximab vedotin for skin involvement in refractory diffuse cutaneous systemic sclerosis, an open-label trial. Rheumatology (Oxford). Published 23 April 2024. doi:10.
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