Systemic sclerosis & Raynaud's
Efficacy and Safety of Botulinum Toxin in Adults with Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Study
Authors' conclusion
Neither the primary nor secondary end points were reached, and our results do not support any beneficial effect of palmar BTA injections to treat SSc-RP.
Study context
- Population
- Adults with RP secondary to SScITT analysis
- Participants
- 46 vs 44
- Comparison
- Single session of 50-unit BTA palmar injections into both hands vs placebo
- BTAn = 46
- Placebon = 44reference
- Primary endpoint
- Between-group difference in median change in number of RP episodes from baseline (day 0)
- Follow-up
- 4 weeks postinjection
Methodological detailsmulticenter, double-blind, placebo-controlled, parallel-group, phase III
- Multicenter
- Double-blind
- Placebo-controlled
- Parallel-group
- Phase III
Primary result
As reported in the abstract
Change in daily RP episodes · 4 weeks
BTA
−1
median · IQR −1.5–0 · episode/day
Placebo
−1
median · IQR −2.5–0 · episode/day
P = 0.77 versus placebo
Secondary outcomes
Raynaud's Condition Score, HAQ-DI, QuickDASH and Cochin Hand Function Scale · weeks 4, 12 and 24
- Did not differ significantly between groups
Safety
| Outcome | P value |
|---|---|
| Transient hand muscle weaknessSignificantly more frequent with BTA | P = 0.003 |
Original publication
Efficacy and Safety of Botulinum Toxin in Adults with Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Study. Arthritis Rheumatol. Published 14 December 2022. doi:10.
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