BRASS
Trial question
What is the role of botulinum toxin injections in patients with systemic sclerosis-associated Raynaud's phenomenon?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
80.0% female
20.0% male
N = 90
90 patients (72 female, 18 male).
Inclusion criteria: adult patients with systemic sclerosis-associated Raynaud's phenomenon.
Key exclusion criteria: history of myasthenia gravis or Eaton Lambert syndrome; active infection in either hand; inflammatory myositis < 2 years or pre-existing motor neurone disease or upper limb motor neuropathy.
Interventions
N=46 botulinum toxin (50 unit of botox injection into the palms of both hands).
N=44 placebo (matching placebo injection into the palms of both hands).
Primary outcome
Reduction in median number of daily Raynaud's phenomenon attacks at 4 weeks postinjection
1 /d
1 /d
1.0/d
0.8/d
0.5/d
0.3/d
0.0/d
Botulinum
toxin
Placebo
No significant
difference ↔
No significant difference in reduction in the median number of daily Raynaud's phenomenon attacks at 4 weeks postinjection (1 episode/day vs. 1 episode/day; RR 1, 95% CI -5.34 to 7.34).
Safety outcomes
No significant differences in pain during injections, Raynaud's Condition Score, QoL, Hand function.
Significant difference in transient hand muscle weakness (35% vs. 5%).
Conclusion
In adult patients with systemic sclerosis-associated Raynaud's phenomenon, botulinum toxin was not superior to placebo with respect to reduction in the median number of daily Raynaud's phenomenon attacks at 4 weeks postinjection.
Reference
Patricia Senet, Hervé Maillard, Elisabeth Diot et al. 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. 2023 Mar;75(3):459-467.
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