6/27/23, 11:47 PM BRASS Pathway Feedback Search Clinical Topics Home Studies BRASS BRASS Disease Disease Raynaud's phenomenon Systemic sclerosis Trial question What is the role of botulinum toxin in patients with systemic sclerosis-associated Raynaud's phenomenon? Study design Multi-center Double blinded RCT Population Characteristics of study participants 80.0% female N = 90 20.0% male 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 1.0/d 1 1 0 8/d https://web.pathway.md/studies/recW2DSmavja7Uy5Q 1/2 6/27/23, 11:47 PM BRASS Pathway 0.8/d 0.5/d 0.3/d No significant difference 0.0/d Botulinum toxin Placebo 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, Quality of Life, 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, Herv 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. Open reference URL https://web.pathway.md/studies/recW2DSmavja7Uy5Q 2/2