Botulinum toxin shots a promising treatment for refractory digital ischaemia

Botulinum toxin injections appear to be a safe and efficacious adjunct in the treatment of refractory digital ischaemia in patients with systemic sclerosis, according to a systematic review and individual participant data meta-analysis.

Researchers searched multiple online databases for studies involving systemic sclerosis patients presenting with acute digital ischaemia, ischaemic digital ulcers, or gangrene. Studies that included patients with Raynaud disease without digital ulcers or gangrene were excluded. A total of 116 studies were identified, of which 31 met inclusion criteria.

The primary outcome was complete response (CR), which was defined as resolution of ischemia or ulcer healing. Secondary outcomes included adverse events and time to response. Cox regression was used to identify factors associated with CR.

Pooled data showed that most patients who received botulinum toxin injections achieved complete response for ischaemia (93.1 percent), ulcers (90.1 percent), and gangrene (87.5 percent).

In terms of safety, the number of patients who experienced adverse events (AEs) was small. The most common AEs were transient muscle weakness (7.6 percent) and injection site pain (5.9 percent).

No significant predictors of complete response emerged in multivariable Cox models. However, autoimmune aetiology and younger age were associated with faster response in Kaplan-Meier analyses.