Systematic Review Shows BTX Effective for Ischemic Digital Complications

Key Takeaways

• Botulinum toxin (BTX) injections achieved high complete response rates in digital ischemia, ulcers, and gangrene, new research indicates.

• Most reported adverse events (such as muscle weakness and injection site pain) were mild and transient.

• While not statistically significant in adjusted models, researchers think (pending larger studies) that autoimmune etiology and younger age may predict faster response.

Botulinum toxin (BTX) injections may offer a promising rescue therapy for patients with refractory digital ischemia, ulcers, or gangrene associated with systemic sclerosis and other vasculopathies, according to findings from a systematic review in JAMA Dermatology.

The analysis included data from 31 studies including 119 patients (75% female; mean age 49 years) treated with BTX for severe ischemic digital complications (such as acute digital ischemia, ischemic ulcers, and gangrene). Patients who had Raynaud disease without ulceration excluded. Complete response (CS) was defined as ulcer healing or ischemia resolution

According to the data, CR was observed in 93.1% of ischemia cases, 90.1% of ulcers, and 87.5% of gangrene cases. Reported adverse events were mild, with transient muscle weakness (7.6%) and injection site pain (5.9%) as the most common. The authors reported no predictors of response attaining statistical significance in multivariable modeling, but noted that Kaplan-Meier analyses indicated that autoimmune disease etiology and younger age may be associated with faster response times.

“These findings suggest that BTX injections are a safe and potentially effective adjunct treatment for refractory digital ischemia in systemic sclerosis,” the authors wrote. “Prospective trials are needed to confirm long-term effectiveness and standardize administration protocols.”

Source: Zhu C, et al. JAMA Dermatology. 2025. Doi:10.1001/jamadermatol.2025.4929