
European Journal of Neurology
2025 Sep;32(9):e70362. doi: 10.1111/ene.70362.
Eva Sole-Cruz, Elise Van Obberghen-Blanc, Chloé Hirtz, Imene Bennour, Michel Lanteri-Minet, Anne Donnet
Abstract
Background: Neuropathic pain (NP) is frequently resistant to conventional treatments. Botulinum toxin type A (BT-A) is a recommended option for focal peripheral NP, but the dynamics of its effect in real-life conditions remain poorly characterized.
Objective: To assess BT-A efficacy in a real-world study of patients with focal peripheral NP, over a 1-year follow-up period.
Methods: In this prospective, observational study, adult patients with chronic focal peripheral NP refractory to standard therapies were treated with BT-A in two French pain centers. Injections were individualized and administered at approximately 3-month intervals. The primary outcome was the patient-reported percentage of improvement since the first injection, assessed at each follow-up visit (Cycles 2-5). Secondary outcomes included the Patient Global Impression of Change (PGIC), average pain intensity over the previous 8 days, and exploratory analysis of response trajectories distinguishing early (≥ 30% improvement at Cycle 3) from late responders.
Results: Eighty-two patients received ≥ 2 BT-A cycles. Mean self-reported improvement increased from 30.7% at Cycle 2 to 51.0% at Cycle 5 (p < 0.001). PGIC and pain intensity also showed significant improvements. Among 59 patients evaluable at Cycle 3, 66% were early responders; late responders showed significant benefit after the third injection. BT-A was well tolerated: 63.6% reported end-of-dose effects, and 25.8% experienced only mild, transient adverse events.
Conclusion: This real-life study over 1 year suggests that BT-A provides progressive and sustained benefit in focal peripheral NP, supporting continued treatment beyond two cycles.
Keywords: botulinum toxins; neuralgia; pain management; peripheral nervous system disorders; real‐world data.
© 2025 The Author(s). European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.
- PMID: 40931442
- PMCID: PMC12423104
- DOI: 10.1111/ene.70362