Objective: Botulinum toxin has been an effective and safe treatment option for hemifacial spasm. This is a report of 5 patients with successful treatment of hemifacial spasm with DaxibotulinumtoxinA, a BoNTA product with a novel formulation that contains a proprietary 35-amino acid cell-penetrating peptide (RTP004)

Background: Hemifacial spasm (HFS) is peripheral hyperkinetic movement disorder characterized by involuntary, rhythmic, clonic or tonic contractions of the muscles innervated by cranial nerve VII. This condition is often chronic, and spontaneous remission is rare [1]. Involuntary movements may cause significant quality of life challenges [2].

Hemifacial Spasm Grading Scale (HSGS) is an objective, reliable tool for HFS assessment and has been used to determine botulinum toxin efficacy [3]. HFS-7 has been a useful tool for quality of life assessment for patients with HFS [4].

While various treatments have been studied, the treatment of choice remains Botulinum Toxin injections [5], and provides a favorable safety profile [6].

Method: 5 patients diagnosed with HFS were injected with DaxibotulinumtoxinA.

HSGS and HFS-7 were performed prior to first injection, 4 weeks after injection, and at 12 weeks.

Patient 2 received DaxibotulinumtoxinA without any prior injections.

All other patients received OnabotulinumtoxinA at 12 week intervals prior to switching.

Unit conversion was 1:1. (OnabotulinumtoxinA to DaxibotulinumtoxinA)

Results: 1.

HSGS – Week(Wk) 0: 9, Wk 4: 3, Wk 12: 5

HFS7 – Wk 0: 22, Wk 4: 14, Wk 12: 16

2.

HSGS – Wk 0: 9, Wk 4: 3, Wk 12: 3

HFS7 – Wk 0: 14, Wk 4: 7: Wk 12: 7

3.

HSGS – Wk 0: 9, Wk 4: 3, Wk 12: 4

HFS7 – Wk 0: 18, Wk 4: 7: Wk 12: 9

4.

HSGS – Wk 0: 9, Wk 4: 3, Wk 12: 4

HFS7 – Wk 0: 18: Wk 4: 9: Wk 12: 9

5.

HSGS – Wk 0: 9, Wk 4: 3, Wk 12: 3

HFS7 – Wk 0: 12, Wk 4: 6, Wk 12: 6

Conclusion: DaxibotulinumtoxinA provided sustained improvement in hemifacial spasm symptoms.

Patients who received OnabotulinumtoxinA before switching to DaxibotulinumtoxinA showed a return of symptoms before starting DaxibotulinumtoxinA (Patients 1, 3, 4, 5).

In comparison, week 12 survey after DaxibotulinumtoxinA revealed sustained efficacy, suggesting a longer duration interval.

All unit conversions were 1:1, OnabotulinumtoxinA to DaxibotulinumtoxinA, but all patients’ symptoms improved. This is important to note as the concentration of botulinum toxin in nanograms is almost half that of OnabotulinumtoxinA. The novel peptide may provide ancillary clinical benefit.

Figure 1 (HSGS)

Figure 2 (HFS-7)

Patient Details

References: 1. DeFazio, G.; Abbruzzese, G.; Girlanda, P.; Vacca, L.; Currà, A.; De Salvia, R.; Marchese, R.; Raineri, R.; Roselli, F.; Livrea, P.; et al. Botulinum toxin A treatment for primary hemifacial spasm: A 10-year multicenter study. Arch. Neurol. 2002, 59, 418–420
2. Heuser, K.; Kerty, E.; Eide, P.K.; Cvancarova, M.; Dietrichs, E. Microvascular decompression for hemifacial spasm: Postoperative neurologic follow-up and evaluation of life quality. Eur. J. Neurol. 2007, 14, 335–340.
3. Tambasco, N.; Simoni, S.; Sacchini, E.; Eusebi, P.; Marsili, E.; Nigro, P.; Brahimi, E.; Paoletti, F.P.; Romoli, M.; Calabresi, P. Validation of the Hemifacial Spasm Grading Scale: A clinical tool for hemifacial spasm. Neurol. Sci. 2019, 40, 1887–1892.
4. Tan EK, Fook-Chong S, Lum SY, Thumboo J. Validation of a short disease specific quality of life scale for hemifacial spasm: correlation with SF-36. J Neurol Neurosurg Psychiatry. 2005 Dec;76(12):1707-10. doi: 10.1136/jnnp.2005.065656. PMID: 16291898; PMCID: PMC1739450.
5. Jost, W.H.; Kohl, A. Botulinum toxin: Evidence-based medicine criteria in blepharospasm and hemifacial spasm. J. Neurol. 2001, 248, I21–I24.
6. Tambasco N, Filidei M, Nigro P, Parnetti L, Simoni S. Botulinum Toxin for the Treatment of Hemifacial Spasm: An Update on Clinical Studies. Toxins (Basel). 2021 Dec 9;13(12):881. doi: 10.3390/toxins13120881. PMID: 34941718; PMCID: PMC8706367.

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