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Botulinum toxin for the management of spasticity in multiple sclerosis: the Italian botulinum toxin network study

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Abstract

Background

Botulinum toxin (BT) is an effective and safe treatment for spasticity, with limited evidence in multiple sclerosis (MS). We aim to describe the use of BT for the management of MS spasticity in the clinical practice, its combination with other anti-spastic treatments in MS and possible MS clinical correlates.

Methods

This is a multicentre cross-sectional observational study including 386 MS patients, receiving BT for spasticity in 19 Italian centres (age 53.6 ± 10.9 years; female 228 (59.1%); disease duration 18.7 ± 9.2 years; baseline Expanded Disability Status Scale (EDSS) 6.5 (2.0–9.0)).

Results

BT was used for improving mobility (n = 170), functioning in activities of daily living (n = 56), pain (n = 56), posturing-hygiene (n = 63) and daily assistance (n = 41). BT formulations were AbobotulinumtoxinA (n = 138), OnabotulinumtoxinA (n = 133) and IncobotulinumtoxinA (n = 115). After conversion to unified dose units, higher BT dose was associated with higher EDSS (Coeff = 0.591; p < 0.001), higher modified Ashworth scale (Coeff = 0.796; p < 0.001) and non-ambulatory patients (Coeff = 209.382; p = 0.006). Lower BT dose was used in younger patients (Coeff = − 1.746; p = 0.009), with relapsing-remitting MS (Coeff = − 60.371; p = 0.012). BT dose was higher in patients with previous BT injections (Coeff = 5.167; p = 0.001), and with concomitant treatments (Coeff = 43.576; p = 0.022). Three patients (0.7%) reported on post-injection temporary asthenia/weakness (n = 2) and hypophonia (n = 1).

Conclusion

BT was used for spasticity and its consequences from the early stages of MS, without significant adverse effects. MS-specific goals and injection characteristics can be used to refer MS patients to BT treatment, to decide for the strategy of BT injections and to guide the design of future clinical trials and observational studies.

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Acknowledgements

Contributors to this project from the Italian Botulinum Toxin Network and/or the the Italian Study Group for Multiple Sclerosis of the Italian Society of Neurology are Francesco Aruta, Nicola Capasso, Marcello De Angelis, Rosa Iodice, Aniello Iovino, Roberta Lanzillo, Martina Petruzzo, Cinzia Russo and Barbara Satelliti (Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Sciences and Odontostomatology, “Federico II” University, Naples, Italy); Barbara Ruzzante (Rehabilitation Unit, Cittadella Hospital, Cittadella, Italy); Marco Rovaris (IRCCS, Fondazione Don Carlo Gnocchi, Multiple Sclerosis Centre, Milan, Italy); Laura Bertolasi, (Department of Neurological Sciences and Vision, Section of Clinical Neurology, University of Verona, Italy); Tamara Ialongo (Movement Disorder Unit, Teaching Hospital “Fondazione Policlinico Universitario A. Gemelli IRCSS”, Rome, Italy; and Institute of Neurology, Catholic University of Sacred Heart, Rome, Italy).

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Author notes

  1. Maria Concetta Altavista, Francesco Bono, Roberto Eleopra and Vincenzo Brescia Morra contributed equally to this work.

Authors and Affiliations

  1. Multiple Sclerosis Clinical Care and Research Centre, Department of Neuroscience, Reproductive Sciences and Odontostomatology, “Federico II” University of Naples, Via Sergio Pansini 5, edificio 17 piano terra, 80131, Naples, Italy

    Marcello Moccia, Antonio Carotenuto & Vincenzo Brescia Morra

  2. Queen Square MS Centre, UCL Queen Square Institute of Neurology, University College London, London, UK

    Marcello Moccia

  3. Multiple Sclerosis Centre, Department of Medical Science and Public Health, University of Cagliari, ATS Sardegna, Cagliari, Italy

    Jessica Frau, Giancarlo Coghe & Cristina Inglese

  4. Department of Neurology, Institute of Experimental Neurology, Scientific Institute “San Raffaele”, Milan, Italy

    Calogera Butera & Ubaldo Del Carro

  5. Neurology Unit, “San Luigi Gonzaga” Hospital, Orbassano, Italy

    Pierangelo Barbero

  6. Neurology Unit, “Ordine Mauriziano di Torino” Hospital, Turin, Italy

    Pierangelo Barbero

  7. Department of Human Neuroscience, “La Sapienza” University, Rome, Italy

    Marco Frontoni

  8. IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy

    Elisabetta Groppo & Anna Castagna

  9. “Sant’Andrea” University Hospital, Rome, Italy

    Morena Giovannelli & Pamela Latino

  10. Neurology Unit, Cittadella Hospital, Cittadella, Italy

    Emma Frasson

  11. Multiple Sclerosis Centre, Neurology and Neuromuscular Unit, “G. Martino” University Hospital, Messina, Italy

    Maria Buccafusca

  12. “Luigi Sacco” Hospital, Department of Neurology, University of Milan, Milan, Italy

    Caterina Nascimbene

  13. “Villa Sofia-Cervello” Hospital, Palermo, Italy

    Marcello Romano

  14. Physical Medicine and Rehabilitation Unit, Popoli Hospital, Pescara, Italy

    Vitalma Liotti

  15. Neurology Unit, “Valle Olona” Hospital, Gallarate, Italy

    Stefania Lanfranchi

  16. Centre for Botulinum Toxin Therapy, Institute of Neurology, “Magna Graecia” University, Catanzaro, Italy

    Laura Rapisarda & Francesco Bono

  17. Regional Referral Centre for Chemical Denervation, Neurophysiology Unit, Department of Neuro-musculoskeletal and Sensory Organs, Careggi Hospital, Florence, Italy

    Silvia Lori

  18. Department of Neuroscience, Reproductive Sciences and Odontostomatology, “Federico II” University, Naples, Italy

    Marcello Esposito

  19. Rehabilitation and Physical Medicine Unit, Department of Aging, Neurological, Orthopaedic Science, Fondazione Policlinico Universitario “A. Gemelli” IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

    Loredana Maggi

  20. Movement Disorder Unit, Teaching Hospital ‘Fondazione Policlinico Universitario A. Gemelli IRCSS’, Rome, Italy

    Martina Petracca

  21. Institute of Neurology, Catholic University of Sacred Heart, Rome, Italy

    Martina Petracca

  22. Multiple Sclerosis Centre, A.O.U. Policlinico “Vittorio Emanuele”, Catania, Italy

    Salvatore Lo Fermo

  23. Neurology Unit, “San Filippo Neri” Hospital, Rome, Italy

    Maria Concetta Altavista

  24. IRCCS Foundation C. Besta Neurological Institute, Milan, Italy

    Roberto Eleopra

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  1. Marcello Moccia
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Correspondence to Marcello Moccia.

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Ethics approval was obtained from the committee of “Federico II” University of Naples, Italy. The study included anonymized data collected in the clinical practice and was conducted in accordance with good clinical practice and the Declaration of Helsinki.

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Moccia, M., Frau, J., Carotenuto, A. et al. Botulinum toxin for the management of spasticity in multiple sclerosis: the Italian botulinum toxin network study. Neurol Sci 41, 2781–2792 (2020). https://doi.org/10.1007/s10072-020-04392-8

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