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01-10-2020 | Multiple Sclerosis | Original Article

Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study

Authors: Francesco Patti, Clara Grazia Chisari, Claudio Solaro, Maria Donata Benedetti, Eliana Berra, Assunta Bianco, Roberto Bruno Bossio, Fabio Buttari, Letizia Castelli, Paola Cavalla, Raffaella Cerqua, Gianfranco Costantino, Claudio Gasperini, Angelica Guareschi, Domenico Ippolito, Roberta Lanzillo, Giorgia Teresa Maniscalco, Manuela Matta, Damiano Paolicelli, Loredana Petrucci, Simona Pontecorvo, Isabella Righini, Margherita Russo, Francesco Saccà, Giovanna Salamone, Elisabetta Signoriello, Gabriella Spinicci, Daniele Spitaleri, Eleonora Tavazzi, Maria Trotta, Mauro Zaffaroni, Mario Zappia, on behalf of the SA.FE. group

Published in: Neurological Sciences | Issue 10/2020

Abstract

Introduction

The approval of 9-δ-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex®) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity. We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice.

Materials and methods

MS patients with drug-resistant spasticity were recruited from 30 Italian MS centers. All patients were eligible for THC:CBD treatment according to the approved label: ≥ 18 years of age, at least moderate spasticity (MS spasticity numerical rating scale [NRS] score ≥ 4) and not responding to the common antispastic drugs. Patients were evaluated at baseline (T0) and after 4 weeks of treatment (T1) with the spasticity NRS scale and were also asked about meaningful improvements in 6 key spasticity-related symptoms.

Results

Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, 1010 patients (70.5%) reached a ≥ 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group.

Conclusion

Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients.

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Title: Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study
Authors: Francesco Patti
Clara Grazia Chisari
Claudio Solaro
Maria Donata Benedetti
Eliana Berra
Assunta Bianco
Roberto Bruno Bossio
Fabio Buttari
Letizia Castelli
Paola Cavalla
Raffaella Cerqua
Gianfranco Costantino
Claudio Gasperini
Angelica Guareschi
Domenico Ippolito
Roberta Lanzillo
Giorgia Teresa Maniscalco
Manuela Matta
Damiano Paolicelli
Loredana Petrucci
Simona Pontecorvo
Isabella Righini
Margherita Russo
Francesco Saccà
Giovanna Salamone
Elisabetta Signoriello
Gabriella Spinicci
Daniele Spitaleri
Eleonora Tavazzi
Maria Trotta
Mauro Zaffaroni
Mario Zappia
on behalf of the SA.FE. group
Publication date: 01-10-2020
Publisher: Springer International Publishing
Keywords: Multiple Sclerosis
Cannabinoid
Published in: Neurological Sciences / Issue 10/2020
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI: https://doi.org/10.1007/s10072-020-04413-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study

Abstract

Introduction

Materials and methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Materials and methods

Results

Conclusion

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