Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a ret
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ORIGINAL ARTICLE
Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study Francesco Patti 1 & Clara Grazia Chisari 1 & Claudio Solaro 2 & Maria Donata Benedetti 3 & Eliana Berra 4 & Assunta Bianco 5 & Roberto Bruno Bossio 6 & Fabio Buttari 7 & Letizia Castelli 8 & Paola Cavalla 9 & Raffaella Cerqua 10 & Gianfranco Costantino 11 & Claudio Gasperini 12 & Angelica Guareschi 13 & Domenico Ippolito 14 & Roberta Lanzillo 15 & Giorgia Teresa Maniscalco 16 & Manuela Matta 17 & Damiano Paolicelli 18 & Loredana Petrucci 19 & Simona Pontecorvo 20 & Isabella Righini 21 & Margherita Russo 22 & Francesco Saccà 15 & Giovanna Salamone 23 & Elisabetta Signoriello 24 & Gabriella Spinicci 25 & Daniele Spitaleri 26 & Eleonora Tavazzi 27 & Maria Trotta 28 & Mauro Zaffaroni 29 & Mario Zappia 1 & on behalf of the SA.FE. group Received: 2 August 2019 / Accepted: 13 April 2020 # Fondazione Società Italiana di Neurologia 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 spasticityrelated symptoms even in non-NRS responder patients. Keywords Multiple sclerosis . Clinical practice . Spasticity-related symptoms . THC . CBD
Introduction
Patti Francesco and G Chisari Clara contributed equally to this work. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10072-020-04413-6) contains supplementary material, which is available to authorized users. * Francesco Patti [email protected] Extended author information availa
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