TY - JOUR
T1 - Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis
T2 - results from a retrospective multicenter study
AU - SA.FE. group
AU - Patti, Francesco
AU - Chisari, Clara Grazia
AU - Solaro, Claudio
AU - Benedetti, Maria Donata
AU - Berra, Eliana
AU - Bianco, Assunta
AU - Bruno Bossio, Roberto
AU - Buttari, Fabio
AU - Castelli, Letizia
AU - Cavalla, Paola
AU - Cerqua, Raffaella
AU - Costantino, Gianfranco
AU - Gasperini, Claudio
AU - Guareschi, Angelica
AU - Ippolito, Domenico
AU - Lanzillo, Roberta
AU - Maniscalco, Giorgia Teresa
AU - Matta, Manuela
AU - Paolicelli, Damiano
AU - Petrucci, Loredana
AU - Pontecorvo, Simona
AU - Righini, Isabella
AU - Russo, Margherita
AU - Saccà, Francesco
AU - Salamone, Giovanna
AU - Signoriello, Elisabetta
AU - Spinicci, Gabriella
AU - Spitaleri, Daniele
AU - Tavazzi, Eleonora
AU - Trotta, Maria
AU - Zaffaroni, Mauro
AU - Zappia, Mario
PY - 2020/4/25
Y1 - 2020/4/25
N2 - 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.
AB - 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.
U2 - 10.1007/s10072-020-04413-6
DO - 10.1007/s10072-020-04413-6
M3 - Article
C2 - 32335779
JO - Neurol. Sci.
JF - Neurol. Sci.
SN - 1590-1874
ER -