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.

Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study / Patti, F.; Chisari, C. G.; Solaro, C.; Benedetti, M. D.; Berra, E.; Bianco, A.; Bruno Bossio, R.; Buttari, F.; Castelli, L.; Cavalla, P.; Cerqua, R.; Costantino, G.; Gasperini, C.; Guareschi, A.; Ippolito, D.; Lanzillo, R.; Maniscalco, G. T.; Matta, M.; Paolicelli, D.; Petrucci, L.; Pontecorvo, S.; Righini, I.; Russo, M.; Saccà, Francesco; Salamone, G.; Signoriello, E.; Spinicci, G.; Spitaleri, D.; Tavazzi, E.; Trotta, M.; Zaffaroni, M.; Zappia, M.. - In: NEUROLOGICAL SCIENCES. - ISSN 1590-1874. - 41:10(2020), pp. 2905-2913. [10.1007/s10072-020-04413-6]

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

Lanzillo R.;Saccà Francesco;
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.
2020
Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study / Patti, F.; Chisari, C. G.; Solaro, C.; Benedetti, M. D.; Berra, E.; Bianco, A.; Bruno Bossio, R.; Buttari, F.; Castelli, L.; Cavalla, P.; Cerqua, R.; Costantino, G.; Gasperini, C.; Guareschi, A.; Ippolito, D.; Lanzillo, R.; Maniscalco, G. T.; Matta, M.; Paolicelli, D.; Petrucci, L.; Pontecorvo, S.; Righini, I.; Russo, M.; Saccà, Francesco; Salamone, G.; Signoriello, E.; Spinicci, G.; Spitaleri, D.; Tavazzi, E.; Trotta, M.; Zaffaroni, M.; Zappia, M.. - In: NEUROLOGICAL SCIENCES. - ISSN 1590-1874. - 41:10(2020), pp. 2905-2913. [10.1007/s10072-020-04413-6]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/821666
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