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.
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.
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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Conflict of interest
Prof Patti has received honoraria for speaking activities by Bayer Schering, Biogen Idec, Merck Serono, Novartis, and Sanofi Aventis; he also served as advisory board member the following companies: Bayer Schering, Biogen Idec, Merck Serono, and Novartis; he was also funded by Pfeizer and FISM for epidemiological studies; finally, he received grant for congress participation from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Aventis, and TEVA. Dr. Chisari CG received grant for congress participation from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Roche, Sanofi Aventis, and TEVA. Dr. Solaro received honoraria from Biogen, Genzyme, Novartis, Merck Serono, Almirall, Roche, and TEVA. Dr. Bruno Bossio R received grant for advisory board activities from Almirall. Dr. Maniscalco GT received speaking and advisory honoraria from Biogen, Novartis, and TEVA. Dr. Matta M received honoraria for serving in the scientific advisory boards of Almirall, Novartis, Biogen, and Genzyme. Prof. Zappia M has received compensation for consulting services from Boehringer-Ingelheim, Lundbeck, Union Chimique Belge, and scientific grants from AIFA - Agenzia Italiana del Farmaco, Novartis, Lundbeck.
Dr. Benedetti MD, Dr. Berra E, Dr. Bianco A, Dr. Buttari, Dr. Castelli L, Dr. Cavalla P, Dr. Cerqua R, Dr. Costantino GF, Dr. Gasperini C, Dr. Guareschi, Dr. Ippolito D, Dr. Lanzillo R, Dr. Paolicelli D, Dr. Petrucci L, Dr. Pontecorvo S, Dr. Righini I, Dr. Russo M, Dr. Saccà F, Dr. Salamone G, Dr. Signoriello E, Dr. Spinicci G, Dr. Spitaleri D, Dr. Tavazzi E, Dr. Trotta M, and Dr. Zaffaroni M declared that they have no conflict of interest.
The study was approved by the Policlinico-Vittorio Emanuele (Catania, Italy) Ethics Committee (no. 37/2015/PO) and by the Ethics Committee of the other participating centers.
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Patti, F., Chisari, C., Solaro, C. et al. Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study. Neurol Sci 41, 2905–2913 (2020). https://doi.org/10.1007/s10072-020-04413-6
- Multiple sclerosis
- Clinical practice
- Spasticity-related symptoms