Format

Send to

Choose Destination
PLoS One. 2019 Jul 30;14(7):e0219670. doi: 10.1371/journal.pone.0219670. eCollection 2019.

The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray).

Author information

1
MS Center Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
2
Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.
3
Multiple Sclerosis Clinical Centre, San Camillo-Forlanini Hospital, Rome, Italy.
4
Multiple Sclerosis Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica, Rome, Italy.
5
MS Center, Department of Systems Medicine, Tor Vergata University, Rome, Italy.
6
Unit of Neurology and Neurorehabilitation, IRCCS Neuromed, Pozzilli, Italy.
7
IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.

Abstract

BACKGROUND:

Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).

OBJECTIVES:

To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.

METHODS:

This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.

RESULTS:

A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).

CONCLUSIONS:

Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment.

Conflict of interest statement

De Giglio L received grants and personal fees from Novartis, Genzyme, Merck and Biogen. Haggiag S received speaking or travel fees from Biogen, Novartis, Genzyme, Eisai, CSL Behrig and Almirall. Monteleone F received personal fees or travel grants from Almirall, Biogen and Sanofi-Genzyme. Marfia G received personal fees from Almirall, Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme and Teva. Prosperini L received personal fees from Biogen, Teva, Almirall, Novartis, Genzyme, Roche and Merck Serono. Galgani S received personal fees from Biogen, Novartis, Genzyme, Almirall, Teva and Merck-Serono. Mirabella M received speaking fees, travel grants or research support from Almirall, Bayer Schering, Biogen, CSL Behring, Merck Serono, Novartis, Sanofi- Genzyme, Teva and Ultragenix. Centonze D received grants, personal fees or research support from Almirall, Bayer Schering, Biogen, GW Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Teva, Mitsubishi and Celgene. Pozzilli C reports grants and personal fees from Allergan, Almirall, Biogen, Genzyme, Hoffmann- La Roche Ltd, Merck Serono, Novartis, Sanofi and Teva. Castelli L received consulting fees from Almirall. The remaining authors have nothing to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Supplemental Content

Full text links

Icon for Public Library of Science Icon for PubMed Central
Loading ...
Support Center