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Observational Study
. 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)

Affiliations
Observational Study

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

Alessandro Enrico Grimaldi et al. PLoS One. .

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.

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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.

Figures

Fig 1
Fig 1
Discontinuation predictors: early discontinuation (a). Late discontinuation (b). Black lines: patients undergoing a physiotherapy; dotted grey lines: patients not undergoing physiotherapy.

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