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

Alessandro Enrico Grimaldi, Laura De Giglio, Shalom Haggiag, Assunta Bianco, Antonio Cortese, Sebastiano Giuseppe Crisafulli, Fabrizia Monteleone, Gerola Marfia, Luca Prosperini, Simonetta Galgani, Massimiliano Mirabella, Diego Centonze, Carlo Pozzilli, Letizia Castelli

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article numbere0219670
JournalPLoS One
Volume14
Issue number7
DOIs
Publication statusPublished - Jan 1 2019

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physical therapy
Physical therapy
Dronabinol
sclerosis
Multiple Sclerosis
rating scales
nabiximols
Hazards
Program Evaluation
observational studies
odds ratio
Italy
Multicenter Studies
Observational Studies
Therapeutics
Odds Ratio
therapeutics

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

Cite this

Grimaldi, A. E., De Giglio, L., Haggiag, S., Bianco, A., Cortese, A., Crisafulli, S. G., ... Castelli, L. (2019). The influence of physiotherapy intervention on patients with multiple sclerosis–related spasticity treated with nabiximols (THC:CBD oromucosal spray). PLoS One, 14(7), [e0219670]. https://doi.org/10.1371/journal.pone.0219670

The influence of physiotherapy intervention on patients with multiple sclerosis–related spasticity treated with nabiximols (THC:CBD oromucosal spray). / Grimaldi, Alessandro Enrico; De Giglio, Laura; Haggiag, Shalom; Bianco, Assunta; Cortese, Antonio; Crisafulli, Sebastiano Giuseppe; Monteleone, Fabrizia; Marfia, Gerola; Prosperini, Luca; Galgani, Simonetta; Mirabella, Massimiliano; Centonze, Diego; Pozzilli, Carlo; Castelli, Letizia.

In: PLoS One, Vol. 14, No. 7, e0219670, 01.01.2019.

Research output: Contribution to journalArticle

Grimaldi, AE, De Giglio, L, Haggiag, S, Bianco, A, Cortese, A, Crisafulli, SG, Monteleone, F, Marfia, G, Prosperini, L, Galgani, S, Mirabella, M, Centonze, D, Pozzilli, C & Castelli, L 2019, 'The influence of physiotherapy intervention on patients with multiple sclerosis–related spasticity treated with nabiximols (THC:CBD oromucosal spray)', PLoS One, vol. 14, no. 7, e0219670. https://doi.org/10.1371/journal.pone.0219670
Grimaldi, Alessandro Enrico ; De Giglio, Laura ; Haggiag, Shalom ; Bianco, Assunta ; Cortese, Antonio ; Crisafulli, Sebastiano Giuseppe ; Monteleone, Fabrizia ; Marfia, Gerola ; Prosperini, Luca ; Galgani, Simonetta ; Mirabella, Massimiliano ; Centonze, Diego ; Pozzilli, Carlo ; Castelli, Letizia. / The influence of physiotherapy intervention on patients with multiple sclerosis–related spasticity treated with nabiximols (THC:CBD oromucosal spray). In: PLoS One. 2019 ; Vol. 14, No. 7.
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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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AU - Grimaldi, Alessandro Enrico

AU - De Giglio, Laura

AU - Haggiag, Shalom

AU - Bianco, Assunta

AU - Cortese, Antonio

AU - Crisafulli, Sebastiano Giuseppe

AU - Monteleone, Fabrizia

AU - Marfia, Gerola

AU - Prosperini, Luca

AU - Galgani, Simonetta

AU - Mirabella, Massimiliano

AU - Centonze, Diego

AU - Pozzilli, Carlo

AU - Castelli, Letizia

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N2 - 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.

AB - 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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