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

Author

Listed:
  • 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

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.

Suggested Citation

  • Alessandro Enrico Grimaldi & Laura De Giglio & Shalom Haggiag & Assunta Bianco & Antonio Cortese & Sebastiano Giuseppe Crisafulli & Fabrizia Monteleone & Gerola Marfia & Luca Prosperini & Simonetta Ga, 2019. "The influence of physiotherapy intervention on patients with multiple sclerosis–related spasticity treated with nabiximols (THC:CBD oromucosal spray)," PLOS ONE, Public Library of Science, vol. 14(7), pages 1-10, July.
    • Handle: RePEc:plo:pone00:0219670
    DOI: 10.1371/journal.pone.0219670
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    1. David Baker & Gareth Pryce & J. Ludovic Croxford & Peter Brown & Roger G. Pertwee & John W. Huffman & Lorna Layward, 2000. "Cannabinoids control spasticity and tremor in a multiple sclerosis model," Nature, Nature, vol. 404(6773), pages 84-87, March.
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