PLoS ONE (Jan 2019)

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

DOI
https://doi.org/10.1371/journal.pone.0219670
Journal volume & issue
Vol. 14, no. 7
p. e0219670

Abstract

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BackgroundNabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).ObjectivesTo examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.MethodsThis 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.ResultsA 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).ConclusionsOur 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.