Patient-reported benefits from nabiximols treatment in multiple sclerosis-related spasticity exceed conventional measures

References

• emc . Sativex Oromucosal Spray. Summary of product characteristics. Last updated: 28 April 2022. www.medicines.org.uk/emc/product/602/smpc (Accessed 4 October 2023 ).
   Google Scholar
• Russo E, Guy GW. A tale of two cannabinoids: the therapeutic rationale for combining tetrahydrocannabinol and cannabidiol. Med. Hypotheses 66(2), 234–246 (2006).
   PubMed Web of Science ®Google Scholar
• Novotna A, Mares J, Ratcliffe S et al. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur. J. Neurol. 18(9), 1122–1131 (2011).
   PubMed Web of Science ®Google Scholar
• Markovà J, Essner U, Akmaz B et al. Sativex® as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial. Int. J. Neurosci. 129, 119–128 (2019).
   PubMed Web of Science ®Google Scholar
• Flachenecker P, Henze T, Zettl UK. Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice-results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity. Eur. Neurol. 71(5–6), 271–279 (2014).
   PubMed Web of Science ®Google Scholar
• Flachenecker P, Henze T, Zettl UK. Long-term effectiveness and safety of nabiximols (tetrahydrocannabinol/cannabidiol oromucosal spray) in clinical practice. Eur. Neurol. 72(1–2), 95–102 (2014).
   PubMed Web of Science ®Google Scholar
• Patti F, Messina S, Solaro C et al. Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity. J. Neurol. Neurosurg. Psychiatry 87(9), 944–951 (2016).
   PubMed Web of Science ®Google Scholar
• Bensmail D, Vermersch P. Épidémiologie et évaluation clinique de la spasticité dans la sclérose en plaques Epidemiology and clinical assessment of spasticity in multiple sclerosis. Rev. Neurol. (Paris) 168(Suppl. 3), S45–S50 (2012).
   PubMedGoogle Scholar
• Kiresuk TJ, Sherman RE. Goal attainment scaling: a general method for evaluating comprehensive community mental health programs. Community Ment. Health J. 4(6), 443–453 (1968).
   PubMed Web of Science ®Google Scholar
• Khan F, Pallant JF, Turner-Stokes L. Use of goal attainment scaling in inpatient rehabilitation for persons with multiple sclerosis. Arch. Phys. Med. Rehabil. 89(4), 652–659 (2008).
   PubMed Web of Science ®Google Scholar
• Rannisto M, Rosti-Otajärvi E, Mäntynen A, Koivisto K, Huhtala H, Hämäläinen P. The use of goal attainment scaling in neuropsychological rehabilitation in multiple sclerosis. Disabil. Rehabil. 37(21), 1984–1991 (2015).
   PubMed Web of Science ®Google Scholar
• Hanssen KT, Saltytė Benth J, Beiske AG, Landrø NI, Hessen E. Goal attainment in cognitive rehabilitation in MS patients. Neuropsychol. Rehabil. 25(1), 137–154 (2015).
   PubMed Web of Science ®Google Scholar
• Ashford S, Turner-Stokes L. Goal attainment for spasticity management using botulinum toxin. Physiother. Res. Int. 11(1), 24–34 (2006).
   PubMedGoogle Scholar
• Ashford S, Turner-Stokes L. Management of shoulder and proximal upper limb spasticity using botulinum toxin and concurrent therapy interventions: a preliminary analysis of goals and outcomes. Disabil. Rehabil. 31(3), 220–226 (2009).
   PubMed Web of Science ®Google Scholar
• Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P. Results from the Upper Limb International Spasticity Study-II (ULISII): a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management. BMJ Open 3(6), e002771 (2013).
   PubMed Web of Science ®Google Scholar
• Singh R, Clarke A. Real-life outcomes in spasticity management: features affecting goal achievement. BMJ Neurol. Open 2(1), e000015 (2020).
   PubMedGoogle Scholar
• Choudhry S, Patritti BL, Woodman R, Hakendorf P, Huang L. Goal attainment: a clinically meaningful measure of success of botulinum toxin-A treatment for lower limb spasticity in ambulatory patients. Arch. Rehabil. Res. Clin. Transl. 3(2), 100129 (2021).
   PubMedGoogle Scholar
• Baccouche I, Bensmail D, Leblong E et al. Goal-setting in multiple sclerosis-related spasticity treated with botulinum toxin: the GASEPTOX Study. Toxins (Basel) 14(9), 582 (2022).
   PubMed Web of Science ®Google Scholar
• Paul F, Vila Silván C. Effect of nabiximols on goal attainment scale scores in patients with treatment-resistant multiple sclerosis spasticity. Neurodegener. Dis. Manag. 11(2), 143–153 (2021).
   PubMed Web of Science ®Google Scholar
• Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P, Zakine B. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice. BMJ Open 3(3), e002230 (2013).
   PubMed Web of Science ®Google Scholar
• Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open 6(6), e011157 (2016).
   PubMed Web of Science ®Google Scholar
• Basler HD. The Marburg questionnaire on habitual health findings–a study on patients with chronic pain. Schmerz 13(6), 385–391 (1999).
   PubMed Web of Science ®Google Scholar
• Kister I, Bacon TE, Chamot E et al. Natural history of multiple sclerosis symptoms. Int. J. MS Care 15(3), 146–158 (2013). [ Erratum in: Int. J. MS Care 16(4), 170 (2014)].
   PubMedGoogle Scholar
• Fernández Ó, Costa-Frossard L, Martínez-Ginés M, Montero P, Prieto JM, Ramió L. The broad concept of “spasticity-plus syndrome” in multiple sclerosis: a possible new concept in the management of multiple sclerosis symptoms. Front. Neurol. 11, 152 (2020).
   PubMed Web of Science ®Google Scholar
• Conte A, Vila Silván C. Review of available data for the efficacy and effectiveness of nabiximols oromucosal spray (Sativex®) in multiple sclerosis patients with moderate to severe spasticity. Neurodegener. Dis. 21(3–4), 55–62 (2021).
   PubMed Web of Science ®Google Scholar
• Patti F, Chisari CG, Fernández Ó et al. A real-world evidence study of nabiximols in multiple sclerosis patients with resistant spasticity: analysis in relation to the newly described ‘spasticity-plus syndrome’. Eur. J. Neurol. 29(9), 2744–2753 (2022).
   PubMed Web of Science ®Google Scholar
• Patti F, Chisari CG, Solaro C et al. Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study. Neurol. Sci. 41(10), 2905–2913 (2020).
   PubMed Web of Science ®Google Scholar
• Coghe G, Pau M, Corona F et al. Walking improvements with nabiximols in patients with multiple sclerosis. J. Neurol. 262(11), 2472–2477 (2015).
   PubMed Web of Science ®Google Scholar
• De Blasiis P, Siani MF, Fullin A et al. Short and long term effects of nabiximols on balance and walking assessed by 3D-gait analysis in people with multiple sclerosis and spasticity. Mult. Scler. Relat. Disord. 51, 102805 (2021).
   PubMed Web of Science ®Google Scholar
• Kiefer RA. An integrative review of the concept of well-being. Holist. Nurs. Pract. 22(5), 244–252; quiz 253–254 (2008).
   PubMedGoogle Scholar
• Thelen J, Zvonarev V, Lam S, Burkhardt C, Lynch S, Bruce J. Polypharmacy in multiple sclerosis: current knowledge and future directions. Mo. Med. 118(3), 239–245 (2021).
   PubMedGoogle Scholar
• Fernández Ó, Costa-Frossard L, Martínez-Ginés ML, Montero P, Prieto-González JM, Ramió-Torrentà L. Integrated management of multiple sclerosis spasticity and associated symptoms using the spasticity-plus syndrome concept: results of a structured specialists’ discussion using the Workmat® methodology. Front. Neurol. 12, 722801 (2021).
   PubMed Web of Science ®Google Scholar