Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness. Methods:
This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion. Results:
Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events. Conclusion:
Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice. © 2014 S. Karger AG, Basel
- Kabus C, Hecht M, Japp G, Jost WH, Pöhlau D, Stuckrad-Barre S, Winterholler M: Botulinum toxin in patients with multiple sclerosis. J Neurol 2006;253(suppl 1):I/26-I/28.
- Beard S, Hunn A, Wight J: Treatments for spasticity and pain in multiple sclerosis: a systematic review. Health Technol Assess 2003;7:iii, ix-x, 1-111.
- Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL: Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004;10:589-595.
- Deutsche Gesellschaft für Neurologie. Leitlinien für Diagnostik und Therapie in der Neurologie - Diagnose und Therapie der Multiplen Sklerose; Version January 2012. http://www.dgn.org/component/content/article/45-leitlinien-der-dgn-2012/2333-II-31-2012-diagnose-und-therapie-der-multiplen-sklerose.html?q=multiple+sklerose (accessed January 23, 2013).
- Novotna A, Mares J, Ratcliffe S, Novakoval I, Vachova M, Zapletalova O, Gasperini C, Pozzilli C, Cefaro L, Comi G, Rossi P, Ambler Z, Stelmasiak Z, Erdmann A, Montalban X, Klimek A, Davies P; Sativex Spasticity Study Group: 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 2011;18:1122-1131.
- Wade DT, Collin C, Scott C, Duncombe P: Meta-analysis of the efficacy and safety of Sativex (nabiximols), on spasticity in people with multiple sclerosis. Mult Scler 2010;16:707-714.
- Nottcut W, Langford R, Davies P, Ratcliffe S, Potts R: A placebo-controlled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex® (nabiximols). Mult Scler 2012;18:219-228.
- Serpell MG, Notcutt W, Collin C: Sativex long-term use: an-open label trial in patients with spasticity due to multiple sclerosis. J Neurol 2013;260:285-295.
- Summary of Product Characteristics (SmPC) Sativex Oromucosal Spray. Date of Revision: July 28, 2011.
- EuroQol Group: EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.
- Szende A, Oppe M, Delvin N: EQ-5D Value Sets: Inventory, Comparative Review and User Guide. EuroQol Group Monographs, vol 2. Berlin, Springer, 2007.
- Vickrey G, Hays RD, Harooni F, Myers LW, Ellison GW: A health-related quality of life measure for multiple sclerosis. Qual Life Res 1995;4:187-202.
- Vickrey BG: Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument (Scoring Manual). Los Angeles, University of California, 1995.
- Farrar JT, Troxel AB, Stott C, Duncombe P, Jensen MP: Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: a post hoc analysis of a randomized, double-blind, placebo-controlled trial. Clin Ther 2008;30:974-985.
- Bohannon RW, Smith MB: Interrater reliability of a modified Ashworth Scale of muscle spasticity. Phys Ther 1987;67:206-207.
- Mahoney FI, Barthel D: Functional evaluation: the Barthel Index. Md State Med J 1965;14:56-61.
- Collin C, Wade DT, Davies S, Horne V: The Barthel ADL Index: a reliability study. Int Disabil Stud 1988;10:61-63.
- Kurtzke JF: Rating neurologic impairment in multiple sclerosis: an Expanded Disability Status Scale (EDSS). Neurology 1983;33:1444-1452.
- Kurtzke JF: Natural history and clinical outcome measures for multiple sclerosis studies. Why at the present time does EDSS scale remain a preferred outcome measure to evaluate disease evolution? Neurol Sci 2000;21:339-341.
- Collin C, Davies P, Mutiboko IK, Ratcliffe S: Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol 2007;14:290-296.
- Collin C, Ehler E, Waberzinek G, Alsindi Z, Davies P, Powell K, Notcutt W, O'Leary C, Ratcliffe S, Nováková I, Zapletalova O, Piková J, Ambler Z: A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiples sclerosis. Neurol Res 2010;32:451-459.
- Fleuren JF, Voerman GE, Erren-Wolters CV, Snoek GJ, Rietman JS, Hermens HJ, Nene AV: Stop using the Ashworth Scale for the assessment of spasticity. J Neurol Neurosurg Psychiatry 2010;81:46-52.
- Sunnerhagen KS: Stop using the Ashworth Scale for the assessment of spasticity. J Neurol Neurosurg Psychiatry 2010;81:2.
- Flachenecker P, Zettl U, Essner U, Henze T: Drug treatment of spasticity in multiple sclerosis - a cross-sectional survey in Germany. Lyon, ECTRIMS, 2012, poster 1029.
Peter Flachenecker, MD
Neurologisches Reha-Zentrum Quellenhof Bad Wildbad
DE-75323 Bad Wildbad (Germany)
Received: July 23, 2013
Accepted: November 17, 2013
Published online: February 12, 2014
Number of Print Pages : 9
Number of Figures : 3, Number of Tables : 3, Number of References : 24
Vol. 71, No. 5-6, Year 2014 (Cover Date: Published online first (Issue-in-Progress))
Journal Editor: Bogousslavsky J. (Montreux)
ISSN: 0014-3022 (Print), eISSN: 1421-9913 (Online)
For additional information: http://www.karger.com/ENE
Copyright / Drug Dosage
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.