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Efficacy and safety of nabiximols (Sativex®) on multiple sclerosis spasticity in a real-life Italian monocentric study

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Abstract

Multiple sclerosis (MS) patients frequently suffer from limb spasticity and pain despite antispastic treatments. To investigate nabiximols efficacy and safety in a real-world monocentric Italian cohort, the following data were collected at baseline, week 4, 14 and 48: Ambulation Index (AI), 10-min walking test (10MWT), combined Modified Ashworth scale (cMAS), scores at numerical rating scale for spasticity (sNRS) and pain (pNRS). Responder status was defined as a ≥20 % reduction in sNRS after 4 weeks of treatment. 144 MS patients (123 progressive and 21 relapsing-remitting) complaining of moderate-to-severe spasticity (mean sNRS: 7.5) were included: 138 (95.8 %) completed the first month of therapy and were classified as follows—23.2 % were non-responders, 5.1 % were responders but discontinued treatment due to side effects, 71.7 % were responders with a mean 32 % reduction in sNRS (p < 0.001). In responders sNRS further decreased between 4 and 14 weeks (p = 0.03). Similarly, pNRS improvement was seen during the first month and between 4 and 14 weeks (p < 0.001 and p = 0.004, respectively). Moreover, at 4 weeks responders showed a significant (p < 0.05) improvement in cMAS, AI and 10MWT, which was maintained at 14 weeks. At 1-year follow-up, a benefit was still evident on spasticity and painful symptoms with a low drop-out rate. Confusion/ideomotor slowing, fatigue and dizziness were the most frequent side effects; no major adverse events were reported. Shorter disease duration at treatment start was associated with better response. This real-world study confirms nabiximols efficacy and safety in the treatment of MS-related spasticity and pain, which is maintained up to 48 weeks.

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    Authors and Affiliations

    1. Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy

      Laura Ferrè, Arturo Nuara, Giulia Pavan, Marta Radaelli, Lucia Moiola, Mariaemma Rodegher, Bruno Colombo, Ignacio Juan Keller Sarmiento, Vittorio Martinelli, Letizia Leocani, Filippo Martinelli Boneschi, Giancarlo Comi & Federica Esposito

    2. Laboratory of Genetics of Complex Neurological Disorders, Institute of Experimental Neurology (INSPE), Division of Neuroscience, San Raffaele Scientific Institute, Milan, Italy

      Laura Ferrè, Ignacio Juan Keller Sarmiento, Filippo Martinelli Boneschi & Federica Esposito

    3. Experimental Neurophysiology Unit, Institute of Experimental Neurology (INSPE), San Raffaele Scientific Institute, Milan, Italy

      Arturo Nuara & Letizia Leocani

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    1. Laura Ferrè
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    Correspondence to Filippo Martinelli Boneschi.

    Ethics declarations

    The study was approved by the internal ethics committee, in agreement with good clinical practice standards and respecting the confidentiality of the demographic and clinical data collected. All the subjects involved in the study gave their approval before data collection and signed a written informed consent.

    Conflict of interest

    Dr. Ferrè, Dr. Nuara, Dr. Pavan, Dr. Radaelli, Mr Keller Sarmiento and Prof. Leocani have nothing to disclose. Dr. Moiola reports speaking fees and/or travel expenses from Merck Serono and from Biogen. Dr. Rodegher reports speaking fees and/or travel expenses from Merck Serono and from Novartis. Dr. Colombo reports speaking fees and/or travel expenses from Merck Serono and from Teva Pharmaceuticals. Dr. Martinelli reports consultancy, speaking fees and/or travel expenses from Biogen-Dompè SG, Merck Serono, Bayer Schering, Novartis, Sanofi-Aventis, Genzyme Europe, Teva Pharmaceuticals. Prof. Comi has received consulting fees for participating on advisory boards from Novartis, Teva Pharmaceutical Ind. Ltd, Sanofi-Aventis, Merck Serono, Bayer Schering, Actelion and Geneuro and lecture fees from Novartis, Teva Pharmaceutical Industries Ltd, Sanofi-Aventis, Merck Serono, BiogenDompè, Bayer Schering and Serono Symposia International Foundation. PLDJ received honoraria for consulting, research grant, lecture and clinical trial from TEVA neuroscience, Biogen IDEC, Merck Serono and Vertex. Dr. Martinelli Boneschi received honoraria for consulting, research grant and travel expenses from TEVA neuroscience, Biogen IDEC, Serono Symposia International Foundation and Genzyme Europe. Dr. Esposito received honoraria from Serono Symposia International Foundation.

    Additional information

    F. Martinelli Boneschi, G. Comi and F. Esposito have contributed equally to this work.

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    10072_2015_2392_MOESM1_ESM.tiff

    10MWT in responders at different time-point. 10MWT values at baseline, 4-, 14- and 48-week visit in responder patients (TIFF 2503 kb)

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    Ferrè, L., Nuara, A., Pavan, G. et al. Efficacy and safety of nabiximols (Sativex®) on multiple sclerosis spasticity in a real-life Italian monocentric study. Neurol Sci 37, 235–242 (2016). https://doi.org/10.1007/s10072-015-2392-x

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