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

Abstract

Aim: This prospective, multicenter, open-label, noninterventional 12-week study investigated the effectiveness and tolerability of add-on nabiximols oromucosal spray (Sativex^®) in the real-world setting in Germany. Patients & methods: The main analysis set comprised 51 adult patients (49 nabiximols responders) with multiple sclerosis (MS) spasticity. Results: The mean overall goal attainment scale score (primary outcome measure) increased by 46% from baseline to week 12 (35.2 vs 51.4; p < 0.001). Mean gait speed was improved by 23% at 4 and 12 weeks. Clinically meaningful improvements in mean 0–10 numerical rating scale scores for spasticity, pain, sleep quality and urinary bladder dysfunction were recorded at 4 and 12 weeks. Conclusion: Nabiximols is a useful therapeutic option for patients with MS spasticity.

Plain language summary

People with multiple sclerosis (MS) spasticity experience a variety of symptoms and have individual expectations about a new treatment. This study investigated patients’ perceptions about the effectiveness and tolerability of nabiximols oromucosal spray (Sativex^®) when added to current medications for spasticity. Common treatment goals for patients (n = 51) were less pain, better walking and improved sleep. After 12 weeks of treatment, 62% of selected treatment goals were achieved ‘as expected’ or ‘better than expected’ and 65% of patients considered their spasticity to be ‘much improved’. Meaningful improvements were recorded in spasticity-related symptoms of pain, sleep quality and bladder problems. Few side effects were reported. Nabiximols may be useful for MS patients with a poor response to usual spasticity medications.

Keywords: :

• goal attainment scale
• multiple sclerosis
• nabiximols oromucosal spray
• patient-reported outcomes
• spasticity

Financial disclosure

The study was funded by Almirall Hermal GmbH. MR Haupts has received speakers’ honoraria and board honoraria from Almirall Hermal, Deutsche MS-Gesellschaft DMSG, Greenwich, Novartis and Roche Pharma. He declares no stock or financial participations. U Essner has received honoraria for consultancy services from Almirall Hermal GmbH and Granzer Regulatory Consulting and Service. M Mäurer has received speakers’ honoraria and board honoraria from Almirall, Bayer, Biogen, Böhringer, Celgene, CSL Behring, Genzyme, Grünenthal, Merck Serono, Novartis, Roche, Sanofi and Teva. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

Medical writing assistance for this article was provided by Content Ed Net with funding from Almirall Hermal GmbH.

Ethical conduct of research

The study was approved by the independent and interdisciplinary Ethics Committee of the Medical Faculty of Heinrich Heine University in Düsseldorf, Germany. The study was conducted in accordance with the current version of the Declaration of Helsinki and followed all German required health authorities, ethics committee and other applicable approval/evaluation processes. This study involved human subjects and informed consent was obtained from the participants.

Open access

This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/