Dataset Information

A post hoc evaluation of the shift in spasticity category in individuals with multiple sclerosis-related spasticity treated with nabiximols.

ABSTRACT:

Background

Over 80% of individuals with multiple sclerosis (MS) experience MS-associated spasticity (MSS). In many European countries, after failure of first-line treatments, moderate or severe MSS can be treated with nabiximols, a cannabis-based add-on treatment.

Objective

This post hoc analysis assessed the shift of participants treated with nabiximols from higher (severe or moderate) to lower (moderate or mild/none) spasticity.

Methods

Previously published data from two randomised controlled trials (RCTs), GWSP0604 (NCT00681538) and SAVANT (EudraCT2015-004451-40), and one large real-world study (consistent with EU label), all enriched for responders, were re-analysed. Spasticity severity, measured using the 0-10 numerical rating scale (spasticity NRS), was categorised as none/mild (score <4), moderate (score ⩾4-7), or severe (score ⩾7).

Results

In the two RCTs, the shift of participants with severe MSS into a lower category was significantly greater at week 12 for those receiving nabiximols versus placebo [GWSP0604: OR (95% CI), 4.4 (1.4, 14.2), p = 0.0125; SAVANT: 5.2 (1.2, 22.3), p = 0.0267]. In all three studies, over 80% of assessed patients with severe spasticity at baseline reported a shift into a lower category of spasticity after 12 weeks.

Conclusions

A meaningful proportion of MSS patients treated with nabiximols shifted to a lower category of spasticity severity, typically maintained to the end of the 12-week study period.

SUBMITTER: Chisari CG

PROVIDER: S-EPMC10515604 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

A <i>post hoc</i> evaluation of the shift in spasticity category in individuals with multiple sclerosis-related spasticity treated with nabiximols.

Chisari Clara Grazia CG Guadagno Joe J Adjamian Peyman P Vila Silvan Carlos C Greco Teresa T Bagul Makarand M Patti Francesco F

Therapeutic advances in neurological disorders 20230921

<h4>Background</h4>Over 80% of individuals with multiple sclerosis (MS) experience MS-associated spasticity (MSS). In many European countries, after failure of first-line treatments, moderate or severe MSS can be treated with nabiximols, a cannabis-based add-on treatment.<h4>Objective</h4>This <i>post hoc</i> analysis assessed the shift of participants treated with nabiximols from higher (severe or moderate) to lower (moderate or mild/none) spasticity.<h4>Methods</h4>Previously published data fr ...[more]

PMID: 37745913

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