Treatment with nabiximols in patients with multiple sclerosis (MS) demonstrated a significant, sustained effect on spasticity numeric rating scale (NRS) score and spasm frequency, regardless of the use of the use of concomitant antispasticity medications (ASMs), such as baclofen. These study findings were presented at the 2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) held from June 1-4, in National Harbor, Maryland.
Spasticity is a common symptom observed in patients with MS, which is often undertreated, with standard therapeutic options failing to provide adequate control. Nabiximols is an oromucosal spray that is a complex botanical mixture that contains delta-9-tetrahydrocannabinol and cannabinoids as the main components, along with noncannabinoid components. The researchers in the current study sought to evaluate treatment outcomes among individuals with MS spasticity being treated with nabiximols with or without such ASMs as baclofen.
Two enriched, placebo-controlled, randomized trials — SAVANT and GWSP0604 — were conducted to study this topic. In both SAVANT and GWSP0604, a single-blind lead-in was used in Part A, which was followed by randomization of all eligible participants in Part B. In the SAVANT study only, participants were permitted to optimize their dose of ASM(s). All patients reported their spasticity NRS score and mean 28-day average daily spasm frequency on a daily basis.
In the SAVANT study, 53 participants were randomized to receive nabiximols, 81% of whom were also taking baclofen, and 53 participants were randomized to receive placebo, 89% of whom were also taking baclofen. In GWSP0604, 124 patients were randomized to receive nabiximols, 53% of whom were also taking baclofen, and 117 participants were randomized to receive placebo, 63% of whom were also taking baclofen.
In both SAVANT and GWSP0604, improvements in spasticity NRS scores and reduction of the frequency of spasms were shown to significantly favor nabiximols compared with placebo in the overall population. The use of baclofen was not significantly associated with improvements in NRS spasticity scores nor with decreased spasm frequency in either study. Further, in the GWSP0604 study, no significant difference between treatment effects was reported when the number of ASMs was assessed (ie, 0, 1, and 2+).
“Nabiximols showed significant and sustained treatment effect on spasticity NRS score and spasm frequency in PwMS regardless of use of concomitant ASMs, such as baclofen,” the researchers concluded.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Amjad F, Boster AL, Carod-Artal J, et al. Post hoc analysis of nabiximols efficacy by concomitant medication use in enriched placebo-controlled randomized trials. Presented at: CMSC 2022 Annual Meeting; June 1-4, 2022; National Harbor, Maryland. Abstract SYM04.