Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study

Abstract

Background: The prospective, non-interventional Mobility Improvement (MOVE) 2 study was designed to provide real life data on clinical outcomes of patients with treatment-resistant multiple sclerosis (MS) spasticity receiving routine treatment with tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®), subsequent to its approval in European countries. Methods: This interim analysis reports on MOVE 2 patients from Italy. Results: Interim data from 322 patients (58.3% female; mean age 51.1 ± 10.2 years) were analyzed. From baseline to month 3 of treatment (Visit 3), the mean 0-10 Numerical Rating Scale (NRS) score decreased by -19.1% (-1.6 points, p < 0.0001) and the mean modified Ashworth score decreased from 2.6 to 2.3 points (p < 0.0001). At Visit 3, 24.6% of 203 patients with available data were clinically relevant responders (≥30% improvement from baseline NRS score; p < 0.001 vs. baseline). The mean reported dose of THC:CBD oromucosal spray was 6.1 ± 2.5 sprays/day at Visit 1 (1 month) and 5.1 ± 2.6 sprays/day at Visit 3 (range 1-12 sprays/day at both timepoints). Forty-one (13.1%) patients reported at least one adverse event (AE), which included 3 serious AEs (1 unrelated). AEs with an incidence ≥1% were dizziness (5.6%), confusion (2.5%), nausea (1.25%) and somnolence (1.25%). Conclusion: In everyday clinical practice in Italy, THC:CBD oromucosal spray provided symptomatic relief of MS spasticity with good tolerability in a relevant number of previously resistant patients.

Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years

“…Relative to the MOVE 2-Germany and RCT populations, AIFA e-registry patients had a longer disease duration, greater degree of disability and more severe MS spasticity. Nevertheless, a higher proportion of patients in the AIFA e-registry achieved an initial response to THC:CBD oromucosal spray at month 1 (70.3 vs. 42 vs. 47%), mirroring the results of the recently published interim analysis of MOVE 2-Italy in which an initial response in 82.9% of the population was documented [4] . Also similar to MOVE 2-Italy, the 30% responder rate at month 3 was lower in the AIFA population than in MOVE 2-Germany and the RCT (27.9 vs. 41 vs. 36%), but increased to 40.2% among patients (n = 559) who had reached the month 6 visit at the time of analysis, suggesting that additional time may be required to achieve a clinically meaningful outcome in the type of patient included in the AIFA e-registry sample.…”

“…Over the past few years, evidence has steadily been accumulating to show that clinical outcomes with Sativex (THC:CBD) oromucosal spray in clinical practice [1][2][3][4] align closely with outcomes generated in clinical trials [5] . In view of the growing interest in observational studies, post-approval surveillance studies and patient registries, we undertook an independent project to collect clinical information on the patient population in Italy who had been prescribed THC:CBD oromucosal spray [6] .…”

Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

“…An interim analysis was preplanned for the main study parameters from the first country to reach a recruitment target of 300 patients. The findings from this interim analysis have recently been published [15] .…”

THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms

“…As at April 2015, 322 patients with moderate to severe MS spasticity had been recruited into MOVE 2-Italy at 33 MS centres across the country [1] . The cohort consisted of 58.3% women and the mean age was 51.1 ± 10.2 years.…”

“…For purposes of the interim analysis, only results for the spasticity 0-10 NRS and modified Ashworth scale (MAS) were to be considered. As Italy was the first country to reach this designated recruitment threshold, the interim findings of MOVE 2-Italy [1] were compared with the previously completed and published MOVE 2-Germany study [2] and the pivotal randomized controlled trial (RCT) of THC:CBD oromucosal spray [3] .…”