Session Time: 3:00pm-4:00pm
Disclosures: Francois Bethoux, MD: Biogen (Products/Services: No) (Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Greenwich Biosciences (Products/Services: Yes) (Consultant/Advisory Board)Springer Publishing (Products/Services: No) (Royalties)
Objective: Assess the relationship between changes in spasticity and muscle strength or mobility in patients with spasticity due to MS inadequately controlled by antispasticity medications enrolled in nabiximols clinical trials.
Design: Analysis of data from GWMS0106, GWSP0604, and SAVANT. Setting : Hospitals in Europe. Participants : 184 patients from GWMS0106, 241 from GWSP0604, and 106 from SAVANT.
Interventions: Treatment with nabiximols or placebo.
Main Outcome Measures: Spasticity was evaluated using the Numerical Rating Scale (NRS) in all 3 trials, muscle strength using Motricity Index (MI) in GWMS0106 and GWSP0604, and mobility using timed 10-Meter Walk Test (10MWT) in GWSP0604 and SAVANT. Adjusted mean differences for change from baseline in outcome measures between nabiximols and placebo are summarized. Pearson correlation analysis was conducted to assess the association between change from baseline in spasticity and strength or mobility for nabiximols and placebo groups separately.
Results: The baseline mean (SD) Expanded Disability Status Scale score was 6.0 (1.42) in GWSP0604 and 5.9 (1.1) in SAVANT. In GWMS0106, nabiximols significantly improved mean NRS spasticity score (-0.52 points [95% CI: -1.029, -0.004]; p=0.048), without significantly affecting the MI for legs (3.86 [-0.06, 7.78]; p=0.054). In GWSP0604, nabiximols significantly improved mean NRS spasticity score from baseline vs placebo (-0.84 [-1.29, -0.40]; p=0.0002), without significantly affecting the MI for legs (0.97 [-1.49, 3.42], p=0.439) or the 10MWT results (-3.34 [-6.95, 0.26]; p=0.069). In SAVANT, nabiximols significantly improved spasticity vs placebo (-1.9 [-2.73, -1.06]; p < 0.0001), without significantly affecting the 10MWT results (-1.71 [-3.84, 0.44]; p=0.11). Correlation was negligible for the association between change in NRS and MI and for the association between change in NRS and 10MWT, except for the low positive correlation between NRS and 10MWT in the nabiximols group in SAVANT (0.326). Conclusions: Improvement in spasticity with nabiximols was not accompanied by muscle weakness often observed with antispasticity medications or by a notable change in preferred walking speed.
Level of Evidence: Level I
To cite this abstract in AMA style:Bethoux F, Nichol KE, Wagner J, Berwaerts J, Checketts D, Gardener EA, Cartwright K. Effect of Nabiximols on Spasticity and Muscle Strength in Patients with Multiple Sclerosis (MS) Across 3 Randomized Controlled Trials [abstract]. PM R. 2020; 12(S1)(suppl 1). https://pmrjabstracts.org/abstract/effect-of-nabiximols-on-spasticity-and-muscle-strength-in-patients-with-multiple-sclerosis-ms-across-3-randomized-controlled-trials/. Accessed September 24, 2023.
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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/effect-of-nabiximols-on-spasticity-and-muscle-strength-in-patients-with-multiple-sclerosis-ms-across-3-randomized-controlled-trials/