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- Title
(SXM01) Effect of Nabiximols on Spasticity and Muscle Strength in Patients with Multiple Sclerosis Across 3 Randomized Controlled Trials.
- Authors
Bethoux, Francois; Nichol, Kathryn; Wagner, Joanne; Berwaerts, Joris; Checketts, Daniel; Gardener, Elizabeth; Cartwright, Karen
- Abstract
Background: Spasticity is a common feature of multiple sclerosis (MS), especially in patients with longstanding illness. Medications that reduce spasticity may also reduce muscle strength, potentially impairing the ability to walk. Patients who do not respond adequately to conventional antispasticity medications need additional treatment options that improve spasticity without causing weakness. Objectives: Assess the relationship between changes in spasticity and muscle strength in lower extremities or mobility, using data from 3 randomized controlled trials (GWMS0106, GWSP0604, SAVANT) of nabiximols vs placebo in patients with spasticity due to MS inadequately controlled by antispasticity medications. Methods: 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 change in strength or mobility for nabiximols and placebo groups separately. Results: This analysis included 184 patients from GWMS0106, 241 from GWSP0604, and 106 from SAVANT. 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 = .048), without significantly affecting the MI for legs (3.86 [-0.06, 7.78]; P = .054). In GWSP0604, nabiximols significantly improved mean NRS spasticity score from baseline vs placebo (-0.84 [-1.29, -0.40]; P = .0002), without significantly affecting the MI for legs (0.97 [-1.49, 3.42], P = .439) or the 10MWT results (-3.34 [-6.95, 0.26]; P = .069). In SAVANT, nabiximols significantly improved spasticity vs placebo (-1.9 [-2.73, -1.06]; P < .0001), without significantly affecting the 10MWT results (-1.71 [-3.84, 0.44]; P = .11). Pearson correlation coefficients were all under ±0.30 (indicating negligible correlation) 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: The improvement in spasticity with nabiximols was not accompanied by the muscle weakness often observed with antispasticity medications or by a notable change in preferred walking speed.
- Subjects
CANNABIS (Genus); CONFERENCES &; conventions; MULTIPLE sclerosis; MUSCLE strength; SPASTICITY; RANDOMIZED controlled trials; TREATMENT effectiveness
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p79
- ISSN
1537-2073
- Publication type
Article