Patient-reported benefits from nabiximols treatment in multiple sclerosis-related spasticity exceed conventional measures

Figures & data

Table 1. Demographics and baseline clinical characteristics of the main analysis set (n = 51).

Parameter	Value
Female sex, n (%)	31 (60.8)
Age (years), mean ± SD	51.4 ± 11.1
BMI (kg/m^2), mean ± SD	25.7 ± 4.9
Time since MS diagnosis (years), mean ± SD	14.9 ± 9.8
Time since onset of spasticity (years), mean ± SD	6.1 ± 6.3
EDSS, mean ± SD	4.1 ± 2.0 (median 4.0)
Modified Ashworth Scale, mean ± SD	1.7 ± 0.8 (median 1.5)
Modified Ashworth Scale, physician-rated grade, n (%):
0	2 (3.9)
1	11 (21.6)
1+	17 (33.3)
2	14 (27.5)
3	6 (11.8)
4	1 (2.0)
Previous spasticity therapy, n (%) ^†	44 (86.3)
Baclofen	34 (66.7)
Tizanidine	10 (19.6)
Gabapentin	4 (7.8)
Other	7 (13.7)

† Other therapies were: fampridine (n = 2), tolperisone (n = 2), botulinum toxin (n = 1), cannabidiol (n = 1), fingolimod (n = 1) and memantine (n = 1).

BMI: Body mass index; EDSS: Expanded disability status scale; MS: Multiple sclerosis; SD: Standard deviation.

Figure 1. The eight most common treatment goals selected at baseline by patients with multiple sclerosis spasticity (n = 51).

The 33 possible multiple sclerosis spasticity-related goals are provided in Supplementary File 1.

Figure 2. Percentage of patients who attained their multiple sclerosis spasticity-related treatment goal at week 12.

Table 2. Mean overall goal attainment scale score at baseline, week 4 and week 12 in the main analysis set.

Timepoint	GAS score	p-value ^†
Baseline (n = 51)	35.2 ± 0.3	–
Week 4 (n = 51)	47.3 ± 14.8	<0.001
Week 12 (n = 45)	51.4 ± 16.8	<0.001

† Student’s t-test comparison vs baseline.

Results are presented as mean ± SD. GAS scores range from 0 and 100, with higher values indicating a better outcome.

GAS: Goal attainment scale; SD: Standard deviation.

Table 3. Evolution of secondary end points in the main analysis set (n = 51).

Parameter	Baseline	Week 4	Week 12
Physician-assessed
Spasticity 0–10 NRS ^†	n = 51 4.5 ± 1.8	n = 51 3.5 ± 2.0	–
Timed 25-foot walk test (T25-FW) (sec)	n = 30 17.3 ± 27.9	n = 31 13.2 ± 9.8	n = 32 13.2 ± 7.0
Patient-assessed
Spasticity 0–10 NRS	n = 36 5.2 ± 1.9	n = 35 3.0 ± 2.2	n = 29 2.6 ± 1.9
Pain 0–10 NRS ^‡	n = 36 4.9 ± 2.3	n = 35 3.3 ± 2.3	n = 29 2.3 ± 1.5
Marburg questionnaire on habitual health (MFHW) ^§	n = 35 15.8 ± 7.7	n = 32 14.9 ± 8.1	n = 26 14.5 ± 8.0
Sleep impairment 0–10 NRS ^‡	n = 36 5.5 ± 2.4	n = 35 2.9 ± 2.0	n = 29 2.2 ± 1.7
Urinary bladder dysfunction 0–10 NRS ^‡	n = 35 4.5 ± 2.8	n = 32 3.2 ± 2.3	n = 26 2.4 ± 2.2

† In accordance with the nabiximols approved label to identify non-responders.

‡ Spasticity-related in the last 24 h. 0–10 NRS scores range from 0 (no impairment) to 10 (worst imaginable impairment).

§ Only in patients with spasticity-related pain (NRS >0). The MFHW is scored from zero to 35 with lower scores corresponding to poorer general wellbeing.

NRS: Numerical rating scale.