Contributions
Abstract: P1297
Type: Poster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Background: Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) [Sativex(®)] is an oromucosal spray formulation is approved in a number of countries, included Italy, as add-on therapy for moderate-to-severe multiple sclerosis (MS) treatment-resistant spasticity symptoms.
Objective: The aim of the study is to provide real- life observational data of effect of Sativex on walking objective measures and patients" perceptions of the impact of MS on walking ability
Materials and methods: This was an observational, prospective study conducted in 2 italian MS centres. Patients with moderate to severe spasticity, with a score at the numerical rating scale (NRS) greater than 4 were included in the study. A battery of tests including Symbol Digit (SDT), Nine Hole Peg Test (9HPT), Fatigue Severity Scale (FSS), 12-item Multiple Sclerosis Walking Scale (MSWS-12), Two Minutes Walking Test (2MWT) and Timed 25-foot Walk (T25FW) was performed at baseline (T0) and 30 days later (T1). Responders had been defined by the literature as subjects with an improvement at the NRS score for spasticity greater than 20%
Results: Out of 75 subjects enrolled 33 were female and 42 male. Mean age was 53.7 years (range 28.26 - 81.43) , mean disease duration 13 years (range 0.7 - 39), 25 (29.3%) subjects had relapsing remitting, 34 (45.3%) secondary progressive and 19 (25.4%) had primary progressive disease course. Mean EDSS score was 6.2 (range 4 - 8.5).
A significant improvement (>20%) at NRS was observed in 49 patients (responders), 26 patients were classified as “no responders”.
Considering patients able to walk (EDSS < = 6.5, n°32) mean NRS for spasticity at T0 was 7.9 (range 1-10) in 20/32 patients mean score decreased greater than >40%. MSWS-12 score decreased more than 6 points in 19/32 patients and an improvement (>20%) in FSS was reported in 5/32 subjects.
An improvement (>20%) in walking speed (T25FW) was observed in 2/32 patient and in endurance (2MWT) in only 1/32 patients. No patients improved in 9HPT and SDT
Conclusions: Real-life data confirm Sativex(®) as an effective on spasticity (65.3% responders) and well tolerated treatment option for MS patients. A positive effect was highlighted on measuring patients" perceptions of walking scale such as fatigue and MS12 while an effect on objective measures on walking performance was not found.
Disclosure: Dr Solaro Claudio have received honoraria and travel grants fromn TEVA; Merck-serono, Biogen, Almirall, GW pharma, Genzyme
Dr. Trabucco Erika: nothing to disclose
Dr. Cella Martina: nothing to disclose
Dr. Mattioda: nothing to disclose
Dr. Masera: nothing to disclose
Dr. Cavalla: nothing to disclose
Abstract: P1297
Type: Poster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Background: Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) [Sativex(®)] is an oromucosal spray formulation is approved in a number of countries, included Italy, as add-on therapy for moderate-to-severe multiple sclerosis (MS) treatment-resistant spasticity symptoms.
Objective: The aim of the study is to provide real- life observational data of effect of Sativex on walking objective measures and patients" perceptions of the impact of MS on walking ability
Materials and methods: This was an observational, prospective study conducted in 2 italian MS centres. Patients with moderate to severe spasticity, with a score at the numerical rating scale (NRS) greater than 4 were included in the study. A battery of tests including Symbol Digit (SDT), Nine Hole Peg Test (9HPT), Fatigue Severity Scale (FSS), 12-item Multiple Sclerosis Walking Scale (MSWS-12), Two Minutes Walking Test (2MWT) and Timed 25-foot Walk (T25FW) was performed at baseline (T0) and 30 days later (T1). Responders had been defined by the literature as subjects with an improvement at the NRS score for spasticity greater than 20%
Results: Out of 75 subjects enrolled 33 were female and 42 male. Mean age was 53.7 years (range 28.26 - 81.43) , mean disease duration 13 years (range 0.7 - 39), 25 (29.3%) subjects had relapsing remitting, 34 (45.3%) secondary progressive and 19 (25.4%) had primary progressive disease course. Mean EDSS score was 6.2 (range 4 - 8.5).
A significant improvement (>20%) at NRS was observed in 49 patients (responders), 26 patients were classified as “no responders”.
Considering patients able to walk (EDSS < = 6.5, n°32) mean NRS for spasticity at T0 was 7.9 (range 1-10) in 20/32 patients mean score decreased greater than >40%. MSWS-12 score decreased more than 6 points in 19/32 patients and an improvement (>20%) in FSS was reported in 5/32 subjects.
An improvement (>20%) in walking speed (T25FW) was observed in 2/32 patient and in endurance (2MWT) in only 1/32 patients. No patients improved in 9HPT and SDT
Conclusions: Real-life data confirm Sativex(®) as an effective on spasticity (65.3% responders) and well tolerated treatment option for MS patients. A positive effect was highlighted on measuring patients" perceptions of walking scale such as fatigue and MS12 while an effect on objective measures on walking performance was not found.
Disclosure: Dr Solaro Claudio have received honoraria and travel grants fromn TEVA; Merck-serono, Biogen, Almirall, GW pharma, Genzyme
Dr. Trabucco Erika: nothing to disclose
Dr. Cella Martina: nothing to disclose
Dr. Mattioda: nothing to disclose
Dr. Masera: nothing to disclose
Dr. Cavalla: nothing to disclose