Contributions
Abstract: P1292
Type: Poster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Spasticity is a frequent and distressing symptom related to multiple sclerosis (MS). Nabiximols (Sativex®) was licensed in the UK in 2010 as an add-on treatment for MS-related spasticity in people with intolerable side effects (SEs) or inadequate response to other treatments.
Objective: This is a prospective observational cohort study to evaluate efficacy of Nabiximols for drug-resistant MS-spasticity.
Methods: Data was collected prospectively from subjects attending the spasticity service since 2011. Baseline measures included demographics, Numeric Rating Scale spasticity (NRS), Multiple Sclerosis Spasticity Scale-88 (MSSS-88). Subjects commenced 4 week trial of Nabiximols, telephone review at ~2 weeks, review at ~4 weeks. Clinically meaningful response was defined by ≥20% reduction in NRS score. Follow up (FU) was at ~6 monthly intervals. Non responders (NR) considered subsequent treatment options included Intrathecal Bacofen Therapy (ITB).
Results: 102 people (95 progressive, 7 relapsing-remitting MS) were treated, 19 were unable to complete the NRS / MSSS-88 reliably. At baseline mean NRS= 7.3, MSSS-88= 233. After 2 weeks 78 reported benefit and returned for FU. Responders n=33 (32.3%), partial responders (< 20% change) n=6 (5.9%), non responders n=20 (19.6%). NRS reduced from 7.2 to 3.9 in CR (-3.3, p< 0.001), in partial responders 7.3 to 6.3 (-1, ns), and unchanged in NRS NR. MSSS-88 decreased by 51.3 in responders (p< 0.001), in NR (-3, ns). Change in NRS correlated with change in MSSS-88 (R=0.61, p< 0.001). Mean dose 7.6 (2-12) sprays daily. Long term treatment: 42 (41.2%) sustained NRS response (p< 0.005) at 6 months, 27 (26.5%) at 12 months and 15 > 24 months. Mean time to discontinuation was 3.8 months in those who stopped early < 6 months and 18.8 months in long term treated patients. 32 subjects (31.4%) had an ITB trial and 24 proceeded with pump. Side effects were mild 48% and 6 people (5.9%) experienced serious AE. Other reported benefits: improved spasm, pain, bladder control and sleep.
Conclusions: In a cohort of people with treatment-resistant MS-related spasticity, Nabiximols provided symptomatic relief in and delayed or avoided the need to proceed with an ITB pump in a proportion. Using the NRS as an outcome measure is challenging in an advanced MS cohort due to cognitive impairment.
Disclosure:
Claire Valentine, Michelle Liddicut, Stefania De Trane, Liz Keenan, Katrina Buchanan, Val Stevenson have nothing to disclose.
Dr Rachel Farrell"s research activity is supported by the UCLH NIHR Biomedical Research Centre. Dr Farrell is Chief Investigator on the Phase II trial of VSN16 R. Dr Farrell has received renumeration for advisory activity from Canbex Therapeutics Ltd, GW Pharma Ltd, Merck, Biogen Idec Ltd and hospitality from Novartis.
Abstract: P1292
Type: Poster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Spasticity is a frequent and distressing symptom related to multiple sclerosis (MS). Nabiximols (Sativex®) was licensed in the UK in 2010 as an add-on treatment for MS-related spasticity in people with intolerable side effects (SEs) or inadequate response to other treatments.
Objective: This is a prospective observational cohort study to evaluate efficacy of Nabiximols for drug-resistant MS-spasticity.
Methods: Data was collected prospectively from subjects attending the spasticity service since 2011. Baseline measures included demographics, Numeric Rating Scale spasticity (NRS), Multiple Sclerosis Spasticity Scale-88 (MSSS-88). Subjects commenced 4 week trial of Nabiximols, telephone review at ~2 weeks, review at ~4 weeks. Clinically meaningful response was defined by ≥20% reduction in NRS score. Follow up (FU) was at ~6 monthly intervals. Non responders (NR) considered subsequent treatment options included Intrathecal Bacofen Therapy (ITB).
Results: 102 people (95 progressive, 7 relapsing-remitting MS) were treated, 19 were unable to complete the NRS / MSSS-88 reliably. At baseline mean NRS= 7.3, MSSS-88= 233. After 2 weeks 78 reported benefit and returned for FU. Responders n=33 (32.3%), partial responders (< 20% change) n=6 (5.9%), non responders n=20 (19.6%). NRS reduced from 7.2 to 3.9 in CR (-3.3, p< 0.001), in partial responders 7.3 to 6.3 (-1, ns), and unchanged in NRS NR. MSSS-88 decreased by 51.3 in responders (p< 0.001), in NR (-3, ns). Change in NRS correlated with change in MSSS-88 (R=0.61, p< 0.001). Mean dose 7.6 (2-12) sprays daily. Long term treatment: 42 (41.2%) sustained NRS response (p< 0.005) at 6 months, 27 (26.5%) at 12 months and 15 > 24 months. Mean time to discontinuation was 3.8 months in those who stopped early < 6 months and 18.8 months in long term treated patients. 32 subjects (31.4%) had an ITB trial and 24 proceeded with pump. Side effects were mild 48% and 6 people (5.9%) experienced serious AE. Other reported benefits: improved spasm, pain, bladder control and sleep.
Conclusions: In a cohort of people with treatment-resistant MS-related spasticity, Nabiximols provided symptomatic relief in and delayed or avoided the need to proceed with an ITB pump in a proportion. Using the NRS as an outcome measure is challenging in an advanced MS cohort due to cognitive impairment.
Disclosure:
Claire Valentine, Michelle Liddicut, Stefania De Trane, Liz Keenan, Katrina Buchanan, Val Stevenson have nothing to disclose.
Dr Rachel Farrell"s research activity is supported by the UCLH NIHR Biomedical Research Centre. Dr Farrell is Chief Investigator on the Phase II trial of VSN16 R. Dr Farrell has received renumeration for advisory activity from Canbex Therapeutics Ltd, GW Pharma Ltd, Merck, Biogen Idec Ltd and hospitality from Novartis.