Contributions
Abstract: P757
Type: Poster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Background: THC:CBD oromucosal spray (Sativex) is a cannabinoid based add-on drug available in Italy since 2013 for multiple sclerosis (MS) resistant spasticity. Earlier availability in Germany allowed daily practice data collection there (Flachenecker 2014). Differences between countries such as the compulsory health authorities registry in Italy for all patients might influence the results. Moreover, observational studies complement the clinical trials experimental setting data.
Aim: Collect effectiveness and tolerability data in everyday life conditions from a large sample of patients starting Sativex.
Methods: Observational, prospective, 3 months follow-up study under approved conditions in Italy (34 centres), Norway and Denmark (3 centres). 1 month trial period (only patients improving at least 20% their spasticity NRS score could continue). Spasticity (0-10 NRS scale as main endpoint), associated symptoms, quality of life (QoL) and tolerability evolution collected.
Results: 433 patients recruited, 98% in Italy. 50.9 y mean age, 55% female, 12.9 y with MS (51.5% Secondary Progressive MS) and 7.4 y with MS spasticity. EDSS mean score of 5.94. Baclofen was used by 78.1% of participants. 349 of participants were prescribed beyond the trial period 1st month visit (80.6%) and 281 (64.9%) beyond the third month visit.Mean used dose was 6 sprays/d. Spasticity improved with stat. significance in the 3 months remaining patients in all the different scales used: 0-10 NRS (mean 6.9 to 5.4), Ashworth scale (mean 2.6 to 2.3) and categorical scale (37.2% to 12.9% severe). Associated symptoms improved also with stat. significance: spasms, fatigue, pain, sleep quality and bladder dysfunction. Patients restricted in daily abilities were reduced from 30.2 to 22.8%
(stat. significant), and the QoL EQ-5D VAS improved from 49.5 to 54.2 (p< 0.0001)A subgroup of patients (19.9%) improved ≥30% their NRS score (mean 48%) and also showed higher improvements in the secondary parameters.10.4% of patients reported adverse events, none severe or serious. Dizziness was the commonest (3.7%).
Conclusions: THC:CBD oromucosal spray is a valid option for managing MS resistant spasticity and associated symptoms, providing clinically noticeable improvement in about 2/3 of the treated subjects with lower than clinical trials reported doses (6 vs 8 sprays/d) and good tolerability. Associated symptoms tracking is important. No relevant differences versus previous published results has been seen.
Disclosure: Study funded by Almirall S.A. (Barcelona, Spain)
Abstract: P757
Type: Poster
Abstract Category: Therapy - symptomatic - Treatment of specific symptoms
Background: THC:CBD oromucosal spray (Sativex) is a cannabinoid based add-on drug available in Italy since 2013 for multiple sclerosis (MS) resistant spasticity. Earlier availability in Germany allowed daily practice data collection there (Flachenecker 2014). Differences between countries such as the compulsory health authorities registry in Italy for all patients might influence the results. Moreover, observational studies complement the clinical trials experimental setting data.
Aim: Collect effectiveness and tolerability data in everyday life conditions from a large sample of patients starting Sativex.
Methods: Observational, prospective, 3 months follow-up study under approved conditions in Italy (34 centres), Norway and Denmark (3 centres). 1 month trial period (only patients improving at least 20% their spasticity NRS score could continue). Spasticity (0-10 NRS scale as main endpoint), associated symptoms, quality of life (QoL) and tolerability evolution collected.
Results: 433 patients recruited, 98% in Italy. 50.9 y mean age, 55% female, 12.9 y with MS (51.5% Secondary Progressive MS) and 7.4 y with MS spasticity. EDSS mean score of 5.94. Baclofen was used by 78.1% of participants. 349 of participants were prescribed beyond the trial period 1st month visit (80.6%) and 281 (64.9%) beyond the third month visit.Mean used dose was 6 sprays/d. Spasticity improved with stat. significance in the 3 months remaining patients in all the different scales used: 0-10 NRS (mean 6.9 to 5.4), Ashworth scale (mean 2.6 to 2.3) and categorical scale (37.2% to 12.9% severe). Associated symptoms improved also with stat. significance: spasms, fatigue, pain, sleep quality and bladder dysfunction. Patients restricted in daily abilities were reduced from 30.2 to 22.8%
(stat. significant), and the QoL EQ-5D VAS improved from 49.5 to 54.2 (p< 0.0001)A subgroup of patients (19.9%) improved ≥30% their NRS score (mean 48%) and also showed higher improvements in the secondary parameters.10.4% of patients reported adverse events, none severe or serious. Dizziness was the commonest (3.7%).
Conclusions: THC:CBD oromucosal spray is a valid option for managing MS resistant spasticity and associated symptoms, providing clinically noticeable improvement in about 2/3 of the treated subjects with lower than clinical trials reported doses (6 vs 8 sprays/d) and good tolerability. Associated symptoms tracking is important. No relevant differences versus previous published results has been seen.
Disclosure: Study funded by Almirall S.A. (Barcelona, Spain)