Contributions
Abstract: P1898
Type: Poster
Abstract Category: Late breaking news
Objective: To evaluate the efficacy of THC: CBD Nabiximols as add on treatment for people with moderate to severe MS related spasticity as an alternative to Intrathecal Baclofen Therapy (ITB).
Methods: Subjects were identified prospectively from the NHNN complex spasticity service. Nabiximols was offered to subjects with moderate to severe spasticity failing 2 or more first line treatments. Baseline data included demographics, current treatment, Numerical Rating Scale (NRS) for spasticity and Multiple Sclerosis Spasticity Scale-88 (MSSS-88). Patients underwent a 4 weeks trial of THC: CBD with a telephone review at 2 weeks. Subjects were deemed Clinical Responders (CR) if they reported ≥20% improvement in NRS from baseline. Partial Responders (PR) were those reporting benefit not meeting CR threshold. Subjects were reviewed at 6 monthly intervals. NRS was repeated at 6 month intervals; MSSS-88 at 12 month intervals. Non Responders (NR) were offered other treatments including proceeded with ITB.
Results: 137 subjects trialled THC:CBD from January 2011 to December 2016.
Baseline mean NRS was 7.2 [10-3], MSSS-88 was 253/352 (walkers) 231/312 (non-walkers). After 4 weeks 44 (32%) were NR and stopped treatments, 10 proceeded with ITB. Of 93 (68%) who reported benefits 53 were CR, 40 were PR with benefits related to spasticity, bladder control, pain and sleeping. Median time to discontinuation was 12.1 months. Of 137 40 remain on treatment.
Mean change NRS in CR was -3.4 (p< 0.001), PR and NR did not show significant changes in NRS.
Mean change MSSS-88 in CR in ambulatory was -57, vs CR non-ambulatory -39.4. PR, NR did not show significant change. 27 patients proceeded to ITB during the follow up period. Response on NRS and MSSS-88 were strongly correlated (R=0.67, p< 0.001). Mean dose was 8 sprays and was in line with literature. SEs (48%) were generally mild and resolved within a few days even when treatment was continued. 10% of the total withdrew treatment due to SEs. 1 suicide was recorded.
Conclusion: THC:CBD provided symptomatic relief in people with treatment resistant spasticity (response rate at 4 weeks = 68%) delaying or avoiding the need to proceed to ITB with 27 having an ITB pump implanted. Strict vigilance is required to identify any pattern of mood disturbance or suicide risk.
Disclosure: Stefania De Trane, Katrina Buchanan, Liz Keenan, Sara Simeoni, Lily O´Brien, Valerie Stevenson: nothing to disclose.
R. Farrell has received honoraria / consultant fees from GW Pharma, Canbex Pharmaceuticals Ltd, Biogen Idec, Merck, Allergan PLC.
Abstract: P1898
Type: Poster
Abstract Category: Late breaking news
Objective: To evaluate the efficacy of THC: CBD Nabiximols as add on treatment for people with moderate to severe MS related spasticity as an alternative to Intrathecal Baclofen Therapy (ITB).
Methods: Subjects were identified prospectively from the NHNN complex spasticity service. Nabiximols was offered to subjects with moderate to severe spasticity failing 2 or more first line treatments. Baseline data included demographics, current treatment, Numerical Rating Scale (NRS) for spasticity and Multiple Sclerosis Spasticity Scale-88 (MSSS-88). Patients underwent a 4 weeks trial of THC: CBD with a telephone review at 2 weeks. Subjects were deemed Clinical Responders (CR) if they reported ≥20% improvement in NRS from baseline. Partial Responders (PR) were those reporting benefit not meeting CR threshold. Subjects were reviewed at 6 monthly intervals. NRS was repeated at 6 month intervals; MSSS-88 at 12 month intervals. Non Responders (NR) were offered other treatments including proceeded with ITB.
Results: 137 subjects trialled THC:CBD from January 2011 to December 2016.
Baseline mean NRS was 7.2 [10-3], MSSS-88 was 253/352 (walkers) 231/312 (non-walkers). After 4 weeks 44 (32%) were NR and stopped treatments, 10 proceeded with ITB. Of 93 (68%) who reported benefits 53 were CR, 40 were PR with benefits related to spasticity, bladder control, pain and sleeping. Median time to discontinuation was 12.1 months. Of 137 40 remain on treatment.
Mean change NRS in CR was -3.4 (p< 0.001), PR and NR did not show significant changes in NRS.
Mean change MSSS-88 in CR in ambulatory was -57, vs CR non-ambulatory -39.4. PR, NR did not show significant change. 27 patients proceeded to ITB during the follow up period. Response on NRS and MSSS-88 were strongly correlated (R=0.67, p< 0.001). Mean dose was 8 sprays and was in line with literature. SEs (48%) were generally mild and resolved within a few days even when treatment was continued. 10% of the total withdrew treatment due to SEs. 1 suicide was recorded.
Conclusion: THC:CBD provided symptomatic relief in people with treatment resistant spasticity (response rate at 4 weeks = 68%) delaying or avoiding the need to proceed to ITB with 27 having an ITB pump implanted. Strict vigilance is required to identify any pattern of mood disturbance or suicide risk.
Disclosure: Stefania De Trane, Katrina Buchanan, Liz Keenan, Sara Simeoni, Lily O´Brien, Valerie Stevenson: nothing to disclose.
R. Farrell has received honoraria / consultant fees from GW Pharma, Canbex Pharmaceuticals Ltd, Biogen Idec, Merck, Allergan PLC.