Author Of 3 Presentations
P1006 - An investigation into the role and impact that carers play in consultations between healthcare professionals and people with MS (ID 1314)
Abstract
Background
The MS in the 21st Century initiative is a Steering Group of international multiple sclerosis (MS) specialists and patient advocates with a current focus of improving education and communication between healthcare professionals and people with MS (PwMS).
Objectives
To understand perceptions of the factors that lead PwMS to bring carers along to their consultations and the potential impacts of this involvement; in particular, how this might affect the communication and relationship between HCPs and PwMS.
Methods
An electronic survey was developed to gain insight into the experiences of HCPs, PwMS and carers. The survey was conducted online in 2019-2020. Multiple answers were solicited in response to 14 questions.
Results
At the time of writing 137 respondents had completed the survey (47 HCPs, 66 PwMS, and 24 carers). The same proportion of carers responded that they “almost always accompanied their PwMS to appointments” (41.7%) and “had never been to an appointment” (41.7%). PwMS reported the most common reasons for taking a carer with them was ‘to provide emotional support’ (47.9%), ‘to help with travel’ (43.8%), and ‘to allow the carer to ask their own questions’ (35.4%). Three quarters (75.0%) of carers said the reason they attend is to help the PwMS understand information given to them. Of the three groups, HCPs were most likely to say the carers’ opinions influence PwMS’ treatment decisions (75.0%). Both HCPs and PwMS recognized that the presence of a carer during an appointment can negatively impact on the time available (40.4% and 28.3% respectively) but both groups also reported that PwMS are more likely to remember the topics that they want to discuss with a carer present (80.9% and 54.3% respectively) and to be happier with care decisions they make (53.2% and 56.5% respectively). Additionally, PwMS (89.1%) and carers (93.3%) both reported that attending consultations was an important way of ensuring the carer feels more involved and better informed about MS.
Conclusions
There are several positive impacts of carers attending consultations, including supporting both the emotional, information and practical needs of PwMS, and the engagement and information needs of carers. Whilst the PwMS should make the decision whether a carer attends the consultation, HCPs should facilitate and support invited carer attendance to optimize these benefits. Currently, this may pose additional social distancing challenges and require creative solutions.
P1066 - Treatment satisfaction in patients with highly-active relapsing multiple sclerosis treated with cladribine tablets: CLARIFY-MS study interim analysis (ID 968)
Abstract
Background
Multiple sclerosis (MS), a chronic disabling disease requiring long-term treatment and regular monitoring, is associated with negative effects on health-related quality of life (HRQoL). CLARIFY-MS (NCT03369665) aims to assess the impact of cladribine tablets (CT) 10 mg (3.5 mg/kg cumulative dose over 2 years; CT3.5) on HRQoL and treatment satisfaction in patients with highly-active relapsing MS (RMS).
Objectives
To present an interim analysis of CLARIFY-MS at 6 months after initiating treatment with CT, assessing treatment satisfaction through the Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4 and safety through the collection of safety assessments in highly-active RMS patients.
Methods
CLARIFY-MS is an ongoing phase IV, open label, single arm, multicenter, 2-year study. Patients with RMS received CT3.5, with 2 weeks of active treatment per course (week 1 and 5 of each year). TSQM v1.4 was used to assess patient-reported treatment satisfaction (a score of 100 is the best possible rating). The TSQM measures 14 items across four domains: effectiveness (three items), side effects (five items), convenience (three items), and global satisfaction (three items).Treatment-emergent adverse events (TEAEs), serious adverse events (AEs), and lymphocyte counts were recorded.
Results
Treatment satisfaction: Of 554 patients screened, 482 received CT. The age and Expanded Disability Status Scale adjusted global treatment satisfaction score (95% confidence interval) at Month 6 was 70.0 (66.6–73.5). Treatment-experienced patients (prior treatment with disease-modifying drugs [DMDs]) reported similar treatment satisfaction scores to DMD-naïve patients (70.2 vs 68.7). At Month 6, >75% of patients rated the TSQM side effects score with 100. The mean side effects score was 91.9, mean convenience 86.6. Safety: 275 patients (57.1%) experienced ≥1 TEAE after drug initiation, most commonly headache and lymphopenia. Most post-baseline lymphopenias were of grade 1-2; 33 patients (6.8%) experienced grade 3 lymphopenia and no grade 4 lymphopenia was observed.
Conclusions
This interim analysis of CLARIFY-MS found that at 6 months, patients were generally satisfied with CT treatment. The convenience of CT treatment and side effect profile were especially important to patients. Safety results at 6 months post-treatment are consistent with the known safety profile, with no new emerging safety signal; most lymphopenias were grade 1-2.
P1094 - Effect of nabiximols cannabinoid oromucosal spray on depressive symptoms, suicidality, and cognition in patients with multiple sclerosis (MS) (ID 1463)
Abstract
Background
Substantial evidence has shown nabiximols, a complex botanical mixture containing delta-9-tetrahydrocannabinol and cannabidiol as the principal cannabinoids, can reduce spasticity associated with MS. This analysis assesses whether nabiximols affects other patient outcomes such as depressive symptoms, suicidality, and cognition.
Objectives
Report the effect of nabiximols on depression, suicidality, and cognition using data from 2 placebo-controlled randomized controlled trials, GWSP0604 (12 weeks) and GWMS1137 (48 weeks), in patients with spasticity due to MS.
Methods
Mood and suicidality were assessed using the Beck Depression Inventory-II (BDI-II) in both trials. In GWMS1137, suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) and working memory/processing speed using the Paced Auditory Serial Addition Test (PASAT). The combined PASAT total score was calculated combining both PASAT-3 and -2 tests scores (total of 120 points). Outcome differences between nabiximols and placebo are summarized.
Results
241 patients from GWSP0604 and 121 from GWMS1137 were included. The baseline and end-of-treatment mean BDI-II total scores were 8.7 vs 9.5 for nabiximols and 9.7 vs 10.4 for placebo in GWSP0604, and 15.7 vs 12.5 for nabiximols and 13.5 vs 11.1 for placebo in GWMS1137. Differences between nabiximols and placebo of the BDI-II change from baseline adjusted means were -0.06 (-1.62, 1.49) in GWSP0604 (no significant difference) and -0.29 (-2.91, 2.33) in GWMS1137 (statistically non-inferior). Question 9 of BDI-II (suicidal thoughts or wishes) showed no notable treatment differences in either trial, with only 1 patient treated with nabiximols reporting a score ≥2. On the Columbia-Suicide Severity Rating Scale, 3 (5.1%) patients randomized to placebo and 1 (1.6%) to nabiximols had a ‘flag’ (ie, ‘Yes’ as a response), but further questioning revealed no emergent suicidal ideations or behavior in any of these patients. For GWMS1137, the baseline and end-of-treatment PASAT total score means were 71.3 vs 78.6 for nabiximols and 74.5 vs 82.7 for placebo; increases may reflect practice effects. Treatment difference of the adjusted mean was -1.47 (-6.41, 3.48), indicating nabiximols does not adversely affect working memory/cognitive processing speed in MS patients over a 48-week period compared with placebo.
Conclusions
Nabiximols had no notable effects on depression, suicidality, or working memory/processing speed in patients with MS. Funding: Greenwich Biosciences, Inc.
Presenter Of 1 Presentation
P1006 - An investigation into the role and impact that carers play in consultations between healthcare professionals and people with MS (ID 1314)
Abstract
Background
The MS in the 21st Century initiative is a Steering Group of international multiple sclerosis (MS) specialists and patient advocates with a current focus of improving education and communication between healthcare professionals and people with MS (PwMS).
Objectives
To understand perceptions of the factors that lead PwMS to bring carers along to their consultations and the potential impacts of this involvement; in particular, how this might affect the communication and relationship between HCPs and PwMS.
Methods
An electronic survey was developed to gain insight into the experiences of HCPs, PwMS and carers. The survey was conducted online in 2019-2020. Multiple answers were solicited in response to 14 questions.
Results
At the time of writing 137 respondents had completed the survey (47 HCPs, 66 PwMS, and 24 carers). The same proportion of carers responded that they “almost always accompanied their PwMS to appointments” (41.7%) and “had never been to an appointment” (41.7%). PwMS reported the most common reasons for taking a carer with them was ‘to provide emotional support’ (47.9%), ‘to help with travel’ (43.8%), and ‘to allow the carer to ask their own questions’ (35.4%). Three quarters (75.0%) of carers said the reason they attend is to help the PwMS understand information given to them. Of the three groups, HCPs were most likely to say the carers’ opinions influence PwMS’ treatment decisions (75.0%). Both HCPs and PwMS recognized that the presence of a carer during an appointment can negatively impact on the time available (40.4% and 28.3% respectively) but both groups also reported that PwMS are more likely to remember the topics that they want to discuss with a carer present (80.9% and 54.3% respectively) and to be happier with care decisions they make (53.2% and 56.5% respectively). Additionally, PwMS (89.1%) and carers (93.3%) both reported that attending consultations was an important way of ensuring the carer feels more involved and better informed about MS.
Conclusions
There are several positive impacts of carers attending consultations, including supporting both the emotional, information and practical needs of PwMS, and the engagement and information needs of carers. Whilst the PwMS should make the decision whether a carer attends the consultation, HCPs should facilitate and support invited carer attendance to optimize these benefits. Currently, this may pose additional social distancing challenges and require creative solutions.