Author Of 4 Presentations
P0187 - A prospective randomized open-label blinded endpoint multicenter non-inferiority study of oral cladribine and rituximab in Multiple Sclerosis (NOR-MS) (ID 1194)
Abstract
Background
Both induction therapy, like oral cladribine, and B-cell depletion therapy, like rituximab, are highly effective disease modulatory treatments (DMTs) in relapsing multiple sclerosis (MS). The high economic costs of the registered DMTs may limit availability of treatment and strain health budgets worldwide.
Oral cladribine is a recently approved DMT in Europe, while rituximab is used off-label, especially in Norway and Sweden. Large observational studies indicate good tolerance and treatment effects in MS and studies from other diseases indicate a good safety profile. However, to our knowledge, no phase three studies have compared rituximab with any established highly effective DMT. Formal safety data is also lacking for rituximab treatment in MS.
Objectives
To perform a prospective randomized open-label blinded endpoint multicenter non-inferiority study. The primary objective is to test whether rituximab is non-inferior to oral cladribine for treatment of relapsing MS.
Methods
In total 264 MS patients with relapsing MS will be recruited from 11 Norwegian centers and followed for 96 weeks. Inclusion criteria are having a relapsing MS diagnosis, age 18-65 years, at least one clinical relapse or one new T2 lesion on MRI within the last year and willingness to use contraception during the study period. Exclusion criteria are contraindications to either treatment, previous use of either or a similar treatment, or treatment with fingolimod or natalizumab (due to risk of rebound activity) within the last six months. The study participants will be treated with either cladribine or rituximab according to current guidelines.
Results
The primary endpoint is difference in number of new or enlarging T2 lesions between the two groups from rebaseline at 12 weeks to the end of the study at 96 weeks. Furthermore, we will study clinical course, blood samples and MRI biomarkers to provide tools for personalized MS treatment. Finally, the health economic consequences of these treatment options will be evaluated. At the time of abstract submission, 55 patients have been included across three study sites. The Covid19 outbreak unfortunately resulted in a temporary halt in inclusion from March to May 2020, but the study has now been reopened. End of study is estimated to fall 2023.
Conclusions
This study will guide clinicians and patients in future treatment choices for MS. The results will provide valuable knowledge concerning treatment strategies and can potentially have a huge impact on the costs of future MS treatments.
P0484 - Prevalence of fatigue in multiple sclerosis (ID 1003)
Abstract
Background
Fatigue is considered to be one of the main causes of impaired quality of life among patients with multiple sclerosis (MS). It affects family life, social activities, and education. Fatigue is one of the main reasons why many patients with MS are unable to work. To our knowledge there have been no larger studies on the prevalence of fatigue in MS in almost 20 years. Previous studies have reported a prevalence ranging between 50-90 %. We assumed that the prevalence of fatigue has changed due to changes in diagnostic criteria and the great change in treatment possibilities over these years.
Objectives
Our objective was to determine the prevalence of fatigue in a contemporary MS population in Norway, and to assess the association between fatigue and sex, age, disease course, disease severity and duration.
Methods
This is a cross-sectional study from a registry comprising MS patients in the counties Buskerud, Oslo and Telemark in Norway. Clinical, demographic and socio-economic data were obtained from the registry. Questionnaires were distributed by postal mail to all living subjects. Self-reported fatigue was assessed with the Fatigue Scale for Motor and Cognitive Functions (FSMC), and anxiety and depression was measured with the Hospital Anxiety and Depression Scale (HADS). We used the Epworth sleepiness scale (ESS) to assess daytime sleepiness.
Results
The response rate was 62.3 % (1599/2566). The prevalence of fatigue was 81.3 %. There was a significantly higher prevalence of fatigue in women than in men (82.9 % vs 77.6 %, p = 0.017). The prevalence was higher in patients aged ≥ 50 years compared with those aged < 50 years (85.7 % vs 75.4 %, p < 0.001). There was also a higher prevalence of fatigue in the group with progressive MS (87.6 % vs 80.0 % in the RR-MS group). 30 % of the patients with fatigue had concomitant anxiety/depression, versus 2.6 % in the non-fatigue group (p<0.001). Daytime sleepiness was more prevalent in patients with fatigue than in patients without fatigue (35 % versus 8 %, p<0.001).
Conclusions
Fatigue is prevalent in contemporary patients with MS and is associated with symptoms of anxiety, depression and daytime sleepiness. Fatigue was more prevalent in women, and in patients older than 50 years of age. Anxiety/depression and daytime sleepiness occurred more often in patients with fatigue.
P0502 - The Natural Course of Multiple Sclerosis Rewritten: A Population Based Study on Disease Demographics and Progression (ID 758)
Abstract
Background
Over the past few decades there has been an improvement in the rate of disability progression in multiple sclerosis (MS) patients, and most studies relate this evolvement to the introduction of disease modifying therapies. However, several other factors have changed over this period, including access to improved MRI and newer diagnostic criteria
Objectives
To investigate changes in the natural course of MS over time in a near-complete and geographically well-defined population from the south-east of Norway.
Methods
This is a registry-based study. We examined disease progression over two decades and assessed the effect of disease modifying therapies using linear mixed-effect models.
Results
In a cohort of 2097 patients we found a significant improvement in disability as measured by the Expanded Disability Status Scale (EDSS) stratified by age, and the improvement remained significant after adjusting for time on disease modifying medications, gender and progressive MS at onset. The time from disease onset to EDSS 6 in the total cohort was 29.8 years (95% CI 28.5-31.1) and was significantly longer in patients diagnosed after 2006 compared to patients diagnosed before. In addition, we found significant differences between patient demographics, as well as time to EDSS 6 in the near-complete, geographically well-defined population compared to the rest of the cohort from Oslo and its affluent suburbs.
Conclusions
The natural course of MS is improving, but the improvement seen in disease progression in the modern MS patient may have multifaceted explanations. This is supported by our findings of changing population demographics with patients being diagnosed earlier in the disease course, but also at an older age and with less severe disease. Our study underlines the fact that historical cohorts are unsuitable for comparison with modern cohorts in MS studies. We also found significant differences in demographics and time to EDSS 6 between our geographically near-complete population and the rest of the database with the cohort from Oslo and its wealthy suburbs, which means that studies done on incomplete populations should be interpreted with caution.
P1129 - Peripartum depression and anxiety in women with MS. A population-based cohort study. (ID 305)
Abstract
Background
People with multiple sclerosis (MS) have increased risk of depression and anxiety. It is not known if pregnancy and birth impact the risk of psychiatric symptoms in women with MS.
Objectives
To assess the occurrence, risk factors and prognosis of peripartum depression and anxiety in women with MS before and after diagnosis.
Methods
This study included women from the prospective Norwegian Mother, Father and Child Cohort study (MoBa) between 1999-2008. We used data from questionnaires at gestational weeks 18 and 30, and at 6 and 18 months postpartum. Self-reported data on depression and anxiety were recorded by Hopkins Symptom Checklist. Identification of women with MS was obtained from the Norwegian MS Registry, Norwegian Patient Registry and hospital records. The identified MS-women (n=546) were divided into 1) Pre-birth diagnosis (n=140), 2) Pre-birth onset with post-birth diagnosis (n=98) and 3) Post-birth onset (n=308). Thirty-five women were diagnosed with MS in the postpartum period. In group 2 and 3 the median follow-up time from birth until diagnosis was 7 years (range 0-17). The reference group consisted of women in MoBa without MS (n=111,267).
Results
Depression in gestational week 30 was more common among women with pre-birth diagnosis compared to the reference group (15% vs. 9%, OR 2.0 95% CI 1.2-3.1), adjusted for age, parity, overweight, socioeconomic factors and clustering among siblings. For those depressed in this group, the symptoms more often persisted to 6 months postpartum (77% vs. 38%, p=0.004), but the prognosis 18 months postpartum was similar. Women who were diagnosed with MS in the postpartum period had higher occurrence of depression compared to the reference group both 6 months (23% vs. 10%, p=0.023) and 18 months postpartum (42% vs. 13%, p<0.001). There was no significant difference in peripartum depression in women with post-birth diagnosis (group 2 and 3) compared to the reference group. Risk factors associated with depression in women with pre-birth diagnosis were adverse socioeconomic factors, history of physical and/or sexual abuse and pre-pregnancy psychiatric disease. There was no difference in peripartum anxiety between any of the MS groups and the reference group.
Conclusions
Women with diagnosed MS have an increased risk of depression in the third trimester. The burden of having a MS diagnosis seems to be the determinant for depression. Clinicians should be aware of postpartum depression in women diagnosed with MS in this period.