Sørlandet Hospital and The Norwegian National Advisory Unit on Tick-borne diseases
Neurology

Author Of 2 Presentations

Clinical Trials Poster Presentation

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.

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Reproductive Aspects and Pregnancy Poster Presentation

P1129 - Peripartum depression and anxiety in women with MS. A population-based cohort study. (ID 305)

Speakers
Presentation Number
P1129
Presentation Topic
Reproductive Aspects and Pregnancy

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.

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