Publications by authors named "Kjell-Morten Myhr"

162 Publications

Humoral immunity to SARS-CoV-2 mRNA vaccination in multiple sclerosis: the relevance of time since last rituximab infusion and first experience from sporadic revaccinations.

J Neurol Neurosurg Psychiatry 2021 Oct 20. Epub 2021 Oct 20.

Department of Neurology, Oslo University Hospital, Oslo, Norway.

Introduction: The effect of disease-modifying therapies (DMT) on vaccine responses is largely unknown. Understanding the development of protective immunity is of paramount importance to fight the COVID-19 pandemic.

Objective: To characterise humoral immunity after mRNA-COVID-19 vaccination of people with multiple sclerosis (pwMS).

Methods: All pwMS in Norway fully vaccinated against SARS-CoV-2 were invited to a national screening study. Humoral immunity was assessed by measuring anti-SARS-CoV-2 SPIKE RBD IgG response 3-12 weeks after full vaccination, and compared with healthy subjects.

Results: 528 pwMS and 627 healthy subjects were included. Reduced humoral immunity (anti-SARS-CoV-2 IgG <70 arbitrary units) was present in 82% and 80% of all pwMS treated with fingolimod and rituximab, respectively, while patients treated with other DMT showed similar rates as healthy subjects and untreated pwMS. We found a significant correlation between time since the last rituximab dose and the development of humoral immunity. Revaccination in two seronegative patients induced a weak antibody response.

Conclusions: Patients treated with fingolimod or rituximab should be informed about the risk of reduced humoral immunity and vaccinations should be timed carefully in rituximab patients. Our results identify the need for studies regarding the durability of vaccine responses, the role of cellular immunity and revaccinations.
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http://dx.doi.org/10.1136/jnnp-2021-327612DOI Listing
October 2021

Wearing-off symptoms during standard and extended natalizumab dosing intervals: Experiences from the COVID-19 pandemic.

J Neurol Sci 2021 10 22;429:117622. Epub 2021 Aug 22.

Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Natalizumab effectively prevents disease activity in relapsing-remitting multiple sclerosis, but many treated patients report subjective wearing-off symptoms at the end of the 4-week interval between infusions. Extended interval dosing (EID) is a promising strategy to mitigate the risk of natalizumab-associated progressive multifocal leukoencephalopathy, but it is unknown whether EID affects wearing-off symptoms. In this observational study, we evaluated if prevalence or intensity of wearing-off symptoms changed when natalizumab dosing intervals were extended from 4 to 6 weeks in 30 treated patients during the outbreak of COVID-19 in Norway. New or increased wearing-off symptoms during EID were reported by 50%. Symptom increase was more frequent among patients with pre-existing wearing-off symptoms during standard dosing compared to patients without such pre-existing symptoms [p = 0.0005]. Our observations support the need to study the effect of EID on wearing-off symptoms in randomized controlled trials.
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http://dx.doi.org/10.1016/j.jns.2021.117622DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8445695PMC
October 2021

Incidence of cancer in multiple sclerosis before and after the treatment era- a registry- based cohort study.

Mult Scler Relat Disord 2021 Oct 9;55:103209. Epub 2021 Aug 9.

Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway; Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway.

Background: Whether disease-modifying therapies (DMTs) influence cancer in multiple sclerosis (MS) is uncertain.

Objectives: Assess incidence of cancer diagnosis among Norwegian MS patients compared to the general population in 1953 to 1995 and 1996 to 2017-reflecting era before and after introduction of DMTs.

Methods: We performed a nationwide cohort study comprising 6949 MS patients and 37,922 controls, matched on age, sex and county. The cohort was linked to Norwegian Cancer Registry, Cause of Death Registry and National Educational database. We used Poisson regression to calculate incidence rate ratio (IRR) of cancer.

Results: During 1953-1995 MS patients had similar cancer frequency compared to controls (IRR: 1.11 (95% Confidence Intervals (CI): 0.90-1.37)), although MS patients had increased frequency of cancer in endocrine glands (IRR: 2.51 (1.27-4.93). During 1996-2017 we identified significant increased frequency of cancer among MS patients compared to controls (IRR: 1.38 (95% CI: 1.28-1.52): in brain (IRR: 1.97 (1.41-2.78)), meninges (IRR: 2.44 (1.54-3.77)), respiratory organs (IRR: 1.96 (1.49-2.63)). The excess cancer diagnosis was most frequent among MS patients ≥ 60 years of age (HR 1.30 (1.15-1.47)).

Conclusion: Incidence of cancer among MS patients compared to controls was higher in 1996 to 2017, corresponding in time to the introduction of DMT for MS. This was observed more frequently among MS patients older than 60 years of age.
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http://dx.doi.org/10.1016/j.msard.2021.103209DOI Listing
October 2021

Real-world discontinuation rate of teriflunomide and dimethyl fumarate in multiple sclerosis.

Mult Scler J Exp Transl Clin 2021 Apr-Jun;7(2):20552173211022027. Epub 2021 Jun 14.

Neuro-SysMed - Centre of Excellence for Experimental Therapy in Neurology, Department of Neurology, Haukeland University Hospital, Bergen, Norway.

Background: For patients with MS, medication switches increase the risk of disease reactivation.

Objective: Compare discontinuation rates due to treatment failure or side effects between teriflunomide and dimethyl fumarate, and investigate clinical variables affecting discontinuation rates.

Methods: All patients who received teriflunomide or dimethyl fumarate at Haukeland University Hospital from 2013 until 2018 were identified. Clinical and demographic variables were extracted from the Norwegian MS Registry. Cause-specific Cox regression models estimated the rate of discontinuation due to treatment failure or side effects.

Results: We included 354 patients treated with either dimethyl fumarate ( = 185) or teriflunomide ( = 169). We found 38% lower risk of discontinuation because of treatment failure for patients using dimethyl fumarate compared to teriflunomide ( < 0.05). In a treatment-naive subgroup ( = 183), we found a 38% reduced risk of discontinuation for any reason among patients using dimethyl fumarate ( < 0.05). There was no significant difference between treatment groups in discontinuation rate due to side effects, although more patients reported side effects when treated with dimethyl fumarate.

Conclusion: Our findings suggests that dimethyl fumarate has a lower risk of discontinuation because of treatment failure among both treatment-experienced and treatment-naive patients.
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http://dx.doi.org/10.1177/20552173211022027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8209840PMC
June 2021

Disease-modifying therapy for multiple sclerosis.

Tidsskr Nor Laegeforen 2021 05 10;141(8). Epub 2021 May 10.

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http://dx.doi.org/10.4045/tidsskr.21.0155DOI Listing
May 2021

Perinatal Depression and Anxiety in Women With Multiple Sclerosis: A Population-Based Cohort Study.

Neurology 2021 06 21;96(23):e2789-e2800. Epub 2021 Apr 21.

From the Departments of Clinical Medicine (K.E., Ø.F.T., K.-M.M., C.F.T., N.E.G., M.-H.B.) and Global Public Health and Primary Care (T.R.), University of Bergen; Neuro-SysMed (Ø.F.T., J.A., K.-M.M., T.R., S.W.), The Norwegian Multiple Sclerosis Registry and Biobank (J.A., S.W.), and The Norwegian Multiple Sclerosis Competence Centre (J.A., T.R.), Department of Neurology (K.E., S.W., N.E.G., M.-H.B.), Haukeland University Hospital, Bergen; Department of Neurology (H.Ø.F.), Telemark Hospital Trust, Skien; Department of Neurology (T.H.), Akershus University Hospital, Lørenskog; Institute of Clinical Medicine (T.H., C.S.), University of Oslo; Department of Neurology and The Norwegian National Advisory Unit on Tick-borne Diseases (Å.R.L.), Sørlandet Hospital, Kristiansand; Department of Neurology (J.S.W.), Møre og Romsdal Hospital Trust, Molde; Department of Neurology (N.Ø.), Nordland Hospital Trust, Bodø; Department of Neurology (C.S.), Vestre Viken Hospital Trust, Drammen; Department of Obstetrics and Gynecology (C.F.T.), Stavanger University Hospital; and Department of Neuromedicine and Movement Science (J.S.W.), Norwegian University of Science and Technology, Trondheim, Norway.

Objective: To assess the occurrence of perinatal depression and anxiety in women before and after diagnosis of multiple sclerosis (MS).

Methods: A total of 114,629 pregnant women were included in the Norwegian Mother, Father and Child Cohort study (1999-2008). We assessed depression and anxiety by questionnaires during and after pregnancy. Women with MS were identified from national health registries and hospital records and grouped into (1) MS diagnosed before pregnancy (n = 140) or MS diagnosed after pregnancy with (2) symptom onset before pregnancy (n = 98) or (3) symptom onset after pregnancy (n = 308). Thirty-five women were diagnosed with MS in the postpartum period. The reference group (n = 111,627) consisted of women without MS.

Results: Women with MS diagnosed before pregnancy had an adjusted odds ratio of 2.0 (95% confidence interval, 1.2-3.1) for depression in the third trimester. Risk factors were adverse socioeconomic factors and history of psychiatric disease and physical/sexual abuse. The risk of anxiety was not increased. Women diagnosed with MS in the postpartum period had especially high risk of postpartum depression. Women with MS symptom onset within 5 years after pregnancy had increased risk of both depression and anxiety during pregnancy, whereas women with more than 5 years until symptom onset did not.

Conclusion: Women diagnosed with MS have increased risk of perinatal depression. Women with MS symptom onset within 5 years after pregnancy have increased risk of both depression and anxiety during pregnancy.
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http://dx.doi.org/10.1212/WNL.0000000000012062DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8205461PMC
June 2021

Safety and efficacy of rituximab as first- and second line treatment in multiple sclerosis - A cohort study.

Mult Scler J Exp Transl Clin 2021 Jan-Mar;7(1):2055217320973049. Epub 2021 Jan 31.

Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway.

Background: Rituximab is increasingly used as off-label therapy in multiple sclerosis (MS). More data are needed on safety and efficacy of rituximab, particularly in cohorts of de novo patients and patients in early therapy escalation.

Objective: To investigate the safety and efficacy of off-label treatment with rituximab in an MS-cohort of predominantly de novo patients or as therapy escalation.

Methods: We retrieved safety and efficacy data from the Norwegian MS-registry and biobank for all MS-patients treated with rituximab at Haukeland University Hospital, Bergen, Norway, during a four year period.

Results: In the 365 MS-patients (320 relapsing-remitting MS (RRMS), 23 secondary progressive MS (SPMS), and 22 primary progressive MS (PPMS)), the overall annualized relapse rate (ARR) was 0.03 and annualized drug discontinuation rate (ADDR) was 0.05. NEDA-3 was achived in 79% of patients with available data (n=351). Sixty-one patients experienced infusion-related adverse events of which two were serious (CTCAE grade 3-4). Eighteen patients experienced serious non-infusion related adverse events, of which 16 were infections. Infections (n = 34; 9.3%, CTCAE grade 2-5), hypogammaglobulinemia (n = 19, 5.2%) and neutropenia (n = 16; 4.4%) were the most common non-infusion-related adverse events.

Conclusion: Rituximab was a safe and highly efficient disease modifying therapy in this cohort of MS-patients; however, infections and neutropenia need to be monitored.
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http://dx.doi.org/10.1177/2055217320973049DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7970692PMC
January 2021

Cuprizone and EAE mouse frontal cortex proteomics revealed proteins altered in multiple sclerosis.

Sci Rep 2021 03 30;11(1):7174. Epub 2021 Mar 30.

Department of Neurology, Norwegian Multiple Sclerosis Competence Centre, Haukeland University Hospital, Jonas Lies vei 65, 5021, Bergen, Norway.

Two pathophysiological different experimental models for multiple sclerosis were analyzed in parallel using quantitative proteomics in attempts to discover protein alterations applicable as diagnostic-, prognostic-, or treatment targets in human disease. The cuprizone model reflects de- and remyelination in multiple sclerosis, and the experimental autoimmune encephalomyelitis (EAE, MOG1-125) immune-mediated events. The frontal cortex, peripheral to severely inflicted areas in the CNS, was dissected and analyzed. The frontal cortex had previously not been characterized by proteomics at different disease stages, and novel protein alterations involved in protecting healthy tissue and assisting repair of inflicted areas might be discovered. Using TMT-labelling and mass spectrometry, 1871 of the proteins quantified overlapped between the two experimental models, and the fold change compared to controls was verified using label-free proteomics. Few similarities in frontal cortex between the two disease models were observed when regulated proteins and signaling pathways were compared. Legumain and C1Q complement proteins were among the most upregulated proteins in cuprizone and hemopexin in the EAE model. Immunohistochemistry showed that legumain expression in post-mortem multiple sclerosis brain tissue (n = 19) was significantly higher in the center and at the edge of white matter active and chronic active lesions. Legumain was associated with increased lesion activity and might be valuable as a drug target using specific inhibitors as already suggested for Parkinson's and Alzheimer's disease. Cerebrospinal fluid levels of legumain, C1q and hemopexin were not significantly different between multiple sclerosis patients, other neurological diseases, or healthy controls.
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http://dx.doi.org/10.1038/s41598-021-86191-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8010076PMC
March 2021

Low vitamin D, but not tobacco use or high BMI, is associated with long-term disability progression in multiple sclerosis.

Mult Scler Relat Disord 2021 May 28;50:102801. Epub 2021 Jan 28.

Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.

Background: Low vitamin D levels, tobacco use and high body mass index (BMI) have been linked to adverse disease outcomes in multiple sclerosis (MS), but their influence on long-term disability progression remains unclear. Therefore, we explored whether these modifiable lifestyle factors were associated with 10-year clinical disability progression in patients with MS.

Methods: In this prospective study, a cohort of 88 patients with relapsing-remitting MS completed a randomized controlled study on ω-3 fatty acids between 2004 and 2008. During 24 months, serum 25-hydroxyvitamin D (25(OH)D), serum cotinine (nicotine metabolite), and BMI were repeatedly measured. In 2017, a follow-up study was conducted among 80 of the participants, including disability assessment by the Expanded Disability Status Scale (EDSS). Linear regression was used to explore associations between the lifestyle factors and the EDSS change over 10 years.

Results: Higher seasonally adjusted 25(OH)D levels were associated with lower 10-year EDSS progression (change in EDSS per 1 SD increase in 25(OH)D in a model adjusted for sex, age and baseline EDSS: -0.45 point, 95% CI: -0.75 to -0.16, p=0.003). Further adjustments for potential confounders related to lifestyle and disease status gave similar results. The association was mainly driven by low 25(OH)D levels during spring, as well as seasonally adjusted levels below 80 nmol/L. No clear association was found for BMI and cotinine.

Conclusion: Lower 25(OH)D levels, but apparently not tobacco use or higher BMI, were significantly associated with worse long-term disability progression in MS.
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http://dx.doi.org/10.1016/j.msard.2021.102801DOI Listing
May 2021

Brain atrophy and clinical characteristics predicting SDMT performance in multiple sclerosis: A 10-year follow-up study.

Mult Scler J Exp Transl Clin 2021 Jan-Mar;7(1):2055217321992394. Epub 2021 Feb 8.

Department of Neurology, Stavanger University Hospital, Stavanger, Norway.

Objectives: To identify Magnetic Resonance Imaging (MRI), clinical and demographic biomarkers predictive of worsening information processing speed (IPS) as measured by Symbol Digit Modalities Test (SDMT).

Methods: Demographic, clinical data and 1.5 T MRI scans were collected in 76 patients at time of inclusion, and after 5 and 10 years. Global and tissue-specific volumes were calculated at each time point. For the primary outcome of analysis, SDMT was used.

Results: Worsening SDMT at 5-year follow-up was predicted by baseline age, Expanded Disability Status Scale (EDSS), SDMT, whole brain volume (WBV) and T2 lesion volume (LV), explaining 30.2% of the variance of SDMT. At 10-year follow-up, age, EDSS, grey matter volume (GMV) and T1 LV explained 39.4% of the variance of SDMT change.

Conclusion: This longitudinal study shows that baseline MRI-markers, demographic and clinical data can help predict worsening IPS. Identification of patients at risk of IPS decline is of importance as follow-up, treatment and rehabilitation can be optimized.
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http://dx.doi.org/10.1177/2055217321992394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876764PMC
February 2021

Cerebrospinal fluid proteome shows disrupted neuronal development in multiple sclerosis.

Sci Rep 2021 02 18;11(1):4087. Epub 2021 Feb 18.

Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Despite intensive research, the aetiology of multiple sclerosis (MS) remains unknown. Cerebrospinal fluid proteomics has the potential to reveal mechanisms of MS pathogenesis, but analyses must account for disease heterogeneity. We previously reported explorative multivariate analysis by hierarchical clustering of proteomics data of MS patients and controls, which resulted in two groups of individuals. Grouping reflected increased levels of intrathecal inflammatory response proteins and decreased levels of proteins involved in neural development in one group relative to the other group. MS patients and controls were present in both groups. Here we reanalysed these data and we also reanalysed data from an independent cohort of patients diagnosed with clinically isolated syndrome (CIS), who have symptoms of MS without evidence of dissemination in space and/or time. Some, but not all, CIS patients had intrathecal inflammation. The analyses reported here identified a common protein signature of MS/CIS that was not linked to elevated intrathecal inflammation. The signature included low levels of complement proteins, semaphorin-7A, reelin, neural cell adhesion molecules, inter-alpha-trypsin inhibitor heavy chain H2, transforming growth factor beta 1, follistatin-related protein 1, malate dehydrogenase 1 cytoplasmic, plasma retinol-binding protein, biotinidase, and transferrin, all known to play roles in neural development. Low levels of these proteins suggest that MS/CIS patients suffer from abnormally low oxidative capacity that results in disrupted neural development from an early stage of the disease.
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http://dx.doi.org/10.1038/s41598-021-82388-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892850PMC
February 2021

Comorbidity in multiple sclerosis patients from Nordland County, Norway - validated data from the Norwegian Patient Registry.

Mult Scler Relat Disord 2021 Feb 21;48:102691. Epub 2020 Dec 21.

Department of Neurology, Nordland Hospital Trust, Bodø, Norway; Institute of Clinical Medicine, University of Tromsø, Tromsø, Norway.

Background: Knowledge of comorbid disorders is important to optimize therapy for multiple sclerosis (MS), but data are limited. The aim of this study was to assess comorbidity in persons with MS living in Nordland County on January 1, 2017.

Methods: Data were retrieved from the Norwegian Patient Registry (2008-2017) and validated through review of electronic hospital charts (1970-2017). Comorbidity was defined as any distinct disorder, classified in the International Classification of Diseases (ICD-10), that had existed or occurred after the diagnosis of MS was established.

Results: Data from 637 subjects were reviewed, and 97.5% were registered with at least one comorbid condition. Malignant melanoma was found in 0.5%, and non-melanoma skin cancers in 1.9%. In female subjects, breast cancer was found in 3.3%. Hypothyroidism was confirmed in 3.1%, type-1 diabetes in 0.3%, type-2 diabetes in 3.9%, psychosis in 0.6%, epilepsy in 2.8%, myocardial infarction in 1.7%, subarachnoid hemorrhage in 0.2%, cerebral infarction in 0.6%, pulmonary embolism in 0.9%, inflammatory bowel disease in 1.3%, and rheumatoid arthritis in 0.6%.

Conclusion: Compared to reports from other Norwegian epidemiological studies, a higher proportion of inflammatory bowel disease and epilepsy was found. This is in accordance with findings from other studies. The prevalence of non-melanoma skin cancers was significantly higher than in the general Norwegian population as they were reported by The Cancer Registry of Norway.
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http://dx.doi.org/10.1016/j.msard.2020.102691DOI Listing
February 2021

A two-year longitudinal follow-up of cognitive performance assessed by BICAMS in newly diagnosed patients with MS.

Mult Scler Relat Disord 2020 Nov 12;46:102577. Epub 2020 Oct 12.

Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Background: Cognitive impairment is common in patients with multiple sclerosis (MS) and may occur at any stage and with any subtype of the disease. Screening and monitoring of cognitive function should therefore be implemented into everyday clinical neurology practice. The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) was developed for this purpose. Although several cross-sectional studies have validated BICAMS, longitudinal studies evaluating its use as part of a clinical follow-up routine are still lacking.

Objective: To investigate cognitive function and trajectories of change assessed by the BICAMS test battery in a cohort of newly diagnosed relapsing-remitting MS (RRMS) patients examined at baseline and after 12 and 24 months.

Methods: BICAMS was used to assess cognitive function in 58 RRMS patients, who also filled in the Hospital Anxiety and Depression Scale (HADS) and the Fatigue Scale for Motor and Cognitive Functions (FSMC), and underwent standard neurological evaluations at baseline and at the two follow-ups.

Results: A total of 27 patients (46.6%) were defined as cognitively impaired at baseline on at least one test, and 22 (37.9%) were defined as impaired at follow-up after 24 months. Throughout the study, 8 (13.8%) and 4 (6.9%) patients were consistently defined as impaired on two or three tests, respectively. The mean raw scores on two BICAMS subtests (SDMT and CVLT-II) improved significantly from baseline to the first follow-up, and then remained stable the next year, whereas the visual memory test (BVMT-R) were overall unchanged from baseline to the end of the study. The correlations between the scores on HADS, FSMC and the BICAMS subtests were non-significant at baseline, but weak to moderate negative correlations were found at the one- and two-year follow-ups.

Conclusion: The patients showed improved test results from baseline to the first follow-up examination, indicating that an effect of previous practise should be taken into account when interpreting the results. With results showing both trajectories of stability and change, our study supported the validity of including BICAMS as part of a clinical follow-up routine of RRMS patients. Anxiety, depression, fatigue and cognition should always be assessed at the same time to reveal interaction effects that are expected to affect the daily-life functioning of at least some of the RRMS patients.
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http://dx.doi.org/10.1016/j.msard.2020.102577DOI Listing
November 2020

Pregnancy outcomes after exposure to interferon beta: a register-based cohort study among women with MS in Finland and Sweden.

Ther Adv Neurol Disord 2020 7;13:1756286420951072. Epub 2020 Oct 7.

StatFinn & EPID Research, Espoo, Finland.

Background: Our aim was to estimate and compare the prevalence of adverse pregnancy outcomes among pregnant women with multiple sclerosis (MS) exposed to interferon beta (IFNB) and among women with MS unexposed to any MS disease-modifying drug (MSDMD).

Methods: This cohort study used Finnish (1996-2014) and Swedish (2005-2014) national register data. Women with MS having IFNB dispensed 6 months before or during pregnancy as the only medication were considered as IFNB exposed (only IFNB-exposed), whereas women with MS unexposed to any MSDMD were considered unexposed (MSDMD-unexposed). Prevalence was described and compared using log-binomial or logistic regression and adjusted for potential confounders including maternal age and comorbidity.

Results: Among 2831 pregnancies, 2.2% of the only IFNB-exposed and 4.0% of the MSDMD-unexposed women had serious adverse pregnancy outcomes [elective termination of pregnancy due to foetal anomaly (TOPFA), major congenital anomaly (MCA) in live, or stillbirth]. After adjustments, the prevalence of serious adverse pregnancy outcomes was lower among the only IFNB-exposed compared with the MSDMD-unexposed [relative risk 0.55, 95% confidence interval (CI) 0.31-0.96]. The prevalence of individual outcomes, including MCA, spontaneous abortions, and stillbirths was not increased with IFNB exposure. Women with MS exposed to IFNB appeared more likely to terminate their pregnancy for reasons other than foetal anomaly, compared with MSDMD-unexposed pregnant MS patients (odds ratio 1.71, 95% CI 1.06-2.78).

Conclusion: In this large cohort study, no increase in the prevalence of adverse pregnancy outcomes was observed in women with MS exposed to IFNB compared with MS patients unexposed to any MSDMDs. This study together with other evidence led to a change in the labels of the IFNB products in September 2019 in the European Union, and IFNB use today may be considered during pregnancy, if clinically needed.
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http://dx.doi.org/10.1177/1756286420951072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7549181PMC
October 2020

Tenofovir as a treatment option for multiple sclerosis.

Mult Scler Relat Disord 2020 Nov 7;46:102569. Epub 2020 Oct 7.

Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.

Some antiretroviral medications are also inhibitors of EBV. We describe a patient with highly active MS who was infected with HIV and started HIV-treatment containing tenofovir alafenamide (TAF), a potent inhibitor of EBV lytic reactivation. Her MS was in complete remission during this treatment, and she had new radiological disease activity again after switching to tenofovir disoproxil fumarate, a HIV drug with less potent activity against EBV replication. Based on the recently detected mechanism of TDF and TAF, we suggest that further studies on these drugs in MS are warranted.
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http://dx.doi.org/10.1016/j.msard.2020.102569DOI Listing
November 2020

Recent progress in maintenance treatment of neuromyelitis optica spectrum disorder.

J Neurol 2021 Dec 3;268(12):4522-4536. Epub 2020 Oct 3.

Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Background: Treatment of neuromyelitis optica spectrum disorder (NMOSD) has so far been based on retrospective case series. The results of six randomized clinical trials including five different monoclonal antibodies targeting four molecules and three distinct pathophysiological pathways have recently been published.

Methods: Literature search on clinical trials and case studies in NMOSD up to July 10. 2020.

Results: We review mechanism of action, efficacy and side effects, and consequences for reproductive health from traditional immunosuppressants and monoclonal antibodies including rituximab, inebilizumab, eculizumab, tocilizumab and satralizumab.

Conclusion: In NMOSD patients with antibodies against aquaporin 4, monoclonal antibodies that deplete B cells (rituximab and inebilizumab) or interfere with interleukin 6 signaling (tocilizumab and satralizumab) or complement activation (eculizumab) have superior efficacy compared to placebo. Tocilizumab and rituximab were also superior to azathioprine in head-to-head studies. Rituximab, tocilizumab and to some extent eculizumab have well-known safety profiles for other inflammatory diseases, and rituximab and azathioprine may be safe during pregnancy.
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http://dx.doi.org/10.1007/s00415-020-10235-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8563615PMC
December 2021

Teriflunomide vs injectable disease modifying therapies for relapsing forms of MS.

Mult Scler Relat Disord 2020 Aug 13;43:102158. Epub 2020 May 13.

Stony Brook University, Stony Brook, NY, USA.

Multiple sclerosis (MS) is a chronic, immune-mediated, inflammatory disease affecting the white and gray matter of the central nervous system. Several disease modifying therapies (DMTs) have been shown to significantly reduce relapse rates, slow disability worsening, and modify the overall disease course of MS. Decision-making when initiating a DMT should be shared between the patient and physician. Important factors such as prognostic indicators, safety, patient preferences, adherence, and convenience should also be considered. Treatment guidelines recommend switching a DMT when a patient experiences breakthrough disease activity, but also for patients who experience adverse events. Compared with injectable therapies, oral DMTs are often associated with increased treatment adherence and patient satisfaction, due to a less burdensome route of administration and greater tolerability. This review will summarize the available scientific evidence for injectable DMTs and the oral DMT teriflunomide, including considerations for both treatment-naïve patients initiating a DMT and patients switching from an injectable DMT.
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http://dx.doi.org/10.1016/j.msard.2020.102158DOI Listing
August 2020

Natural Variation of Vitamin D and Neurofilament Light Chain in Relapsing-Remitting Multiple Sclerosis.

Front Neurol 2020 30;11:329. Epub 2020 Apr 30.

Department of Clinical Medicine, University of Bergen, Bergen, Norway.

High serum levels of 25-hydroxyvitamin D (25(OH)D) have been found among patients with a favorable disease course in relapsing-remitting MS (RRMS), indicating that this may limit clinical deterioration. Clinical deterioration in RRMS correlates with increasing serum levels of neurofilament light chain (NfL). To examine the association between physiological variations in serum 25(OH)D and NfL levels in RRMS patients before and during disease modifying therapy (DMT). Serum 25(OH)D and NfL concentrations were measured in 85 newly diagnosed RRMS patients enrolled in a 24-month randomized double-blinded placebo-controlled trial of ω-3 fatty acid supplementation without vitamin D. Patients were without DMT until interferon β-1a (IFN-β) initiation at study month 6. Longitudinal serum measurements and brain magnetic resonance imaging (MRI) were obtained. Associations between 25(OH)D and NfL levels were analyzed with linear regression models for the whole study period and the periods before and during IFN-β treatment. Analyses with adjustment for inflammatory MRI disease activity were also performed. No significant associations were found between variations in 25(OH)D and NfL levels during the whole study period ( = 0.95), or the periods without ( = 0.78) or with ( = 0.33) IFN-β therapy. Patients with inflammatory MRI disease activity had significantly higher serum NfL levels than patients without inflammatory MRI disease activity [mean (SD) difference 12.6 (2.0) pg/mL, < 0.01]. Adjustment for this did not change the relationship between 25(OH)D and NfL concentrations. Natural variations in serum 25(OH)D values do not seem to be associated with alterations in serum NfL concentrations in RRMS patients.
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http://dx.doi.org/10.3389/fneur.2020.00329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7205013PMC
April 2020

Wearing-off at the end of natalizumab dosing interval and risk of MS disease activity: A prospective 1-year follow-up study.

J Neurol Sci 2020 08 5;415:116880. Epub 2020 May 5.

Neuro-SysMed, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway. Electronic address:

Natalizumab effectively prevents disease activity in relapsing-remitting multiple sclerosis by binding α4 integrin and inhibiting leukocyte migration to the central nervous system. We recently reported an association between low natalizumab receptor occupancy and subjective wearing-off symptoms at the end of the 4-week dosing interval. Here, we aimed to evaluate the short-term risk of disease activity in a 1-year prospective follow-up of the same patient cohort (n = 40). We found that all patients available for follow-up after one year (n = 35) fulfilled the criteria for no evidence of disease activity (NEDA). Thus, wearing-off symptoms were not associated with increased short-term risk of disease activity. Longer follow-up in a larger patient cohort is required to establish whether therapeutic efficacy is maintained in patients with wearing-off symptoms.
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http://dx.doi.org/10.1016/j.jns.2020.116880DOI Listing
August 2020

High incidence and prevalence of MS in Møre and Romsdal County, Norway, 1950-2018.

Neurol Neuroimmunol Neuroinflamm 2020 05 26;7(3). Epub 2020 Mar 26.

From the Department of Neurology (J.S.W., R.M.), Møre og Romsdal Hospital Trust, Molde; Department of Neuromedicine and Movement Science (J.S.W.), Norwegian University of Science and Technology, Trondheim; Department of Neurology (J.H.A.), Haukeland University Hospital, The Norwegian Multiple Sclerosis Registry and Biobank, Bergen; Department of Neurology (K.-M.M.), Haukeland University Hospital, Neuro-SysMed; Department of Clinical Medicine (K.-M.M.), University of Bergen; and St. Olavs University Hospital and Norwegian University of Science and Technology (R.M.), Clinical Trial Unit Central Norway, Trondheim.

Objective: To determine prevalence and longitudinal trends in incidence of MS in Møre and Romsdal County, Western Norway, from 1950 to 2018.

Methods: Retrospective longitudinal population-based observational study. All patients diagnosed, or living, with MS in Møre and Romsdal were identified as incident or prevalent cases from local, regional, and national sources. We compiled the data in the Norwegian Multiple Sclerosis Registry and Biobank and used the aggregated data set to calculate incidence and prevalence rates using population measures obtained from Statistics Norway.

Results: On January 1, 2018, the estimated prevalence was 335.8 (95% CI, 314.1-358.5) per 100,000 inhabitants, with a female:male ratio of 2.3. From 1950 through 2017, we observed a considerable ( < 0.001) increase in average annual incidence rates from 2.1 (95% CI, 1.3-3.3) to 14.4 (95% CI, 11.9-17.3) per 100,000. From 2005 through 2017, the incidence among women increased from 17.1 (95% CI, 14.0-20.7) to 23.2 (95% CI, 18.7-28.5) per 100,000, whereas the incidence among men declined from 10.3 (95% CI, 7.9-13.2) to 5.9 (95% CI, 3.4-8.8) per 100,000.

Conclusion: Møre and Romsdal County in Western Norway has the highest prevalence of MS reported in Norway. The incidence has steadily increased since 1950, and during the latest 15 years, we observed opposing trends in sex-specific incidence rates.
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http://dx.doi.org/10.1212/NXI.0000000000000713DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7136041PMC
May 2020

Brain atrophy and employment in multiple sclerosis patients: a 10-year follow-up study.

Mult Scler J Exp Transl Clin 2020 Jan-Mar;6(1):2055217320902481. Epub 2020 Jan 27.

Department of Neurology, Stavanger University Hospital, Norway.

Background: Multiple sclerosis is often associated with unemployment. The contribution of grey matter atrophy to unemployment is unclear.

Objectives: To identify magnetic resonance imaging biomarkers of grey matter and clinical symptoms associated with unemployment in multiple sclerosis patients.

Methods: Demographic, clinical data and 1.5 T magnetic resonance imaging scans were collected in 81 patients at the time of inclusion and after 5 and 10 years. Global and tissue-specific volumes were calculated at each time point. Statistical analysis was performed using a mixed linear model.

Results: At baseline 31 (38%) of the patients were unemployed, at 5-year follow-up 44 (59%) and at 10-year follow-up 34 (81%) were unemployed. The unemployed patients had significantly lower subcortical deep grey matter volume ( < 0.001), specifically thalamus, pallidus, putamen and hippocampal volumes, and cortical volume ( = 0.011); and significantly greater T1 ( < 0.001)/T2 ( < 0.001) lesion volume than the employed patient group at baseline. Subcortical deep grey matter volumes, and to a lesser degree cortical volume, were significantly associated with unemployment throughout the follow-up.

Conclusion: We found significantly greater atrophy of subcortical deep grey matter and cortical volume at baseline and during follow-up in the unemployed patient group. Atrophy of subcortical deep grey matter showed a stronger association to unemployment than atrophy of cortical volume during the follow-up.
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http://dx.doi.org/10.1177/2055217320902481DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6987492PMC
January 2020

Wearing-off at the end of natalizumab dosing intervals is associated with low receptor occupancy.

Neurol Neuroimmunol Neuroinflamm 2020 05 4;7(3). Epub 2020 Feb 4.

From the Neuro-SysMed (G.H.B., K.-M.M., C.A.V., S.G.), Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine (G.H.B., K.-M.M., C.A.V., S.G.), University of Bergen, Bergen, Norway; and Department of Informatics (N.B.), University of Bergen, Bergen, Norway.

Objective: We aimed to investigate whether wearing-off symptoms at the end of the natalizumab dosing interval were associated with clinical and demographic patient characteristics or natalizumab receptor occupancy (RO) on leukocytes.

Methods: In this cross-sectional study of 40 patients with relapsing-remitting MS (RRMS) receiving natalizumab at the Department of Neurology, Haukeland University Hospital, we recorded clinical and demographic data including age, body mass index (BMI), working status, smoking habits, disease characteristics, treatment duration, vitamin D levels, and wearing-off symptoms. We quantified neurofilament light chain in serum and measured natalizumab RO in leukocyte subtypes by high-parameter mass cytometry. Associations with wearing-off symptoms were analyzed.

Results: Eight (20.0%) patients who reported regular occurrence of wearing-off symptoms, 9 (22.5%) who sometimes had wearing-off symptoms, and 23 (57.5%) who did not have wearing-off symptoms were evaluated. Patients who regularly had wearing-off symptoms had lower natalizumab RO than patients who reported having such symptoms sometimes or never. The former group also had higher BMI and higher frequency of sick leave. High BMI was associated with low RO. No other demographic or disease characteristics were associated with the phenomenon.

Conclusions: Low RO may explain the wearing-off phenomenon observed in some patients with RRMS treated with natalizumab, and high BMI may be the underlying cause.
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http://dx.doi.org/10.1212/NXI.0000000000000678DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051203PMC
May 2020

The association between exposure to interferon-beta during pregnancy and birth measurements in offspring of women with multiple sclerosis.

PLoS One 2019 30;14(12):e0227120. Epub 2019 Dec 30.

Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden.

Background: Interferon-beta (IFN-beta) is a commonly used treatment for multiple sclerosis (MS). Current guidelines recommend cessation of treatment during pregnancy, however the results of past studies on the safety of prenatal exposure to IFN-beta have been conflicting. A large scale study of a population of MS women is therefore warranted.

Objectives: To assess whether, among those born to women with MS, infants prenatally exposed to IFN-beta show evidence of smaller size at birth relative to infants which were not prenatally exposed to any MS disease modifying drugs.

Methods: Swedish and Finnish register data was used. Births to women with MS in Sweden and Finland between 2005-2014 for which a birth measurement for weight, height, and head circumference was available were included. The exposure window was from 6 months prior to LMP to the end of pregnancy.

Results: In Sweden, 411 pregnancies were identified as exposed to IFN-beta during the exposure window, and 835 pregnancies were counted as unexposed to any MS DMD. The corresponding numbers for Finland were 232 and 331 respectively. Infants prenatally exposed to interferon-beta were on average 28 grams heavier (p = 0.17), 0.01 cm longer (p = 0.95), and had head circumferences 0.14 cm larger (p = 0.13) in Sweden. In Finland, infants were 50 grams lighter (p = 0.27), 0.02 cm shorter (p = 0.92) and had head circumferences 0.22 cm smaller (p = 0.15) relative to those unexposed.

Conclusions: This study provides evidence that exposure to IFN-beta during pregnancy does not influence birth weight, length, or head circumference.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0227120PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6936848PMC
April 2020

Safety and efficacy of autologous hematopoietic stem cell transplantation for multiple sclerosis in Norway.

Mult Scler 2020 12 13;26(14):1889-1897. Epub 2019 Dec 13.

Department of Clinical Medicine, University of Bergen, Bergen, Norway/Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital, Bergen, Norway.

Background: Hematopoietic stem cell treatment (HSCT) is a promising treatment option for multiple sclerosis (MS), but detailed safety and efficacy measures are still scarce.

Objective: To evaluate the efficacy and safety of HSCT in MS.

Methods: Retrospective single-center observational study of all MS patients that underwent HSCT in Norway during January 2015 to January 2018. The primary outcome was no evidence of disease activity (NEDA-3) status.

Results: A total of 30 patients with a median follow-up time of 26 months (range: 11-48) were evaluated. In total, 25 (83%) achieved NEDA-3 status, and none received disease-modifying treatment after HSCT. For 13 (43%) of the patients, there were sustained improvement in Expanded Disability Status Scale (EDSS) score, and 10 (33%) were working full time after the treatment, compared to only 1 (3%) before treatment. There were no serious treatment-related complications and was no mortality. Five patients (17%) were diagnosed with an autoimmune thyroid disease after the procedure, and 10 (43%) of the women had amenorrhea lasting >12 months and symptoms of ovarian failure.

Conclusion: HSCT in MS is an effective and relatively safe treatment option, with few serious complications and no mortality in Norway, so far. However, long-term adverse event with amenorrhea is a common problem.
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http://dx.doi.org/10.1177/1352458519893926DOI Listing
December 2020

Fingolimod downregulates brain sphingosine-1-phosphate receptor 1 levels but does not promote remyelination or neuroprotection in the cuprizone model.

J Neuroimmunol 2020 02 31;339:577091. Epub 2019 Oct 31.

Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Fingolimod is used to treat patients with relapsing-remitting multiple sclerosis; it crosses the blood-brain barrier and modulates sphingosine-1-phosphate receptors (S1PRs). Oligodendrocytes, astrocytes, microglia, and neuronal cells express S1PRs, and fingolimod could potentially improve remyelination and be neuroprotective. We used the cuprizone animal model, histo-, immunohistochemistry, and quantitative proteomics to study the effect of fingolimod on remyelination and axonal damage. Fingolimod was functionally active during remyelination by downregulating S1PR1 brain levels, and fingolimod-treated mice had more oligodendrocytes in the secondary motor cortex after three weeks of remyelination. However, there were no differences in remyelination or axonal damage compared to placebo. Thus, fingolimod does not seem to directly promote remyelination or protect against axonal injury or loss when given after cuprizone-induced demyelination.
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http://dx.doi.org/10.1016/j.jneuroim.2019.577091DOI Listing
February 2020

Serum NFL levels should be used to monitor multiple sclerosis evolution - No.

Mult Scler 2020 01 18;26(1):19-21. Epub 2019 Oct 18.

Department of Clinical Medicine, University of Bergen, Bergen, Norway.

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http://dx.doi.org/10.1177/1352458519872891DOI Listing
January 2020

The Norwegian translation of the brief international cognitive assessment for multiple sclerosis (BICAMS).

Mult Scler Relat Disord 2019 Nov 21;36:101408. Epub 2019 Sep 21.

Norwegian Multiple Sclerosis Competence Center, Department of Neurology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Background: Cognitive impairment is a common symptom in all stages of multiple sclerosis (MS), yet it is underreported and not routinely evaluated. The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) is a short and easily administered test battery for screening of cognitive impairment in MS that can be completed within 15 min and incorporated into routine clinical practice. The test battery consists of the oral version of the Symbols Digit Modalities Test (SDMT) and the initial learning trials of the California Verbal Learning Test 2nd edition (CVLT-II) and the Brief Visuospatial Memory Test Revised (BVMT-R).

Objective: To investigate if the Norwegian version of the BICAMS could identify cognitive impairment in early stages of MS and be used as part of routine follow-up procedures.

Methods: A total of 65 relapsing-remitting MS (RRMS) patients and 68 healthy controls were examined with the BICAMS test battery. A randomly selected subset of 29 controls were retested 1-4 weeks after baseline. All participants were screened for anxiety and depression using the Hospital Anxiety and Depression Scale (HADS).

Results: There were statistically significant differences between the patients with MS and the healthy controls on all three subtests, and the differences remained significant for the CVLT-II (p = 0.003) and BVMT-R (p = 0.011) after adjusting for education. There were no statistically significant correlations between BICAMS scores and anxiety and depression. SDMT and BVMT-R results in the control group at baseline and re-test were strongly correlated (r ≥ 0.70, p < 0.001), and CVLT-II achieved an adequate value of r = 0.60 (p = 0.001). On the SDMT, there was a statistically significant improvement between the two test-sessions. Cognitive impairment, defined as an abnormal test score on ≥1 subtest, was identified in 46.2% of the patient sample, whereas 15.4% were considered cognitively impaired on ≥2 subtests.

Conclusion: This study supports that the Norwegian version of the BICAMS should be included as a screening procedure for cognitive impairment in Norwegian MS patients.
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http://dx.doi.org/10.1016/j.msard.2019.101408DOI Listing
November 2019

Validation of the multiple sclerosis diagnosis in the Norwegian Patient Registry.

Brain Behav 2019 11 4;9(11):e01422. Epub 2019 Oct 4.

Department of Neurology, Nordland Hospital Trust, Bodø, Norway.

Background: Health registries may yield important data for epidemiological studies. However, in order to be a valuable source for information, the registered data have to be correct.

Objectives: The aim of the study was to validate data from the Norwegian Patient Registry (NPR) regarding multiple sclerosis (MS).

Materials And Methods: We obtained data on individuals residing in Nordland County and registered with a MS diagnosis in the NPR or in local hospital records. The NPR data included a unique 11-digit personal identity number that made it possible to identify the individuals medical records. For each individual registered with MS in the NPR, the hospital record was scrutinized in order to confirm or rule out the diagnosis.

Results: In Nordland County, 657 individuals had MS 1 January 2017. Of these, 637 were recorded with a correct diagnosis of MS in the NPR, while 59 were recorded incorrectly. Incorrect registration was due to a diagnosis that did not fulfill the diagnostic criteria, later investigation had ruled out MS or it was an error in the diagnostic code registration process. Twenty individuals were not registered with MS in the NPR. These were patients who received their diagnosis before data in the NPR were person identifiable (before 2008), and who later had no MS-registered contact with public specialist healthcare services. The sensitivity is 0.97, and the positive predictive value is 0.92.

Conclusion: Data from the NPR gave a good estimate of the occurrence of MS, but nearly one in 10 registered diagnoses was not correct.
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http://dx.doi.org/10.1002/brb3.1422DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851797PMC
November 2019

Risk of cancer among multiple sclerosis patients, siblings, and population controls: A prospective cohort study.

Mult Scler 2020 10 1;26(12):1569-1580. Epub 2019 Oct 1.

Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital, Bergen, Norway/Department of Clinical Medicine, University of Bergen, Bergen, Norway/Department of Neurology, Haukeland University Hospital, Bergen, Norway.

Background: Risk of cancer in multiple sclerosis (MS) patients compared to their siblings is unknown.

Objective: The objective was to prospectively investigate the risk of cancer among MS patients compared to siblings without MS and to population controls.

Methods: We retrieved data on MS patients born between 1930 and 1979 from the Norwegian Multiple Sclerosis Registry and population studies and on cancer diagnosis from the Cancer Registry of Norway. We used adjusted Cox proportional hazard regression to estimate cancer risk among 6883 MS patients, 8918 siblings without MS, and 37,919 population controls.

Results: During 65 years of follow-up, cancer risk among MS patients was higher than that among population controls (hazard ratio (HR) = 1.14, 95% confidence interval (CI): 1.05-1.23) in respiratory organs (HR = 1.66, 95% CI: 1.26-2.19), urinary organs (HR = 1.51, 95% CI: 1.12-2.04), and the central nervous system (HR = 1.52, 95% CI: 1.11-2. 09). Siblings had higher risk of hematological cancers compared with MS patients (HR = 1.82, 95% CI: 1.21-2.73) and population controls (HR = 1.72, 95% CI: 1.36-2.18).

Conclusion: MS patients were associated with increased risk of cancer compared to population controls. Siblings had increased risk of hematological cancer. This indicates that MS and hematological cancer could share a common etiology.
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http://dx.doi.org/10.1177/1352458519877244DOI Listing
October 2020
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