Relapse Rate In Multiple Sclerosis Research Articles

Seasonal Variations in Multiple Sclerosis Relapses in Oman: A Single Tertiary Centre Experience

(1) Background and Aims: The seasonal factors influencing multiple sclerosis (MS) relapses remain elusive. This study aims to investigate the seasonal variation of MS relapses in Oman and compare it globally. (2) Subject and Methods: This retrospective study was conducted on N = 183 Omani MS patients treated at Sultan Qaboos University Hospital, a tertiary hospital in Muscat, Oman, over sixteen-year period (2007–2022). Demographic and clinical data of all MS patients were juxtaposed with the monthly weather data during this period, using descriptive and inferential statistical techniques. (3) Results: Among the N = 183 MS patients studied, 508 relapses were recorded during the study period. The average number of relapses per patient was 2.8 (range: 1–15). There were significant seasonal variations in MS relapse rate, with the highest prevalence in the winter months of January and February. However, no correlation was found between MS relapses and other climatic parameters (humidity, temperature, and rainfall). (4) Conclusion: The seasonal patterns of MS relapses in Oman differ from other parts of the world, which the local clinicians should take into account while diagnosing and making management decisions. The potential impact of climate change on the anomalous changes in the seasonality of MS relapses warrants further investigation.

Evaluation of ovarian reserve and the assisted reproductive technology (ART) cycles’ outcome as well as the relapse rate within one year after ART in women with multiple sclerosis: a case-control study

ObjectiveTo compare the ovarian reserve and the results of infertility treatment, as well as to investigate the relapse rate in the first year after the assisted reproductive technology (ART) cycle in patients with multiple sclerosis (MS) referred to Royan Institute.Materials and methodsThis retrospective study was carried out to evaluate all women diagnosed with MS and referred to Royan Institute for assessment and treatment of possible infertility between 2011 and 2022. The control group consisted of randomly selected healthy women with tubal factor infertility who were referred for treatment during the same time period and matched in terms of age. A comparison was made between groups in terms of ovarian reserve and infertility treatment outcomes. Additionally, patients with MS who met the criteria were monitored via telephone to evaluate the symptoms, disability and relapse rate both pre- and post-ART.ResultsOver the course of a decade, the database documented a total of 60 cases diagnosed with MS. Upon examination of the records, it was found that in 27 patients only admission was done without any hormonal assessment or infertility treatment cycle and 5 patients proceeded with the intrauterine insemination cycle. Eventually, 28 women with MS underwent the ART cycle and all of them were treated with interferon beta, glatiramer acetate, or some oral disease modifying therapies. No statistically significant difference in terms of the basal levels of luteinizing hormone, follicle-stimulating hormone and anti-Müllerian hormone was found between the MS and control groups (P > 0.05). Two groups were comparable in terms of menstrual status. The study revealed that both groups exhibited similarities in terms of the controlled ovarian stimulation protocol and duration, the dosage of gonadotropin administered, as well as the ovarian response type, clinical pregnancy rate, and live birth rate (P > 0.05). After follow up, only 2 patients (9.5%) reported relapse of symptoms within one year after ART.ConclusionThe ovarian reserve and ovarian stimulation cycle and pregnancy outcomes following the ART cycle in MS patients were similar to the age-matched control group. The relapse rate of multiple sclerosis did not show a significant increase within a year following the ART cycle.

Treatment of Multiple Sclerosis with Cladribine Tablets: Literature Review and the Guidance of the Lithuanian Association of Neurologists

Cladribine is a disease-modifying drug used for the treatment of the highly active relapsing-remitting form of multiple sclerosis. Cladribine is a purine nucleoside analogue which selectively targets lymphocyte subpopulations involved in the pathogenesis of multiple sclerosis, and therefore it is classified as an immune reconstitution therapy drug. Two short courses of cladribine tablets given over two years significantly reduce the multiple sclerosis relapse rate and disability progression. For most patients, the effect persists in the third and the fourth year. This makes cladribine convenient for patients with multiple comorbidities, difficulties in adhering to their prescribed treatment regimen, those planning a pregnancy, or those for whom long-term immunosuppression is undesirable. Cladribine tablets are denoted by good safety characteristics, with the most prominent adverse effect being lymphopenia, which does not lead to an increased risk of infections other than Herpes zoster.However, in clinical practice, there are a number of issues related both to the initial administration of cladribine tablets and the strategy of treatment in different clinical situations during the first-to-fourth years of treatment, and particularly after the fourth year. Although there are no contraindications for additional courses of cladribine tablets, the product information does not provide detailed guidance on their continued use. During more than five years after the approval of the medicinal product, the new clinical trial data and the Real-World Evidence (RWE) on the efficacy and safety of cladribine tablets have become available, based on which, several national and international expert panels, as well as the Lithuanian Association of Neurologists, have issued guidance on the use of cladribine tablets reviewed in this article. Upon reactivation of the disease, additional courses of cladribine tablets or other disease-modifying therapies may be prescribed, depending on various factors related to the severity of the relapse, patient characteristics, and previously used medications. If the patient’s condition remains stable after the fourth year, extension of the treatment-free period with the structured monitoring approach could be appropriate.

Physical activity is related to disease severity and fatigue, but not to relapse rate in persons with relapsing remitting multiple sclerosis - a self-reported questionnaire based study.

Based on theoretical models, physical activity has been introduced as a promoting method to mitigate the disease severity, fatigue and relapse rate in multiple sclerosis. The primary objective of the study was to investigate the relation between self-reported physical activity level and disease severity, fatigue and relapse rate in persons with relapsing remitting multiple sclerosis (RRMS). A survey was offered to persons with RRMS from March 2019 to August 2021 (n = 253). Physical activity level, fatigue and disease severity were determined using the Godin Leisure-Time Questionnaire (GLTEQ), the Patient Determined Disease Steps (PDDS) scale and the Fatigue Scale for Motor and Cognitive Functions (FSMC). Additionally, participants' relapse rate was recorded. Bivariate correlations revealed an inverse relation between physical activity level and PDDS (ρ = -0.279; p < 0.001) as well as between physical activity and FSMC (r = -0.213, p < 0.001), but not between physical activity and relapse rate (r = 0.033, p > 0.05). Multiple linear regression analyses explained 12.6% and 5.2% of the variance of PDDS and FSMC. Our findings confirm a relation between self-reported physical activity, disease severity and fatigue in persons with RRMS. However, self-reported physical activity level does not seem to affect the annualised relapse rate.

Deep learning-based PET/MR radiomics for the classification of annualized relapse rate in multiple sclerosis.

Background Annualized Relapse Rate (ARR) is one of the most important indicators of disease progression in patients with Multiple Sclerosis (MS). However, imaging markers that can effectively predict ARR are currently unavailable. In this study, we developed a deep learning-based method for the automated extraction of radiomics features from Positron Emission Computed Tomography (PET) and Magnetic Resonance (MR) images to predict ARR in patients with MS. Methods Twenty-five patients with a definite diagnosis of Relapsing-Remitting MS (RRMS) were enrolled in this study. We designed a multi-branch fully convolutional neural network to segment lesions from PET/MR images. After that, radiomics features were extracted from the obtained lesion volume of interest. Three feature selection methods were used to retain features highly correlated with ARR. We combined four classifiers with different feature selection methods to form twelve models for ARR classification. Finally, the model with the best performance was chosen. Results Our network achieved precise automatic lesion segmentation with a Dice Similarity Coefficient (DSC) of 0.81 and a precision of 0.86. Radiomics features from lesions filtered by Recursive Feature Elimination (RFE) achieved the best performance in the Support Vector Machines (SVM) classifier. The classification model performance was best when radiomics from both PET and MR were combined to predict ARR, with high accuracy at 0.88 and Area Under the ROC curves (AUC) at 0.96, which outperformed MR or PET-based model and clinical indicators-based model. Conclusion Our automatic segmentation masks can replace manual ones with excellent performance. Furthermore, the deep learning and PET/MR radiomics-based model in our research is an effective tool in assisting ARR classification of MS patients.

The relevance of fatigue to relapse rate in multiple sclerosis: Applying patient preference data to the OPTIMUM trial

Background: In the OPTIMUM trial in patients with relapsing MS, treatment differences in annualized relapse rate (ARR, 0.088) and change in fatigue at week 108 (3.57 points, measured using the Fatigue Symptoms and Impacts Questionnaire–Relapsing Multiple Sclerosis, symptom domain (FSIQ-RMS-S)) favored ponesimod over teriflunomide. However, the importance of the fatigue outcome to patients was unclear. Objective: To assess the importance of the OPTIMUM FSIQ-RMS-S results using data from an MS discrete choice experiment (DCE). Methods: The DCE included components to correlate levels of physical and cognitive fatigue with FSIQ-RMS-S scores. Changes in relapses/year and time to MS progression equivalent to the treatment difference in fatigue in OPTIMUM were determined for similar fatigue levels as mean baseline fatigue in OPTIMUM. Results: DCE participants would accept 0.06 more relapses/year or a 0.15–0.17 year decrease in time to MS progression for a 3.57-point difference in physical fatigue on the FSIQ-RMS-S. To improve cognitive fatigue by 3.57-points on the FSIQ-RMS-S, DCE participants would accept 0.09–0.10 more relapses/year or a 0.24–0.28 year decrease in time to MS progression. Conclusion: MS patients would accept 0.06 more relapses/year to change their fatigue by a similar magnitude as the between-treatment difference observed in the OPTIMUM trial.

Anti-CD20 therapy for multiple sclerosis-associated uveitis: Acase series.

Approximately 1% of patients with multiple sclerosis (MS) have uveitis, but data on the effects of immunotherapies for MS on MS-associated uveitis are scarce. The aim of this study was to investigate the ophthalmological outcomes in patients with MS-associated uveitis treated with anti-CD20 therapy. A retrospective study of 12 eyes of six patients with MS-associated uveitis, refractory to previous immunotherapies, was conducted. Uveitis activity was assessed before initiation of anti-CD20 therapy and at regular follow-up visits. Primary outcome measures were: vitreous haze score; retinal vasculitis score, determined on fluorescein angiography images; macular edema, as quantified by central retinal thickness (CRT) on optical coherence tomography; and visual acuity (VA). Secondary outcomes included number of annualized uveitis or MS relapses, disease activity on cerebral magnetic resonance imaging (cMRI) and Expanded Disability Status Scale (EDSS) score. After a median (interquartile range [IQR]) treatment time of 28.5 (8-43) months, anti-CD20 therapy was associated with an improvement of vitreous haze score (p= 0.002), retinal vasculitis score (p= 0.001), CRT (p= 0.002), and VA (p= 0.007). The median (IQR) annualized uveitis relapse rate declined from 0.59 (0.56-0.94) before to 0 (0-0.49) after the start of anti-CD20 therapy. The median (IQR) annualized MS relapse rate declined from 0.62 (0.26-2.84) before to 0 (0-0) after the start of anti-CD20 therapy. After initiation of anti-CD20 therapy, there was no disease activity on cMRI, and EDSS score improved (n= 2) or remained stable (n= 4). No severe adverse events were observed. These findings suggest that anti-CD20 therapy may be a valuable treatment option for MS-associated uveitis.

Decreasing Multiple Sclerosis Treatment Expenditures and Improving Quality at the Health System Level.

ObjectiveThis study was undertaken to evaluate a multicomponent health system intervention designed to reduce escalating disease‐modifying treatment (DMT) expenditures and improve multiple sclerosis (MS) outcomes by increasing use of preferred formulary and highly effective DMTs (HETs).MethodsWe conducted a trend study of treatment utilization and expenditure outcomes prior to (2009–2011) and during (2012–2018) MS Treatment Optimization Program (MSTOP) implementation in Kaiser Permanente Southern California (KPSC) compared to a Kaiser Permanente region of similar size. Annual relapse rates (ARRs) were obtained from KPSC's electronic health records.ResultsAdherence to preferred formulary DMTs increased from 25.4% in 2011 to 72.2% in 2017 following MSTOP implementation in KPSC and 22.1% to 43.8%, respectively, in the comparator. KPSC's annual DMT expenditures in 2018 were less than in 2011 despite an 11.3% increase in DMT‐treated members. The decline in average per patient per year of treatment expenditures from a peak of $43.1 K in 2014 to $26.3 K in 2018 in KPSC was greater than the comparator, which peaked at $52.1 K and declined to $40.0 K in 2018. Over the 7 years following initiation of MSTOP, cumulative MS DMT expenditures were $161.6 million less than the comparator. HET use increased to 62.5% of per patient treatment‐years versus 32.4% in the comparator. This corresponded to a 69% decline in adjusted ARR (95% confidence interval = 64.1–73.2%; p < 0.0001) among DMT‐treated patients in KPSC.InterpretationA novel, expert‐led health system intervention reduced MS DMT expenditures despite rising prices while simultaneously reducing MS relapse rates. Our focus on health system progress toward meaningful, measurable targets could serve as a model to improve quality and affordability of MS care in other settings. ANN NEUROL 2022;92:164–172

Deep Learning-Based PET/MR Radiomics for the Prediction of Annualized Relapse Rate in Multiple Sclerosis

Deep Learning-Based PET/MR Radiomics for the Prediction of Annualized Relapse Rate in Multiple Sclerosis

Encephalitogenic and Regulatory CD8 T Cells in Multiple Sclerosis and Its Animal Models.

Multiple sclerosis (MS), a neuroinflammatory disease that affects millions worldwide, is widely thought to be autoimmune in etiology. Historically, research into MS pathogenesis has focused on autoreactive CD4 T cells because of their critical role in the animal model, experimental autoimmune encephalomyelitis, and the association between MS susceptibility and single-nucleotide polymorphisms in the MHC class II region. However, recent studies have revealed prominent clonal expansions of CD8 T cells within the CNS during MS. In this paper, we review the literature on CD8 T cells in MS, with an emphasis on their potential effector and regulatory properties. We discuss the impact of disease modifying therapies, currently prescribed to reduce MS relapse rates, on CD8 T cell frequency and function. A deeper understanding of the role of CD8 T cells in MS may lead to the development of more effective and selective immunomodulatory drugs for particular subsets of patients.

Changes in structural and functional connectivity during two years of fingolimod therapy for multiple sclerosis

BackgroundFingolimod, an oral drug, has been reported to reduce relapse rate in multiple sclerosis (MS). However disease progression may still occur in spite of control of inflammation. Functional imbalances within and between cerebral networks associated with disruption of structural and functional network integrity, have been reported in MS. An effective therapy is expected to stabilize such functional network integrity. ObjectiveThe purpose of this study was to investigate changes in structural and resting-state functional connectivity of motor and cognitive networks, and associated changes in neurologic scores in MS, during 2 years of fingolimod therapy. MethodsTwenty five subjects with MS were recruited for this study. Subjects were scanned with diffusion tensor imaging (DTI) and resting-state functional connectivity MRI (fcMRI) scan protocol at 3 T with 6-month interval over a period of 2 years. Neurologic performance scores of motor and cognitive performances were also obtained. ResultsDTI measures worsened during the 1st year and then stabilized; any trend of stabilization of fcMRI was delayed until the 2nd year. While motor performance did not change, cognitive performance showed improvement. Several baseline DTI measures correlated with relevant neurologic scores. ConclusionInitial worsening of motor and cognitive network was reported after 1 year of treatment, but seems DTI and fcMRI measures seem to stabilize after around one year fingolimod therapy.

Discontinuation of disease-modifying treatments in multiple sclerosis to plan a pregnancy: A retrospective registry study

BackgroundFor safety reasons multiple sclerosis (MS) treatment guidelines recommend stopping or delaying the onset of disease-modifying therapies (DMT) before a planned pregnancy, but disease stability after DMT discontinuation is not well studied. The objective of this study is to describe the course of MS in patients who interrupted DMT before a planned pregnancy. MethodsThis was a retrospective study using 2008–2016 data from a multicenter register of pregnancies in women with MS. In this paper, we present data from the subgroup of women with relapsing-remitting MS (RRMS) who interrupted DMT to try to conceive. Data from 1 and 3 years before DMT interruption, the period between DMT interruption and conception or resuming DMT, during pregnancy and one year postpartum were analyzed. Annualized relapse rates (ARR), Expanded Disability Status Scale (EDSS) scores, and magnetic resonance imaging (MRI), obstetric, and neonatal data were collected. ResultsTwenty-seven women interrupted DMT (19 β-interferon, 5 glatiramer acetate, 2 natalizumab and 1 fingolimod) to try to conceive. After a mean of 10.6 months 6 women stopped trying to conceive and resumed DMT, while 21 women became pregnant after a mean of 7.0 months. In the overall cohort, in the period from when DMT was discontinued to when pregnancy was confirmed or DMT resumed, the ARR was 1.08, which was significantly higher than the ARR 1 year (0.44; p = 0.01) and 3 years (0.4; p = 0.06) before DMT discontinuation. The mean EDSS score when pregnancy was confirmed or DMT resumed was significantly higher than at DMT discontinuation (1.8 vs 1.36, p = 0.011). In the subgroup of patients who became pregnant, the ARR in the untreated period before pregnancy was 0.98, which was significantly higher than the ARR 1 year (0.38; p = 0.03) and 3 years (0.39; p = 0.0077) before DMT discontinuation. The ARR decreased to 0.51 during pregnancy and then increased to 0.76 during the first postpartum trimester (not significant). One year after delivery, the mean EDSS score (1.86) was significantly higher than at DMT cessation (1.35, p = 0.027) or pregnancy confirmation (1.45, p = 0.026). Patients who suffered relapses following DMT cessation before becoming pregnant had an 11-fold higher risk of relapse during pregnancy (relative risk [RR] = 11.1 [95%CI 1.6, 75], p = 0.002) and a 3-fold higher risk during the postpartum year (RR = 3.0 [95%CI 1.3,6.6], p = 0.007) than those who did not suffer relapses in period between DMT withdrawal and pregnancy. ConclusionsIn this retrospective registry study, discontinuation of DMT (mostly immunomodulatory drugs), to try to conceive resulted in an increase in MS relapse rates and disability progression.

The Effect of Interferon on Relapse Rate in Multiple Sclerosis

Multiple sclerosis (MS) is a chronic inflammatory demyelinating central nervous system disease that typically strikes young adults, especially women. The pathobiology of MS includes inflammatory and neurodegenerative mechanisms that affect both white and gray matter. This was a retrospective comparative study conducted on 50 patients with Multiple Sclerosis (MS); to assess EDSS score (Expanded Disability Status Scale) and Relapse Rate of M.S patients after one year of receiving Interferon. This is Retrospective, randomized study included Fifty Egyptian patients with relapsing RRMS were recruited from Neurology department of Maadi military hospital and Ain Shams university hospital, as well as outpatient clinics. The included patients were all receiving medications in the form of disease modifying therapies (DMTs) (Immunomodulators). Results; the mean age of all patients was (32.5 ± 3.6) years. Regarding gender of the patients, the majority (66%) of patients were males; while (34%) were females. Comparative study between the 3 groups revealed Non-significant difference as regards age and sex of the patients (p > 0.05). highly significant decrease in 1-year EDSS score and relapse rate, in Rebif® then Betaferon® group; compared to Avonex® group (p < 0.01 respectively). Spearman's correlation analysis shows that; Age, and age at onset, had a highly significant positive correlation with 1-year relapse rate (p < 0.05 respectively).

Discovery of fingolimod based on the chemical modification of a natural product from the fungus, Isaria sinclairii.

Fingolimod is a first-in-class of sphingosine-1-phosphate (S1P) receptor modulator and is widely used a therapeutic drug for multiple sclerosis (MS), autoimmune disease in the central nervous system. About 25 year ago, a natural product, myriocin was isolated from culture broths of the fungus Isaria sinclairii. Myriocin, a rather complex amino acid having three successive asymmetric centers, was found to show a potent immunosuppressive activity in vitro; however, it induced a strong toxicity in vivo. To find out a less toxic immunosuppressive candidate, the chemical structure of myriocin was simplified to a nonchiral symmetric 2-substituted-2-aminoproane-1,3-diol framework. Finally, a highly potent immunosuppressant, fingolimod was found by the extensive chemical modification and pharmacological evaluation using skin allograft model in vivo. Throughout the analyses of the mechanism action of fingolimod, it is revealed that S1P receptor 1 (S1P1) plays an essential role in lymphocyte circulation and that the molecular target of fingolimod is S1P1. Phosphorylated fingolimod acts as a "functional" antagonist at S1P1, modulates lymphocyte circulation, and shows a potent immunosuppressive activity. Fingolimod significantly reduced the relapse rate of MS in the clinical studies and has been approved as a new therapeutic drug for MS in more than 80 countries.

Change in pregnancy-associated multiple sclerosis relapse rates over time: a meta-analysis

BackgroundWomen with MS are advised that relapse rates fall during pregnancy and rebound post-partum. This advice originates from 1998; smaller, more recent, studies have not been previously pooled. MethodsAll studies published since 1998 providing raw relapse data were considered for inclusion. Single arm meta-analysis was performed using a restricted maximum likelihood random effects model with inverse variance; secondary subgroup analysis and meta regression were then performed. Annualised relapse rates (ARR), or relapse numbers/rates suitable for conversion into ARR during pregnancy and the post-partum period were included. Secondary subgroup analysis examined year of data collection, DMT exposure, breastfeeding and data source. Results7034 pregnancies from 6430 women were included. ARR fell from 0.57 (95%CI 0.45-0.70) pre-pregnancy to 0.36 (0.28-0.44), 0.29 (0.21-0.36) and 0.16 (0.11-0.21) during trimesters 1,2, and 3, with a post-partum rebound (ARR 0.85, 95%CI 0.70-1.00). ARR reduced pre-pregnancy and post-partum over time (p<0.001). Relapse rates were lower in claims databases than elsewhere. ConclusionsDespite high heterogeneity, we confirm the historic assumption that ARR reduces during pregnancy, and demonstrate an overall reduction in ARR over time. Studies using data originating from claims databases demonstrated a lower relapse rate at all time points, which has not previously been demonstrated.

Multiple sclerosis relapse rates and healthcare costs of two versions of glatiramer acetate

Objective: To compare relapse rates and healthcare costs in MS patients treated with Glatopa 20 mg (generic glatiramer acetate) versus Copaxone 20 mg in a US managed care population.Methods: A retrospective claims study was conducted using the HealthCore Integrated Research Database. Patients with ≥1 Glatopa or Copaxone claim between 01 April 2015 (Glatopa) or 01 January 2013 (Copaxone) and 30 April 2018 were included. Patients with prior Copaxone 40 mg use or <1 year continuous health plan enrollment were excluded. Patients who switched from Glatopa to Copaxone were censored. Glatopa users were matched to Copaxone users, and outcomes measured at 6–12 months follow-up.Results: A total of 357 Glatopa and 2291 Copaxone patients qualified for inclusion; 158 per cohort were retained after matching. Baseline characteristics were well-balanced (mean age 49.9 years, 75% female, mean 3.8 Copaxone fills). At baseline, 8% of patients had ≥1 relapse with mean annualized relapse rates (ARR) of 0.18; at follow-up, the relapse rates were 8% versus 15% (Glatopa versus Copaxone; p = .05), and ARRs were 0.12 versus 0.30 (p = .05). 45% of Glatopa patients switched (back) to Copaxone 20/40 mg and were censored at that point. Mean (SD) all-cause medical and pharmacy costs were $51,507 ($28,494) versus $55,085 ($37,061; p = .50). Mean MS-related costs were $45,379 ($24,732) versus $47,949 ($32,615; p = .67), of which mean disease modifying therapy costs were $42,926 ($23,196) versus $44,932 ($28,554; p = .59). Results were similar in sensitivity analyses.Conclusions: In this real-world study, MS patients treated with Glatopa experienced similar health outcomes and costs compared to those treated with Copaxone, with a trend towards lower relapse rates (borderline statistically significant) and cost savings (not statistically significant).

Treatment and management of cognitive dysfunction in patients with multiple sclerosis.

Cognitive impairment is a common and devastating manifestation of multiple sclerosis (MS). Although disease-modifying therapies have been efficacious for reducing relapse rates in MS, such treatments are ineffective for treating cognitive dysfunction. Alternative treatment approaches for mitigating cognitive problems are greatly needed in this population. To date, cognitive rehabilitation and exercise training have been identified as possible candidates for treating MS-related cognitive impairment; however, cognitive dysfunction is still often considered to be poorly managed in patients with MS. This Review provides a comprehensive overview of recent developments in the treatment and management of cognitive impairment in people with MS. We describe the theoretical rationales, current states of the science, field-wide challenges and recent advances in cognitive rehabilitation and exercise training for treating MS-related cognitive impairment. We also discuss future directions for research into the treatment of cognitive impairment in MS that should set the stage for the inclusion of cognitive rehabilitation and exercise training into clinical practice within the next decade.

Impact of Switching to Fingolimod Versus Injectable Disease-Modifying Therapy Cycling on Risk of Multiple Sclerosis-Related Relapses: A Retrospective Analysis.

Clinical and real-world studies have shown significant reductions in multiple sclerosis (MS) relapses with fingolimod versus injectable disease-modifying therapies (DMTs). Multiple sclerosis relapse rate and incidence were compared in patients switching from an injectable DMT to fingolimod and those cycling from one injectable DMT to another or remaining on their original injectable DMT. Retrospective analysis was performed using Commercial and Medicare Supplemental claims data (July 1, 2010, to June 30, 2016) of adults with MS receiving ≥1 injectable DMT. Relapses were identified from MS-related hospitalization, outpatient emergency department or office visit, and corticosteroid administration. Annualized relapse rate ratio was estimated. Of 16,352 patients, 1110 were switchers to fingolimod, 908 were injectable DMT cyclers, and 14,334 were nonswitchers. At baseline, rate and incidence of MS relapses were higher in switchers and injectable DMT cyclers versus nonswitchers (P < .001); mean ± SD relapse rates declined from 0.4 ± 0.7, 0.4 ± 0.7, and 0.2 ± 0.5 at baseline to 0.2 ± 0.5, 0.3 ± 0.6, and 0.1 ± 0.4 after follow-up in switchers, injectable DMT cyclers, and nonswitchers, respectively. Relapse incidence declined in each cohort. The highest reductions in relapse rate and incidence were in switchers to fingolimod, where relapse risk was significantly reduced versus injectable DMT cyclers (22%, P = .0433) and nonswitchers (47%, P < .001). This study provides evidence that patients switching from an injectable DMT to fingolimod have the highest reductions in annualized rate and incidence of MS relapses and significantly reduced risk of relapse versus injectable DMT cyclers and nonswitchers.

Effect of pregnancy and exclusive breastfeeding on multiple sclerosis relapse rate and degree of disability within two years after delivery

ObjectivesPregnancy and lactation are important issues for women with multiple sclerosis (MS). The purpose of this study was to investigate the effect of pregnancy and exclusive breastfeeding on the rate of relapse and degree of disability within two years after delivery among patients with relapsing remitting multiple sclerosis (RRMS). Patients and Methods30 pregnant women with RRMS who had exclusive breastfeeding for 4 months were compared with 67 non-pregnant women with RRMS between 2012 and 2017. Each patient was examined every three months for 33 months. In the study group, patients were examined at the beginning of pregnancy, and then every three months till 24th months after delivery. ResultsIn the study group, Expanded Disability Status Scale (EDSS) during the third trimester of pregnancy, between four to nine month after delivery, and the last 6 months of the study were significantly lower than the control group (p < 0.05). At the end of the study, the mean EDSS of the study group was significantly lower than the control group (p < 0.05). Also, EDSS during the second and third trimesters of pregnancy were significantly lower than the EDSS before pregnancy (p < 0.05). The mean number of relapses in the second and third trimesters of pregnancy, between four to six months after delivery, and the total number of relapses were significantly lower than the control group. ConclusionPregnancy and exclusive breastfeeding can have a positive effect in reducing relapse rate and disability. This effect will continue until the 24th month after childbirth.

Recommendations for neurological, obstetrical and gynaecological care in women with multiple sclerosis: a statement by a working group convened by the Section of Multiple Sclerosis and Neuroimmunology of the Polish Neurological Society.

Multiple sclerosis (MS) is the most common non-traumatic neurological cause of disability in young adults, affecting women 1-3 times more often than men. Several specific challenges arise from the fact that young women diagnosed with MS often have to make decisions related to treatment and family planning at the same time. These issues are connected with fertility, the impact of pregnancy on disease course, the choice of pregnancy timing, and the optimal mode of disease-modifying therapy in the context of a planned pregnancy, contraception, urological complaints, and sexual dysfunction. While MS does not in itself adversely affect fertility, pregnancy or childbirth, pregnancy needs to be carefully planned. This requires the interdisciplinary co-operation of a neurologist, gynaecologist and psychologist. Data on the impact of disease-modifying drugs on foetal development are very limited, and none of these drugs is 100% safe during pregnancy. In the second and third trimesters, MS relapse rate decreases. Unfortunately, it increases within the first 3-6 months after delivery. Adequate disease control should be achieved before pregnancy, as relapse rate in the period of two years preceding pregnancy is one of the strongest predictive factors for post-partum relapses. The following is a statement by a working group of experts in neurology, gynaecology, obstetrics and urology, convened by the Section of Multiple Sclerosis and Neuroimmunology of the Polish Neurological Society, addressing the issues that are specific to the female MS population. The aim of this statement is to provide guidance in pregnancy planning and disease management, both during pregnancy and post-partum. This statement reflects expert opinion and is not intended to be read as guidelines. It rather provides up-to-date information on how to optimise care of female MS patients of childbearing age.