Use Of Disease-modifying Therapies Research Articles

Impact of previous treatment history and B-cell depletion treatment duration on infection risk in relapsing-remitting multiple sclerosis: a nationwide cohort study

BackgroundB-cell depletion displays striking effectiveness in relapsing-remitting multiple sclerosis (RRMS), but is also associated with increased infection risk. To what degree previous treatment history, disease-modifying therapy (DMT) switching pattern and...

Association of patient-reported cognitive impairment with quality of life and employment in multiple sclerosis

Background:Cognition is frequently affected in persons with multiple sclerosis (MS). Cognitive impairment (CI) is associated with decreased quality of life (QOL) and employment status. Yet, CI assessed using patient-reported outcome measures is not as well studied and is thought to be influenced by other symptoms. Health Utilities Index 3 (HUI3) is a multi-attribute health-status classification system that assesses 8 different single attributes, including cognition.Methods:The North American Consortium of Multiple Sclerosis (NARCOMS) Registry, a voluntary, self-report registry for persons with MS, Spring 2019 survey collected the HUI3 and self-reported assessment of health-related QOL (RAND-12), cognitive status, depression, fatigue, disability, employment, disease-modifying therapy use, and sociodemographic data. We assessed the relationship between patient-reported cognitive CI from the HUI3 (HUI-C), QOL, and employment while adjusting for factors previously associated with the outcomes. For employment outcomes, the cohort was limited to participants 65 years of age or younger.Results: Of the 6,227 respondents, 56.4% reported cognitive difficulty with the HUI-C. After adjusting for multiple covariates, cognitive difficulty was associated with 1.2 point lower physical QOL for each 0.1 decrease in HUI-C (p <0.0001). Mental QOL decreased by 2 points for each 0.1 decrease in HUI-C (p <0.0001). Cognitive difficulty was associated with a 10% decreased odds of employment in the multivariable model (p <0.0001).Discussion: Patient reported CI was associated with lower health-related and vocational outcomes for MS patients, even after accounting for age, income, depression, fatigue, and disability associated with cognition. The HUI-C is a single attribute score derived from the HUI3 that may facilitate the evaluation of CI in MS.

Association Between Disease-Modifying Therapy and Information Processing Speed in Multiple Sclerosis.

Cognitive impairment (CI) is common in multiple sclerosis (MS). Processing speed (PS) is often affected, making it an ideal target for monitoring CI. This study aims to evaluate the association between disease-modifying therapy (DMT) use and intensity and longitudinal changes in Processing Speed Test (PST) scores for individuals with MS. A retrospective analysis of individual PST scores at a single MS center was conducted. Individuals with 2 or more PST assessments were included. Scores on the PST were compared longitudinally between those who had been on a DMT for 2 or more years and those who had been off a DMT for 2 or more years and between those on high-efficacy DMTs and those on low-/moderate-efficacy DMTs. A linear regression model was approximated to evaluate the rate of cognitive change over time. A propensity score adjustment was conducted using a multivariable logistic regression. The cohort was 642 individuals, 539 on DMT and 103 off DMT. Median age and disease duration was 49.7 (IQR 42.4-57.9) and 16.6 years (IQR 9.3-23.0) in the DMT group, and 58.9 (IQR 52.2-65.3) and 20.0 years (IQR 14.1-31.4) in the non-DMT group. Both cohorts were predominantly female (75% DMT, 79.6% non-DMT), with a mean of 4 assessments (IQR 3-5), and an average monitoring duration of 1.9 years (1.2-2.4) in the DMT group, and 1.8 years (1.4-2.4) in the non-DMT group. After adjusting for multiple factors, DMT status and intensity were not found to be significant predictors of longitudinal PST change. Neither DMT status nor intensity was a significant predictor of cognitive processing speed over a period of approximately 2 years. Future prospective studies are needed to further support these findings.

Iraqi experts consensus on the management of relapsing remitting multiple sclerosis in adults

Objective In Iraq, a lack of evidence-based management protocols for diagnosing, treating, and managing multiple sclerosis (MS) poses risks of suboptimal outcomes and clinical practice variability and potential harm to the patients. This study aimed to develop consensus recommendations regarding the diagnosis and management of MS in Iraq, specifically focusing on treatment-naïve patients, suboptimal responders, and women of childbearing age during preconception, pregnancy planning, and lactation. Methods A survey was conducted to collect feedback from a panel of ten key opinion leaders (KOLs), who evaluated and discussed the statements to determine agreement levels. The mini-Delphi method was employed to establish a consensus on the management recommendations, and a meeting was held to analyze the responses and ensure that the recommendations were based on current evidence and followed a consensus-driven approach. Results The Revised McDonald Criteria is recommended for MS diagnosis, which includes evidence of dissemination of disease characteristics in space and time. Disease activity and progression can be monitored using relapses, MRI activity, and short-term disability progression. Experts suggest initiating treatment at diagnosis using higher efficacy medications, such as cladribine, ocrelizumab, natalizumab, or rituximab, for patients with high disease activity after careful risk stratification. Injectable interferon preparations have a tolerable risk profile but have drawbacks, such as the route and frequency of administration. Overall, disease-modifying therapies (DMTs) have shown efficacy in reducing relapse rates and short-term disability. Conclusion This article presents expert panel recommendations for managing MS in Iraq, taking into account international guidelines, medication updates, and local resources. However, practical questions remain regarding the real-world use of disease-modifying therapies (DMTs). Personalizing treatment based on disease severity, prognosis, and individual risk factors while adhering to guidelines is crucial. A collaborative approach between healthcare providers and patients, considering individual preferences, is vital for achieving treatment goals.

Patterns of multiple sclerosis presentation to the emergency department.

Multiple sclerosis (MS) patients are no strangers to the emergency department (ED) due to the relapsing and progressive nature of the disease and the associated complications. This study aimed to identify patterns of ED visits among patients diagnosed with MS, the underlying causes of these visits, and the factors associated with these visits. This was a single center retrospective cohort study which utilized a non-probability consecutive sampling technique to include all patients diagnosed with MS (471 patients) from March 2016 to October 2021 in King Abdulaziz Medical City, Jeddah, Saudi Arabia. ED visits were categorized as directly related to MS, indirectly related to MS, or unrelated to MS. One in four people with MS visited the ED at least once with a total of 280 ED visits. Most ED visits were ones directly related to MS 43.6%, closely followed by unrelated to MS 41.1%, and then indirectly-related MS visits 15.4%. The most common presenting symptoms in directly-related MS visits were weakness 56.6% and numbness/tingling 56.6% followed by gait impairment 29.5%. Indirectly related to MS or unrelated to MS ED visits were commonly due to neurological 17.7% and gastrointestinal 17.1% causes. Using disease modifying therapy (DMT) was significantly associated with no ED visits (p < 0.001). The use of high-efficacy DMTs was significantly associated with no ED visits than using moderate efficacy DMT (p < 0.001). The use of B-cell depleting therapy (ocrelizumab and rituximab) was significantly associated with no visits to the ED than using any other DMT (p < 0.001). Evidence of brain atrophy on imaging was significantly associated with patients who presented to the ED ≥3 times (p = 0.006, UOR = 3.92). Due to the nature of the disease, many MS patients find themselves visiting the ED due to MS related and unrelated issues. These patients are not only required to be treated by neurologists but also by multiple disciplines. The use of high-efficacy DMTs and B-cell depleting therapy may reduce the total frequency of ED visits. Special attention should be paid to patients who have evidence of brain atrophy on imaging.

Is disease-modifying therapy use in multiple sclerosis a risk factor during the COVID-19 pandemic? A large cohort study

Objective: This study aims to investigate the relationship between disease-modifying therapies (DMTs) used in people with MS (pwMS) and the risk of COVID-19 infection. Methods: This longitudinal cohort study included the MS cohort of 3402 people followed for COVID-19 infection. The whole MS cohort was interviewed at least once for information about COVID-19. A semi-structured interview was developed and performed by a team consisting of a medical doctor, nurse, and physiotherapist. Clinical information was obtained from the patient's medical records. This study was approved by the Noninvasive Research Ethics Board (Date: 08.09.2021, Decision No: 2021/25-06). Results: Of the 487 pwMS infected with COVID-19, 35 reported reinfections. The major differences regarding DMT between pwMS with and without COVID-19 infection were observed for fingolimod, ocrelizumab, and azathioprine. Forty-three (8.9%) people experienced the COVID-19 infection severely or critically; 12 (37.5%) had MS treatment with ocrelizumab. Fifty percent of pwMS who were treated in intensive care (7/14 patients) and died (3/6 patients) were being treated with ocrelizumab. As a result of regression analysis, being younger and using dimethyl fumarate, fingolimod, ocrelizumab, and cladribine DMTs were the main factors associated with having COVID-19 infection group. Conclusions: Current results show that disability due to MS and increased disease duration are not risk factors for COVID-19 infection, while age is negatively associated with contracting COVID-19 infection. These results show no relationship between the MS clinic and COVID-19 infection. We have found that using certain DMTs in pwMS increases the risk of contracting COVID-19 infection.

Disease-modifying therapies for sickle cell disease: Decisional needs and supports among adolescents and young adults.

Shared decision-making is one promising solution to addressing barriers in use of disease-modifying therapies for adolescents and young adults (AYAs) with sickle cell disease (SCD). A thorough understanding of decisional needs can guide the development of decisional supports and promote shared decision-making. Informed by the Ottawa Decision Support Framework (ODSF), we conducted a qualitative analysis to assess decisional needs and supports reported by AYAs with SCD, their caregivers, and healthcare providers. Semi-structured qualitative interviews were conducted with AYAs and their caregivers, and online crowdsourcing was used with SCD providers. Thematic and descriptive content analyses were used to summarize perspectives on decisional needs and supports regarding disease-modifying therapies. Fourteen AYAs (Mage =21years, 57% male, 93% non-Hispanic Black, 79% HbSS), 11 caregivers (80% female, 100% non-Hispanic Black), and 40 healthcare providers (65% female, 65% non-Hispanic White, Myears in practice =14.8years, 75% physicians) participated. Thematic analysis revealed needs related to: decisional conflict, inadequate knowledge, unclear expectations, and inadequate supports and resources. Six forms of support emerged as important for decision-making: establishing an open and trusting patient/family-provider relationship, providing information, accepting ambivalence and unreadiness, supporting implementation of a decision, addressing inadequate health and social services, and promoting adequate social, emotional, and instrumental help. This is the first study to assess decisional needs and supports for AYAs with SCD considering disease-modifying therapies. Additional research is needed to examine which decision supports are the most impactful to promote effective shared decision-making in this population.

Geographical Variation In Medication and Health Resource Use In Multiple Sclerosis.

Understanding disease-modifying therapy (DMT) use and healthcare resource utilization by different geographical areas among people living with multiple sclerosis (pwMS) may identify care gaps that can be used to inform policies and practice to ensure equitable care. Administrative data was used to identify pwMS on April 1, 2017 (index date) in Alberta. DMT use and healthcare resource utilization were compared between those who resided in various geographical areas over a 2-year post-index period; simple logistic regression was applied. Among the cohort (n = 12,338), a higher proportion of pwMS who resided in urban areas (versus rural) received ≥ 1 DMT dispensation (32.3% versus 27.4%), had a neurologist (67.7% versus 63.9%), non-neurologist specialist (88.3% versus 82.9%), ambulatory care visit (87.4% versus 85.3%), and MS tertiary clinic visit (59.2% versus 51.7%), and a lower proportion had an emergency department (ED) visit (46.3% versus 62.4%), and hospitalization (20.4% versus 23.0%). Across the provincial health zones, there were variations in DMT selection, and a higher proportion of pwMS who resided in the Calgary health zone, where care is managed by MS tertiary clinic neurologists, had an outpatient visit to a neurologist or MS tertiary clinic versus those who resided in other zones where delivery of MS-related care is more varied. Urban/rural inequalities in DMT use and healthcare resource utilization appear to exist among pwMS in Alberta. Findings suggest the exploration of barriers with consequent strategies to increase access to DMTs and provide timely outpatient MS care management, particularly for those pwMS residing in rural areas.

Comparative Effectiveness of Natalizumab, Fingolimod, and Injectable Therapies in Pediatric-Onset Multiple Sclerosis: A Registry-Based Study.

Patients with pediatric-onset multiple sclerosis (POMS) typically experience higher levels of inflammation with more frequent relapses, and though patients with POMS usually recover from relapses better than adults, patients with POMS reach irreversible disability at a younger age than adult-onset patients. There have been few randomized, placebo-controlled clinical trials of multiple sclerosis (MS) disease-modifying therapies (DMTs) in patients with POMS, and most available data are based on observational studies of off-label use of DMTs approved for adults. We assessed the effectiveness of natalizumab compared with fingolimod using injectable platform therapies as a reference in pediatric patients in the global MSBase registry. This retrospective study included patients with POMS who initiated treatment with an injectable DMT, natalizumab, or fingolimod between January 1, 2006, and May 3, 2021. Patients were matched using inverse probability treatment weighting. The primary outcome was time to first relapse from index therapy initiation. Secondary study outcomes included annualized relapse rate; proportions of relapse-free patients at 1, 2, and 5 years; time to treatment discontinuation; and times to 24-week confirmed disability worsening and confirmed disability improvement. A total of 1,218 patients with POMS were included in this analysis. Patients treated with fingolimod had a significantly lower risk of relapse than patients treated with injectable DMTs (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.29-0.83; p = 0.008). After adjustment for prior DMT experience in the unmatched sample, patients treated with natalizumab had a significantly lower risk of relapse than patients treated either with injectable DMTs (HR, 0.15; 95% CI 0.07-0.31; p < 0.001) or fingolimod (HR, 0.37; 95% CI 0.14-1.00; p = 0.049). The adjusted secondary study outcomes were generally consistent with the primary outcome or with previous observations. The findings in the inverse probability treatment weighting-adjusted patient populations were confirmed in multiple sensitivity analyses. Our analyses of relapse risk suggest that natalizumab is more effective than fingolimod in the control of relapses in this population with high rates of new inflammatory activity, consistent with previous studies of natalizumab and fingolimod in adult-onset patients and POMS. In addition, both fingolimod and natalizumab were more effective than first-line injectable therapies. This study provides Class II evidence that patients with POMS treated with natalizumab had a lower risk of relapse than those with fingolimod.

Practical Considerations for Managing Pregnancy in Patients With Multiple Sclerosis: Dispelling the Myths.

Lack of consistent data and guidance have led to variations between clinicians in the management of pregnancy in women with multiple sclerosis (MS). Pregnant and/or lactating women are often excluded from clinical trials conducted in MS, and thus, the labeling for most disease-modifying therapies (DMTs) excludes use during pregnancy. This has led to heterogeneity in interpretation and labeling regarding the safety of DMTs during pregnancy and lactation and the required preconception washout periods. This review identifies key themes where there is conflicting information surrounding family planning and pregnancy in MS, focusing on the most common discussion points between physicians and patients during preconception planning, pregnancy, postpartum, and lactation. The goal was to inform the patient-physician conversation and provide best practice recommendations based on expert clinical expertise and experience. We outline the latest evidence-based data for DMT use during pregnancy and lactation, the effect of MS on fertility and fertility treatments, the risk of adverse pregnancy and delivery outcomes, the risk of postpartum relapse, and immunization and clinical imaging safety during pregnancy and breastfeeding. Management of family planning and pregnancy in patients with MS requires the most current information. Health care providers should discuss family planning early and frequently with patients with MS, and partners where practicable. Because management of pregnant people with MS will often require a risk/benefit analysis of their needs, shared decision-making in family planning discussions is emphasized. Additional data are needed for specific and underrepresented populations with MS (e.g., single parents or those from the LGBTQ+ community) and those at risk of racial and socioeconomic disparities in care. Pregnancy registries and the design and conduct of clinical trials focused on pregnant and lactating patients should provide additional data to guide the ongoing management of patients with MS.

Shifting our attention earlier in the multiple sclerosis disease course.

Revisions of multiple sclerosis (MS) diagnostic criteria enable clinicians to diagnose patients earlier in the biologic disease course. Prompt initiation of therapy correlates with improved clinical outcomes. This has led to increased attention on the earliest stages of MS, including the MS prodrome and radiologically isolated syndrome (RIS). Here, we review current understanding and approach to patients with preclinical MS. MS disease biology often begins well before the onset of typical MS symptoms, and we are increasingly able to recognize preclinical and prodromal stages of MS. RIS represents the best characterized aspect of preclinical MS, and its diagnostic criteria were recently revised to better capture patients at highest risk of conversion to clinical MS. The first two randomized control trials evaluating disease modifying therapy use in RIS also found that treatment could delay or prevent onset of clinical disease. Despite progress in our understanding of the earliest stages of the MS disease course, additional research is needed to systematically identify patients with preclinical MS as well as capture those at risk for developing clinical disease. Recent data suggests that preventive immunomodulatory therapies may be beneficial for high-risk patients with RIS; though management remains controversial.

Persons with multiple sclerosis older than 55years: an analysis from the German MS registry.

Persons with MS (PwMS) ≥ 55years are underrepresented in therapy studies leading to a lack of evidence. To study the subgroup of PwMS ≥ 55years in the German MS registry in comparison with PwMS < 55years. Endpoints of interest were the grade of disability, leading symptoms, clinical and magnetic resonance imaging activity, and use of disease modifying therapy. At the time of analysis, data from 40,428 PwMS were available for analysis. In PwMS aged ≥ 65 and PwMS aged ≥ 55 to 64years, compared with PwMS aged < 55years, the mean Expanded Disability Status Scale Scores were higher (5.3, 4.2 and 2.7, respectively), while the proportion of individuals with current use of disease modifying therapy was lower (42.6%, 60.9% and 76.7%, respectively). The older patient groups were more likely to be labeled with progressive MS and the frequency of occupational invalidity was high (38.8% in PwMS aged ≥ 55 to 64years). Gait disorder, fatigue, bladder dysfunction, and spasticity were among the leading symptoms in PwMS aged ≥ 55years. PwMS ≥ 55years have a high degree of disability, but a large proportion do not receive disease modifying therapy, exposing an unmet need.

Male sexual and reproductive health in multiple sclerosis: a scoping review.

Multiple sclerosis (MS) is a chronic neuroinflammatory disease with highest incidence during the period of optimal reproductive health. This scoping review aimed to identify and summarize available data on sexual/reproductive health in males with MS (MwMS). This review was based on PRISMA extension for Scoping Review. PubMed database was searched for keyword "multiple sclerosis" alongside keywords "sexual health", "reproductive health", "family planning", "male fertility", "male infertility", "sexual dysfunction", and "erectile dysfunction", iteratively using the "AND" logical operator. Descriptive analysis was performed on the included articles. Thirty-four studies were included, and four topics emerged: sexual dysfunction, erectile dysfunction, fertility, and family planning. Sexual dysfunction is common in MwMS (35-72%), yet only a minority of MwMS discuss their sexual health with their treatment teams. Both MS disability and depression were associated with sexual dysfunction in MwMS, with erectile dysfunction and decreased libido as the most prevalent aspects of sexual dysfunction. Positively, phosphodiesterase-5 inhibitors appear effective for treating erectile dysfunction and improving sexual quality of life in MwMS. There may also be a relationship between MS and male infertility, though changes in sexual behavior may underlie this association. Finally, a prominent knowledge gap was observed for disease-modifying therapy use and family planning in MwMS. Sexual dysfunction is common, impacted by MS severity, and associates with decreased quality of life in MwMS. Communication barriers regarding sexual and reproductive health appear to exist between MwMS and providers, as do literature gaps related to MS therapeutics and sexual/reproductive health.

Limited utility of adding 3T cervical spinal cord MRI to monitor disease activity in multiple sclerosis

Background: Performing routine brain magnetic resonance imaging (MRI) is widely accepted as the standard of care for disease monitoring in multiple sclerosis (MS), but the utility of performing routine spinal cord (SC) MRI for this purpose is still debatable. Objective: This study aimed to measure the frequency of new isolated cervical spinal cord lesions (CSLs) in people with MS (pwMS) undergoing routine brain and cervical SC-MRI for disease monitoring and determine the factors associated with the development of new CSLs and their prognostic value. Methods: We retrospectively identified 1576 pwMS who underwent follow-up 3T brain and cervical SC-MRI over a 9-month period. MRI was reviewed for the presence of new brain lesions (BLs) and CSLs. Clinical records were reviewed for interval relapses between sequential scans and subsequent clinical relapse and disability worsening after the follow-up MRI. Results: In 1285 pwMS (median interval: 13–14 months) who were clinically stable with respect to relapses, 73 (5.7%) had new CSLs, of which 49 (3.8%) had concomitant new BLs and 24 (1.9%) had new isolated CSLs only. New asymptomatic CSLs were associated with ⩾ 3 prior relapses (p = 0.04), no disease-modifying therapy (DMT) use (p = 0.048), and ⩾ 3 new BLs (p < 0.001); ⩾ 3 new BLs (OR: 7.11, 95% CI: 4.3–11.7, p < 0.001) remained independently associated with new CSLs on multivariable analysis. Having new asymptomatic CSLs was not independently associated with subsequent relapse or disability worsening after the follow-up MRI (median follow-up time of 26 months). Conclusion: Routine brain and cervical SC-MRI detected new isolated CSLs in only < 2% of clinically stable pwMS. Developing new asymptomatic CSLs was associated with concomitant new BLs and did not confer an independent increased risk of relapse or disability worsening. Performing SC-MRI may not be warranted for routine monitoring in most pwMS, and performing only brain MRI may be sufficient to capture the vast majority of clinically silent disease activity.

Seizures in Multiple Sclerosis are, above all, a Matter of Brain Viability

Objectives: Most patients with Multiple Sclerosis (MS) never have a seizure, although they are at risk for seizures since the onset of MS. This paradox leads us to suppose that MS plays a minor role in seizure generation and epileptogenesis. Methods: Qualitative study using data triangulation and inductive content analysis. A comprehensive literature search was carried out in four electronic databases (MEDLINE, Embase, Web of Science, and Google Scholar). Results: In MS patients, unprovoked seizures occur rarely (in about 3 percent of cases). Pediatric MS involves seizures more common than adult or late-onset MS. In general, children with seizures do not have poorer MS prognoses than children without seizures. Contrary to the general population, seizures do not peak in older MS patients. Since the use of disease-modifying therapies in the treatment of MS (i.e., since 1993), the frequency of seizures in MS patients has not changed considerably. Epilepsy syndrome cannot be recognized in MS patients with seizures. As a rule, seizures in MS are not difficult to treat. A sudden unexpected death in MS patients with seizures has not been observed more commonly than in the general epilepsy population. A disruption of the blood–brain barrier is the most obvious proconvulsive factor of MS. However, neither MS relapses nor a high rate of MS relapses is normally accompanied by seizures. Structural brain abnormalities usually accumulate over the course of MS. However, a high brain magnetic resonance imaging lesion load does not have a substantial impact on seizure occurrence in MS. Conclusion: MS does not have a major role in seizure generation and epileptogenesis. In most cases, the seizure-promoting effects of MS can be successfully counteracted by the brain´s protective mechanisms.

Disease-modifying therapy use and health resource utilisation associated with multiple sclerosis over time: A retrospective cohort study from Alberta, Canada

BackgroundEstimating multiple sclerosis (MS) prevalence and incidence, and assessing the utilisation of disease-modifying therapies (DMTs) and healthcare resources over time is critical to understanding the evolution of disease burden and impacts of therapies upon the healthcare system. MethodsA retrospective population-based study was used to determine MS prevalence and incidence (2003–2019), and describe utilisation of DMTs (2009–2019) and healthcare resources (1998–2019) among people living with MS (pwMS) using administrative data in Alberta. ResultsPrevalence increased from 259 (95% confidence interval [CI]: 253–265) to 310 (95% CI: 304, 315) cases per 100,000 population, and incidence decreased from 21.2 (95% CI: 19.6–22.8) to 12.7 (95% CI: 11.7–13.8) cases per 100,000 population. The proportion of pwMS who received ≥1 DMT dispensation increased (24% to 31% annually); use of older platform injection therapies decreased, and newer oral-based, induction, and highly-effective therapies increased. The proportion of pwMS who had at least one MS-related physician, ambulatory, or tertiary clinic visits increased, and emergency department visits and hospitalizations decreased. ConclusionsAlberta has one of the highest rates of MS globally. The proportion of pwMS who received DMTs and had outpatient visits increased, while acute care visits decreased over time. The landscape of MS care appears to be rapidly evolving in response to changes in disease burden and new highly-effective therapies.

Prognostic indicators for hospitalization and ICU admission in people with multiple sclerosis and COVID-19: an analysis of the COVID-19 in MS global data sharing initiative dataset

Objectives: To analyze the symptoms and severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (pwMS) on disease-modifying therapies using data from the COVID-19 in multiple sclerosis (MS) Global Data Sharing Initiative dataset. Methods: The open-access COVID-19 in MS Global Data Sharing Initiative dataset was obtained through credentialed access using PhysioNet. The variables analyzed included BMI, symptoms of COVID-19, age, current use of disease-modifying therapy (DMT), efficacy of DMT, comorbidities, hospitalization status, and type of MS. A linear regression analysis was completed. Data analysis and visualization were completed using STATA v15, R-Studio v1.1.447, Python v3.8, and its associated libraries, including NumPy, Pandas, and Matplotlib. Results: A total of 1141 participants were included in the analysis. 904 women and 237 men were diagnosed with MS. Among the pwMS included in the study; 208 (19.54%) had a suspected infection with COVID-19 and only 49 (5.25%) were confirmed. Any COVID-19 symptom was present in 360 individuals. The commonly reported DMT agents included dimethyl fumarate (12.71%) and fingolimod (10.17%). 101 in total (8.85%) reported not using any DMT. Factors associated with hospitalization and/or admission to the ICU included having any comorbidity (P=0.01), neuromuscular disorder (P=0.046), hypertension (P=0.005), chronic kidney disease (P&lt;0.001), and immunodeficiency (P=0.003). The type of MS, the duration of the disease, and high-efficacy DMT therapy did not have a statistically significant influence on hospitalization. Conclusion: This study underscores the importance of comorbidities, especially neuromuscular disorders, hypertension, chronic kidney disease, and immunodeficiencies, as possible prognostic indicators for worse outcomes of COVID-19 in pwMS. On the contrary, the type of MS, the duration of the disease, and the efficacy of disease-modifying therapy did not significantly affect the severity of the symptoms of COVID-19 in this cohort.

Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

IntroductionAutologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial,...

Use of multiple sclerosis disease-modifying therapies during pregnancy in France: Nationwide study between 2010 and 2021.

Multiple sclerosis (MS) frequently affects women of childbearing age and pregnant women. To assess the use of MS disease-modifying therapies (DMTs) during pregnancy in France over the last decade, marked by an increasing DMTs availability. All pregnancies ended from April 2010 to December 2021 in women with MS were identified based on the nationwide Mother-Child Register EPI-MERES, built from the French National Health Data System (Système National des Données de Santé (SNDS)). Of a total of 20,567 pregnancies in women with MS, 7587 were exposed to DMT. The number of DMT-exposed pregnancies markedly increased from 1079 in 2010-2012 to 2413 in 2019-2021 (+124%), especially those exposed to glatiramer acetate, natalizumab, dimethyl fumarate, and anti-CD20. Among pregnancies of women on DMT 6 months before pregnancy, 78.0% underwent DMT discontinuation and 7.6% switched DMT, generally before (33.0% and 77.0%, respectively) or during the first trimester of pregnancy (58.3% and 17.8%, respectively). DMT discontinuation decreased from 84.0% in 2010-2012 to 72.4% in 2019-2021 and was less frequent among women aged ⩾35 years and those socioeconomically disadvantaged. Despite MS therapeutic management adaptations to pregnancy, exposure during pregnancy to treatments whose safety profile has not yet been clearly established has increased sharply over the last decade.

Recent trends in disease-modifying therapy use and associated sickness absence and disability pension among people with multiple sclerosis in Sweden

Background: Disease-modifying therapies (DMTs) have led to improved health and work productivity among people with multiple sclerosis (PwMS). Objectives: To describe trajectories of recent DMT use and their association with sickness absence and/or disability pension (SADP) among PwMS in Sweden. Methods: A longitudinal register–based study was conducted among 1395 PwMS with treatment start in 2014/2015. While DMT use over 5 years was assessed using sequence analysis resulting in four clusters, a 7-year (Y−2 toY4) trend of SADP was analyzed using zero-inflated negative binomial regression. Results: Four clusters of DMT use trajectories were identified: long-term non-high-efficacy (483, 34.6%), long-term high-efficacy (572, 41%), escalation (221, 15.8%), and discontinuation (119, 8.5%). Progressive MS and higher expanded disability status scale scores were associated with the escalation, long-term high-efficacy, or discontinuation clusters. PwMS in the long-term high-efficacy and escalation clusters had higher likelihood of being on SADP. However, PwMS initiating high-efficacy DMTs demonstrated steeper decline in SADP than others. Conclusion: Using sequence analysis, this study showed recent DMT use trajectories among PwMS where initiation of high-efficacy DMTs has become more common. The trend of SADP was stable and lower in those using non-high-efficacy DMTs and larger improvements were shown in those initiating high-efficacy DMTs.