Pregnancy Outcomes in Men and Women Treated With Teriflunomide. A Population-Based Nationwide Danish Register Study

Background: The majority of persons diagnosed with multiple sclerosis (MS) experience their first MS symptoms in the reproductive age. Teriflunomide (TFL, Aubagio), was first released in Denmark for relapsing-remitting MS in December 2013. TFL treatment is contraindicated in women of childbearing potential who are not using reliable contraception. TFL can be transmitted via semen and a low risk of male-mediated embryo-fetal toxicity is described.Objective: To report pregnancy outcomes of TFL-treated women and partners to TFL-treated men: gestation week.Methods: Prospective cohort study comparing pregnancy outcomes of TFL-treated men and women, matched on age at conception, 1:4 with controls from the general population. Data on TFL-treated patients treated 1st of January 2014–31st of December 2016 for at least 30 consecutive days prior to conception, and with conception occurring latest 2 years after treatment discontinuation were extracted from The Danish Multiple Sclerosis Registry and merged with several national reproductive registries. Logistic regression was used to analyse the association between TFL exposure and any adverse event.Results: A total of 31 pregnancies were recorded, 13 women and 18 of partners to a TFL-treated man. All 18 partners of TFL-treated men completed their pregnancies: livebirth (18), gestation time >37 weeks (17), gestation time 33–36 weeks (1), normal birth weight (18), spontaneous and elective abortion (0), congenital malformation (plagiocephali) (1), normal delivery (14), induced delivery (2), cesarean section (2), Apgar score ≥7 (18). Among the 13 pregnancies in women exposed to TFL: elective abortion (11), spontaneous abortion (0), livebirth (2), gestation time >37 weeks (2), normal birth weight (2), congenital malformations (0), normal delivery (1), induced delivery (1), Apgar score ≥7 (2). The TFL group was associated with a 22% reduction in the odds of any adverse event relative to controls, although this association was not significant (OR 0.78; 95% CI 0.16–3.72, p = 0.753).Conclusion: Pregnancy outcomes were consistent with those of the general population. The malformation reported of the partner to a TFL-treated man is comparable to the rate of plagiocephaly reported in Denmark

Comorbidity in the aging population with multiple sclerosis: a Danish nationwide study

IntroductionMultiple sclerosis (MS) is a neurodegenerative disease accumulating disabilities over time. However, the mean age of individuals with MS is increasing, consequently elevating their risk of developing comorbidities. Comorbidities' impact on MS is widely debated. Yet very few countries possess population-based registries, which provide unique opportunities for individual-level data linkage. This study aims to assess acute and chronic comorbidities among elderly patients with MS, comparing them to matched controls. Additionally, this study seeks to investigate the influence of chronic comorbidities on all-cause mortality.MethodsA nationwide register-based study using the Danish Multiple Sclerosis Registry to identify all living patients with MS older than 50 years at the reference date (January 1st, 2022). Patients were matched 1:10 with individuals from the general population. Comprehensive healthcare data within the Danish hospital system were obtained. Chronic comorbidities were classified according to the Charlson Comorbidity Index, while acute comorbidities were based on ICD-10 codes and an “acute” admission type. To investigate all-cause mortality, a Cox regression analysis was conducted.ResultsThe study encompassed a total of 8,688 individuals with MS, matched with 86,880 controls. The mean age was 63.5 years, with females constituting 68.3%. Individuals with MS exhibited a higher frequency of acute hospitalizations (OR: 2.1, 95% CI: 1.9–2.2), primarily due to various infectious diseases, along with longer median hospital stays (4 vs. 3 days, p < 0.001). When assessed using the Charlson Comorbidity Index, individuals with MS carried a significantly greater burden of chronic comorbidities (p < 0.001). The most prevalent chronic comorbidity among individuals with MS was “Uncomplicated Diabetes” (20.1%). Notably, while individuals with MS displayed an overall lower 5-year survival rate, this difference ceased to be statistically significant among those with a high Charlson Comorbidity Index score of ≥4 (p = 0.32).ConclusionThis study highlights a heightened prevalence of both acute and chronic comorbidities among individuals with MS, with chronic comorbidities significantly increasing the risk of mortality. These findings underscore the critical importance of factoring in comorbidities when devising treatment strategies for individuals living with MS

Patient involvement in the development of PROMs within the MS Field: A systematic review

This review reports on the development of patient-reported outcome measures (PROMs), published within the past ten years, for people with multiple sclerosis (PwMS). Moreover, this review evaluates the extent to which patient participation was integrated in the development of the PROMs. A systematic review was conducted, and four relevant articles were extracted, from which nine PROMs were identified. Patient involvement in the development phase was identified in three PROMs. The results emphasize the need for more patient involvement in the development of new MS-specific PROMs to ensure that the measures reflect the needs and priorities of PwMS. Experience Framework This article is associated with the Policy & Measurement lens of The Beryl Institute Experience Framework. (https://www.theberylinstitute.org/ExperienceFramework). Access other PXJ articles related to this lens. Access other resources related to this lens

Anti-SARS-CoV-2 vaccination in people with multiple sclerosis: Lessons learnt a year in.

It has been over a year since people with multiple sclerosis (pwMS) have been receiving vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With a negligible number of cases in which vaccination led to a relapse or new onset MS, experts around the world agree that the potential consequences of COVID-19 in pwMS by far outweigh the risks of vaccination. This article reviews the currently available types of anti-SARS-CoV-2 vaccines and the immune responses they elicit in pwMS treated with different DMTs. Findings to date highlight the importance of vaccine timing in relation to DMT dosing to maximize protection, and of encouraging pwMS to get booster doses when offered

Real-world operation of multiple sclerosis centres in Central-Eastern European countries covering 107 million inhabitants

In 2018 multiple sclerosis (MS) care unit (MSCU) recommendations were defined. Nevertheless, the information on MS care, and whether MS centres fulfil the international recommendation is limited. Thus our objectives were to assess whether centres meet the MSCU recommendations and gain a comprehensive overview of MS care in Central-Eastern European countries.A self-report questionnaire assessing aspects of the MSCU recommendations, disease-modifying therapy (DMT) and registry use and the patient number was assembled and sent to nine Central-Eastern European countries. Furthermore, one Danish and one German centre were contacted as a reference.In 9/9 countries, MS care was pursued in centres by MS neurologists and MS nurses. In Austria and the Czech Republic, management of MS was conducted under strict regulations displaying a referral centre system, fundamentally similar to but independent of the MSCU criteria. Several centres fulfilled all aspects of the MSCU criteria, while others had similar insufficiencies consisting of a speech therapist, continence, pain and spasticity specialist, neuro-ophthalmologist, and oto-neurologist. In 9/9 countries, DMTs were reimbursed. However, some centres did not provide every available DMT. A national registry was available in 4/9 countries with mandatory registry use only in Austria and the Czech Republic.In countries where MSCU recommendations are not fulfilled, a strictly regulated centre system similar to the Austrian and Czech model with a registry-based quality control might ensure appropriate care for people with MS