Search

Background: Immunosuppressive therapies as azathioprine (AZA), mycophenolate mofetil (MMF) and rituximab (RTX) are widely prescribed as first-line treatment to prevent relapses in NMOSD. However, the rate of response to these traditional therapies is unknown in Argentina. We aimed to describe and compare treatment failure rates in NMOSD patients included in the Argentinean MS and NMOSD registry (RelevarEM, NCT03375177)., Methods: A retrospective cohort study was conducted in NMOSD patients included in RelevarEM (a nationwide, longitudinal, observational, non-mandatory registry of MS and NMOSD in Argentina). NMOSD patients were defined based on validate diagnostic criteria. Only NMOSD patients who received AZA or MMF for at least 6 months or RTX for at least 1 month were included. Patients who were receiving AZA, MMF, or RTX and then switched to another 1 of these 3 therapies were included if the above-mentioned criteria for each drug were fulfilled. Data on patient demographics, clinical, neuroradiological findings, and treatments administered were collected. Treatment failure was defined as any new attack/relapse that occurred despite immunosuppressive treatment., Results: We included 139 NMOSD patients who were receiving AZA (n = 105), MMF (n = 5) or RTX (n = 29) with a mean follow-up time of 41.3 ± 11.4 months and median of EDSS at treatment initiation of 3. We observed a reduction in the annualized relapse rate from pre-treatment to post-treatment of 51.1 %, 48.4 %, and 79.1 % respectively with a Hazard Risk relative to RTX (95 % CI) of 1.67 (1.34-3.54, p = 0.01) for AZA and 2.01 (1.86-4.43, p = 0.008) for MMF. AZA, MMF and RTX failure was observed in 45/105 (42.8 %), 2/5 (40 %) and 3/29 (10.3 %) patients, respectively., Conclusions: Treatment failure rates were higher for AZA and MMF than RTX in Argentinean NMOSD patients in a real-world setting. High-efficacy treatment increases the opportunity to prevent attacks of NMOSD., Competing Interests: Declaration of competing interest The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Introduction: Cladribine was approved for Multiple Sclerosis (MS) in our country in 2018. A previous study by our group showed that its use among high efficacy therapies options has been increasing along the years., Objective: to analyze the cladribine use trend across time since its approval., Method: A retrospective cohort study was performed. People with MS (pwMS) treated with cladribine were included. Two periods were defined: P1 = 2018 - 2020 and P2 = 2021 - 2023. A comparative analysis was carry out between P1 and P2 to assess the trend of use, clinical/demographic characteristics, and effectiveness., Results: One hundred ninety- seven people with MS (pwMS) were included, mean EDSS: 2.2 ± 3.08, 72.6% female, mean age: 35.2 ± 9 years, mean disease duration: 6.6 ± 5.6 years, mean time lapse under cladribine: 26.1 ± 12.4 months. Regarding patient profile, we found significant differences between P1 and P2 in the MS evolution (p = 0.001) and EDSS ( p = 0.018) prior to initiation of cladribine. In the individualized analysis by year, we found a decrease in relapse number in the year prior to starting cladribine (p = 0.02). A higher proportion of No Evidence of Disease Activity (NEDA) was found in patients treated at P2 compared to those treated at P1 (p < 0.001)., Conclusion: An earlier use of cladribine achieved a significant increase in reaching NEDA. This learning curve in the use of cladribine allows a better identification of the candidate patient and influences the treatment effectiveness., Competing Interests: Declarations Ethics approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Ethics Committee of the institutions involved. Competing interests None of the authors present conflicts of interest in relation to this research., (© 2024. Fondazione Società Italiana di Neurologia.)

Background: We assessed the effectiveness, safety and patient-reported outcomes (PROs) of dimethyl fumarate (DMF) in real-world clinical practice in patients with multiple sclerosis (PwMS) from Argentina., Methods: We conducted a multicenter ambispective cohort study in Argentina between September 2020 and March 2023. Changes in annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score, magnetic resonance imaging (MRI), no evidence of disease activity (NEDA), PROs (depression, anxiety, fatigue, burden of treatment and quality of life), and safety data were collected at clinical visits performed every 6 months for at least 24 months., Results: We included 161 PwMS (64% female). DMF treatment was associated with a significant reduction in ARR from baseline after 24 months of treatment (from 0.87 to 0.23, p < 0.001). Disability progression was observed in 27.9% vs. 9.3% pre- and post-DMF, and disability improvement was found in 13% of patients from baseline to month 24. MRI activity was significantly reduced compared with baseline. Fatigue, depression, and quality of life scores were significantly improved from baseline to 24 months. Flushing was the most frequent adverse event reported in 19.2%. No significant reduction was observed in the hospitalization rate pre- and post-DMF (19.8% vs. 5.6%, p = 0.32). During follow-up, 135 (83%) patients were relapse-free, 110 (68.3%) were MRI free activity (Gad + lesion) and 108 (67%) reached NEDA., Conclusions: DMF significantly reduced disease activity in PwMS from Argentina with a good safety profile in real-world settings. A significant impact on the quality of life during follow-up was found., Competing Interests: Declarations Ethics approval and consent to participate This study was approved by the ethics committee of each participating center. Informed consent A written or verbal informed consent for the use of the anonymized data for research objectives was obtained from all participants before data collection. Conflict of interest Edgar Carnero Contentti has received reimbursement for developing educational presentations, educational and research grants, consultation fees and travel stipends from Bayer Pharmaceuticals Corp., Merck, Roche, Novartis, Raffo, Amgen, TEVA, Biogen, Genzyme Corp, Biosidus, AstraZeneca, LACTRIMS, Harvard Medical School (Postgraduate Medical Education), The Guthy-Jackson Charitable Foundation and The Sumaira Foundation. Ricardo Alonso has received reimbursement for research grants and travel stipends from Merck, Biogen and Genzyme. Marcos Burgos has received reimbursement for developing educational presentations, consultations fees, clinical trials fees and travel stipends from Biogen, Genzyme, Merck, Novartis, Teva, Tuteur. Liliana Patrucco has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Darío Tavolini has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Edgardo Cristiano has received reimbursement for developing educational presentations and travel/accommodations stipends from Merck-Serono Argentina, Biogen-Idec Argentina, Genzyme Argentina, Bayer Inc., Novartis Argentina and TEVA-Tuteur Argentina. Juan I. Rojas has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen, Genzyme, Merck, Novartis, Roche and MSIF. Berenice Silva has received reimbursement for developing educational presentations, educational and research grants, consultation fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Pablo Lopez has received reimbursement for research grants and travel stipends from Merck, Biogen and Genzyme. Verónica Tkachuk has received reimbursement for developing educational presentations, consultations fees, clinical trials fees and travel stipends from Biogen, Genzyme, Merck, Novartis, Teva, Tuteur. Carolina Mainella has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen and Merck. Geraldine Luetic has received reimbursement for developing educational presentations, educational and research grants, consultations fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Emanuel Silva, Felisa Leguizamon, Santiago Tizio, Marina Alonso Serena has nothing disclose., (© 2024. Fondazione Società Italiana di Neurologia.)

We aimed to assess the treatment strategies utilized in patients with neuromyelitis optica spectrum disorder (NMOSD) experiencing relapses, including their frequency, types, and response after 6 months based on the Expanded Disability Status Scale (EDSS) score., Methods: We conducted a retrospective study involving NMOSD patients from the Argentinean MS and NMOSD registry (RelevarEM, NCT03375177). Treatment response at 6 months was categorized as "good" if the EDSS score decreased by ≥1 point after a nadir EDSS score ≤ 3, or by ≥2 points after a nadir EDSS score > 3, "poor" if the EDSS score decrease was slighter, and as "absent" if the EDSS score remained unchanged or worsened., Results: We included 120 NMOSD patients (seropositive N = 75), who experienced 250 NMOSD-related relapses and received 248 treatments. At 6 months, complete recovery was achieved in 70/98 (71.4%) and 15/19 (79%) patients, respectively. Predictors of a "good" response in our regression model were a younger age at disease onset (OR:3.54, CI95% 2.45-5.01, p < 0.0001) and a short delay from onset of relapse to treatment initiation (OR:1.56, CI95% 1.22-2.13, p = 0.004)., Conclusions: Approximately two-thirds of patients experienced complete recovery, and younger age and a short delay to start treatment were independent predictors of a "good" response., Competing Interests: Declaration of Competing Interest The authors declared no potential conflict of interest with respect to this research, authorship, and/or publication of this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Objective: The aim was to evaluate patient profiles, effectiveness and safety of cladribine (CLAD) in patients with relapsing-remitting multiple sclerosis in Argentina., Methods: This was a substudy included in RelevarEM (MS and neuromyelitis optica registry in Argentina, NCT03375177). Patients with MS who received CLAD tablets and were followed up for at least 24 months were included. Clinical evaluations every 3 months collect information about: a) clinical relapses; b) progression of physical disability, evaluated through Expanded Disability Status Scale, and c) new lesions found in the magnetic resonance imaging. Lymphopenia was evaluated during the follow-up and defined as grade 1: absolute lymphocyte count (ALC) 800-999/μL; grade 2: ALC 500-799/μL; grade 3: ALC 200-499/μL and grade 4: ALC <200/μL., Results: A total of 240 patients were included from 19 centers from Argentina. The mean annualized relapse rate during the 12-month pre-CLAD initiation was 1.19 ± 0.56 versus 0.22 ± 0.18 at month 12 and 0.19 ± 0.15 at month 24 ( P < 0.001). A total of 142 (59.2%) fulfilled the criteria of disease activity during the 12 months before treatment initiation, whereas 27 (11.3%) fulfilled it at month 12 and 38 (15.8%) at month 24, P < 0.001. Regarding no evidence of disease activity (NEDA), 202 (84.2%) patients achieved NEDA status at month 12 and 185 (77%) at month 24. The most frequent incidence density of lymphopenia for course 2 observed was also for grade 1, 6.1 (95% confidence interval [CI] = 5.5-7.1). The overall incidence density of lymphopenia grade 4 was 0.1 (95% CI = 0.06-0.19)., Conclusion: This information will help when choosing the best treatment option for Argentinean patients., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: We aimed to assess the frequency, duration, and severity of area postrema syndrome (APS) during follow-up in neuromyelitis optica spectrum disorder (NMOSD) patients, as well as its association with inflammatory activity and prognostic factors of APS severity in a real-world setting., Methods: We conducted a retrospective study on a cohort of Latin American (LATAM) NMOSD patients who had experienced APS during their follow-up. Patients from Mexico, Peru, Brazil, Colombia, Panama, Chile and Argentina patients who met 2015 NMOSD criteria were included. We evaluated data on symptom type (nausea, vomiting and/or hiccups), frequency, duration, severity (measured by APS severity scale), association with other NMOSD core relapses, and acute treatments (symptomatic and immunotherapy or plasmapheresis). Logistic regression was conducted to evaluate factors associated with APS severity (vs. mild-moderate)., Results: Out of 631 NMOSD patients, 116 (18.3%) developed APS during their follow-up. The most common APS phenotype was severe. Inflammatory activity (i.e., relapses) significantly decreased after the onset of APS. Half of the patients experienced isolated APS with a median duration of 10 days, and the most frequently used acute treatment was IV steroids. All three symptoms were present in 44.6% of the patients. APS symptoms resolved following immunotherapy. Logistic regression did not identify independent factors associated with the severity of APS., Conclusions: Our findings indicate that 18.3% of NMOSD patients developed APS during the follow-up period, with most patients fulfilling criteria for severe APS. The inflammatory activity decreased after the onset of APS compared to the previous year., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Knowledge of the safety and efficacy of disease-modifying therapies (DMTs) in older patients with Multiple Sclerosis (pwMS) is limited due to their exclusion from clinical trials. Our purpose is to evaluate the choice of DMTs in pwMS older than 50 years old in a real-world setting., Methods: Cross-sectional study of pwMS from the Argentine MS and NMOSD Registry. We included patients under 35 and above 50 years old prescribed DMTs. Disease activity was categorized as highly active (HA) or not highly active (NHA), and DMTs were classified as low efficacy therapies (LET) or high efficacy therapies (HET)., Results: 1460 patients (65% females) were enrolled. The HA group comprised 241 patients, 198 young (82.2%) and 43 older (17.8%). The NHA group included 1219 patients, 893 young (73%) and 326 older (27%). In the NHA group, older patients received LET more frequently than younger patients (66% versus 44%; p < 0.01). In the HA group, older patients received LET in 61% of cases, whereas younger patients received HET in 71% (p = 0.01)., Conclusion: The study shows the preference of LET in older patients regardless of disease activity. However it does not demonstrate a difference in disability in older patients based on low vs high efficacy DMTs used, probably due to the design of the study. Further longitudinal studies are warranted to address this issue., (Copyright © 2024 Elsevier B.V. All rights reserved.)

The objective of this study was to describe and compare the burden of treatment (BOT) and the quality of life (QoL) in early high efficacy therapy (HET) vs. escalation therapy in relapsing remitting multiple sclerosis (RRMS) patients included in RelevarEM, the Argentinean registry of MS (RelevarEM, NCT 03,375,177)., Methods: cross sectional study conducted between September and December 2022. Participating patients were adults, RRMS patients who initiated (during the last three years) their treatment with a HET (natalizumab, ocrelizumab, alemtuzumab, cladribine) or with escalation treatment (beta interferon, glatiramer acetate, teriflunomide, dimethyl fumarate or fingolimod). Clinical and demographic aspect were collected. QoL and BOT was measured with the validated to Spanish MusiQol and BOT questionnaire. Propensity score (PS)-based nearest-neighbor matching was applied to homogenize groups. Comparisons were be done using a linear regression analysis model stratified by matched pairs, with BOT and QoL assessments as main outcomes., Results: 269 patients were included in the analysis, mean age 33.7 ± 5.7 years, 193 (71.7 %) were female. A total of 136 patients were on early HET while 133 were on escalation therapy. In the entire group the mean total BOT score (±SD) was 48.5 ± 15.3 while in the group of patients receiving early HET we observed that the mean BOT score (±SD) was 43.5 ± 12.2 vs. 54.3 ± 13.3 in escalation treatment (p < 0.0001). Regarding the score QoL (±SD), in the entire sample we observed a global score of 77.4 ± 11.2. When we stratified groups, in HET (±SD) it was 81.3 ± 14 vs. 74.1 ± 18.3 in escalation therapy (p = 0.0003)., Conclusion: in this multicenter study that included 269 patients from Argentina we observed in early HET a significantly lower BOT and higher QoL than patients receiving escalation therapy., Competing Interests: Declaration of competing interest We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Clinical trials of disease-modifying therapies (DMTs) for people with multiple sclerosis (pMS) are conducted in selected populations, excluding patients with comorbidities or concomitant medications. However, a large percentage of pMS have some additional disease, which could affect the response and choice of the DMT. The objective of this review is to assess how concurrent pathologies can impact the choice of DMTs. Relevant articles were selected through a systematic search in PubMed. Comorbidities were grouped for better classification into autoimmune, chronic infections, cardiovascular and metabolic, oncological and neuropsychiatric. In autoimmune pathologies, it is key to take into account the effects of TME on them and the possibility of interaction with their specific treatments. Immunomodulatory therapies are safe for people with chronic infections. Immunosuppressive treatments are generally contraindicated in people with active infections. In cardiovascular and metabolic comorbidities, infusion reactions associated with monoclonal antibodies, and the phenomena of starting treatment with S1P modulators, must be taken into account. DMTs with an immunosuppressive effect are contraindicated in people with active malignancies. Although psychiatric pathology per se does not preclude the use of DMTs, caution should be exercised when new psychiatric symptoms appear. For these reasons, among the multiple factors that must be considered when starting or changing a DMT in pMS, comorbidities constitute a decisive element.

We aimed to evaluate the incidence of SARS-CoV-2 breakthrough infection of SARS-CoV-2 vaccines in people with MS (PwMS) on high-efficacy disease-modifying therapies (HET) included in the national MS registry in Argentina (RelevarEM)., Methods: Non-interventional, retrospective cohort study that collected information directly from RelevarEM. Adult PwMS who had been treated for at least 6 months with a HET (ocrelizumab, natalizumab, alemtuzumab, cladribine) who had received at least two doses of SARS-CoV-2 vaccines available in Argentina were included. Full course of vaccination was considered after the second dose of the corresponding vaccines. Cumulative incidence of SARS-CoV-2 infection was reported for the whole cohort by Kaplan-Meier survival curves (which is expressed in percentage) as well as incidence density (which is expressed per 10.000 patients/day with 95% CI)., Results: Two hundred twenty-eight PwMS were included. Most frequent first and second dose received was AstraZeneca vaccine, followed by Sputnik vaccine. Most frequent HETs used in included patients were cladribine in 79 (34.8%). We found an incidence density of breakthrough COVID-19 infection of 3.5 × 10.000 patients/day (95% CI 2.3-6.7) after vaccination in Argentina. We described the incidence rate after vaccination for every HET used, it being significantly higher for ocrelizumab compared with other HETs (p = 0.005). Only five patients presented a relapse during the follow-up period with no differences regarding the pre-vaccination period., Conclusions: We found an incidence density of breakthrough COVID-19 infection of 3.5 × 10.000 patients/day (95% CI 2.3-6.7) after vaccination in Argentina., (© 2023. Fondazione Società Italiana di Neurologia.)

Background: We aimed to assess the frequency of new asymptomatic lesions on brain and spinal imaging (magnetic resonance imaging (MRI)) and their association with subsequent relapses in a large cohort of neuromyelitis optica spectrum disorder (NMOSD) patients in Argentina., Methods: We retrospectively reviewed 675 MRI (225 performed during an attack and 450 during the relapse-free period (performed at least 3 months from the last attack)) of NMOSD patients who had at least 2 years of clinical and MRI follow-up since disease onset. Kaplan-Meier (KM) curves were used for depicting time from remission MRI to subsequent relapse., Results: We included 135 NMOSD patients (64.4% were aquaporin-4-immunoglobulin G (AQP4-IgG)-positive). We found that 26 (19.26%) and 66 (48.88%) of patients experienced at least one new asymptomatic MRI lesion during both the relapse-free period and attacks, respectively. The most frequent asymptomatic MRI lesions were optic nerves followed by short-segment myelitis during the relapse-free period and attacks. KM curves did not show differences in the time taken to develop a new relapse., Conclusion: Our findings showed that new asymptomatic lesions are relatively frequent. However, the presence of new asymptomatic MRI lesions during the relapse-free period and at relapses was not associated with a shorter time to developing subsequent relapses.

Background: The use of telemedicine has quickly increased during of the COVID-19 pandemic. Given that unmet needs and barriers to multiple sclerosis (MS) care have been reported, telemedicine has become an interesting option to the care of these patients. The objective of these consensus recommendations was to elaborate a guideline for the management of people with MS using telemedicine in order to contribute to an effective and high-quality healthcare., Methods: A panel of Argentinean neurologist's experts in neuroimmunological diseases and dedicated to the diagnosis, management,and care of MS patients gathered virtually during 2021 and 2022 to conduct a consensus recommendation on the use of telemedicine in clinical practice in adult people with MS. To reach consensus, the methodology of "formal consensus RAND/UCLA Appropriateness method" was used., Results: Recommendations were established based on relevant published evidence and expert opinion focusing on definitions, general characteristics and ethical standards, diagnosis of MS, follow-up (evaluation of disability and relapses of MS), identification and treatment of relapses, and finally disease-modifying treatments using telemedicine., Conclusion: The recommendations of this consensus would provide a useful guide for the proper use of telemedicine for the assessment, follow-up, management, and treatment of people with MS. We suggest the use of these guidelines to all the Argentine neurologists committed to the care of people with MS., (© 2022. Fondazione Società Italiana di Neurologia.)

Introduction: Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe neuroimmunological condition associated with a significant financial burden. NMOSD is also associated with increased health care utilization, including neurology outpatient visits, magnetic resonance imaging (MRI) use, long-term medication, among others. We aimed to evaluate real-world patient experiences in access to care and NMOSD burden in an Argentinean cohort., Methods: This cross-sectional study used a self-administered survey and was conducted in Argentina (2022). Patients with NMOSD were divided into three groups: private health insurance (PHI), social health insurance (SHI), and public health insurance (PHI, Ministry of Public Health). Differences in access and health care barriers were assessed., Results: One hundred patients with NMOSD (74 women) with a mean age at diagnosis of 38.7 years were included. Their EDSS was 2.8 and they were followed for 5.2 years. Of them, 51%, 11%, and 13% were employed (full-time: 57.5%), currently unemployed and retired by NMOSD, respectively. 55% of them visited between 2-3 specialists before NMOSD diagnosis. Aquaporin-4-antibody and/or myelin oligodendrocyte glycoprotein-antibody testing was requested in 91% (health insurance covered this partially in 15.3% and 32.9% of the time the test was entirely paid by patient/family). Patients with NMOSD receiving private medical care reported greater access to MRI, outpatient visits, and fewer issues to obtain NMOSD medications compared to those treated at public institutions. A longer mean time to MRI and neurology visit was found in the PHI group when compared with the other two subgroups. Regression analysis showed that private insurance (OR=3.84, p=0.01) was the only independent factor associated with appropriate access to NMOSD medications in Argentina., Conclusion: These findings suggest that barriers to access and utilization of NMOSD care services in Argentina are common. NMOSD patients experienced problems to receive NMOSD medication properly, especially those from the public sector., Competing Interests: Declaration of competing interest None of the authors has any potential financial conflict of interest relating to this manuscript., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Shared decision making is a way of incorporating patients' preferences and values into the decisions regarding the treatment and follow-up plan for the condition that affects them. It is currently applied mainly in the context of chronic disorders for which there is no cure available but nevertheless many therapeutic alternatives, such as multiple sclerosis (MS). Current views and opinions on shared decision making for the treatment of MS are discussed in this consensus based on a modified Delphi method that included a group of neurologists from Argentina. A set of statements was defined by the experts and seeks to serve as a guide to apply this concept in clinical practice., Competing Interests: Declaration of Competing Interest Medical writing support was provided by Biogen. S. Batagelj is an employee of Biogen. All other authors have no conflict of interests to report. The authors were not paid for their work developing the manuscript. Views and opinions expressed in this manuscript are solely those of the authors., (Copyright © 2022. Published by Elsevier B.V.)

The objective was to evaluate time to reach an EDSS of 4, 6, and 7 in NMOSD and MOGAD patients included in the Argentinean MS and NMOSD registry (RelevarEM, NCT 03,375,177)., Methods: NMOSD patients diagnosed according to 2015 criteria and with MOGAD were identified. Patients with at least 3 years of follow-up and periodic clinical evaluations with EDSS outcomes were included. AQP4-antibody and MOG-antibody status was recorded, and patients were stratified as seropositive and seronegative for AQP4-antibody. EDSS of 4, 6, and 7 were defined as dependent variables. Log rank test was used to identify differences between groups., Results: Registry data was provided for a total of 137 patients. Of these, seventy-five presented AQP4-ab-positive NMOSD, 45 AQP4-ab-negative NMOSD, and 11 MOGAD. AQP4-ab status was determined by cell-based assay (CBA) in 72% of NMOSD patients. MOG-ab status was tested by CBA in all cases. Mean time to EDSS of 4 was 53.6 ± 24.5 vs. 63.1 ± 32.2 vs. 44.7 ± 32 months in seropositive, seronegative NMOSD, and MOGAD, respectively (p = 0.76). Mean time to EDSS of 6 was 79.2 ± 44.3 vs. 75.7 ± 48.6 vs. 54.7 ± 50 months in seropositive, seronegative NMOSD, and MOGAD (p = 0.23), while mean time to EDSS of 7 was 86.8 ± 54 vs. 80.4 ± 51 vs. 58.5 ± 47 months in seropositive, seronegative NMOSD, and MOGAD (p = 0.39)., Conclusion: No differences were observed between NMOSD (seropositive and seronegative) and MOGAD in survival curves., (© 2022. Fondazione Società Italiana di Neurologia.)

The objective of the study was to evaluate the incidence of COVID-19 after complete vaccination in people with multiple sclerosis (PwMS) included in the Argentinean MS and NMOSD registry (RelevarEM, NCT03375177)., Methods: cohort study conducted between May 2021 and December 2021. The primary outcome was the appearance of infection during the follow-up time (at least three months after complete vaccination (second dose)). Data was collected through the contact between the treating physician and the patient. Specific information was requested (date, symptoms, need for hospitalization, ventilatory assistance, treatment, and evolution). The contact was made every 30 days during the period of 3 months after the full dose vaccination. A positive COVID-19 case was defined according to the definition established by the Ministry of Health in Argentina. Cumulative incidence was reported by Kaplan Meier survival curves as well as incidence density., Results: A total of 576 PwMS were included, mean age 45.2 ± 13 years, 432 (75%) RRMS, 403 (70%) were female. The mean and median time of follow-up after the second dose was 91 ± 17 and 94 ± 21 days respectively. Most frequent first and second dose received was Astra-Zeneca vaccine, followed by Sputnik V vaccine. During follow-up a total of twenty COVID-19 cases were observed for a total exposure time of 39,557 days. The overall cumulative incidence for the observed period was 3.4% (SE 0.4%) with an overall incidence density of 5 × 10.000 patients/day (95%CI 0.7-12). We observed more cases in woman than men with an incidence density of 6 × 10.000 patients/day (95%CI 0.9-9) vs. 3 × 10.000 patients/day (95%CI 0.2-6) respectively, but not significantly different (IRR 1.7 95% CI 0.56-7.37 p = 0.15)., Conclusion: we found an incidence density of breakthrough COVID-19 infection of 5 × 10.000 patients/day (95%CI 0.7-12) after vaccination in Argentina., Competing Interests: Declaration of Competing Interest Authors declare no potential conflicts of interest regarding this research, authorship and/or publication of this article. We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome, (Copyright © 2022 Elsevier B.V. All rights reserved.)

Introduction: We aimed to analyze the accumulative risk of MRI and OB factors for evolution from RIS to MS in subjects included in the Argentinean MS registry (NCT03375177)., Methods: RIS subjects were identified according to RIS diagnosis criteria. Subjects were longitudinally followed with clinical and MRI at intervals of 6 months. Time from RIS identification to the first clinical event was estimated using Kaplan-Meier. Multivariable Cox regression models were created to assess the independent predictive value of demographic characteristics, as well as clinical, OB and MRI data on time to the first clinical event. The single and increased risk factor of evolution of RIS was quantified., Results: A total of 88 RIS subjects, mean follow-up time 42 ± 4 months were included. 39 (44.3%) and 23 (26.1%) had a new MRI lesion or a clinical event, respectively, during the follow-up. OB (HR 5.9, 95% CI 1.29-10.1, p = 0.004), infratentorial lesions (HR 3.7, 95% CI 1.09-7.5) and spinal cord lesions (HR 5.3, 95% CI 1.4-8.2, p = 0.01) at RIS identification were independent predictors associated with a subsequent clinical event. The accumulative risk showed that when two of the three factors (OB, infratentorial or spinal cord lesions) were present the HR was 10.4, 95% CI 4.4-22, p < 0.001, and when three factors were present, it was HR 15.6, 95% CI 5.7-28, p < 0.001 for a relapse., Conclusion: The presence of three factors significantly increased the risk of clinical event; high-risk subjects should probably be managed by a different approach than those used for individuals without high-risk factors., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: In multiple sclerosis demographics there is a well-known female prevalence and male patients have been less specifically evaluated in clinical studies, though some clinical differences have been reported between sexes., Objective: The objective of this study was to assess clinical and demographic differences between male and female patients included in the national Argentine MS Registry-RelevarEM., Material and Methods: This study was observational, retrospective, and was based on the data of 3099 MS patients included as of 04 April 2021. The statistical analysis plan included bivariate analyses with the crude data and also after adjustment for the MS phenotype, further categorized as progressive-onset MS or relapsing-onset MS. In the adjusted analysis, the Mantel-Haenszel odds ratio was compared to the crude odds ratio, to account for the phenotype as a confounder., Results: The data from 1,074 (34.7%) men and 2,025 (65.3%) women with MS diagnosis were analysed. Males presented primary progressive disease two times more often than women (11% and 5%, respectively). In the crude analyses by sex, the presence of exclusively infratentorial lesions in the magnetic resonance imaging studies was more frequent in males than in females, but after adjustment by MS onset phenotype, such difference was only present in males with relapsing-onset MS (p = 0.00006). Similarly, worse Expanded Disability Status Scale scores were confirmed only in men with relapsing-onset disease after phenotype adjustment (p = 0.02)., Conclusion: We did not find any statistically significant clinical or demographic difference between sexes when the progressive MS phenotype was specifically considered. However, the differences we found between the clinical phenotypes are in line with the literature and highlight the importance of stratifying the analyses by sex and phenotype when designing MS studies., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Identification of triggers that potentially instigate attacks in neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS) has remained challenging. We aimed to analyze the seasonality of NMOSD and MS attacks in an Argentinean cohort seeking differences between the two disorders., Methods: A retrospective study was conducted in a cohort of NMOSD and MS patients followed in specialized centers from Argentina and enrolled in RelevarEM, a nationwide, longitudinal, observational, non-mandatory registry of MS/NMOSD patients. Patients with complete relapse data (date, month and year) at onset and during follow-up were included. Attack counts were analyzed by month using a Poisson regression model with the median monthly attack count used as reference., Results: A total of 551 patients (431 MS and 120 NMOSD), experiencing 236 NMOSD-related attacks and 558 MS-related attacks were enrolled. The mean age at disease onset in NMOSD was 39.5 ± 5.8 vs. 31.2 ± 9.6 years in MS (p < 0.01). Mean follow-up time was 6.1 ± 3.0 vs. 7.4 ± 2.4 years (p < 0.01), respectively. Most of the included patients were female in both groups (79% vs. 60%, p < 0.01). We found a peak of number of attacks in June (NMOSD: 28 attacks (11.8%) vs MS: 33 attacks (5.9%), incidence rate ratio 1.82, 95%CI 1.15-2.12, p = 0.03), but no differences were found across the months in both disorders when evaluated separately. Strikingly, we observed a significant difference in the incidence rate ratio of attacks during the winter season when comparing NMOSD vs. MS (NMOSD: 75 attacks (31.7%) vs MS: 96 attacks (17.2%), incidence rate ratio 1.82, 95%CI 1.21-2.01, p = 0.02) after applying Poisson regression model. Similar results were observed when comparing the seropositive NMOSD (n = 75) subgroup vs. MS., Conclusions: Lack of seasonal variation in MS and NMOSD attacks was observed when evaluated separately. Future epidemiological studies about the effect of different environmental factors on MS and NMOSD attacks should be evaluated prospectively in Latin America population., (Copyright © 2021 Elsevier B.V. All rights reserved.)

We aimed to examine treatment interventions implemented in patients experiencing neuromyelitis optica spectrum disorders (NMOSD) attacks (frequency, types, and response)., Methods: Retrospective study. Data on patient demographic, clinical and radiological findings, and administered treatments were collected. Remission status (complete [CR], partial [PR], no remission [NR]), based on changes in the EDSS score was evaluated before treatment, during attack, and at 6 months. CR was analyzed with a generalized estimating equations (GEEs) model., Results: A total of 131 patients (120 NMOSD and 11 myelin oligodendrocyte glycoprotein-antibody-associated diseases [MOGAD]), experiencing 262 NMOSD-related attacks and receiving 270 treatments were included. High-dose steroids (81.4%) was the most frequent treatment followed by plasmapheresis (15.5%). CR from attacks was observed in 47% (105/223) of all treated patients. During the first attack, we observed CR:71.2%, PR:16.3% and NR:12.5% after the first course of treatment. For second, third, fourth, and fifth attacks, CR was observed in 31.1%, 10.7%, 27.3%, and 33.3%, respectively. Remission rates were higher for optic neuritis vs. myelitis (p < 0.001). Predictor of CR in multivariate GEE analysis was age in both NMOSD (OR = 2.27, p = 0.002) and MOGAD (OR = 1.53, p = 0.03)., Conclusions: This study suggests individualization of treatment according to age and attack manifestation. The outcome of attacks was generally poor., (© The Author(s) 2021.)

The objectives of the present study were to describe the frequency of aggressive multiple sclerosis (aMS) as well as to compare clinical and radiological characteristics in aMS and non-aMS patients included in RelevarEM (NCT03375177)., Methods: The eligible study population and cohort selection included adult-onset patients (≥18 years) with definite MS. AMS were defined as those reaching confirmed EDSS ≥ 6 within 5 years from symptom onset. Confirmation was achieved when a subsequent EDSS ≥ 6 was recorded at least six months later but within 5 years of the first clinical presentation. AMS and non-aMS were compared using the χ2 test for categorical and the Mann-Whitney for continuous variables at MS onset and multivariable analysis was performed using forward stepwise logistic regression with baseline characteristics at disease onset., Results: A total of 2158 patients with MS were included: 74 aMS and 2084 non-aMS. The prevalence of aMS in our cohort was 3.4% (95%CI 2.7-4.2). AMS were more likely to be male (p = 0.003), older at MS onset (p < 0.001), have primary progressive MS (PPMS) phenotype (p = 0.03), multifocal presentation (p < 0.001), and spinal cord as well as infratentorial lesions at MRI during disease onset (p = 0.004 and p = 0.002, respectively)., Conclusion: 3.4% of our patient population could be considered aMS. Men, patients older at symptom onset, multifocal presentation, PPMS phenotype, and spinal cord as well as brainstem lesions on MRI at clinical presentation all had higher odds of having aMS., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: The purpose of this study was to assess family planning (FP) among women with multiple sclerosis (WwMS)., Methods: We invited 604 WwMS to answer a survey focused on FP: a) Temporal relationship between pregnancy and the diagnosis of multiple sclerosis; b) History of FP; c) Childbearing desire; d) Information on family planning. Comparisons between pregnancy and not pregnancy after MS, as well as, planned and unplanned pregnancy were analyzed. Multivariate and univariate analyses were used to assess the impact of independent variables and FP., Result: 428 (71.7%) WwMS completed the survey. A 19.1% got pregnant after MS diagnosis and we evaluated FP in the last pregnancy, 56.1% patients had a planned pregnancy. Professional addressing FP (OR = 0.27, 95%-CI 0.08-0.92, p = 0.03) and non-injection drug treatment before pregnancy (OR = 2.88, 95%-CI 1.01-8.21, p = 0.047) were independent predictors of unplanned pregnancy in our multivariate model. Among WwMS ≤ 40 years, 48.7% had future childbearing desire. Young age (p < 0.001), PDDS <3 (p = 0.018), disease duration <5 years (p = 0.02), not childbearing before MS diagnosis (p < 0.001) and neurologist addressing family planning (p = 0.01) were significantly associated with childbearing desire., Conclusions: This research highlights that pregnancy remains an important concern among WwMS., (© The Author(s) 2021.)

Background: The use of cannabis to treat some symptoms of neurological diseases, including multiple sclerosis (MS), has increased worldwide. We aimed to assess the use of cannabis in patients with MS (PwMS) from Argentina, its reasons and patients' perceptions on the management of MS symptoms. Additionally, we assessed their association with socio-demographic and clinical aspects., Methods: A cross-sectional online survey that included 281 PwMS from Argentina was conducted. Screening instruments: Demographics and clinical data, health-related QoL (MS Impact Scale-29), Fatigue Severity Scale, The Hospital Anxiety and Depression Scale, sleep disorders, physical disability (self-administrated Expanded Disability Status Scale) and medical or recreational cannabis use were evaluated. A logistic regression model was carried out., Results: Current users (cannabis was used within the past year) was reported in 34.2% and former users (had tried cannabis but not used it within the past year) in 22.7%. Daily cannabis use was reported in 31.3% (current + former users) of the studied cohort, 41.9% started their use after MS diagnosis and 54.3% of them had never discussed about cannabis use with their neurologist. Recreational use was reported in 47.5%. Younger (age below 30 years) PwMS (OR = 2.39, p = 0.03), presence of chronic pain (OR = 2.42, p = 0.002) and current alcohol intake (OR = 3.33, p = 0.001) were predictors of current cannabis use in our multivariate model., Conclusion: A high prevalence of use of cannabis in PwMS from Argentina was observed. Demographic, symptoms and lifestyle factors predict cannabis use. Identifying the presence and severity of these conditions would contribute to a better MS management and treatment., Competing Interests: Declaration of Competing Interest None of the authors have any potential financial conflict of interest relating to this manuscript., (Copyright © 2021. Published by Elsevier B.V.)

Background: There is no data regarding COVID-19 in Multiple Sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) patients in Latin America., Objective: The objective of this study was to describe the clinical characteristics and outcomes of patients included in RELACOEM, a LATAM registry of MS and NMOSD patients infected with COVID-19., Methods: RELACOEM is a longitudinal, strictly observational registry of MS and NMOSD patients who suffer COVID-19 and Dengue in LATAM. Inclusion criteria to the registry were either: (1) a biologically confirmed COVID-19 diagnosis based on a positive result of a COVID-19 polymerase chain reaction (PCR) test on a nasopharyngeal swab; or (2) COVID-19-typical symptoms (triad of cough, fever, and asthenia) in an epidemic zone of COVID-19. Descriptive statistics were performed on demographic and clinical variables. The cohort was later stratified for MS and NMOSD and univariate and multivariate logistic regression analysis was performed to identify variables associated with hospitalizations/intensive critical units (ICU) admission., Results: 145 patients were included in the registry from 15 countries and 51 treating physicians. A total of 129 (89%) were MS patients and 16 (11%) NMOSD. 81.4% patients had confirmed COVID-19 and 18.6% were suspected cases. 23 (15.8%) patients were hospitalized, 9 (6.2%) required ICU and 5 (3.4 %) died due to COVID-19. In MS patients, greater age (OR 1.17, 95% CI 1.05 - 1.25) and disease duration (OR 1.39, 95%CI 1.14-1.69) were associated with hospitalization/ICU. In NMOSD patients, a greater age (54.3 vs. 36 years, p=<0.001), increased EDSS (5.5 vs 2.9, p=0.0012) and disease duration (18.5 vs. 10.3 years, p=0.001) were significantly associated with hospitalization/ICU., Conclusion: we found that in MS patients, age and disease duration was associated with hospitalization and ICU admission requirement, while age, disease duration and EDSS was associated in NMOSD., Competing Interests: Disclosure of conflicts of interest Edgardo Cristiano has received fees for consultations as a scientific advisory board member and for travel to meetings, conferences, and clinical trials of the following companies: Avanir, Bayer, Biogen, Merck, Novartis, Roche and Teva. Juan Ignacio Rojas has received honoraria from Novartis as a scientific advisor. He has received travel grants and attended courses and conferences on behalf of Merck-Serono Argentina, Novartis Argentina. Liliana Patrucco has received honoraria for scientific and research grants from Teva Tuteur, Merck Serono, Biogen Idec, and Bayer Schering. Ricardo Alonso and Berenice Silva has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities from Biogen, Merck Serono, Novartis, Sanofi -Genzyme and Roche. Orlando Garcea has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities from Biogen, Merck Serono, Novartis, Sanofi -Genzyme and Roche. Liesbet M. Peeters has no personal pecuniary interests to disclose, other than being the chair of The MS Data Alliance (MSDA), which receives income from a range of corporate sponsors, recently including: Biogen, BristolMyersSquibb (formerly Celgene), Canopy Growth Corporation, Genzyme, Icometrix, Merck, Mylan, Novartis, QMENTA, Quanterix, Roche. The rest of authors declares no conflict of interest with the study project., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Myelin oligodendrocyte glycoprotein antibodies (MOG-ab) have been described in aquaporin-4-antibodies(AQP4-ab)-negative neuromyelitis optica spectrum disorder (NMOSD) patients. We aimed to evaluate the percentage of AQP4-ab-negative NMOSD patients who are positive for MOG-ab in a cohort of Argentinean patients included in RelevarEM (Clinical Trials registry number NCT03375177)., Methods: RelevarEM is a longitudinal, strictly observational multiple sclerosis (MS) and NMOSD registry in Argentina. Of 3031 consecutive patients (until March 2020), 165 patients with phenotype of suspected NMOSD, whose relevant data for the purpose of this study were available, were included. Data on demographic, clinical, paraclinical and treatment in AQP4-ab (positive, negative and unknown) and MOG-ab (positive and negative) patients were evaluated., Results: A total of 165 patients (79 AQP4-Ab positive, 67 AQP4-Ab negative and 19 unknown) were included. Of these, 155 patients fulfilled the 2015 NMOSD diagnostic criteria. Of 67 AQP4-Ab-negative patients, 36 (53.7%) were tested for MOG-Ab and 10 of them (27.7%) tested positive. Serum AQP4-ab levels were tested by means of cell-based assay (CBA) in 48 (35.2%), based on tissue-based indirect immunofluorescence assays in 58 (42.6%) and enzyme-linked immunosorbent assay in 4 (2.9%). All MOG-ab were tested by CBA. Optic neuritis (90%) was the most frequent symptom at presentation and optic nerve lesions the most frequent finding (80%) in neuroimaging of MOG-ab-associated disease. Of these, six (60%) patients were under immunosuppressant treatments at latest follow-up., Conclusion: We observed that 27.7% (10/36) of the AQP4-ab-negative patients tested for MOG-ab were positive for this antibody, in line with results from other world regions., (Copyright © 2021. Published by Elsevier B.V.)

Introduction: The identification, diagnosis, follow-up, and treatment of patients with secondary progressive multiple sclerosis (SPMS) show significant differences between health care professionals in Argentina., Aim: To provide consensus recommendations on the management of patients with SPMS in Argentina to optimize patient care., Development: A panel of expert neurologists from Argentina dedicated to the diagnosis and care of multiple sclerosis patients gathered during 2019 and 2020 to carry out a consensus recommendation on the diagnosis and treatment of SPMS patients in Argentina. To achieve consensus, the methodology of 'formal consensus-RAND/UCLA method' was used. Recommendations were established based on published evidence and the expert opinion. Recommendations focused on how to define SPMS and how to follow SPMS patients., Conclusion: The recommendations of this consensus guidelines attempt to optimize the care of SPMS patients in Argentina.

Background: Primary progressive multiple sclerosis (PPMS) is an infrequent clinical form of multiple sclerosis (MS). Scarce information is available about PPMS in Latin America. The aim of this work is to describe the clinical and demographic characteristics of PPMS patients in Argentina., Material and Methods: RelevarEM is a longitudinal, strictly observational registry in Argentina. Clinical and epidemiological data from PPMS patients were described., Results: There were 144 cases of PPMS. They represented 7% of MS patients. The mean age was 44.1 years. The female:male ratio was 1.08. The mean Expanded Disability Status Scale (EDSS) score was 5.5 and the mean disease evolution time was 10.6 years. Oligoclonal bands were found in 72.9%. At the time of diagnosis, magnetic resonance imaging showed spinal cord lesions in 82.6% and contrast-enhancing brain lesions in 18.1% of patients. Almost one third of patients were treated with a disease-modifying drug, and ocrelizumab was the most frequently used (55.8%)., Conclusions: PPMS is an infrequent subtype of MS and its recognition is of the highest importance as it has its own evolution, treatment, and prognosis. The importance of our research resides in providing local data and contributing to a better understanding of PPMS and its treatment in Latin America.

Background: Multiple sclerosis (MS) is the most common chronic immune-mediated neurological disorder in young adults, more frequently found in women than in men. Therefore, pregnancy-related issues have become an object of concern for MS professionals and patients. The aim of this work was to review the existing data to develop the first Argentine consensus for family planning and pregnancy in MS patients., Methods: A panel of expert neurologists from Argentina engaged in the diagnosis and care of MS patients met both virtually and in person during 2019 to carry out a consensus recommendation for family planning and pregnancy in MS. To achieve consensus, the procedure of the "formal consensus-RAND/UCLA method" was used., Results: Recommendations were established based on published evidence and expert opinion focusing on pre-pregnancy counseling, pregnancy, and postpartum issues., Conclusion: The recommendations of these consensus guidelines are intended to optimize the management and treatment of MS patients during their reproductive age in Argentina., Competing Interests: Declaration of Competing Interest Nora Fernández Liguori has received consulting fees from Biogen Argentina, Novartis Argentina and Genzyme Argentina, as a lecturer from Merck Argentina, Novartis Argentina, Genzyme Argentina and Biogen Argentina, and collaboration for attendance to national and international congresses from Biogen Argentina, Novartis Argentina, Merck Argentina, Bayer Argentina, Gador and Roche Argentina. Ricardo Alonso has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities with Biogen Argentina, Genzyme Argentina, Merck Argentina, Novartis Argentina and Roche Argentina. María Eugenia Balbuena has received personal compensation for speaking from Roche, professional travel/accommodation stipends from Merck, Novartis and Teva and funding for research from Genzyme and Novartis. Andrés Barboza has received reimbursement for developing educational presentations, educational and research grants, consultation fees and travel stipends from Biogen, Sanofi, Merck, Roche, Novartis, Teva, Gador, Raffo, Biosidus and Synthon-Bagó. Santiago Bestoso has received personal compensation for speaking, professional travel/accommodation stipends or other activities from Merck, Biogen, Novartis, Gador and Genzyme. Marcos Burgos has received personal compensation for speaking from Merck, Novartis, Raffo, Sanofi Genzyme, Biogen, Roche and for research from Novartis and Biogen. Fernando Cáceres has received fees for being a member of advisory boards, for research, being a speaker and for traveling/accommodation for scientific medical meetings of the following companies: Novartis, Teva, Roche, Biogen, Sanofi Genzyme and Merck. Edgar Carnero Contentti has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities with Biogen Argentina, Genzyme Argentina, Merck Argentina, Novartis Argentina, Teva Argentina, Roche Argentina and Bayer Argentina. Adriana Carrá has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities with Bayer; Biogen; Biosidus; Genzyme; Merck; MS Synthon-Bago; Novartis; Roche; Teva, Tuteur. Edgardo Cristiano received consulting fees, funding for advisory boards and educational support from Biogen, Genzyme, Merck, Novartis and Roche. Norma Deri has received personal compensation for advisory boards for Bayer Argentina, Bayer Latinoamerica, Bayer Global, Merck Serono Argentina, Merck Serono Global, Genzyme Argentina, Genzyme Latinoamerica, Genzyme Global and Sanofi Global; for travel/ accommodation from Schering, Bayer, Serono, Merck Serono, Novartis, Biogen Idec, Teva-Tuteur, Teva and Roche; for research from Bayer Argentina, Biogen Idec Argentina,Genzyme Argentina, Novartis Argentina, Roche Argentina, Teva Argentina and Sanofi Argentina and for educational presentations from Bayer Argentina, Merck Serono Argentina and Genzyme Argentina. Marcela Fiol has received personal compensation for developing educational presentations, serving on a scientific advisory board from Merck-Serono Argentina, Sanofi Genzyme Argentina, TEVA-Tuteur Argentina and has received travel/accommodations stipends from Merck-Serono Argentina, Sanofi Genzyme Argentina, Biogen INC, Bayer Inc, Novartis, TEVA-Tuteur Argentina, ROCHE Argentina. María Inés Gaitán has received reimbursement for developing educational presentations, from Roche Argentina, Merck Argentina, Biogen Argentina, Sanofi-Genzyme Argentina, Bayer Inc Argentina and Novartis Argentina, and has received travel/accommodations stipends from Merck Argentina, Biogen Argentina, Roche Argentina, Novartis Argentina, and TEVA Argentina. Orlando Garcea has received personal compensation for consulting and speaking from Bayer, Merck, Biogen, Novartis and Genzyme. Mario Javier Halfon has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities from Biogen Argentina, Merck Argentina, Roche, Gador, Novartis, and Genzyme Argentina. Javier Hryb has received honoraria for the development of educational activities, and travel grants to congresses from Teva, Merck, Biogen, Roche, Tuteur, Synthon Bago and Novartis. Miguel Jacobo has received honoraria for the development of educational activities, research and travel grants to congresses from Biogen, Roche, Merck, Genzyme Novartis, Teva, Bayer, Raffo and Gador. Eduardo Knorre has received personal compensation for professional travel/accommodation stipends or other activities from Bagó, Tuteur and Roche. Pablo López has received personal compensation for consulting, serving on scientific advisory boards, speaking, professional travel/accommodation stipends or other activities with Biogen, Genzyme, Merck-Serono, Novartis, Teva, Roche and Bayer. Jimena Miguez has received personal compensation for professional travel/accommodation stipends or other activities from Merck, Novartis, Genzyme, Roche and for speaking from Merck, Novartis and Roche. Pedro Nofal has received honoraria for the development of educational activities, research and travel grants to congress from Novartis, Biogen, Merck Serono, Raffo, Genzyme, Gador and Bayer Schering. Raúl Piedrabuena has received personal compensation for the development of educational activities, serving on a scientific advisory board and research from Biogen, Merck, Novartis, Genzyme, Roche and Teva. Cecilia Pita has received honoraria for the development of educational activities, research and travel grants to congress from Biogen, Genzyme, Merck, Novartis and Roche. Juan Ignacio Rojas has received reimbursement for developing educational presentations, educational and research grants, consultation fees and travel stipends from Biogen, Genzyme, Merck, Novartis. Berenice Silva has received economic retribution for the development of educational, scientific activities and travel grants to congresses from Biogen, Novartis, Merck, Genzyme, TEVA, Bayer, Tuteur and Roche. Vladimiro Sinay has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities with Bayer, Biogen, Genzyme, Merck, Novartis, Roche, Biosidus, Gador, Tuteur and Raffo/ Asofarma. Adriana Tarulla reports personal fees for speaking and support for travel to meetings from Bayer,Biogen Idec,Biosidus,Gador,Ivax-Teva,Merck Serono and Roche, out-side the submitted work. Darío Tavolini has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities Bayer, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva. Santiago Tizio has received professional travel accommodation stipends from Merck-Serono, Synthon Bago, Biogen-Idec, TEVA, Genzyme, Novartis and Roche; reimbursement for developing educational presentations from Biogen-Idec and Novartis and honoraria for advisory services from Merck-Serono, and Novartis. Verónica Tkachuk: has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities from Biogen, Roche, Merck, TEVA, Sanofi Genzyme, Novartis, Bayer y Raffo. Carlos Vrech has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities from Merck, Novartis, Biogen, Synthon Bago, Gador and Genzyme. Maria Célica Ysrraelit has received personal compensation for consulting, serving on a scientific advisory board, speaking, professional travel/accommodation stipends or other activities from Merck, Biogen, Novartis, Roche and Bayer Argentina. Liliana Patrucco has received speaker honoraria from Biogen, Genzyme, Merck-Serono, Novartis and Roche. Has received travel grants and attended courses and conferences on behalf of Merck-Serono, Genzyme and Roche. All the other authors have nothing to disclose., (Copyright © 2020 Elsevier B.V. All rights reserved.)

The objective of this study was to describe and compare the baseline epidemiological data of multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) patients included in RelevarEM (Clinical Trials registry number NCT03375177)., Methods: RelevarEM is a longitudinal, strictly observational MS and NMOSD registry in Argentina. Epidemiological and comorbidity data from MS and NMOSD patients were described and compared. For comorbidities, the Charlson comorbidity index (CCI) was used to calculate the burden at entry. CCI was stratified in 0 and ≥ 1 and described for the entire cohort., Results: A total of 1588 and 75 MS and NMOSD patients (respectively) were included. For MS patients, the mean age was 42 ± 7 years, female sex 65.3%, mean EDSS 2, and mean disease duration 8 ± 6 years. In NMOSD, the mean age was 40 ± 7 years, female sex 78.7%, mean disease duration 5 ± 3.5 years, and mean EDSS 2.5. The most frequent MS phenotype was RRMS in 82.4%. In MS, the CCI was 0 in 85.8.2% while ≥ 1 was in 14.2% of patients. Regarding phenotype stratification, CCI ≥ 1 was 3.9% in CIS, 13.5% in RRMS, 28.7% in SPMS, and 17.4% in PPMS (p < 0.001 between groups). In NMOSD, the CCI was 0 in 64% while ≥ 1 was in 36%. The MS/NMOSD ratio found was 21/1., Conclusions: This is the first analysis of the longitudinal Argentinean registry of MS and NMOSD describing and comparing conditions that contributes to provide reliable real-world data in the country.

Despite that different registries already exist in various countries in Europe and North America, no ongoing nationwide registry exists in Latin America (LATAM), a region where the disease behaves differently than in other regions. The objective of this document is to describe the methodology behind RelevarEM, the first nationwide MS registry in Argentina and LATAM. METHODS: In this article, we described the creation, implementation and data management of the nationwide MS registry in Argentina. The registry contains information on the structure, ethical aspects, implementation and variables of the registry (Clinical Trials registry number NCT NCT03375177). CONCLUSION: RelevarEM is the first MS nationwide registry in Argentina, as well as in LATAM, with the objective of providing reliable real-world data of MS in the country., (Copyright © 2019 Elsevier B.V. All rights reserved.)