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Multiple sclerosis is an inflammatory demyelinating disease and represents a global health concern. Ocrelizumab, a humanized IgG monoclonal antibody, selectively targets CD20 on B cells and CD20-expressing T cells. This study aimed to compare the efficacy and safety of the biosimilar ocrelizumab candidate (Xacrel) to the originator product (Ocrevus) in Relapsing Multiple Sclerosis (RMS) patients. In this randomized trial, patients received either Xacrel or Ocrevus for 96 weeks. The primary endpoint was the equivalency of the medications in reducing the annualized relapse rate (ARR) at week 48. The secondary endpoints included time to the onset of disability progression confirmed at 12 and 24 weeks, the proportion of relapse-free patients, magnetic resonance imaging (MRI) evaluations, safety assessments, and immunogenicity over 96 weeks. A total of 170 patients were randomized (1:1 ratio). In the per protocol analysis, the upper and lower limits of 95% two-sided confidence intervals of difference between treatments in the 48-week ARR rate were in the predefined margin of - 0.2 to 0.2 (- 0.002; 95% CI - 0.080 to 0.075). The two products were also comparable in terms of other efficacy parameters, safety, and immunogenicity. The results confirmed that Xacrel is equivalent to Ocrevus in terms of 48-week ARR in RMS patients, with no considerable difference in other efficacy parameters and the safety profile during the 96 weeks. The trial was registered in Iranian registry of clinical trials (IRCT) on 10/06/2019 with the registration number of IRCT20150303021315N13 and in Clinicaltrials.gov on 19/07/2021 with the registration code of NCT04966338., (© 2024. The Author(s).)

Background: The treatment of multiple sclerosis, an autoimmune disease that predominantly affects women of reproductive age, has undergone considerable advancements. Nevertheless, their unique needs, particularly those related to motherhood, continue to be disregarded. This study aims to ascertain the needs of women diagnosed with MS about motherhood., Methods: Using the Noblit and Hare methods, meta-synthesis research was conducted on 10 qualitative studies. The relevant studies were obtained by conducting a comprehensive search using keywords in the PubMed, Scopus, Web of Science (ISI), and ProQuest databases without any time limitations until June 2023. The CASP checklist was used to assess the quality of the articles, while the technique of Brown and Clark (2006) was utilized for data synthesis., Results: Four key themes emerged from this meta-synthesis, highlighting the significance of a support system, psychoeducational counseling, knowledge promotion, and continuous, comprehensive, and unique care., Conclusion: Identifying the needs of women diagnosed with MS and addressing these needs concerning motherhood can enhance the quality of services rendered and enhance women's contentment with their choice to embark on motherhood. Furthermore, recognizing these needs during subsequent stages can be utilized in formulating tailored programs catering to this specific cohort of women., (© 2024. The Author(s).)

Background: The rising prevalence of familial multiple sclerosis (MS) in Iran has spurred interest in the potential impact of parental consanguinity on the risk of developing the disease. This study aims to aggregate current knowledge on parental consanguinity and its possible effect on MS risk, particularly among familial MS patients from various regions and ethnicities in Iran. The objective is to enhance the understanding of MS genetics and encourage further research in this field., Materials and Methods: A cross-sectional study was conducted on clinically definite familial MS (FMS) patients registered in the nationwide MS registry of Iran (NMSRI). Data were extracted and supplemented with structured telephone follow-ups to gather detailed histories of MS in relatives and the familial relationships of the patients' parents. A family penetration score was proposed. Descriptive statistics and inferential statistical tests were used to analyze the data at a significance level of 0.05, adhering to ethical guidelines., Results: Out of 19,911 individuals registered in the NMSRI, 2307 FMS patients across 13 provinces were included in the final analysis. Among these, 385 (19.3 %) reported parental consanguinity, with 283 (14.2 %) having parents who were cousins and 102 (5.1 %) having parents who were distant relatives. The data showed no significant association between parental kinship and variables such as MS phenotype, number of affected relatives with MS, hospitalization rates, and expanded disability status scale score. Similarly, MS severity did not differ based on parental consanguinity ( P -value >0.05). While the rate of consanguineous marriage was higher among patients with an onset age less than 18 years, there was no statistically significant difference in disease onset age based on parental consanguinity status., Conclusion: Our study highlights the complexity of factors influencing MS development, including genetic and environmental components. These results highlight the need for further research to achieve a more comprehensive understanding of MS etiology., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Sharareh Eskandarieh reports financial support was provided by 10.13039/501100004484Tehran University of Medical Sciences. Sharareh Eskandarieh reports a relationship with 10.13039/501100004484Tehran University of Medical Sciences that includes: consulting or advisory, employment, equity or stocks, and funding grants. Sharareh Eskandarieh has patent licensed to NMSRI. None If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Support for the Reported Work: Tehran University of Medical Sciences. Relevant support: advisory positions, consulting fees. Intellectual Property: National multiple sclerosis registry system of Iran (NMSRI). Other Activities: None. The entire data of the study has been sent to the journal in Excel file format. If needed, it will be provided by contacting the website https://nmsri.ir/or by email., (© 2024 The Authors.)

Background: The maternal role is one of the most challenging yet rewarding roles that women experience in their lives. It begins when a woman becomes pregnant, and as the pregnancy progresses, she prepares to fulfill her role as a mother. A woman's health plays a crucial role in her ability to fulfill the maternal role. Multiple sclerosis (MS), as an autoimmune disease, presents unique challenges in achieving this role. Failing to fulfill the maternal role can have lasting consequences for both the mother and the baby. Given the increasing number of women with MS of reproductive age in Iran and the absence of specific programs for this group during pregnancy and postpartum, researchers have decided to develop a supportive program by exploring the meaning of the maternal role and identifying the needs of these women during this period., Methods/materials: This study will be conducted in 3 stages. The first stage involves a qualitative study to explore the meaning of the "maternal role" in women with MS through a descriptive and interpretive phenomenological approach based on Van Manen's method. Data will be collected through semi-structured interviews with pregnant women with MS and mothers with MS who have children under one-year-old, recruited from the Multiple Sclerosis Society of Mashhad, Iran. The second stage will involve designing a support program based on the findings of the phenomenological study, literature review, and exploratory interviews. A logical model will guide the development of the program, and validation will be conducted using the nominal group technique., Discussion: This study is the first of its kind in Iran to explore the meaning of the maternal role and develop a support program for women with MS. It is hoped that the results of this study will help address the challenges of motherhood faced by these women., (© 2024. The Author(s).)

Introduction: One of the main complications of multiple sclerosis (MS) is imbalance and walking problems that can lead to falls. This study investigated the association between a fall measurement scale called the Hopkins Falls Grading Scale (HFGS) and motor function tests in patients with MS., Material and Methods: This cross sectional study was conducted using convenience sampling on 85 patients referred to the MS Association of Mashhad, Iran, in 2023. The HFGS examined falls during the past year and divided them into 4 degrees, and the function test included the timed 25 foot walk (T25FW) test and the timed up and go (TUG) test. Kruskal-Wallis test and Spearman's correlation coefficient were used for data analysis., Results: A statistically significant association was obtained between HFGS and functional tests (T25FW and TUG) (for both P < 0.0001). A significant association was observed between the variables of age ( P = 0.006), duration of the disease ( P = 0.03), the use of mobility devices ( P = 0.05), and HFGS., Conclusion: Considering the association between HFGS and motor function tests in MS patients, clinical experts should pay attention to patients who have slower movement and evaluate them in terms of falling status when performing motor function tests., Competing Interests: There are no conflicts of interest., (Copyright: © 2024 Journal of Family Medicine and Primary Care.)

Objective: The time to diagnosis of multiple sclerosis (MS) is of great importance for early treatment, thereby reducing the disability and burden of the disease. The purpose of this study was to determine the time from the onset of clinical symptoms to the diagnosis of MS and to evaluate the factors associated with a late diagnosis in Iranian MS patients., Methods: The present cross-sectional study was conducted on patients with MS who were registered in the National MS Registry System of Iran (NMSRI)., Results: Overall, 23291 MS patients registered in 18 provinces of Iran were included in this study. The mean (standard deviation) interval between the onset of the disease and diagnosis of MS was 13.42 (32.40) months, and the median was one month. The diagnostic interval of 41.6% of patients was less than one month, and 14.8% of them had a one-month time to diagnosis. Patients with an age of onset below 18 years and those diagnosed after the age of 50 years had a longer time to diagnosis (P<0.001). Patients with primary progressive MS (PPMS) had the longest time to diagnose and those with relapsing-remitting MS (RRMS) had the shortest time (P<0.001). The results of negative binominal regression showed that the average rate of delay in diagnosis in women was 12% less than that in men. The average delay in diagnosis in patients with a positive family history of MS was 23% more than that in others. The rate of delay in the diagnosis of patients with PPMS and secondary progressive MS was 2.22 and 1.66 times higher, respectively, compared with RRMS., Conclusion: The findings of the present study revealed that more than half of the MS patients were diagnosed within a one-month interval from the symptom onset, which is an acceptable period. More attention should be paid to patients' access to medical facilities and MS specialists., (Copyright © 2024. Published by Elsevier B.V.)

Background: Ocrelizumab is a humanized antiCD20, thought to be a highly effective disease-modifying therapy (DMT). Its most frequent adverse effects are infusion-related reactions (IRRs). To reduce these reactions, the first dose of ocrelizumab is administered as two 300 mg infusions separated by two weeks. However, in the phase II trial of ocrelizumab, severe IRRs were not significantly different between two doses of 600 mg dose (two separate 300 mg doses) and 2000 mg dose (two separate 1000 mg doses). We compared the IRRs in undivided full (one 600 mg) and divided (two 300 mg) doses of ocrelizumab which is the standard protocol., Methods: MS patients (relapsing or primary progressive MS) who are selected to receive ocrelizumab by neurologist or MS fellowship were enrolled in an open-label randomized controlled trial. Iranian biosimilar of the drug (Xacrel ® by Cinnagen, approved by the Iranian Food and Drug Administration in 2021) was used. The participants received the first dose of ocrelizumab as either one 600 mg dose in one session or two 300 mg doses in two weeks apart. IRRs during or in the first 24 h after infusion were recorded., Results: Of 332 participants, 150 received two 300 mg doses, and 182 received one 600 mg dose (by random selection). Life-threatening adverse effects were not observed in both groups. Overnight admission or permanent drug discontinuation was not needed. Temporary drug discontinuation was significantly higher in the one 600 mg dose group (p-value < 0.001). During the infusions, malaise (p-value: 0.003), skin reactions (p-value: 0.04), throat swelling (p-value: 0.03), and dyspnea (p-value: 0.01) were significantly increased in the intervention group. However, in the first 24 h, there was no significant difference between two different treatment protocols (one 600 mg dose or two 300 mg doses) in the onset of IRRS (p-value: 0.12)., Conclusion: These findings suggest one 600 mg dose of ocrelizumab administration for the first dose is relatively safe. With some protocol modifications, it could lead to fewer patient referrals, saving time and cost and improvement the access for patients., (© 2023. The Author(s) under exclusive licence to Belgian Neurological Society.)

Introduction: It is generally recommended to avoid live attenuated vaccines in patients treated with high efficacy disease-modifying treatment (DMT). However, a delay in starting DMT in highly active or aggressive multiple sclerosis (MS) might lead to a significant disability., Objective: We aimed to report a case series of 16 highly active RRMS patients who received the live-attenuated varicella-zoster virus (VZV) vaccine during treatment with natalizumab., Methods: This retrospective case series was conducted between September 2015 and February 2022 at the MS Research Center of Sina and Qaem hospital, Tehran, Mashhad, Iran, to identify the outcome of highly active MS patients who received the live-attenuated VZV vaccine on natalizumab., Results: Two males and 14 females were included in this study, with a mean age of 25.5 ± 8.4-year-old. 10 patients were naïve cases of highly active MS, and six were escalated to natalizumab. The patients received two doses of live attenuated VZV vaccine after a mean of 6.72 cycles of natalizumab treatment. Except for the one who experienced mild chickenpox infection, no serious adverse event or disease activity was evident after vaccination., Conclusion: While our data do not confirm the safety of the live attenuated VZV vaccine in natalizumab recipients, it highlights the importance of case-by-case decision-making in MS management based on the risk-benefit assessment., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interest, and no funding has been used for the manuscript., (Copyright © 2023. Published by Elsevier B.V.)

Purpose: The present research translated and validated the Persian version of the Everyday Memory Questionnaire-Revised (EMQ-R) in patients with multiple sclerosis (MS)., Methods: A two-step study was performed in the current work. First, the scale was translated and culturally adopted to Persian. In the second step, the translated questionnaire was presented to 150 patients with MS and 50 individuals in the control group. Then, construct validity (factor analysis and clinical validity) and reliability measures (test-retest reliability and internal consistency) were computed for this questionnaire., Results: Patients with MS obtained higher scores in EMQ-R than the control group ( p   <  .001). The findings of the Kaiser-Meyer-Olkin and Bartlett test approved the sampling adequacy for computing the factor analysis ( p   <  .001). The accuracy of the three-dimensional structure was confirmed by confirmatory factor analysis (CFA). Findings of test-retest (ICC = .95, 95%CI .91-.98, p   <  .001) and internal consistency revealed a satisfactory value ( α  = .95, p   <  .001)., Conclusions: Satisfactory findings for construct validity and high values for reliability revealed that the Persian version of EMQ-R is a reliable and valid scale to measure the everyday memory of patients with MS in the cognitive assessments of this group.IMPLICATIONS FOR REHABILITATIONPersian EMQ-R is a valid, reliable, fast, and easy to administer tool for evaluating the beliefs and insights of patients suffering from MS or other clinical conditions about their cognitive dysfunctions, in day-to-day lives with some differentiation between memory and attentional difficulties. This questionnaire can be a practical clinical tool for the assessment of the cognitive deficits, which might not be detected via formal neuropsychological assessments, and could be a valuable scale to measure the effects of treatment approaches to level up memory function in a way that could be generalized to daily life performance.

Background: Data on perioperative risk stratification in patients with multiple sclerosis (MS) are limited. In this regard, the present study was conducted to investigate Iranian specialists' approach to surgical counseling for patients with MS (PwMS). Methods: 21 MS specialists were asked about 11 case scenarios with different MS disease statuses, disease-modifying therapies (DMTs), and urgency of the operation. The reasons for refusing surgery or factors that have to be considered before surgery were studied. Results: Overall, Fleiss Kappa was estimated to be 0.091 [95% confidence interval (CI): 0.090-0.093, P < 0.001] indicating a very poor level of agreement among responders. Conclusion: PwMS face surgery for various reasons. Risk assessment of surgery, the effect of various drugs such as anesthetics and DMT on patients, as well as many other aspects of MS are issues challenging the practitioners. Clarifying the various dimensions of these issues requires further research., Competing Interests: The authors declare no conflict of interest in this study., (Copyright © 2023 Iranian Neurological Association, and Tehran University of Medical Sciences Published by Tehran University of Medical Sciences.)

The objective of this study is to describe our COVID-19 patients with herpesviridae reactivation in the central nervous system (CNS). Four patients were described including two with acute encephalitis and two with acute encephalomyelitis. Three of four patients had abnormal findings on neuroimaging studies. One of four patients died, one survived with major neurological sequelae, and two others fully recovered. Herpesviridae reactivation in the CNS in patients with COVID-19 is a rare but serious coincidence. The optimal therapeutic management has not been investigated and until more information is available, it is prudent to treat these patients with appropriate antivirals with or without anti-inflammatory agents., (© 2023. The Author(s) under exclusive licence to The Journal of NeuroVirology, Inc.)

Background: Today, it is estimated that around 5% of multiple sclerosis (MS) patients are in the late-onset category (age at disease onset ≥ 50). Diagnosis and treatment in this group could be challenging. Here, we report the latest update on the characteristics of Iranian patients with late-onset MS (LOMS)., Methods: This cross-sectional study used the information provided by the nationwide MS registry of Iran (NMSRI). The registrars from 14 provinces entered data of patients with a confirmed diagnosis of MS by neurologists. Patients with disease onset at or later than 50 years of age were considered LOMS., Results: Of 20,036 records, the late-onset category included 321 patients (1.6%). The age-standardized LOMS prevalence was around 75 per 100,000 people. 215 patients (67%) were female. Median Expanded Disability Status Scale (EDSS) was 3 (interquartile range: 1.5-5). The majority of the cases (56%) suffered from relapsing-remitting (RR) course while 20% were diagnosed with primary progressive (PP) MS. Significantly higher proportion of male sex, PPMS, and higher EDSS were seen in the late-onset group compared with early-onset and adult-onset cases (p-value < 0.05). Seventy-five (23%) patients did not receive any disease-modifying treatment., Discussion: The more prominent degenerative pathology of LOMS may be the underlying mechanism of the observed differences in comparison to non-LOMS., Conclusion: There are substantial differences and knowledge gaps regarding LOMS which could be the subject of further research., Competing Interests: Declarations of Competing Interests None., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: People with multiple sclerosis ‎(MS) and their physicians recognize cognitive retention as an important desired outcome of disease-modifying therapies (DMTs). In this study, we attempted to gather the opinions of Iranian MS experts regarding the treatment approach toward clinical cases with different physical and cognitive conditions. Methods: Opinions of 20 MS specialists regarding the best approach to 6 case scenarios (with different clinical, cognitive, and imaging characteristics) were gathered via a form. Results: The estimated kappa of 0.16 [95% confidence interval (CI): 0.159-0.163; P < 0.001] suggested a poor degree of agreement on the treatment choice among the professionals. Conclusion: Although most specialists agreed with treatment escalation in cases with cognitive impairment, there was no general agreement. Furthermore, there was not enough clinical evidence in the literature to develop consensus guidelines on the matter., Competing Interests: The authors declare no conflict of interest in this study., (Copyright © 2023 Iranian Neurological Association, and Tehran University of Medical Sciences Published by Tehran University of Medical Sciences.)

Background: Therapeutic plasma exchange (TPE) is a conventional second-line treatment for patients with multiple sclerosis (MS) or clinically isolated syndrome with steroid-refractory relapses., Methods: MS and clinically isolated syndrome patients with a steroid-refractory relapse, who fulfilled the indications for TPE were enrolled in this study. An expert nurse recorded the data comprising age, sex, type of MS, disease modifying therapy, disease duration, relapse rate, vital signs at the beginning, during and at the end of each plasma exchange session, plasma exchange volume, normal saline volume, and TPE complications. Ultimately, the statistical association was estimated amongst the variables., Results: A total of 122 cases were assessed. Twelve cases (9.8%) received plasmapheresis for the second time. The mean age was 32.2±8.7 years and 107 (87.7%) were female. In total, 609 plasma exchange sessions were completed. Hypotension and skin reaction were the most clinical complications. Hemoglobin loss and hypokalemia were the most laboratory complications. Fifty-four cases (44.3%) had no complications, 40 (32.8%) had 1 complication, 21 (17.2%) 2 complications, 6 (4.9%) had 3 complications, and 1 (0.8%) disclosed 4 complications. The relapse rate in the past 12 months and the mean plasma volume exchange were significantly different between the groups., Conclusions: We revealed that TPE could be considered as a safe second-line therapy in MS relapses. Hypotension, skin reaction, hemoglobin loss, and hypokalemia were the most complications of TPE in our patients., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

The XCL1-XCR1 axis has a potential role in the recruitment of immune cells to the site of inflammation. The present study aimed to examine the relation of XCL1 serum levels with Multiple sclerosis (MS) and HTLV-1-associated myelopathy (HAM), as chronic inflammatory diseases of the central nervous system (CNS). DNA was extracted to evaluate HTLV-1 proviral load (PVL) using real-time PCR. Serum levels of XCL1 was determined by using an ELISA assay. The serum level of XCL1 was significantly higher in patients with HAM than that of asymptomatic carriers (ACs) and healthy controls (HCs) (p < 0.001 and p < 0.0001, respectively) and was also higher in MS patients compared to HCs (p < 0.0001). Moreover, the concentration of XCL1 serum level was significantly different between the ACs and HCs group (p < 0.0001). In conclusion, increased expression of XCL1 might contribute to the migration of autoreactive T cells to the central nervous system and play a critical role in the development and pathogenesis of inflammatory neurological diseases including HAM and MS., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Multiple sclerosis (MS) is a chronic, predominantly immune-mediated degenerative disease of the central nervous system. Due to prolonged use of immunomodulatory and immunosuppressive medications, vaccine hesitancy could be common among MS patients. Our main aim in the current study was to evaluate the willingness and acceptability of COVID-19 vaccination in patients with MS. In our multicenter cross-sectional questionnaire-based clinical study, 892 patients completed the questionnaire between May to June 2021. The questionnaire consisted of demographic data, MS disease-related factors, history of COVID-19 infection/vaccination, and any existing comorbidities. Statistical analysis was performed using SPSS software version 19. Overall, 68% of the participants expressed willingness to be vaccinated. Major causes of vaccine refusal in our patients were the fear of reducing the efficacy of disease modifying drugs (DMDs) upon vaccination as well as distrusting the vaccines and overestimation bias in the power of their innate immunity and potential COVID-19 resistance. Some demographic factors affected vaccination enthusiasm in our study. Our findings did not show significant correlation between the age and comorbidity and vaccine willingness. Only one-third of our patients received their vaccine information from healthcare providers. The majority of them received these data from official broadcasting channels and social media. However, despite several concerns, the willingness of COVD-19 vaccination in the Iranian MS patients is remarkable.