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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.)