Observational Study on the Safety and Efficacy of Rituximab in Multiple Sclerosis: Insights from North-Eastern Iran Rituximab Efficacy and Safety in MS: Iran
Iranian Journal of Pharmaceutical Sciences,
Vol. 21 No. 1 (2025),
21 January 2025
,
Page 125-133
https://doi.org/10.22037/ijps.v21i1.45962
Abstract
Multiple sclerosis (MS) is a chronic autoimmune and inflammatory disease that affects young people and causes demyelination and axon loss in the central nervous system. According to several studies, rituximab (RTX) reduces inflammation and relapse in patients with relapsing-remitting MS. This study aimed to evaluate the efficacy and safety of RTX in patients suffering from MS. MS patients were treated in the comprehensive MS clinic of Ghaem Hospital, Mashhad, Iran, and RTX administration was approved for them (1000 mg). Before initiating the study, demographic characteristics (e.g., age, gender, and type of MS disease), clinical variables (e.g., annual relapse rate [ARR] in the year before the intervention, Expanded Disability Status Scale (EDSS) score, and magnetic resonance imaging [MRI] findings), laboratory variables (e.g., complete blood count [CBC], liver and kidney function tests) for the patients were recorded. After the intervention, the variables were checked and re-recorded, and the patients were followed up at 6 and 12 months. In total, 50 patients with relapsing-remitting MS (RRMS), primary progressive MS (PPMS), or secondary progressive MS (SPMS) with mean age and treatment duration of 37.60±8.91 and 6.72±5.28 years, respectively, were included in the study. The results showed no significant difference among the three time periods regarding the mean disability level (P=0.73). Moreover, the mean ARR decreased significantly after the intervention (P=0.007). This study showed that RTX administration effectively reduces the ARR, and no significant safety issues were recorded. However, the results of this study could not prove RTX's efficacy in preventing confirmed disability progression.
- Annual relapse rate
- EDSS values
- Multiple sclerosis
- Rituximab
How to Cite
References
Huang, W.J., W.W. Chen, and X. Zhang, Multiple sclerosis: Pathology, diagnosis and treatments. Exp Ther Med, 2017. 13(6): p. 3163-3166.
Thompson, A.J., et al., Multiple sclerosis. Lancet, 2018. 391(10130): p. 1622-1636.
Gruchot, J., et al., The Molecular Basis for Remyelination Failure in Multiple Sclerosis. Cells, 2019. 8(8).
Walton, C., et al., Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler, 2020. 26(14): p. 1816-1821.
Eskandarieh, S., et al., Prevalence and Incidence of Multiple Sclerosis in Tehran, Iran. Iran J Public Health, 2017. 46(5): p. 699-704.
Qian, Z., et al., Global, regional, and national burden of multiple sclerosis from 1990 to 2019: Findings of global burden of disease study 2019. Front Public Health, 2023. 11: p. 1073278.
Hauser, S.L. and B.A.C. Cree, Treatment of Multiple Sclerosis: A Review. Am J Med, 2020. 133(12): p. 1380-1390.e2.
Galetta, S.L., C. Markowitz, and A.G. Lee, Immunomodulatory agents for the treatment of relapsing multiple sclerosis: a systematic review. Arch Intern Med, 2002. 162(19): p. 2161-9.
Massacesi, L., et al., Active and passively induced experimental autoimmune encephalomyelitis in common marmosets: a new model for multiple sclerosis. Ann Neurol, 1995. 37(4): p. 519-30.
Hauser, S.L., The Charcot Lecture | beating MS: a story of B cells, with twists and turns. Mult Scler, 2015. 21(1): p. 8-21.
Reff, M.E., et al., Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood, 1994. 83(2): p. 435-45.
Pescovitz, M.D., Rituximab, an anti-cd20 monoclonal antibody: history and mechanism of action. Am J Transplant, 2006. 6(5 Pt 1): p. 859-66.
Chisari, C.G., et al., Rituximab for the treatment of multiple sclerosis: a review. J Neurol, 2022. 269(1): p. 159-183.
Alping, P., Disease-modifying therapies in multiple sclerosis: A focused review of rituximab. Basic Clin Pharmacol Toxicol, 2023. 133(5): p. 550-564.
Boremalm, M., P. Sundström, and J. Salzer, Discontinuation and dose reduction of rituximab in relapsing-remitting multiple sclerosis. J Neurol, 2021. 268(6): p. 2161-2168.
Naismith, R.T., et al., Rituximab add-on therapy for breakthrough relapsing multiple sclerosis: a 52-week phase II trial. Neurology, 2010. 74(23): p. 1860-7.
de Flon, P., et al., Improved treatment satisfaction after switching therapy to rituximab in relapsing-remitting MS. Mult Scler, 2017. 23(9): p. 1249-1257.
Svenningsson, A., et al., Safety and efficacy of rituximab versus dimethyl fumarate in patients with relapsing-remitting multiple sclerosis or clinically isolated syndrome in Sweden: a rater-blinded, phase 3, randomised controlled trial. Lancet Neurol, 2022. 21(8): p. 693-703.
Fakih, A.U., et al., Effectiveness and safety of switching from fingolimod and natalizumab to rituximab in patients with relapsing remitting multiple sclerosis. Mult Scler Relat Disord, 2023. 71: p. 104564.
Hauser, S.L., et al., B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med, 2008. 358(7): p. 676-88.
Salzer, J., et al., Rituximab in multiple sclerosis: A retrospective observational study on safety and efficacy. Neurology, 2016. 87(20): p. 2074-2081.
Kasi, P.M., et al., Clinical review: Serious adverse events associated with the use of rituximab - a critical care perspective. Crit Care, 2012. 16(4): p. 231.
Torgauten, H.M., et al., Safety and efficacy of rituximab as first- and second line treatment in multiple sclerosis - A cohort study. Mult Scler J Exp Transl Clin, 2021. 7(1): p. 2055217320973049.
Alvarez, E., et al., Tolerability and Safety of Switching from Rituximab to Ocrelizumab: Evaluating Factors Associated with Infusion Related Reactions. Mult Scler J Exp Transl Clin, 2022. 8(1): p. 20552173211069359.
Hu, Y., et al., Efficacy and safety of rituximab for relapsing-remitting multiple sclerosis: A systematic review and meta-analysis. Autoimmun Rev, 2019. 18(5): p. 542-548.
Chico-García, J.L., et al., B-lymphocyte-guided retreatment contributes to establish good effectiveness and safety profile in MS patients treated with rituximab. Mult Scler Relat Disord, 2022. 68: p. 104218.
Bar-Or, A., et al., Rituximab in relapsing-remitting multiple sclerosis: a 72-week, open-label, phase I trial. Ann Neurol, 2008. 63(3): p. 395-400.
de Flon, P., et al., Reduced inflammation in relapsing-remitting multiple sclerosis after therapy switch to rituximab. Neurology, 2016. 87(2): p. 141-7.
Hawker, K., et al., Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol, 2009. 66(4): p. 460-71.
Yamout, B.I., et al., Safety and Efficacy of Rituximab in Multiple Sclerosis: A Retrospective Observational Study. J Immunol Res, 2018. 2018: p. 9084759.
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