Document Type: Original Article
Department of Neurology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Department of Neurology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Background: The study aimed to judge the safety and possible side effects of rituximab (RTX) drug in patients with multiple sclerosis (MS).
Methods: This retrospective observational study was performed on 91 patients with MS who had been treated with RTX between 2016 and 2019. Each patient was visited and examined a minimum of once. The side effects of the drug and therefore the drug-related reactions to the injection were asked via phone calls, which were recorded separately as mild, moderate, and severe modes with the necessity for hospitalization.
Results: A total of 91 patients were enrolled within the study: 80 patients with relapsing-remitting MS (RRMS), 6 patients with secondary progressive MS (SPMS), and 5 patients with primary progressive MS (PPMS). The mean age of the patients was 32.18 ± 8.71 years (18 to 60 years). The injection-related side effects occurred in 30.8% of the injections, most of which were mild and one of the mild complications was urinary tract infection (UTI). Two cases of complications with moderate severity were recorded.
Conclusion: The observations from this study demonstrated that RTX did not cause serious complications in patients with MS.
- Alldredge B, Jordan A, Imitola J, Racke M. Safety and efficacy of rituximab: Experience of a single multiple sclerosis center. Clin Neuropharmacol 2018; 41(2): 56-9.
- Castillo-Trivino T, Braithwaite D, Bacchetti P, Waubant E. Rituximab in relapsing and progressive forms of multiple sclerosis: A systematic review. PLoS One 2013; 8(7): e66308.
- Samuels MA, Ropper AH, Klein J. Adams and Victor's principles of neurology. 10th ed. New York, NY: McGraw-Hill Education; 2014. p. 917.
- He D, Guo R, Zhang F, Zhang C, Dong S, Zhou H. Rituximab for relapsing-remitting multiple sclerosis. Cochrane Database Syst Rev 2013; (12): CD009130.
- Hauser SL, Waubant E, Arnold DL, Vollmer T, Antel J, Fox RJ, et al. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med 2008; 358(7): 676-88.
- Rahmanzadeh R, Weber MS, Bruck W, Navardi S, Sahraian MA. B cells in multiple sclerosis therapy-A comprehensive review. Acta Neurol Scand 2018; 137(6): 544-56.
- Rommer PS, Dorner T, Freivogel K, Haas J, Kieseier BC, Kumpfel T, et al. Safety and clinical outcomes of rituximab treatment in patients with multiple sclerosis and neuromyelitis optica: Experience from a National Online Registry (GRAID). J Neuroimmune Pharmacol 2016; 11(1): 1-8.
- Gasperi C, Stuve O, Hemmer B. B cell-directed therapies in multiple sclerosis. Neurodegener Dis Manag 2016; 6(1): 37-47.
- Lulu S, Waubant E. Humoral-targeted immunotherapies in multiple sclerosis. Neurotherapeutics 2013; 10(1): 34-43.
- Bar-Or A, Calabresi PA, Arnold D, Markowitz C, Shafer S, Kasper LH, et al. Rituximab in relapsing-remitting multiple sclerosis: A 72-week, open-label, phase I trial. Ann Neurol 2008; 63(3): 395-400.
- Salzer J, Svenningsson R, Alping P, Novakova L, Bjorck A, Fink K, et al. Rituximab in multiple sclerosis: A retrospective observational study on safety and efficacy. Neurology 2016; 87(20): 2074-81.
- Berenguer-Ruiz L, Sempere AP, Gimenez-Martinez J, Gabaldon-Torres L, Tahoces L, Sanchez-Perez R, et al. Rescue therapy using rituximab for multiple sclerosis. Clin Neuropharmacol 2016; 39(4): 178-81.
- Barra ME, Soni D, Vo KH, Chitnis T, Stankiewicz JM. Experience with long-term rituximab use in a multiple sclerosis clinic. Mult Scler J Exp Transl Clin 2016; 2: 2055217316672100.
- Naser MA, Darki A, Masoumi P, Hashemi SN, Ghadiri F. Evaluating the efficacy and safety of Zytux(TM) (Rituximab, AryoGen pharmed) in Iranian multiple sclerosis patients: An observational study. Mult Scler Relat Disord 2019; 36: 101419.
- Bartok B, Silverman GJ. Development of anti-CD20 therapy for multiple sclerosis. Exp Cell Res 2011; 317(9): 1312-8.
- Granqvist M, Boremalm M, Poorghobad A, Svenningsson A, Salzer J, Frisell T, et al. Comparative effectiveness of rituximab and other initial treatment choices for multiple sclerosis. JAMA Neurol 2018; 75(3): 320-7.
- Alping P, Frisell T, Novakova L, Islam-Jakobsson P, Salzer J, Bjorck A, et al. Rituximab versus fingolimod after natalizumab in multiple sclerosis patients. Ann Neurol 2016; 79(6): 950-8.
- Hawker K, O'Connor P, Freedman MS, Calabresi PA, Antel J, Simon J, 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): 460-71.
- Rezaali S, Khalilnezhad A, Naser MA, Chaibakhsh S, Sahraian MA. Epidemiology of multiple sclerosis in Qom: Demographic study in Iran. Iran J Neurol 2013; 12(4): 136-43.
- Eskandarieh S, Molazadeh N, Moghadasi AN, Azimi AR, Sahraian MA. The prevalence, incidence and familial recurrence of multiple sclerosis in Tehran, Iran. Mult Scler Relat Disord 2018; 25: 143.
- Eskandarieh S, Heydarpour P, Elhami SR, Sahraian MA. Prevalence and Incidence of Multiple Sclerosis in Tehran, Iran. Iran J Public Health 2017; 46(5): 699-704.
- Berntsson SG, Kristoffersson A, Bostrom I, Feresiadou A, Burman J, Landtblom AM. Rapidly increasing off-label use of rituximab in multiple sclerosis in Sweden - Outlier or predecessor? Acta Neurol Scand 2018; 138(4): 327-31.