Document Type : Original Article
Authors
1 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
2 Department of Neurology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
3 Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Abstract
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.
Keywords
- 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.