Volume 80, Issue 4 (July 2022)
Tehran Univ Med J 2022, 80(4): 323-330 |
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Razazian N, Rezaei M, Ahmadi P, Fakhri N. Evaluation of the one-year effectiveness and side effects of rituximab in patients with multiple sclerosis in Kermanshah. Tehran Univ Med J 2022; 80 (4) :323-330
URL: http://tumj.tums.ac.ir/article-1-11815-en.html
URL: http://tumj.tums.ac.ir/article-1-11815-en.html
1- Department of Neurology, Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.
2- Department of Biostatistics, Social Development and Health Promotion Research Center, Faculty of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.
3- Clinical Research Development Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.
4- Student’s Research Committee, Faculty of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.
2- Department of Biostatistics, Social Development and Health Promotion Research Center, Faculty of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.
3- Clinical Research Development Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.
4- Student’s Research Committee, Faculty of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Abstract: (3245 Views)
Background: Multiple sclerosis (MS) is an inflammatory disease affecting the central nervous system. Rituximab (Zytux) is a type of monoclonal antibody against B cells with CD20 antigen that reduces B cells. The present study examined the one-year effectiveness and side effects of Rituximab.
Methods: This quasi-experimental clinical trial was conducted from September 2018 to September 2019 in Imam Reza Hospital in Kermanshah. 44 eligible patients were selected by the available sampling method and entered the study after evaluation in terms of inclusion and exclusion criteria. Patients were treated with rituximab for one year. At the beginning of the study and at the end of the year, the disability score based on the Expanded Disability Status Scale (EDSS) and active lesions based on MRI for patients were evaluated. Also, the patients were followed up in terms of relapse and medication side effects throughout the year. This study was performed with the support of Kermanshah University of Medical Sciences. Informed consent was obtained from all participants. The data were analyzed by SPSS-25 software.
Methods: This quasi-experimental clinical trial was conducted from September 2018 to September 2019 in Imam Reza Hospital in Kermanshah. 44 eligible patients were selected by the available sampling method and entered the study after evaluation in terms of inclusion and exclusion criteria. Patients were treated with rituximab for one year. At the beginning of the study and at the end of the year, the disability score based on the Expanded Disability Status Scale (EDSS) and active lesions based on MRI for patients were evaluated. Also, the patients were followed up in terms of relapse and medication side effects throughout the year. This study was performed with the support of Kermanshah University of Medical Sciences. Informed consent was obtained from all participants. The data were analyzed by SPSS-25 software.
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Results: 44 patients with MS including 29 (65.9%) female and 15 (34.1%) male were studied. 22 patients had RRMS and 22 patients had progressive-relapsing MS (PRMS). In patients with RRMS, the EDSS score at the end of the study was significantly reduced compared to the beginning of the study (P=0.010) but in PRMS patients EDSS was increased but this increase was not significant (P=0.148). In both RRMS and PRMS patients, the number of MRI lesions at the end of the study was lower than the beginning of the study and this decrease was not significant (P>0.05). More Immediate side effects occurred in RRMS patients (13.6% vs. 4.5%) and more delayed side effects were observed in PRMS patients (54.5% vs. 36.3%).
Conclusion: rituximab caused a greater reduction in EDSS in the treatment of RRMS than PRMS and its use had few side effects. |
Type of Study: Original Article |
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