Rituximab and glatiramer acetate in secondary progressive multiple sclerosis: A randomized clinical trial

Acta Neurologica ScandinavicaVolume 143, Issue 2 p. 178-187 ORIGINAL ARTICLE Rituximab and glatiramer acetate in secondary progressive multiple sclerosis: A randomized clinical trial Masoumeh Cheshmavar, Masoumeh Cheshmavar orcid.org/0000-0002-5112-2310 Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, IranSearch for more papers by this authorOmid Mirmosayyeb, Omid Mirmosayyeb orcid.org/0000-0002-3756-2985 Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, IranSearch for more papers by this authorNegin Badihian, Negin Badihian orcid.org/0000-0002-3520-5212 Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, IranSearch for more papers by this authorShervin Badihian, Shervin Badihian orcid.org/0000-0002-9140-3061 Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USASearch for more papers by this authorVahid Shaygannejad, Corresponding Author Vahid Shaygannejad Shaygannejad@med.mui.ac.ir orcid.org/0000-0002-6226-0161 Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran Correspondence Vahid Shaygannejad, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan 73461-81746, Iran. Email: Shaygannejad@med.mui.ac.irSearch for more papers by this author Masoumeh Cheshmavar, Masoumeh Cheshmavar orcid.org/0000-0002-5112-2310 Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, IranSearch for more papers by this authorOmid Mirmosayyeb, Omid Mirmosayyeb orcid.org/0000-0002-3756-2985 Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, IranSearch for more papers by this authorNegin Badihian, Negin Badihian orcid.org/0000-0002-3520-5212 Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, IranSearch for more papers by this authorShervin Badihian, Shervin Badihian orcid.org/0000-0002-9140-3061 Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USASearch for more papers by this authorVahid Shaygannejad, Corresponding Author Vahid Shaygannejad Shaygannejad@med.mui.ac.ir orcid.org/0000-0002-6226-0161 Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran Correspondence Vahid Shaygannejad, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan 73461-81746, Iran. Email: Shaygannejad@med.mui.ac.irSearch for more papers by this author First published: 08 September 2020 https://doi.org/10.1111/ane.13344Citations: 2 Trial registration: IRB registration code: 396514; Clinicaltrials.gov ID: NCT03315923. Funding information: This study was funded by vice-chancellor for research and technology of Isfahan University of Medical Sciences (grant number: 396514). Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract Background Treatment options for secondary progressive multiple sclerosis (SPMS) are limitedly investigated. We aimed to compare the efficacy of rituximab (RTX) and glatiramer acetate (GA) in SPMS patients. Method This open, randomized clinical trial was conducted on 84 SPMS patients, assigned to receive RTX or GA for 12 months. In RTX group, patients received 1 g intravenous RTX primarily and then every 6-months. In GA group, patients received 40 mg of GA 3-times/week subcutaneously. We measured EDSS as the primary outcome and neuroimaging findings, relapse rate (RR), and side effects as the secondary outcomes. Results Seventy-three patients completed the study (37 and 36 in RTX and GA groups, respectively). The mean EDSS increased from 3.05 ± 1.01 to 4.14 ± 0.91 in RTX group (p < 0.001) and from 3.22 ± 1.20 to 4.60 ± 0.67 in GA group (p < 0.001). No statistically significant difference was observed in EDSS between two groups (F(1, 67) = 3.377; p = 0.071). The number of active lesions in brain and cervical spine decreased with no difference between groups (p > 0.05). Also, RR decreased in both groups without significant difference between them (F(1, 67) = 0.390; p = 0.534). Non-serious complications were observed in both groups. Conclusion Neither RTX nor GA affects EDSS in SPMS patients. They are equally effective in the relapse control of these patients. Open Research DATA AVAILABILITY STATEMENT The data that support the findings of this study are available on request from the corresponding author upon reasonable request. The data are not publicly available due to privacy and ethical restrictions. Citing Literature Supporting Information Filename Description ane13344-sup-0001-FileS1.docxWord document, 14.1 KB Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article. Volume143, Issue2February 2021Pages 178-187 RelatedInformation