Xintong Xu , Lindan Xie , Lili Wei , Meixuan Li , Hao Wang , Huanfen Zhou , Mingming Sun , Mo Yang , Quangang Xu , Kehu Yang , Shihui Wei
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Randomized controlled trials of monoclonal antibodies were the targets of the review.</p></div><div><h3>Results</h3><p>We included seven trials containing 775 patients (485 in the monoclonal antibody group and 290 in the control group). Patients in the monoclonal group (HR 0.24, 95% CI: 0.14 to 0.40, <em>P</em> < 0.00001), as well as patients with seropositive AQP4-IgG (HR 0.18, 95% CI: 0.11 to 0.29, <em>P</em> < 0.00001), both had a higher free recurrence rate than that in the control group. In the first year (HR 0.25, 95% CI: 0.09 to 0.71, <em>P</em> = 0.009) and the second year (HR 0.32, 95% CI: 0.13 to 0.81, <em>P</em> = 0.02), no relapses were documented. The average changes of the expanded disability status scale (EDSS) score decreased by 0.29 (95% CI: −0.09 to 0.51, <em>P</em> = 0.005). Upper respiratory tract infection (OR 1.52, 95% CI: 0.76 to 3.04, <em>P</em> = 0.24), urinary tract infection(OR 0.79, 95% CI: 0.51 to 1.21, <em>P</em> = 0.27), and headache (OR 1.30, 95% CI: 0.78 to 2.17, <em>P</em> = 0.31) were three most frequent adverse reactions.</p></div><div><h3>Conclusions</h3><p>Monoclonal antibodies are particularly effective treatments in avoiding recurrence for NMOSD patients, according to this meta-analysis. The associated adverse responses are not significantly different from those seen with traditional immunosuppressants.</p></div>","PeriodicalId":72103,"journal":{"name":"Advances in ophthalmology practice and research","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d0/d2/main.PMC10577852.pdf","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of monoclonal antibodies in neuromyelitis optica spectrum disorders: A survival meta-analysis of randomized controlled trials\",\"authors\":\"Xintong Xu , Lindan Xie , Lili Wei , Meixuan Li , Hao Wang , Huanfen Zhou , Mingming Sun , Mo Yang , Quangang Xu , Kehu Yang , Shihui Wei\",\"doi\":\"10.1016/j.aopr.2022.100064\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Monoclonal antibodies such as rituximab (RTX), eculizumab, inebilizumab, satralizumab, and tocilizumab have been found to be effective therapies for neuromyelitis optica spectrum disease (NMOSD) in several clinical randomized controlled trials.</p></div><div><h3>Objective</h3><p>The purpose of this meta-analysis of randomized controlled trials was to assess the efficacy and safety of monoclonal antibodies in the treatment of NMOSD.</p></div><div><h3>Methods</h3><p>We searched the following databases for relevant English language literature from the establishment of the database to June 2021: PubMed, Embase, Cohorane Library, the Central Register of Controlled Trials (CENTRAL), and Web of Science. Randomized controlled trials of monoclonal antibodies were the targets of the review.</p></div><div><h3>Results</h3><p>We included seven trials containing 775 patients (485 in the monoclonal antibody group and 290 in the control group). Patients in the monoclonal group (HR 0.24, 95% CI: 0.14 to 0.40, <em>P</em> < 0.00001), as well as patients with seropositive AQP4-IgG (HR 0.18, 95% CI: 0.11 to 0.29, <em>P</em> < 0.00001), both had a higher free recurrence rate than that in the control group. In the first year (HR 0.25, 95% CI: 0.09 to 0.71, <em>P</em> = 0.009) and the second year (HR 0.32, 95% CI: 0.13 to 0.81, <em>P</em> = 0.02), no relapses were documented. The average changes of the expanded disability status scale (EDSS) score decreased by 0.29 (95% CI: −0.09 to 0.51, <em>P</em> = 0.005). Upper respiratory tract infection (OR 1.52, 95% CI: 0.76 to 3.04, <em>P</em> = 0.24), urinary tract infection(OR 0.79, 95% CI: 0.51 to 1.21, <em>P</em> = 0.27), and headache (OR 1.30, 95% CI: 0.78 to 2.17, <em>P</em> = 0.31) were three most frequent adverse reactions.</p></div><div><h3>Conclusions</h3><p>Monoclonal antibodies are particularly effective treatments in avoiding recurrence for NMOSD patients, according to this meta-analysis. The associated adverse responses are not significantly different from those seen with traditional immunosuppressants.</p></div>\",\"PeriodicalId\":72103,\"journal\":{\"name\":\"Advances in ophthalmology practice and research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d0/d2/main.PMC10577852.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in ophthalmology practice and research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2667376222000415\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in ophthalmology practice and research","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2667376222000415","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
在一些临床随机对照试验中,单克隆抗体如利妥昔单抗(RTX)、eculizumab、inebilizumab、satralizumab和tocilizumab已被发现是治疗视神经脊髓炎(NMOSD)的有效方法。目的本荟萃分析的目的是评估单克隆抗体治疗NMOSD的疗效和安全性。方法检索自建库至2021年6月的相关英文文献:PubMed、Embase、Cohorane Library、Central Register of Controlled Trials (Central)和Web of Science。该综述的目标是单克隆抗体的随机对照试验。结果纳入7项试验,共775例患者(单克隆抗体组485例,对照组290例)。单克隆组患者(HR 0.24, 95% CI: 0.14 ~ 0.40, P <0.00001),以及血清AQP4-IgG阳性患者(HR 0.18, 95% CI: 0.11 ~ 0.29, P <0.00001),两组游离复发率均高于对照组。第一年(HR 0.25, 95% CI: 0.09 ~ 0.71, P = 0.009)和第二年(HR 0.32, 95% CI: 0.13 ~ 0.81, P = 0.02)均无复发记录。扩展残疾状态量表(EDSS)评分的平均变化减少了0.29 (95% CI:−0.09 ~ 0.51,P = 0.005)。上呼吸道感染(OR 1.52, 95% CI: 0.76 ~ 3.04, P = 0.24)、尿路感染(OR 0.79, 95% CI: 0.51 ~ 1.21, P = 0.27)和头痛(OR 1.30, 95% CI: 0.78 ~ 2.17, P = 0.31)是三个最常见的不良反应。结论根据这项荟萃分析,单克隆抗体是避免NMOSD患者复发的有效治疗方法。相关的不良反应与传统免疫抑制剂的不良反应没有显著差异。
Efficacy and safety of monoclonal antibodies in neuromyelitis optica spectrum disorders: A survival meta-analysis of randomized controlled trials
Background
Monoclonal antibodies such as rituximab (RTX), eculizumab, inebilizumab, satralizumab, and tocilizumab have been found to be effective therapies for neuromyelitis optica spectrum disease (NMOSD) in several clinical randomized controlled trials.
Objective
The purpose of this meta-analysis of randomized controlled trials was to assess the efficacy and safety of monoclonal antibodies in the treatment of NMOSD.
Methods
We searched the following databases for relevant English language literature from the establishment of the database to June 2021: PubMed, Embase, Cohorane Library, the Central Register of Controlled Trials (CENTRAL), and Web of Science. Randomized controlled trials of monoclonal antibodies were the targets of the review.
Results
We included seven trials containing 775 patients (485 in the monoclonal antibody group and 290 in the control group). Patients in the monoclonal group (HR 0.24, 95% CI: 0.14 to 0.40, P < 0.00001), as well as patients with seropositive AQP4-IgG (HR 0.18, 95% CI: 0.11 to 0.29, P < 0.00001), both had a higher free recurrence rate than that in the control group. In the first year (HR 0.25, 95% CI: 0.09 to 0.71, P = 0.009) and the second year (HR 0.32, 95% CI: 0.13 to 0.81, P = 0.02), no relapses were documented. The average changes of the expanded disability status scale (EDSS) score decreased by 0.29 (95% CI: −0.09 to 0.51, P = 0.005). Upper respiratory tract infection (OR 1.52, 95% CI: 0.76 to 3.04, P = 0.24), urinary tract infection(OR 0.79, 95% CI: 0.51 to 1.21, P = 0.27), and headache (OR 1.30, 95% CI: 0.78 to 2.17, P = 0.31) were three most frequent adverse reactions.
Conclusions
Monoclonal antibodies are particularly effective treatments in avoiding recurrence for NMOSD patients, according to this meta-analysis. The associated adverse responses are not significantly different from those seen with traditional immunosuppressants.