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Daclizumab for relapsing remitting multiple sclerosis
Liu, Jia1; Wang, Lu-Ning1; Zhan, Siyan2; Xia, Yinyin3
关键词Antibodies, Monoclonal, Humanized [therapeutic use] Immunoglobulin G [therapeutic use] Immunosuppressive Agents [therapeutic use] Interferon-beta [therapeutic use] Multiple Sclerosis, Relapsing-Remitting [drug therapy] Randomized Controlled Trials as Topic Humans
刊名COCHRANE DATABASE OF SYSTEMATIC REVIEWS
2013
DOI10.1002/14651858.CD008127.pub4
12
收录类别SCI
文章类型Review
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
资助者Department of Geriatric Neurology, Chinese PLA General Hospital, China ; Department of Geriatric Neurology, Chinese PLA General Hospital, China
研究领域[WOS]General & Internal Medicine
关键词[WOS]DIAGNOSTIC-CRITERIA ; MONOCLONAL-ANTIBODY ; IN-VIVO ; CELLS ; GUIDELINES ; THERAPY ; TRIAL
英文摘要

Background

Monoclonal antibodies such as daclizumab could be a possible alternative immunotherapy to interferon beta treatment in people with multiple sclerosis (MS). It blocks the interleukin-2 receptor alpha subunit (CD25), and seems to be beneficial to patients with relapsing remitting multiple sclerosis (RRMS) in clinical and magnetic resonance imaging (MRI) measures of outcomes.

This is an update of a Cochrane review first published in 2010, and previously updated in 2012.

Objectives

To assess the safety of daclizumab and its efficacy to prevent clinical worsening in patients with RRMS.

Search methods

The Trials Search Co-ordinator searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register (17 May 2013). We handsearched the references quoted in the identified trials and reports (May 2013) from the most important neurological associations and MS societies. We contacted researchers participating in trials on daclizumab.

Selection criteria

All randomised controlled clinical trials (RCTs) evaluating daclizumab, alone or combined with other treatments versus placebo, or any other treatment for patients with RRMS.

Data collection and analysis

Two review authors independently assessed references retrieved for possible inclusion, extracted eligible data, cross-checked the data for accuracy and assessed the methodological quality. We resolved any disagreements by consensus among review authors.

Main results

We included two trials with 851 patients that evaluated the efficacy and safety of daclizumab versus placebo for RRMS. We judged them to be at low risk of bias. Due to different time point evaluations and available data on primary studies, we were unable to undertake a meta-analysis. At 24 weeks, the median change was 0 (range -2 to 3) in the interferon beta and placebo group, 0 (-2 to 4) in the interferon beta and low-dose daclizumab group and 0 (-2 to 2) in the interferon beta and high-dose daclizumab group in 230 participants. The proportion of patients who had new clinical relapses were the following: 16 patients (21%) in the interferon beta and high-dose daclizumab group, 19 (24%) in the interferon beta and low-dose daclizumab group and 19 (25%) in the interferon beta and placebo group had relapses (P value = 0.87). At 52 weeks, the changes in Expanded Disability Status Scale (EDSS) from baseline was 0.09 +/- 0.71 in placebo group, -0.08 +/- 0.52 in low-dose daclizumab group and 0.05 +/- 0.61 in high-dose daclizumab group in 621 participants. There was a significant difference between placebo and low-dose daclizumab groups (P value = 0.01), but no significant difference between placebo and high-dose daclizumab groups (P value = 0.49). The proportion of patients with new relapsing MS was significantly reduced in both daclizumab groups (19% in low-dose daclizumab group, 20% in high-dose daclizumab group) compared with placebo group (36%) (P value < 0.0001 and P value = 0.00032, respectively). There was no increased number of patients in any adverse events (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.89 to 1.07) or serious adverse events in daclizumab groups compared with placebo (RR 1.15, 95% CI 0.29 to 4.54). Infections were the most frequent adverse events in treated participants and were resolved with standard therapies. One trial was still ongoing.

Authors′ conclusions

There was insufficient evidence to determine whether daclizumab was more effective than placebo in patients affected by RRMS in terms of clinical and MRI measures of outcomes. Daclizumab appeared to be relatively well tolerated. Infections were the most frequent adverse events, and were resolved with standard therapies.

语种英语
资助者Department of Geriatric Neurology, Chinese PLA General Hospital, China ; Department of Geriatric Neurology, Chinese PLA General Hospital, China
WOS记录号WOS:000329188500004
引用统计
被引频次:1[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/68301
专题北京大学公共卫生学院
作者单位1.Chinese Peoples Liberat Army Gen Hosp, Dept Geriatr Neurol, Beijing 100853, Peoples R China
2.Peking Univ, Sch Publ Hlth, Ctr Evidence Based Med & Clin Res, Beijing 100871, Peoples R China
3.China CDC, Natl Ctr TB Control & Prevent, Dept Surveillance & Stat, Beijing, Peoples R China
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GB/T 7714
Liu, Jia,Wang, Lu-Ning,Zhan, Siyan,et al. Daclizumab for relapsing remitting multiple sclerosis[J]. COCHRANE DATABASE OF SYSTEMATIC REVIEWS,2013(12).
APA Liu, Jia,Wang, Lu-Ning,Zhan, Siyan,&Xia, Yinyin.(2013).Daclizumab for relapsing remitting multiple sclerosis.COCHRANE DATABASE OF SYSTEMATIC REVIEWS(12).
MLA Liu, Jia,et al."Daclizumab for relapsing remitting multiple sclerosis".COCHRANE DATABASE OF SYSTEMATIC REVIEWS .12(2013).
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