113 lines
35 KiB
Text
113 lines
35 KiB
Text
<!DOCTYPE html>
|
|
<html xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" class="no-js no-jr">
|
|
<head>
|
|
<!-- For pinger, set start time and add meta elements. -->
|
|
<script type="text/javascript">var ncbi_startTime = new Date();</script>
|
|
|
|
<!-- Logger begin -->
|
|
<meta name="ncbi_db" content="books">
|
|
<meta name="ncbi_pdid" content="book-part">
|
|
<meta name="ncbi_acc" content="NBK571858">
|
|
<meta name="ncbi_domain" content="livertox">
|
|
<meta name="ncbi_report" content="reader">
|
|
<meta name="ncbi_type" content="fulltext">
|
|
<meta name="ncbi_objectid" content="">
|
|
<meta name="ncbi_pcid" content="/NBK571858/?report=reader">
|
|
<meta name="ncbi_pagename" content="Aducanumab - LiverTox - NCBI Bookshelf">
|
|
<meta name="ncbi_bookparttype" content="chapter">
|
|
<meta name="ncbi_app" content="bookshelf">
|
|
<!-- Logger end -->
|
|
|
|
<!--component id="Page" label="meta"/-->
|
|
<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Aducanumab - LiverTox - NCBI Bookshelf</title>
|
|
<meta charset="utf-8">
|
|
<meta name="apple-mobile-web-app-capable" content="no">
|
|
<meta name="viewport" content="initial-scale=1,minimum-scale=1,maximum-scale=1,user-scalable=no">
|
|
<meta name="jr-col-layout" content="auto">
|
|
<meta name="jr-prev-unit" content="/books/n/livertox/Adefovir/?report=reader">
|
|
<meta name="jr-next-unit" content="/books/n/livertox/Afamelanotide/?report=reader">
|
|
<meta name="bk-toc-url" content="/books/n/livertox/?report=toc">
|
|
<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE">
|
|
<meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]">
|
|
<meta name="citation_title" content="Aducanumab">
|
|
<meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
|
|
<meta name="citation_date" content="2021/06/25">
|
|
<meta name="citation_pmid" content="34251780">
|
|
<meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK571858/">
|
|
<link rel="schema.DC" href="http://purl.org/DC/elements/1.0/">
|
|
<meta name="DC.Title" content="Aducanumab">
|
|
<meta name="DC.Type" content="Text">
|
|
<meta name="DC.Publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
|
|
<meta name="DC.Date" content="2021/06/25">
|
|
<meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK571858/">
|
|
<meta name="description" content="Aducanumab is a human monoclonal antibody to amyloid β which has been approved for use in Alzheimer disease. Aducanumab is associated with a minimal rate of serum aminotransferase elevations during therapy and has not been linked to instances of clinically apparent liver injury.">
|
|
<meta name="og:title" content="Aducanumab">
|
|
<meta name="og:type" content="book">
|
|
<meta name="og:description" content="Aducanumab is a human monoclonal antibody to amyloid β which has been approved for use in Alzheimer disease. Aducanumab is associated with a minimal rate of serum aminotransferase elevations during therapy and has not been linked to instances of clinically apparent liver injury.">
|
|
<meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK571858/">
|
|
<meta name="og:site_name" content="NCBI Bookshelf">
|
|
<meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png">
|
|
<meta name="twitter:card" content="summary">
|
|
<meta name="twitter:site" content="@ncbibooks">
|
|
<meta name="bk-non-canon-loc" content="/books/n/livertox/Aducanumab/?report=reader">
|
|
<link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK571858/">
|
|
<link href="https://fonts.googleapis.com/css?family=Archivo+Narrow:400,700,400italic,700italic&subset=latin" rel="stylesheet" type="text/css">
|
|
<link rel="stylesheet" href="/corehtml/pmc/jatsreader/ptpmc_3.22/css/libs.min.css">
|
|
<link rel="stylesheet" href="/corehtml/pmc/jatsreader/ptpmc_3.22/css/jr.min.css">
|
|
<meta name="format-detection" content="telephone=no">
|
|
<link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css">
|
|
<link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css//books_print.min.css" type="text/css" media="print">
|
|
<link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_reader.min.css" type="text/css">
|
|
<style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} .body-content h2, .body-content .h2 {border-bottom: 1px solid #97B0C8} .body-content h2.inline {border-bottom: none} a.page-toc-label , .jig-ncbismoothscroll a {text-decoration:none;border:0 !important} .temp-labeled-list .graphic {display:inline-block !important} .temp-labeled-list img{width:100%}</style>
|
|
|
|
<link rel="shortcut icon" href="//www.ncbi.nlm.nih.gov/favicon.ico">
|
|
<meta name="ncbi_phid" content="CE8E116A7D7B66910000000000620051.m_5">
|
|
<meta name='referrer' content='origin-when-cross-origin'/><link type="text/css" rel="stylesheet" href="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/css/3852956/3849091.css"></head>
|
|
<body>
|
|
<!-- Book content! -->
|
|
|
|
|
|
<div id="jr" data-jr-path="/corehtml/pmc/jatsreader/ptpmc_3.22/"><div class="jr-unsupported"><table class="modal"><tr><td><span class="attn inline-block"></span><br />Your browser does not support the NLM PubReader view.<br />Go to <a href="/pmc/about/pr-browsers/">this page</a> to see a list of supported browsers<br />or return to the <br /><a href="/books/NBK571858/?report=classic">regular view</a>.</td></tr></table></div><div id="jr-ui" class="hidden"><nav id="jr-head"><div class="flexh tb"><div id="jr-tb1"><a id="jr-links-sw" class="hidden" title="Links"><svg xmlns="http://www.w3.org/2000/svg" version="1.1" x="0px" y="0px" viewBox="0 0 70.6 85.3" style="enable-background:new 0 0 70.6 85.3;vertical-align:middle" xml:space="preserve" width="24" height="24">
|
|
<style type="text/css">.st0{fill:#939598;}</style>
|
|
<g>
|
|
<path class="st0" d="M36,0C12.8,2.2-22.4,14.6,19.6,32.5C40.7,41.4-30.6,14,35.9,9.8"></path>
|
|
<path class="st0" d="M34.5,85.3c23.2-2.2,58.4-14.6,16.4-32.5c-21.1-8.9,50.2,18.5-16.3,22.7"></path>
|
|
<path class="st0" d="M34.7,37.1c66.5-4.2-4.8-31.6,16.3-22.7c42.1,17.9,6.9,30.3-16.4,32.5h1.7c-66.2,4.4,4.8,31.6-16.3,22.7 c-42.1-17.9-6.9-30.3,16.4-32.5"></path>
|
|
</g>
|
|
</svg> Books</a></div><div class="jr-rhead f1 flexh"><div class="head"><a href="/books/n/livertox/Adefovir/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="body"><div class="t">Aducanumab</div><div class="j">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]</div></div><div class="tail"><a href="/books/n/livertox/Afamelanotide/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></div><div id="jr-tb2"><a id="jr-bkhelp-sw" class="btn wsprkl hidden" title="Help with NLM PubReader">?</a><a id="jr-help-sw" class="btn wsprkl hidden" title="Settings and typography in NLM PubReader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 512 512" preserveAspectRatio="none"><path d="M462,283.742v-55.485l-29.981-10.662c-11.431-4.065-20.628-12.794-25.274-24.001 c-0.002-0.004-0.004-0.009-0.006-0.013c-4.659-11.235-4.333-23.918,0.889-34.903l13.653-28.724l-39.234-39.234l-28.72,13.652 c-10.979,5.219-23.68,5.546-34.908,0.889c-0.005-0.002-0.01-0.003-0.014-0.005c-11.215-4.65-19.933-13.834-24-25.273L283.741,50 h-55.484l-10.662,29.981c-4.065,11.431-12.794,20.627-24.001,25.274c-0.005,0.002-0.009,0.004-0.014,0.005 c-11.235,4.66-23.919,4.333-34.905-0.889l-28.723-13.653l-39.234,39.234l13.653,28.721c5.219,10.979,5.545,23.681,0.889,34.91 c-0.002,0.004-0.004,0.009-0.006,0.013c-4.649,11.214-13.834,19.931-25.271,23.998L50,228.257v55.485l29.98,10.661 c11.431,4.065,20.627,12.794,25.274,24c0.002,0.005,0.003,0.01,0.005,0.014c4.66,11.236,4.334,23.921-0.888,34.906l-13.654,28.723 l39.234,39.234l28.721-13.652c10.979-5.219,23.681-5.546,34.909-0.889c0.005,0.002,0.01,0.004,0.014,0.006 c11.214,4.649,19.93,13.833,23.998,25.271L228.257,462h55.484l10.595-29.79c4.103-11.538,12.908-20.824,24.216-25.525 c0.005-0.002,0.009-0.004,0.014-0.006c11.127-4.628,23.694-4.311,34.578,0.863l28.902,13.738l39.234-39.234l-13.66-28.737 c-5.214-10.969-5.539-23.659-0.886-34.877c0.002-0.005,0.004-0.009,0.006-0.014c4.654-11.225,13.848-19.949,25.297-24.021 L462,283.742z M256,331.546c-41.724,0-75.548-33.823-75.548-75.546s33.824-75.547,75.548-75.547 c41.723,0,75.546,33.824,75.546,75.547S297.723,331.546,256,331.546z"></path></svg></a><a id="jr-fip-sw" class="btn wsprkl hidden" title="Find"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 550 600" preserveAspectRatio="none"><path fill="none" stroke="#000" stroke-width="36" stroke-linecap="round" style="fill:#FFF" d="m320,350a153,153 0 1,0-2,2l170,170m-91-117 110,110-26,26-110-110"></path></svg></a><a id="jr-rtoc-sw" class="btn wsprkl hidden" title="Table of Contents"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M20,20h10v8H20V20zM36,20h44v8H36V20zM20,37.33h10v8H20V37.33zM36,37.33h44v8H36V37.33zM20,54.66h10v8H20V54.66zM36,54.66h44v8H36V54.66zM20,72h10v8 H20V72zM36,72h44v8H36V72z"></path></svg></a></div></div></nav><nav id="jr-dash" class="noselect"><nav id="jr-dash" class="noselect"><div id="jr-pi" class="hidden"><a id="jr-pi-prev" class="hidden" title="Previous page"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a><div class="pginfo">Page <i class="jr-pg-pn">0</i> of <i class="jr-pg-lp">0</i></div><a id="jr-pi-next" class="hidden" title="Next page"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div><div id="jr-is-tb"><a id="jr-is-sw" class="btn wsprkl hidden" title="Switch between Figures/Tables strip and Progress bar"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><rect x="10" y="40" width="20" height="20"></rect><rect x="40" y="40" width="20" height="20"></rect><rect x="70" y="40" width="20" height="20"></rect></svg></a></div><nav id="jr-istrip" class="istrip hidden"><a id="jr-is-prev" href="#" class="hidden" title="Previous"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M80,40 60,65 80,90 70,90 50,65 70,40z M50,40 30,65 50,90 40,90 20,65 40,40z"></path><text x="35" y="25" textLength="60" style="font-size:25px">Prev</text></svg></a><a id="jr-is-next" href="#" class="hidden" title="Next"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M20,40 40,65 20,90 30,90 50,65 30,40z M50,40 70,65 50,90 60,90 80,65 60,40z"></path><text x="15" y="25" textLength="60" style="font-size:25px">Next</text></svg></a></nav><nav id="jr-progress"></nav></nav></nav><aside id="jr-links-p" class="hidden flexv"><div class="tb sk-htbar flexh"><div><a class="jr-p-close btn wsprkl">Done</a></div><div class="title-text f1">NCBI Bookshelf</div></div><div class="cnt lol f1"><a href="/books/">Home</a><a href="/books/browse/">Browse All Titles</a><a class="btn share" target="_blank" rel="noopener noreferrer" href="https://www.facebook.com/sharer/sharer.php?u=https://www.ncbi.nlm.nih.gov/books/NBK571858/"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 33 33" style="vertical-align:middle" width="24" height="24" preserveAspectRatio="none"><g><path d="M 17.996,32L 12,32 L 12,16 l-4,0 l0-5.514 l 4-0.002l-0.006-3.248C 11.993,2.737, 13.213,0, 18.512,0l 4.412,0 l0,5.515 l-2.757,0 c-2.063,0-2.163,0.77-2.163,2.209l-0.008,2.76l 4.959,0 l-0.585,5.514L 18,16L 17.996,32z"></path></g></svg> Share on Facebook</a><a class="btn share" target="_blank" rel="noopener noreferrer" href="https://twitter.com/intent/tweet?url=https://www.ncbi.nlm.nih.gov/books/NBK571858/&text=Aducanumab"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 33 33" style="vertical-align:middle" width="24" height="24"><g><path d="M 32,6.076c-1.177,0.522-2.443,0.875-3.771,1.034c 1.355-0.813, 2.396-2.099, 2.887-3.632 c-1.269,0.752-2.674,1.299-4.169,1.593c-1.198-1.276-2.904-2.073-4.792-2.073c-3.626,0-6.565,2.939-6.565,6.565 c0,0.515, 0.058,1.016, 0.17,1.496c-5.456-0.274-10.294-2.888-13.532-6.86c-0.565,0.97-0.889,2.097-0.889,3.301 c0,2.278, 1.159,4.287, 2.921,5.465c-1.076-0.034-2.088-0.329-2.974-0.821c-0.001,0.027-0.001,0.055-0.001,0.083 c0,3.181, 2.263,5.834, 5.266,6.438c-0.551,0.15-1.131,0.23-1.73,0.23c-0.423,0-0.834-0.041-1.235-0.118 c 0.836,2.608, 3.26,4.506, 6.133,4.559c-2.247,1.761-5.078,2.81-8.154,2.81c-0.53,0-1.052-0.031-1.566-0.092 c 2.905,1.863, 6.356,2.95, 10.064,2.95c 12.076,0, 18.679-10.004, 18.679-18.68c0-0.285-0.006-0.568-0.019-0.849 C 30.007,8.548, 31.12,7.392, 32,6.076z"></path></g></svg> Share on Twitter</a></div></aside><aside id="jr-rtoc-p" class="hidden flexv"><div class="tb sk-htbar flexh"><div><a class="jr-p-close btn wsprkl">Done</a></div><div class="title-text f1">Table of Content</div></div><div class="cnt lol f1"><a href="/books/n/livertox/?report=reader">Title Information</a><a href="/books/n/livertox/toc/?report=reader">Table of Contents Page</a></div></aside><aside id="jr-help-p" class="hidden flexv"><div class="tb sk-htbar flexh"><div><a class="jr-p-close btn wsprkl">Done</a></div><div class="title-text f1">Settings</div></div><div class="cnt f1"><div id="jr-typo-p" class="typo"><div><a class="sf btn wsprkl">A-</a><a class="lf btn wsprkl">A+</a></div><div><a class="bcol-auto btn wsprkl"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 200 100" preserveAspectRatio="none"><text x="10" y="70" style="font-size:60px;font-family: Trebuchet MS, ArialMT, Arial, sans-serif" textLength="180">AUTO</text></svg></a><a class="bcol-1 btn wsprkl"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M15,25 85,25zM15,40 85,40zM15,55 85,55zM15,70 85,70z"></path></svg></a><a class="bcol-2 btn wsprkl"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M5,25 45,25z M55,25 95,25zM5,40 45,40z M55,40 95,40zM5,55 45,55z M55,55 95,55zM5,70 45,70z M55,70 95,70z"></path></svg></a></div></div><div class="lol"><a class="" href="/books/NBK571858/?report=classic">Switch to classic view</a><a href="/books/NBK571858/pdf/Bookshelf_NBK571858.pdf">PDF (88K)</a><a href="/books/NBK571858/?report=printable">Print View</a></div></div></aside><aside id="jr-bkhelp-p" class="hidden flexv"><div class="tb sk-htbar flexh"><div><a class="jr-p-close btn wsprkl">Done</a></div><div class="title-text f1">Help</div></div><div class="cnt f1 lol"><a id="jr-helpobj-sw" data-path="/corehtml/pmc/jatsreader/ptpmc_3.22/" data-href="/corehtml/pmc/jatsreader/ptpmc_3.22/img/bookshelf/help.xml" href="">Help</a><a href="mailto:info@ncbi.nlm.nih.gov?subject=PubReader%20feedback%20%2F%20NBK571858%20%2F%20sid%3ACE8B5AF87C7FFCB1_0191SID%20%2F%20phid%3ACE8E116A7D7B66910000000000620051.4">Send us feedback</a><a id="jr-about-sw" data-path="/corehtml/pmc/jatsreader/ptpmc_3.22/" data-href="/corehtml/pmc/jatsreader/ptpmc_3.22/img/bookshelf/about.xml" href="">About PubReader</a></div></aside><aside id="jr-objectbox" class="thidden hidden"><div class="jr-objectbox-close wsprkl">✘</div><div class="jr-objectbox-inner cnt"><div class="jr-objectbox-drawer"></div></div></aside><nav id="jr-pm-left" class="hidden"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 40 800" preserveAspectRatio="none"><text font-stretch="ultra-condensed" x="800" y="-15" text-anchor="end" transform="rotate(90)" font-size="18" letter-spacing=".1em">Previous Page</text></svg></nav><nav id="jr-pm-right" class="hidden"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 40 800" preserveAspectRatio="none"><text font-stretch="ultra-condensed" x="800" y="-15" text-anchor="end" transform="rotate(90)" font-size="18" letter-spacing=".1em">Next Page</text></svg></nav><nav id="jr-fip" class="hidden"><nav id="jr-fip-term-p"><input type="search" placeholder="search this page" id="jr-fip-term" autocorrect="off" autocomplete="off" /><a id="jr-fip-mg" class="wsprkl btn" title="Find"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 550 600" preserveAspectRatio="none"><path fill="none" stroke="#000" stroke-width="36" stroke-linecap="round" style="fill:#FFF" d="m320,350a153,153 0 1,0-2,2l170,170m-91-117 110,110-26,26-110-110"></path></svg></a><a id="jr-fip-done" class="wsprkl btn" title="Dismiss find">✘</a></nav><nav id="jr-fip-info-p"><a id="jr-fip-prev" class="wsprkl btn" title="Jump to previuos match">◀</a><button id="jr-fip-matches">no matches yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK571858_"><span class="title" itemprop="name">Aducanumab</span></h1><p class="fm-aai"><a href="#_NBK571858_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Aducanumab.OVERVIEW"><h2 id="_Aducanumab_OVERVIEW_">OVERVIEW</h2><div id="Aducanumab.Introduction"><h3>Introduction</h3><p>Aducanumab is a human monoclonal antibody to amyloid β which has been approved for use in Alzheimer disease. Aducanumab is associated with a minimal rate of serum aminotransferase elevations during therapy and has not been linked to instances of clinically apparent liver injury.</p></div><div id="Aducanumab.Background"><h3>Background</h3><p>Aducanumab (a” due can’ ue mab) is a human monoclonal IgG1 antibody directed against amyloid β which was developed as therapy for Alzheimer disease, based upon the theory that the dementia and neurological decline in Alzheimer disease is caused by accumulation of amyloid β oligomers and fibrils in the frontal lobes of the brain. Studies in animal models and in humans demonstrated that the monoclonal antibody causes a decrease in amyloid β accumulation as shown by advanced imaging techniques. Whether this results in improvement in dementia or lessens clinical progression of disease has not been shown. Aducanumab was evaluated in two large, randomized double-blind controlled trials in more than 3200 patients with early stages of Alzheimer disease and evidence of amyloid β plaques accumulation. Clinical responses were minimal although analysis of a subgroup of patients who received the highest dose in one of the two trials showed evidence of a significant improvement in the clinical dementia rating scale. Because of the severity of Alzheimer disease, the lack of any therapy that slows the progression of disease and the firm biologic basis for possible efficacy of aducanumab, it was given provisional approval in the United States in 2021 as therapy in patients with Alzheimer disease who have evidence of progression and presence of amyloid β plaques. The provisional approval requires conduct of a phase IV study to further evaluate and confirm its safety and efficacy. Aducanumab is available in single dose vials of 170 in 1.7 mL and 300 mg in 3 mL (100 mg/mL) under the brand name Aduhelm. The recommended dose is 10 mg per kilogram body weight administered intravenously (over approximately 1 hour) every 4 weeks with regularly scheduled evaluations for efficacy. Common side effects include infusion reactions, headache, falls, and amyloid related imaging abnormalities such as edema, hemorrhage and hemosiderin deposition. Uncommon, potentially severe adverse reactions include hypersensitivity reactions.</p></div><div id="Aducanumab.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>Serum aminotransferase elevations were infrequent in the large controlled trials of aducanumab in Alzheimer disease. The elevations were generally mild-to-moderate in severity, transient and asymptomatic. In the preregistration trials there were no instances of clinically apparent liver injury or severe hepatic adverse events attributed to aducanumab. Clinical use outside of randomized controlled trials has been limited so far.</p><p>Likelihood score: E (unlikely cause of clinically apparent acute liver injury).</p></div><div id="Aducanumab.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The possible mechanisms by which aducanumab might cause liver injury are unclear. Monoclonal antibodies and immunoglobulins are generally taken up and metabolized intracellularly to short peptides and amino acids. There is no evidence to suggest that inhibition of amyloid β accumulation or increase in its clearance would trigger liver injury or autoimmune liver conditions.</p><p>Drug Class: <a href="/books/n/livertox/MonoclonalAntibodies/?report=reader">Monoclonal Antibodies</a>, <a href="/books/n/livertox/AlzheimersDrugs/?report=reader">Alzheimer Disease Agents</a></p><p>Other Alzheimer Monoclonal Antibodies: <a href="/books/n/livertox/Lecanemab/?report=reader">Lecanemab</a></p></div></div><div id="Aducanumab.PRODUCT_INFORMATION"><h2 id="_Aducanumab_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
|
|
<b>REPRESENTATIVE TRADE NAMES</b>
|
|
</p><p>Aducanumab – Aduhelm®</p><p>
|
|
<b>DRUG CLASS</b>
|
|
</p><p>Alzheimer Disease Agents</p><p>
|
|
<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Aducanumab" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
|
|
</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="Aducanumab.CHEMICAL_FORMULA_AND_STRUCTUR"><h2 id="_Aducanumab_CHEMICAL_FORMULA_AND_STRUCTUR_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figAducanumabTc"><a href="/books/NBK571858/table/Aducanumab.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figAducanumabTc" rid-ob="figobAducanumabTc"><img class="small-thumb" src="/books/NBK571858/table/Aducanumab.Tc/?report=thumb" src-large="/books/NBK571858/table/Aducanumab.Tc/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Aducanumab.Tc"><a href="/books/NBK571858/table/Aducanumab.Tc/?report=objectonly" target="object" rid-ob="figobAducanumabTc">Table</a></h4></div></div></div><div id="Aducanumab.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Aducanumab_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 25 June 2021</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Aducanumab.REF.roberson.2018">Roberson ED. Alzheimer Disease. Treatment of central nervous system degenerative disorders. In, Brunton LL, Hilal-Danan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 333-5.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Aducanumab.REF.fda">FDA. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/Aducanumab_BLA761178_Dunn_2021_06_07.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.accessdata<wbr style="display:inline-block"></wbr>​.fda.gov/drugsatfda_docs<wbr style="display:inline-block"></wbr>​/nda/2021/Aducanumab<wbr style="display:inline-block"></wbr>​_BLA761178_Dunn_2021_06_07.pdf</a>.<div><i>(Multidisciplinary FDA review of aducanumab in support of its approval for use in Alzheimer disease in the US with discussion of safety, mentions that the laboratory findings from the prelicensure studies “did not identify any clinically meaningful change in patients treated with aducanumab</i>”<i>).</i></div></div></li><li><div class="bk_ref" id="Aducanumab.REF.ratner.2015.438">Ratner M. Biogen's early Alzheimer's data raise hopes, some eyebrows. <span><span class="ref-journal">Nat Biotechnol. </span>2015;<span class="ref-vol">33</span>:438.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/25965736" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25965736</span></a>]<div>
|
|
<i>(News report on release of interim results of a phase 1 study of aducanumab in Alzheimer disease which described decreases in β-amyloid plaques in treated patients as assessed by PET scan, but with no data on clinical efficacy in reversing or slowing progression of dementia; the results were encouraging enough directly go to phase 3 trials of the monoclonal antibody).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Aducanumab.REF.selkoe.2016.595">Selkoe DJ, Hardy J. The amyloid hypothesis of Alzheimer's disease at 25 years. <span><span class="ref-journal">EMBO Mol Med. </span>2016;<span class="ref-vol">8</span>:595–608.</span> [<a href="/pmc/articles/PMC4888851/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4888851</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27025652" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27025652</span></a>]<div>
|
|
<i>(Analysis of the role of amyloid-β in the etiology of Alzheimer disease supported by findings that the dominant mutations in amyloid precursor protein [APP] or the protease that metabolizes presenilin and generates amyloid-β are associated with early onset dementia, suggesting that imbalance of generation and clearance of amyloid-β is the early and perhaps initiating factor in Alzheimer disease, and that monoclonal antibody therapy by increasing clearance might help correct the dyshomeostasis).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Aducanumab.REF.ferrero.2016.169">Ferrero J, Williams L, Stella H, Leitermann K, Mikulskis A, O'Gorman J, Sevigny J. First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease. <span><span class="ref-journal">Alzheimers Dement (N Y). </span>2016;<span class="ref-vol">2</span>:169–76.</span> [<a href="/pmc/articles/PMC5651340/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5651340</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29067304" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29067304</span></a>]<div>
|
|
<i>(Phase one study of escalating single doses of aducanumab [0.3, 1, 3 10, 20, 30 and 60 mg/kg] vs placebo in 53 patients with mild-to-moderate Alzheimer disease; four receiving the 60 mg/kg dose developed symptomatic amyloid related imaging abnormalities; no mention of ALT elevations or hepatotoxicity).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Aducanumab.REF.sevigny.2016.50">Sevigny J, Chiao P, Bussière T, Weinreb PH, Williams L, Maier M, Dunstan R, et al. The antibody aducanumab reduces Aβ plaques in Alzheimer's disease. <span><span class="ref-journal">Nature. </span>2016;<span class="ref-vol">537</span>:50–6.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/27582220" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27582220</span></a>]<div>
|
|
<i>(Among 165 patients with early Alzheimer disease treated with 1 of 4 doses of aducanumab [1, 3, 6, or 10 mg/kg] or placebo monthly for one year, those treated with the higher doses showed evidence of decrease in brain amyloid-β accumulation and a trend for clinical improvement, but also higher rates of vasogenic edema [37% to 40%] compared with placebo [5%]; ALT elevations arose in 4 of 125 [3.2%] on aducanumab vs none of 40 on placebo).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Aducanumab.REF.hawkes.2017.j845">Hawkes N. Merck ends trial of potential Alzheimer's drug verubecestat. <span><span class="ref-journal">BMJ. </span>2017;<span class="ref-vol">356</span>:j845.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/28202490" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28202490</span></a>]<div>
|
|
<i>(News report on the termination of a large randomized controlled trial of verubecestat [a small molecule inhibitor of β site amyloid precursor protein cleaving enzyme 1: BACE-1] because of futility).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Aducanumab.REF.knopman.2021.696">Knopman DS, Jones DT, Greicius MD. Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019. <span><span class="ref-journal">Alzheimers Dement. </span>2021;<span class="ref-vol">17</span>:696–701.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/33135381" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33135381</span></a>]<div>
|
|
<i>(In a reanalysis of results from two large controlled trials of aducanumab in early Alzheimer disease, the authors conclude that there was likely a dose related effect on brain amyloid-β plaque accumulation, but the studies did not show evidence of clinical benefit, which calls for a third, adequately powered trial using higher doses and in more extended populations of subjects with Alzheimer disease).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Aducanumab.REF.alexander.2021.1717">Alexander GC, Emerson S, Kesselheim AS. Evaluation of aducanumab for Alzheimer disease: scientific evidence and regulatory review involving efficacy, safety, and futility. <span><span class="ref-journal">JAMA. </span>2021;<span class="ref-vol">325</span>:1717–8.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/33783469" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33783469</span></a>]<div>
|
|
<i>(Summary of the conclusions of the FDA advisory committee on aducanumab which were based upon results of two phase III randomized controlled trials in early Alzheimer disease patients, both of which were terminated early after interim analyses indicated futility; but on post-hoc reanalysis, statistically significant benefit was found with the higher dose in one of the 2 trials; because of discrepancies in outcomes in the two trials and only slight clinical benefit achieved in one arm of the 2 studies, the committee recommended that aducanumab not be approved until another trial confirms the efficacy and safety of the high dose regimen).</i>
|
|
</div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK571858_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">June 25, 2021</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a></div></div><h3>Publisher</h3><p><a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Aducanumab. [Updated 2021 Jun 25].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Adefovir/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/livertox/Afamelanotide/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="table-wrap" id="figobAducanumabTc"><div id="Aducanumab.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK571858/table/Aducanumab.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Aducanumab.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Aducanumab.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Aducanumab.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NO.</th><th id="hd_h_Aducanumab.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Aducanumab.Tc_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Aducanumab.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Aducanumab</td><td headers="hd_h_Aducanumab.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/381127201" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">1384260-65-4</a>
|
|
</td><td headers="hd_h_Aducanumab.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Monoclonal Antibody</td><td headers="hd_h_Aducanumab.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not Available</td></tr></tbody></table></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
|
|
|
|
|
|
|
|
|
|
<!-- Book content -->
|
|
|
|
<script type="text/javascript" src="/portal/portal3rc.fcgi/rlib/js/InstrumentNCBIBaseJS/InstrumentPageStarterJS.js"> </script>
|
|
|
|
|
|
<!-- CE8B5AF87C7FFCB1_0191SID /projects/books/PBooks@9.11 portal107 v4.1.r689238 Tue, Oct 22 2024 16:10:51 -->
|
|
<span id="portal-csrf-token" style="display:none" data-token="CE8B5AF87C7FFCB1_0191SID"></span>
|
|
|
|
<script type="text/javascript" src="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/js/3968615.js" snapshot="books"></script></body>
|
|
</html>
|