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<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="Apremilast" /><meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases" /><meta name="citation_date" content="2017/07/25" /><meta name="citation_pmid" content="31643307" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK547974/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Apremilast" /><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="2017/07/25" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK547974/" /><meta name="description" content="Apremilast is an orally available, small molecule inhibitor of phosphodiesterase-4 (PDE-4) and an immunomodulating agent that is used for treatment of refractory psoriatic arthritis. Apremilast has been linked to a low rate of serum enzyme elevations during therapy, but has not been implicated in cases of clinically apparent acute liver injury." /><meta name="og:title" content="Apremilast" /><meta name="og:type" content="book" /><meta name="og:description" content="Apremilast is an orally available, small molecule inhibitor of phosphodiesterase-4 (PDE-4) and an immunomodulating agent that is used for treatment of refractory psoriatic arthritis. Apremilast has been linked to a low rate of serum enzyme elevations during therapy, but has not been implicated in cases of clinically apparent acute liver injury." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK547974/" /><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/Apremilast/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK547974/" /><link rel="stylesheet" href="/corehtml/pmc/css/figpopup.css" type="text/css" media="screen" /><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" /><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><script type="text/javascript" src="/corehtml/pmc/js/jquery.hoverIntent.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/common.min.js?_=3.18"> </script><script type="text/javascript" src="/corehtml/pmc/js/large-obj-scrollbars.min.js"> </script><script type="text/javascript">window.name="mainwindow";</script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/book-toc.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/books.min.js"> </script><meta name="book-collection" content="NONE" />
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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. </p></div><div class="iconblock clearfix whole_rhythm no_top_margin bk_noprnt"><a class="img_link icnblk_img" title="All Drug Records" href="/books/n/livertox/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" alt="Cover of LiverTox" height="100px" width="80px" /></a><div class="icnblk_cntnt eight_col"><h2>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].</h2><a data-jig="ncbitoggler" href="#__NBK547974_dtls__">Show details</a><div style="display:none" class="ui-widget" id="__NBK547974_dtls__"><div>Bethesda (MD): <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>; 2012-.</div></div><div class="half_rhythm"><ul class="inline_list"><li style="margin-right:1em"><a class="bk_cntns" href="/books/n/livertox/">Drug Records</a></li></ul></div><div class="bk_noprnt"><form method="get" action="/books/n/livertox/" id="bk_srch"><div class="bk_search"><label for="bk_term" class="offscreen_noflow">Search term</label><input type="text" title="Search this book" id="bk_term" name="term" value="" data-jig="ncbiclearbutton" /> <input type="submit" class="jig-ncbibutton" value="Search this book" submit="false" style="padding: 0.1em 0.4em;" /></div></form></div></div><div class="icnblk_cntnt two_col"><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/livertox/Apomorphine/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/livertox/Aprepitant/" title="Next page in this title">Next ></a></div></div></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK547974_"><span class="title" itemprop="name">Apremilast</span></h1><p class="small">Last Update: <span itemprop="dateModified">July 25, 2017</span>.</p></div><div class="body-content whole_rhythm" itemprop="text"><div id="Apremilast.OVERVIEW"><h2 id="_Apremilast_OVERVIEW_">OVERVIEW</h2><div id="Apremilast.Introduction"><h3>Introduction</h3><p>Apremilast is an orally available, small molecule inhibitor of phosphodiesterase-4 (PDE-4) and an immunomodulating agent that is used for treatment of refractory psoriatic arthritis. Apremilast has been linked to a low rate of serum enzyme elevations during therapy, but has not been implicated in cases of clinically apparent acute liver injury.</p></div><div id="Apremilast.Background"><h3>Background</h3><p>Apremilast (a pre' mi last) is a small molecule inhibitor of the enzyme phosphodiesterase-4 (PDE-4) that is responsible for the degradation of cyclic adenosine monophosphate (cAMP), thereby blocking an important step in the inflammatory signaling of immune effector cells including T lymphocytes, monocytes and macrophages. Apremilast therapy has been shown to decrease the level of circulating proinflammatory cytokines and to improve symptoms in cases of psoriatic arthritis that have not responded to conventional therapies. Apremilast was approved as oral therapy of active psoriatic arthritis and for moderate-to-severe plaque psoriasis in the United States in 2014. It has been used experimentally and off-label to treat scalp and nail psoriasis and is under evaluation as therapy of other chronic inflammatory conditions. Apremilast is available in tablets of 10, 20 and 30 mg under the brand name Otezla. The recommended initial dose is 10 mg twice daily, which can be increased based upon tolerance to the recommended maintenance dose of 30 mg twice daily. Side effects include diarrhea, nausea, weight loss and headache which generally arise during the first few weeks of treatment and improve thereafter. Rare, but potentially severe adverse events include reactivation of tuberculosis, depression, severe infections and increased risk of malignancy.</p></div><div id="Apremilast.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In multiple, large scale randomized controlled trials of apremilast in psoriasis and psoriatic arthritis, serum enzyme elevations were no more frequent among recipients of apremilast than placebo treatment. In these studies, serum <a class="def" href="/books/n/livertox/glossary/def-item/glossary.alanine-aminotransferase-alt-/">ALT</a> values rose above 150 U/L (3 to 4 times ULN) in 0.4% of apremilast- compared to 0.2% of placebo-recipients, and no patient developed clinically apparent liver injury with jaundice. Since approval there have been no published reports of hepatotoxicity attributed to apremilast, but it has had limited clinical use. Because apremilast is immunosuppressive, it may cause reactivation of viral infections including hepatitis B, but such cases have not been reported.</p><p><a class="def" href="/books/n/livertox/glossary/def-item/glossary.likelihood-score/">Likelihood score</a>: E (unlikely cause of clinically apparent liver injury, but experience with its use is limited).</p></div><div id="Apremilast.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The mechanism by which apremilast might cause serum aminotransferase elevations or liver injury is not known. It is extensively metabolized by the liver predominantly by the cytochrome P450 system and is susceptible to drug-drug interactions with agents that induce or inhibit CYP 3A4 activity.</p><p>Drug Class: Dermatologic Agents, <a href="/books/n/livertox/PsoriasisDrugs/">Psoriasis Agents</a></p><p>Other drugs used to treat psoriasis: <a href="/books/n/livertox/Acitretin/">acitretin</a>, <a href="/books/n/livertox/Methotrexate/">methotrexate</a>, <a href="/books/n/livertox/TNFAntagonists/">tumor necrosis factor (TNF)-inhibitors</a>, <a href="/books/n/livertox/Secukinumab/">secukinumab</a>, <a href="/books/n/livertox/Ustekinumab/">ustekinumab</a></p></div></div><div id="Apremilast.PRODUCT_INFORMATION"><h2 id="_Apremilast_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div id="Apremilast.BPI" class="box"><p>
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<b> REPRESENTATIVE TRADE NAMES</b>
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</p><p>Apremilast – Otezla®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Dermatologic Agents, Psoriasis Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Apremilast" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div></div><div id="Apremilast.CHEMICAL_FORMULA_AND_STRUCTUR"><h2 id="_Apremilast_CHEMICAL_FORMULA_AND_STRUCTUR_">CHEMICAL FORMULA AND STRUCTURE</h2><div id="Apremilast.T1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK547974/table/Apremilast.T1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Apremilast.T1_lrgtbl__"><table><thead><tr><th id="hd_h_Apremilast.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">DRUG</th><th id="hd_h_Apremilast.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Apremilast.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Apremilast.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Apremilast.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Apremilast</td><td headers="hd_h_Apremilast.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135195808" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">608141-41-9</a>
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</td><td headers="hd_h_Apremilast.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">C22-H24-N2-O7-S</td><td headers="hd_h_Apremilast.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">
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<div class="graphic"><img src="/books/NBK547974/bin/Apremilast_structure.jpg" alt="Apremilast structure" /></div>
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</td></tr></tbody></table></div></div></div><div id="Apremilast.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Apremilast_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 25 July 2017</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Apremilast.R1">Zimmerman HJ. Hepatotoxicity. The adverse effects of drugs and other chemicals upon the liver. 2nd edition. Philadelphia: Lippincott, 1999.<div><i>(Textbook of drug induced liver injury published in 1999 before the availability of apremilast).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R2">Samrao A, Berry TM, Goreshi R, Simpson EL. A pilot study of an oral phosphodiesterase inhibitor (apremilast) for atopic dermatitis in adults. Arch Dermatol 2012; 148: 890-7. [<a href="/pmc/articles/PMC3614494/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3614494</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/22508772" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22508772</span></a>]<div><i>(Among 16 patients with atopic dermatitis treated with apremilast [20 or 30 mg twice daily] for 6 months, symptom scores were improved and common side effects included nausea [33% and 90%] which was usually mild and decreased with continued therapy; no mention of ALT elevations or hepatotoxicity; one patient developed herpes zoster).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R3">Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu C, et al. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet 2012; 380 (9843): 738-46. [<a href="https://pubmed.ncbi.nlm.nih.gov/22748702" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22748702</span></a>]<div><i>(Among 352 patients with psoriasis treated with 3 doses of apremilast or placebo twice daily, response rates at 16 weeks were higher with apremilast in higher doses [10 mg 11%, 20 mg 29%, 30 mg 41%] than placebo [6%] and adverse events included nausea [11-18% vs 8%], diarrhea [7-14% vs 5%], and headache [6-10% vs 6%] and “no apparent safety concerns” were raised from routine and hepatic chemistry testing).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R4">Schett G, Wollenhaupt J, Papp K, Joos R, Rodrigues JF, Vessey AR, Hu C, et al. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 2012; 64: 3156-67. [<a href="https://pubmed.ncbi.nlm.nih.gov/22806399" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22806399</span></a>]<div><i>(Among 204 patients with psoriatic arthritis treated with apremilast [20 mg twice daily or 40 mg once daily] or placebo for 12-24 weeks, clinical responses were more frequent with active drug [44% and 36%] than placebo [12%] and side effects included diarrhea, headache, nausea and fatigue which were greater with once daily dosing; one patient developed ALT elevations above 3 times ULN which resolved with lowering the dose, and there were no cases of liver related serious adverse events or clinically apparent liver injury with jaundice).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R5">Pathan E, Abraham S, Van Rossen E, Withrington R, Keat A, Charles PJ, Paterson E, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in ankylosing spondylitis. Ann Rheum Dis 2013; 72: 1475-80. [<a href="https://pubmed.ncbi.nlm.nih.gov/22984171" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22984171</span></a>]<div><i>(Among 38 patients with ankylosing spondylitis treated with apremilast [30 mg twice daily] or placebo twice daily for 12 weeks, rates of clinical improvement did not differ between groups; side effects include loose stools and headaches, and there were no serious adverse events and no mention of ALT elevations).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R6">Papp KA, Kaufmann R, Thaçi D, Hu C, Sutherland D, Rohane P. Efficacy and safety of apremilast in subjects with moderate to severe plaque psoriasis: results from a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison study. J Eur Acad Dermatol Venereol 2013; 27: e376-83. [<a href="https://pubmed.ncbi.nlm.nih.gov/23030767" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23030767</span></a>]<div><i>(Among 259 patients with plaque psoriasis treated with apremilast [20 mg] once or twice daily or placebo for 12 weeks, clinical responses were achieved in 24% of apremilast vs 10% of placebo recipients and side effects included nausea, diarrhea and headache; one patient on placebo and one on apremilast developed transient serum enzyme elevations but there were no hepatic related serious adverse events).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R7">Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO, Wollenhaupt J, Gladman DD, Lespessailles E, et al. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis 2014; 73: 1020-6. [<a href="/pmc/articles/PMC4033106/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4033106</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/24595547" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24595547</span></a>]<div><i>(Among 504 patients with psoriatic arthritis treated with apremilast [20 or 30 mg] or placebo twice daily for 24 weeks, clinical responses at 16 weeks were more frequent with apremilast [31% and 40%] than placebo [19%], while ALT elevations occurred in 8% of apremilast- vs 13% of placebo-treated subjects).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R8">Apremilast (Otezla) for psoriatic arthritis. Med Lett Drugs Ther 2014; 56 (1443): 41-2. [<a href="https://pubmed.ncbi.nlm.nih.gov/24869713" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24869713</span></a>]<div><i>(Concise review of the mechanism of action, clinical efficacy, safety and costs of apremilast shortly after its approval in the US as therapy of psoriatic arthritis, mentions adverse events of diarrhea, nausea and headache, but does not mention ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R9">Drugs for psoriasis. Med Lett Drugs Ther 2015; 57 (1470): 81-4. [<a href="https://pubmed.ncbi.nlm.nih.gov/26035746" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26035746</span></a>]<div><i>(Concise review of drugs for psoriasis including systemic therapies such as methotrexate, cyclosporine, acitretin, apremilast, tofacitinib and biologics such as TNF inhibitors, ustekinumab and secukinumab).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R10">Drugs for psoriatic arthritis. Med Lett Drugs Ther 2015; 57 (1470): e88-92. [<a href="https://pubmed.ncbi.nlm.nih.gov/26035749" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26035749</span></a>]<div><i>(Concise review of drugs for psoriatic arthritis including NSAIDs, corticosteroids, methotrexate, leflunomide, sulfasalazine, cyclosporine, apremilast and several biologics such as TNF inhibitors, ustekinumab and secukinumab).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R11">Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO, Wollenhaupt J, Gladman DD, Hochfeld M, et al. Long term (52-week) results of a phase III randomized, controlled trial of apremilast in patients with psoriatic arthritis. J Rheumatol 2015; 42: 479-88. [<a href="https://pubmed.ncbi.nlm.nih.gov/25593233" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25593233</span></a>]<div><i>(504 patients with psoriatic arthritis were treated with apremilast [20 or 30 mg] or placebo twice daily for 16 weeks and then re-randomized if not responding; among patients who finished 52 weeks on drug, side effects included diarrhea, nausea and headache; during the first 16 weeks of treatment, any elevation in ALT occurred in 8% of patients on apremilast vs 13% on placebo, while elevations above 150 U/L occurred in 0.3% on apremilast vs none [of 167] on placeb).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R12">Paul C, Cather J, Gooderham M, Poulin Y, Mrowietz U, Ferrandiz C, Crowley J, et al. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe plaque psoriasis over 52 weeks: a phase III, randomized controlled trial (ESTEEM 2). Br J Dermatol 2015; 173: 1387-99. [<a href="https://pubmed.ncbi.nlm.nih.gov/26357944" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26357944</span></a>]<div><i>(Among 411 patients with plaque psoriasis treated with apremilast [30 mg] or placebo twice daily for 52 weeks, clinical responses at 16 weeks were more frequent with apremilast than placebo [29% vs 6%], and marked laboratory abnormalities were uncommon and similar in frequency in both groups, while clinical chemistry abnormalities “were transient and resolved with continued treatment”).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R13">Papp K, Reich K, Leonardi CL, Kircik L, Chimenti S, Langley RG, Hu C, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol 2015; 73: 37-49. [<a href="https://pubmed.ncbi.nlm.nih.gov/26089047" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26089047</span></a>]<div><i>(Among 844 patients with plaque psoriasis treated with apremilast [30 mg] or placebo twice daily, clinical responses at 16 weeks were more frequent with apremilast than placebo [33% vs 15%], while serum ALT elevations above 3 times ULN occurred in 0.2% vs 0.4%, and there were no liver related serious adverse events).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R14">Genovese MC, Jarosova K, Cieślak D, Alper J, Kivitz A, Hough DR, Maes P, et al. Apremilast in Patients with active rheumatoid arthritis: a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheumatol 2015; 67: 1703-10. [<a href="https://pubmed.ncbi.nlm.nih.gov/25779750" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25779750</span></a>]<div><i>(Among 237 patients with rheumatoid arthritis with an inadequate response to methotrexate who were treated with apremilast [20 or 30 mg] or placebo twice daily for at least 16 weeks, clinical response rates were similar in all groups while gastrointestinal side effects were more common with apremilast; there were no liver related serious adverse events and no “clinical meaningful changes … in clinical chemistry variables”).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R15">Busa S, Kavanaugh A. Drug safety evaluation of apremilast for treating psoriatic arthritis. Expert Opin Drug Saf 2015; 14: 979-85. [<a href="https://pubmed.ncbi.nlm.nih.gov/25827658" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25827658</span></a>]<div><i>(Review of the mechanism of action, clinical efficacy and safety of apremilast in psoriatic arthritis focuses upon gastrointestinal adverse events, depression and weight loss, but mentions that “abnormalities in laboratory parameters were infrequent, mostly transient and comparable across treatment groups”).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R16">Haber SL, Hamilton S, Bank M, Leong SY, Pierce E. Apremilast: A Novel Drug for Treatment of Psoriasis and Psoriatic Arthritis. Ann Pharmacother 2016; 50: 282-90. [<a href="https://pubmed.ncbi.nlm.nih.gov/26783350" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26783350</span></a>]<div><i>(Systematic review of mechanism of action, clinical efficacy and safety of apremilast in severe psoriasis and psoriatic arthritis, mentions that the common side effects [diarrhea, nausea and headache] tend to occur in the first 2 weeks and resolve with time without dose modification and that severe adverse events, including ALT elevations, can occur but are usually transient and self-limited).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R17">Rich P, Gooderham M, Bachelez H, Goncalves J, Day RM, Chen R, Crowley J. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2). J Am Acad Dermatol 2016; 74: 134-42. [<a href="https://pubmed.ncbi.nlm.nih.gov/26549249" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26549249</span></a>]<div><i>(Among 1255 patients with nail or scalp psoriasis treated with apremilast [30 mg] or placebo twice daily for 16 weeks, psoriasis severity index scores improvement more on apremilast; no mention of adverse events).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R18">Edwards CJ, Blanco FJ, Crowley J, Birbara CA, Jaworski J, Aelion J, Stevens RM, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis 2016; 75: 1065-73. [<a href="/pmc/articles/PMC4893110/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4893110</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26792812" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26792812</span></a>]<div><i>(Among 505 patients with psoriatic arthritis treated with apremilast [20 or 30 mg] or placebo twice daily, clinical responses at 16 weeks were more frequent with drug [28-41%] than placebo [18%]; side effects were mild and included ALT elevations above 150 U/L in 0.5% vs 0%).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R19">Bissonnette R, Pariser DM, Wasel NR, Goncalves J, Day RM, Chen R, Sebastian M. Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) clinical trials in patients with moderate to severe psoriasis. J Am Acad Dermatol 2016; 75: 99-105. [<a href="https://pubmed.ncbi.nlm.nih.gov/27021239" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27021239</span></a>]<div><i>(A pooled analysis of 2 trials of apremilast [30 mg] vs placebo twice daily in patients with palmoplantar psoriasis for 16 weeks, there was a higher rate of response with apremilast than placebo [48% vs 27%] and common side effects included diarrhea [19% vs 6%], nausea [16% vs 6%], and headache [15% vs 3%]; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R20">Cutolo M, Myerson GE, Fleischmann RM, Lioté F, Díaz-González F, Van den Bosch F, Marzo-Ortega H, et al. A phase III, randomized, controlled trial of apremilast in patients with psoriatic arthritis: results of the PALACE 2 trial. J Rheumatol 2016; 43: 1724-34. [<a href="https://pubmed.ncbi.nlm.nih.gov/27422893" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27422893</span></a>]<div><i>(Among 484 patients with psoriatic arthritis treated with apremilast [20 or 30 mg] or placebo twice daily for up to 52 weeks, clinical responses by week 16 occurred in 32-37% of apremilast recipients vs 19% of placebo recipients, while ALT elevations above 150 U/L occurred in 0.7% vs 0.8% and there were no liver related serious adverse events).</i></div></div></li><li><div class="bk_ref" id="Apremilast.R21">Reich K, Gooderham M, Green L, Bewley A, Zhang Z, Khanskaya I, Day RM, et al. The efficacy and safety of apremilast, etanercept, and placebo, in patients with moderate to severe plaque psoriasis: 52-week results from a phase 3b, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venereol 2016 Oct 21. [<a href="/pmc/articles/PMC5363370/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5363370</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27768242" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27768242</span></a>]<div><i>(Among 250 patients with moderate to severe plaque psoriasis treated with apremilast [30 mg] or placebo twice daily or etanercept weekly, clinical responses at week 16 occurred in 40% on apremilast, 47% of etanercept and 12% on placebo; side effects of apremilast included nausea, diarrhea and headache while elevations of serum ALT above 3 times ULN occurred in 1.2% on apremilast and 1.2% on placebo, but none of etanercept).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div>
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<div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Views</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PDF_download" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/NBK547974/?report=reader">PubReader</a></li><li><a href="/books/NBK547974/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK547974" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK547974" style="display:none" title="Cite this Page"><div class="bk_tt">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Apremilast. [Updated 2017 Jul 25].<span class="bk_cite_avail"></span></div></div></li><li><a href="/books/NBK547974/pdf/Bookshelf_NBK547974.pdf">PDF version of this page</a> (121K)</li><li><a href="#" class="toggle-glossary-link" title="Enable/disable links to the glossary">Disable Glossary Links</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>New and Updated</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="https://pubmed.ncbi.nlm.nih.gov/?term=%22LiverTox%22+AND+pmcbook&sort=date&size=200" ref="pagearea=source-links&targetsite=external&targetcat=link&targettype=uri">In PubMed</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Bulk Download</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="https://ftp.ncbi.nlm.nih.gov/pub/litarch/29/31/" ref="pagearea=source-links&targetsite=external&targetcat=link&targettype=uri">Bulk download LiverTox data from FTP</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Overviews</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/n/livertox/intro/">Introduction</a></li><li><a href="/books/n/livertox/ClinicalCourse/">Clinical Course</a></li><li><a href="/books/n/livertox/ClinicalOutcome/">Clinical Outcomes</a></li><li><a href="/books/n/livertox/ImmuneFeatures/">Immune Features</a></li><li><a href="/books/n/livertox/Phenotypes_intro/">Phenotypes</a></li><li><a href="/books/n/livertox/Causality/">Causality</a></li><li><a href="/books/n/livertox/DrugCategory/">Likelihood Scale</a></li><li><a href="/books/n/livertox/Severity/">Severity Grading</a></li><li><a href="/books/n/livertox/CaseReport/">Writing a Case Report</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Support Links</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/n/livertox/">LiverTox Homepage</a></li><li><a href="/books/n/livertox/masterlistintro/">Master List of LiverTox Drugs [with Metadata]</a></li><li><a href="/books/n/livertox/drugliverinjury/">LiverTox Drugs by Drug Class</a></li><li><a href="/books/n/livertox/aboutus/">About LiverTox</a></li><li><a href="/books/n/livertox/editorsandreviewers/">Editors and Review Committee</a></li><li><a href="/books/n/livertox/alert/">Meetings and News</a></li><li><a href="/books/n/livertox/abbreviation/">Abbreviations Used</a></li><li><a href="/books/n/livertox/glossary/">Glossary</a></li><li><a href="/books/n/livertox/resource/">Information Resources</a></li><li><a href="/books/n/livertox/disclaimer/">User/Medical Advice Disclaimer</a></li><li><a href="/books/n/livertox/Contactus/">Contact Us</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>OTHER REFERENCE LINKS</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="document-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li>
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<a href="https://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&pubmedfilters=true&term=(Apremilast)+AND+Human%5BMH%5D+AND+(drug+induced+liver+injury+OR+jaundice/CI+OR+bile+duct+diseases/CI+OR+liver/DE+OR+liver+diseases/CI)+AND+(%221900/1/1%22%5BEDat%5D%3A%222999/12/31%22%5BEDat%5D)" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">Recent References on Apremilast: from PubMed.gov</a>
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<a href="https://clinicaltrials.gov/ct2/results?term=Apremilast" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">: from ClinicalTrials.gov</a>
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<a href="https://clinicaltrials.gov/ct2/results?term=Apremilast" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">Trials on Apremilast: from ClinicalTrials.gov</a>
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Epub 2015 Oct 15.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/24595547" ref="ordinalpos=1&linkpos=4&log$=relatedarticles&logdbfrom=pubmed">Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor.</a><span class="source">[Ann Rheum Dis. 2014]</span><div class="brieflinkpop offscreen_noflow">Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO, Wollenhaupt J, Gladman DD, Lespessailles E, Hall S, Hochfeld M, Hu C, et al. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">Ann Rheum Dis. 2014 Jun; 73(6):1020-6. Epub 2014 Mar 4.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/23569359" ref="ordinalpos=1&linkpos=5&log$=relatedreviews&logdbfrom=pubmed"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast.</a><span class="source">[Drug Des Devel Ther. 2013]</span><div class="brieflinkpop offscreen_noflow"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Palfreeman AC, McNamee KE, McCann FE. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">Drug Des Devel Ther. 2013; 7:201-10. Epub 2013 Mar 27.</em></div></div></li></ul><a class="seemore" href="/sites/entrez?db=pubmed&cmd=link&linkname=pubmed_pubmed_reviews&uid=31643307" ref="ordinalpos=1&log$=relatedreviews_seeall&logdbfrom=pubmed">See reviews...</a><a class="seemore" href="/sites/entrez?db=pubmed&cmd=link&linkname=pubmed_pubmed&uid=31643307" ref="ordinalpos=1&log$=relatedarticles_seeall&logdbfrom=pubmed">See all...</a></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Recent Activity</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="recent_activity" id="Shutter"></a></div><div class="portlet_content"><div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" id="HTDisplay" class=""><div class="action"><a href="javascript:historyDisplayState('ClearHT')">Clear</a><a href="javascript:historyDisplayState('HTOff')" class="HTOn">Turn Off</a><a href="javascript:historyDisplayState('HTOn')" class="HTOff">Turn On</a></div><ul id="activity"><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=1" href="/portal/utils/pageresolver.fcgi?recordid=67c8ddfbb15b832ebc029ad5">Apremilast - LiverTox</a><div class="ralinkpop offscreen_noflow">Apremilast - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=2" href="/portal/utils/pageresolver.fcgi?recordid=67c8ddfaf4a390645e242360">Apomorphine - LiverTox</a><div class="ralinkpop offscreen_noflow">Apomorphine - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=3" href="/portal/utils/pageresolver.fcgi?recordid=67c8ddf9ab82281a802f576c">Apoaequorin - LiverTox</a><div class="ralinkpop offscreen_noflow">Apoaequorin - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=4" href="/portal/utils/pageresolver.fcgi?recordid=67c8ddf8f4a390645e241c49">Apixaban - LiverTox</a><div class="ralinkpop offscreen_noflow">Apixaban - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li><li class="ra_rcd ralinkpopper two_line"><a class="htb ralinkpopperctrl" ref="log$=activity&linkpos=5" href="/portal/utils/pageresolver.fcgi?recordid=67c8ddf7ab82281a802f5040">Apalutamide - LiverTox</a><div class="ralinkpop offscreen_noflow">Apalutamide - LiverTox<div class="brieflinkpopdesc"></div></div><div class="tertiary"></div></li></ul><p class="HTOn">Your browsing activity is empty.</p><p class="HTOff">Activity recording is turned off.</p><p id="turnOn" class="HTOff"><a href="javascript:historyDisplayState('HTOn')">Turn recording back on</a></p><a class="seemore" href="/sites/myncbi/recentactivity">See more...</a></div></div></div>
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