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)

Background In the phase III double-blind Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2, apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in moderate to severe psoriasis. Objective We sought to evaluate efficacy of apremilast in n...

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Veröffentlicht in:Journal of the American Academy of Dermatology 2016-01, Vol.74 (1), p.134-142
Hauptverfasser: Rich, Phoebe, MD, Gooderham, Melinda, MD, Bachelez, Hervé, MD, PhD, Goncalves, Joana, MD, Day, Robert M., PhD, Chen, Rongdean, PhD, Crowley, Jeffrey, MD
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container_end_page 142
container_issue 1
container_start_page 134
container_title Journal of the American Academy of Dermatology
container_volume 74
creator Rich, Phoebe, MD
Gooderham, Melinda, MD
Bachelez, Hervé, MD, PhD
Goncalves, Joana, MD
Day, Robert M., PhD
Chen, Rongdean, PhD
Crowley, Jeffrey, MD
description Background In the phase III double-blind Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2, apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in moderate to severe psoriasis. Objective We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2. Methods A total of 1255 patients were randomized (2:1) to apremilast 30 mg twice daily or placebo. At week 16, placebo patients switched to apremilast through week 32, followed by a randomized withdrawal phase to week 52. A priori efficacy analyses included patients with nail (target nail Nail Psoriasis Severity Index score ≥1) and moderate to very severe scalp (Scalp Physician Global Assessment score ≥3) psoriasis at baseline. Results At baseline, 66.1% and 64.7% of patients had nail psoriasis; 66.7% and 65.5% had moderate to very severe scalp psoriasis in ESTEEM 1 and 2. At week 16, apremilast produced greater improvements in Nail Psoriasis Severity Index score versus placebo; mean percent change: −22.5% versus +6.5% (ESTEEM 1; P  
doi_str_mv 10.1016/j.jaad.2015.09.001
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Objective We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2. Methods A total of 1255 patients were randomized (2:1) to apremilast 30 mg twice daily or placebo. At week 16, placebo patients switched to apremilast through week 32, followed by a randomized withdrawal phase to week 52. A priori efficacy analyses included patients with nail (target nail Nail Psoriasis Severity Index score ≥1) and moderate to very severe scalp (Scalp Physician Global Assessment score ≥3) psoriasis at baseline. Results At baseline, 66.1% and 64.7% of patients had nail psoriasis; 66.7% and 65.5% had moderate to very severe scalp psoriasis in ESTEEM 1 and 2. At week 16, apremilast produced greater improvements in Nail Psoriasis Severity Index score versus placebo; mean percent change: −22.5% versus +6.5% (ESTEEM 1; P  &lt; .0001) and −29.0% versus −7.1% (ESTEEM 2; P  = .0052). At week 16, apremilast produced greater NAPSI-50 response (50% reduction from baseline in target nail Nail Psoriasis Severity Index score) versus placebo (both studies P  &lt; .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P  &lt; .0001). Improvements were generally maintained over 52 weeks in patients with Psoriasis Area and Severity Index response at week 32. Limitations Baseline randomization was not stratified for nail/scalp psoriasis. Conclusion Apremilast reduces the severity of nail/scalp psoriasis.</description><identifier>ISSN: 0190-9622</identifier><identifier>EISSN: 1097-6787</identifier><identifier>DOI: 10.1016/j.jaad.2015.09.001</identifier><identifier>PMID: 26549249</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Administration, Oral ; Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal - administration &amp; dosage ; apremilast ; Dermatology ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Nail Diseases - drug therapy ; Nail Diseases - pathology ; nail psoriasis ; phosphodiesterase 4 inhibitor ; Phosphodiesterase 4 Inhibitors - administration &amp; dosage ; psoriasis ; Psoriasis - diagnosis ; Psoriasis - drug therapy ; Risk Assessment ; Scalp Dermatoses - drug therapy ; Scalp Dermatoses - pathology ; scalp psoriasis ; Severity of Illness Index ; systemic therapy ; Thalidomide - administration &amp; dosage ; Thalidomide - analogs &amp; derivatives ; Time Factors ; Treatment Outcome</subject><ispartof>Journal of the American Academy of Dermatology, 2016-01, Vol.74 (1), p.134-142</ispartof><rights>American Academy of Dermatology, Inc.</rights><rights>2015 American Academy of Dermatology, Inc.</rights><rights>Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c525t-c6c96a53f6945d6b2f7d566b42996f2b66698b73e1a54743cccc7a86456976133</citedby><cites>FETCH-LOGICAL-c525t-c6c96a53f6945d6b2f7d566b42996f2b66698b73e1a54743cccc7a86456976133</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0190962215021398$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26549249$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rich, Phoebe, MD</creatorcontrib><creatorcontrib>Gooderham, Melinda, MD</creatorcontrib><creatorcontrib>Bachelez, Hervé, MD, PhD</creatorcontrib><creatorcontrib>Goncalves, Joana, MD</creatorcontrib><creatorcontrib>Day, Robert M., PhD</creatorcontrib><creatorcontrib>Chen, Rongdean, PhD</creatorcontrib><creatorcontrib>Crowley, Jeffrey, MD</creatorcontrib><title>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)</title><title>Journal of the American Academy of Dermatology</title><addtitle>J Am Acad Dermatol</addtitle><description>Background In the phase III double-blind Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2, apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in moderate to severe psoriasis. Objective We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2. Methods A total of 1255 patients were randomized (2:1) to apremilast 30 mg twice daily or placebo. At week 16, placebo patients switched to apremilast through week 32, followed by a randomized withdrawal phase to week 52. A priori efficacy analyses included patients with nail (target nail Nail Psoriasis Severity Index score ≥1) and moderate to very severe scalp (Scalp Physician Global Assessment score ≥3) psoriasis at baseline. Results At baseline, 66.1% and 64.7% of patients had nail psoriasis; 66.7% and 65.5% had moderate to very severe scalp psoriasis in ESTEEM 1 and 2. At week 16, apremilast produced greater improvements in Nail Psoriasis Severity Index score versus placebo; mean percent change: −22.5% versus +6.5% (ESTEEM 1; P  &lt; .0001) and −29.0% versus −7.1% (ESTEEM 2; P  = .0052). At week 16, apremilast produced greater NAPSI-50 response (50% reduction from baseline in target nail Nail Psoriasis Severity Index score) versus placebo (both studies P  &lt; .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P  &lt; .0001). Improvements were generally maintained over 52 weeks in patients with Psoriasis Area and Severity Index response at week 32. Limitations Baseline randomization was not stratified for nail/scalp psoriasis. 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dosage</subject><subject>Thalidomide - analogs &amp; derivatives</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0190-9622</issn><issn>1097-6787</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ktGO1CAUhhujccfVF_DCcLkm0wq00MEYk81m1EnWmLjrNaFwmqEypQtUs76b7yZ1Ri-8kIQA4f9_wvlOUTwnuCKY8FdDNShlKooJq7CoMCYPihXBoi15u2kfFitMBC4Fp_SseBLjgDEWTd0-Ls4oZ42gjVgVPy-nAAfrVExrpEbkg3Jo2vuYp7EQEwQVATXIjnvb2eTDOm_RpJKFMUX03aY9MrbvrZ5dKpMvUwCV0Kisy3kGRa3chKbog1XRxtfoM8SsjMj3iOaXlvTdbodCFvuD_QFmjbQfU_DOgUEp21xEF9ub2-32IyK_M08H-vJp8ajP1_DstJ4XX95tb68-lNef3u-uLq9LzShLpeZacMXqnouGGd7RvjWM866hQvCedpxzsenaGohiTdvUOo9WbXjDuGg5qevz4uKYOwV_N-eqyIONGpxTI_g5StIyIgRmG56l9CjVwccYoJdTsAcV7iXBcsEmB7lgkws2iYXM2LLpxSl_7g5g_lr-cMqCN0cB5F9-sxBk1BmABmMD6CSNt__Pf_uPXTs72ozmK9xDHPwcxlw_SWSkEsubpXGWviEMU1KLTf0LSRO9sQ</recordid><startdate>20160101</startdate><enddate>20160101</enddate><creator>Rich, Phoebe, MD</creator><creator>Gooderham, Melinda, MD</creator><creator>Bachelez, Hervé, MD, PhD</creator><creator>Goncalves, Joana, MD</creator><creator>Day, Robert M., PhD</creator><creator>Chen, Rongdean, PhD</creator><creator>Crowley, Jeffrey, MD</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20160101</creationdate><title>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)</title><author>Rich, Phoebe, MD ; Gooderham, Melinda, MD ; Bachelez, Hervé, MD, PhD ; Goncalves, Joana, MD ; Day, Robert M., PhD ; Chen, Rongdean, PhD ; Crowley, Jeffrey, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c525t-c6c96a53f6945d6b2f7d566b42996f2b66698b73e1a54743cccc7a86456976133</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Aged</topic><topic>Anti-Inflammatory Agents, Non-Steroidal - administration &amp; dosage</topic><topic>apremilast</topic><topic>Dermatology</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nail Diseases - drug therapy</topic><topic>Nail Diseases - pathology</topic><topic>nail psoriasis</topic><topic>phosphodiesterase 4 inhibitor</topic><topic>Phosphodiesterase 4 Inhibitors - administration &amp; dosage</topic><topic>psoriasis</topic><topic>Psoriasis - diagnosis</topic><topic>Psoriasis - drug therapy</topic><topic>Risk Assessment</topic><topic>Scalp Dermatoses - drug therapy</topic><topic>Scalp Dermatoses - pathology</topic><topic>scalp psoriasis</topic><topic>Severity of Illness Index</topic><topic>systemic therapy</topic><topic>Thalidomide - administration &amp; dosage</topic><topic>Thalidomide - analogs &amp; derivatives</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rich, Phoebe, MD</creatorcontrib><creatorcontrib>Gooderham, Melinda, MD</creatorcontrib><creatorcontrib>Bachelez, Hervé, MD, PhD</creatorcontrib><creatorcontrib>Goncalves, Joana, MD</creatorcontrib><creatorcontrib>Day, Robert M., PhD</creatorcontrib><creatorcontrib>Chen, Rongdean, PhD</creatorcontrib><creatorcontrib>Crowley, Jeffrey, MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American Academy of Dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rich, Phoebe, MD</au><au>Gooderham, Melinda, MD</au><au>Bachelez, Hervé, MD, PhD</au><au>Goncalves, Joana, MD</au><au>Day, Robert M., PhD</au><au>Chen, Rongdean, PhD</au><au>Crowley, Jeffrey, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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)</atitle><jtitle>Journal of the American Academy of Dermatology</jtitle><addtitle>J Am Acad Dermatol</addtitle><date>2016-01-01</date><risdate>2016</risdate><volume>74</volume><issue>1</issue><spage>134</spage><epage>142</epage><pages>134-142</pages><issn>0190-9622</issn><eissn>1097-6787</eissn><abstract>Background In the phase III double-blind Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2, apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in moderate to severe psoriasis. Objective We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2. Methods A total of 1255 patients were randomized (2:1) to apremilast 30 mg twice daily or placebo. At week 16, placebo patients switched to apremilast through week 32, followed by a randomized withdrawal phase to week 52. A priori efficacy analyses included patients with nail (target nail Nail Psoriasis Severity Index score ≥1) and moderate to very severe scalp (Scalp Physician Global Assessment score ≥3) psoriasis at baseline. Results At baseline, 66.1% and 64.7% of patients had nail psoriasis; 66.7% and 65.5% had moderate to very severe scalp psoriasis in ESTEEM 1 and 2. At week 16, apremilast produced greater improvements in Nail Psoriasis Severity Index score versus placebo; mean percent change: −22.5% versus +6.5% (ESTEEM 1; P  &lt; .0001) and −29.0% versus −7.1% (ESTEEM 2; P  = .0052). At week 16, apremilast produced greater NAPSI-50 response (50% reduction from baseline in target nail Nail Psoriasis Severity Index score) versus placebo (both studies P  &lt; .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P  &lt; .0001). Improvements were generally maintained over 52 weeks in patients with Psoriasis Area and Severity Index response at week 32. Limitations Baseline randomization was not stratified for nail/scalp psoriasis. Conclusion Apremilast reduces the severity of nail/scalp psoriasis.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26549249</pmid><doi>10.1016/j.jaad.2015.09.001</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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subjects Administration, Oral
Adult
Aged
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
apremilast
Dermatology
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Male
Middle Aged
Nail Diseases - drug therapy
Nail Diseases - pathology
nail psoriasis
phosphodiesterase 4 inhibitor
Phosphodiesterase 4 Inhibitors - administration & dosage
psoriasis
Psoriasis - diagnosis
Psoriasis - drug therapy
Risk Assessment
Scalp Dermatoses - drug therapy
Scalp Dermatoses - pathology
scalp psoriasis
Severity of Illness Index
systemic therapy
Thalidomide - administration & dosage
Thalidomide - analogs & derivatives
Time Factors
Treatment Outcome
title 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)
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