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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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 < .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 < .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P < .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 & 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</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 < .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 < .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P < .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><subject>Administration, Oral</subject><subject>Adult</subject><subject>Aged</subject><subject>Anti-Inflammatory Agents, Non-Steroidal - administration & dosage</subject><subject>apremilast</subject><subject>Dermatology</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nail Diseases - drug therapy</subject><subject>Nail Diseases - pathology</subject><subject>nail psoriasis</subject><subject>phosphodiesterase 4 inhibitor</subject><subject>Phosphodiesterase 4 Inhibitors - administration & dosage</subject><subject>psoriasis</subject><subject>Psoriasis - diagnosis</subject><subject>Psoriasis - drug therapy</subject><subject>Risk Assessment</subject><subject>Scalp Dermatoses - drug therapy</subject><subject>Scalp Dermatoses - pathology</subject><subject>scalp psoriasis</subject><subject>Severity of Illness Index</subject><subject>systemic therapy</subject><subject>Thalidomide - administration & dosage</subject><subject>Thalidomide - analogs & 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 & 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 & 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 & dosage</topic><topic>Thalidomide - analogs & 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 < .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 < .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P < .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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