Joo-Heung Lee, Jai-Il Youn, Tae-Yoon Kim, Jee-Ho Choi, Chul-Jong Park, Yong-Beom Choe, Hae-Jun Song, Nack-In Kim, Kwang-Joong Kim, Jeung-Hoon Lee, Hyun-Jeong Yoo
{"title":"一项多中心、随机、开放标签的试点试验，评估依那西普50 mg每周2次，随后依那西普25 mg每周2次，依那西普25 mg每周2次与阿维甲素联合，以及单独使用阿维甲素治疗中重度牛皮癣患者的疗效和安全性。","authors":"Joo-Heung Lee, Jai-Il Youn, Tae-Yoon Kim, Jee-Ho Choi, Chul-Jong Park, Yong-Beom Choe, Hae-Jun Song, Nack-In Kim, Kwang-Joong Kim, Jeung-Hoon Lee, Hyun-Jeong Yoo","doi":"10.1186/s12895-016-0048-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Etanercept, a soluble tumor necrosis factor receptor, and acitretin have been shown to be effective in treating psoriasis. Acitretin is widely used in Korea. However, the combination of etanercept plus acitretin has not been evaluated among Korean patients with psoriasis. The objective of this study was to investigate the efficacy and safety of combination therapy with etanercept and acitretin in patients with moderate to severe plaque psoriasis.</p><p><strong>Methods: </strong>Sixty patients with psoriasis were randomized to receive etanercept 50 mg twice weekly (BIW) for 12 weeks followed by etanercept 25 mg BIW for 12 weeks (ETN-ETN); etanercept 25 mg BIW plus acitretin 10 mg twice daily (BID) for 24 weeks (ETN-ACT); or acitretin 10 mg BID for 24 weeks (ACT). The primary efficacy measurement was the proportion of patients achieving 75 % improvement in Psoriasis Area and Severity Index (PASI 75) at week 24. Secondary end points included 50 % improvement in PASI (PASI 50) at week 24 and clear/almost-clear by Physician Global Assessment (PGA) at each visit through week 24.</p><p><strong>Results: </strong>The proportions of patients achieving PASI 75, PASI 50, and PGA clear/almost-clear at week 24 in the ETN-ETN (52.4, 71.4, and 52.4 %, respectively) and ETN-ACT groups (57.9, 84.2, and 52.6 %, respectively) were higher than in the ACT group (22.2, 44.4, and 16.7 %, respectively). The incidence of adverse events was similar across all arms. This was an open-label study with a small number of patients.</p><p><strong>Conclusion: </strong>In Korean patients with moderate to severe plaque psoriasis, etanercept alone or in combination with acitretin was more effective than acitretin. All treatments were well tolerated throughout the study.</p><p><strong>Trial registration: </strong>This study was registered on July 7, 2009 at ClinicalTrials.gov, NCT00936065 .</p>","PeriodicalId":9014,"journal":{"name":"BMC Dermatology","volume":"16 1","pages":"11"},"PeriodicalIF":0.0000,"publicationDate":"2016-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s12895-016-0048-z","citationCount":"0","resultStr":"{\"title\":\"A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis.\",\"authors\":\"Joo-Heung Lee, Jai-Il Youn, Tae-Yoon Kim, Jee-Ho Choi, Chul-Jong Park, Yong-Beom Choe, Hae-Jun Song, Nack-In Kim, Kwang-Joong Kim, Jeung-Hoon Lee, Hyun-Jeong Yoo\",\"doi\":\"10.1186/s12895-016-0048-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Etanercept, a soluble tumor necrosis factor receptor, and acitretin have been shown to be effective in treating psoriasis. Acitretin is widely used in Korea. However, the combination of etanercept plus acitretin has not been evaluated among Korean patients with psoriasis. The objective of this study was to investigate the efficacy and safety of combination therapy with etanercept and acitretin in patients with moderate to severe plaque psoriasis.</p><p><strong>Methods: </strong>Sixty patients with psoriasis were randomized to receive etanercept 50 mg twice weekly (BIW) for 12 weeks followed by etanercept 25 mg BIW for 12 weeks (ETN-ETN); etanercept 25 mg BIW plus acitretin 10 mg twice daily (BID) for 24 weeks (ETN-ACT); or acitretin 10 mg BID for 24 weeks (ACT). The primary efficacy measurement was the proportion of patients achieving 75 % improvement in Psoriasis Area and Severity Index (PASI 75) at week 24. Secondary end points included 50 % improvement in PASI (PASI 50) at week 24 and clear/almost-clear by Physician Global Assessment (PGA) at each visit through week 24.</p><p><strong>Results: </strong>The proportions of patients achieving PASI 75, PASI 50, and PGA clear/almost-clear at week 24 in the ETN-ETN (52.4, 71.4, and 52.4 %, respectively) and ETN-ACT groups (57.9, 84.2, and 52.6 %, respectively) were higher than in the ACT group (22.2, 44.4, and 16.7 %, respectively). The incidence of adverse events was similar across all arms. This was an open-label study with a small number of patients.</p><p><strong>Conclusion: </strong>In Korean patients with moderate to severe plaque psoriasis, etanercept alone or in combination with acitretin was more effective than acitretin. All treatments were well tolerated throughout the study.</p><p><strong>Trial registration: </strong>This study was registered on July 7, 2009 at ClinicalTrials.gov, NCT00936065 .</p>\",\"PeriodicalId\":9014,\"journal\":{\"name\":\"BMC Dermatology\",\"volume\":\"16 1\",\"pages\":\"11\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2016-07-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1186/s12895-016-0048-z\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Dermatology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s12895-016-0048-z\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Dermatology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s12895-016-0048-z","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis.
Background: Etanercept, a soluble tumor necrosis factor receptor, and acitretin have been shown to be effective in treating psoriasis. Acitretin is widely used in Korea. However, the combination of etanercept plus acitretin has not been evaluated among Korean patients with psoriasis. The objective of this study was to investigate the efficacy and safety of combination therapy with etanercept and acitretin in patients with moderate to severe plaque psoriasis.
Methods: Sixty patients with psoriasis were randomized to receive etanercept 50 mg twice weekly (BIW) for 12 weeks followed by etanercept 25 mg BIW for 12 weeks (ETN-ETN); etanercept 25 mg BIW plus acitretin 10 mg twice daily (BID) for 24 weeks (ETN-ACT); or acitretin 10 mg BID for 24 weeks (ACT). The primary efficacy measurement was the proportion of patients achieving 75 % improvement in Psoriasis Area and Severity Index (PASI 75) at week 24. Secondary end points included 50 % improvement in PASI (PASI 50) at week 24 and clear/almost-clear by Physician Global Assessment (PGA) at each visit through week 24.
Results: The proportions of patients achieving PASI 75, PASI 50, and PGA clear/almost-clear at week 24 in the ETN-ETN (52.4, 71.4, and 52.4 %, respectively) and ETN-ACT groups (57.9, 84.2, and 52.6 %, respectively) were higher than in the ACT group (22.2, 44.4, and 16.7 %, respectively). The incidence of adverse events was similar across all arms. This was an open-label study with a small number of patients.
Conclusion: In Korean patients with moderate to severe plaque psoriasis, etanercept alone or in combination with acitretin was more effective than acitretin. All treatments were well tolerated throughout the study.
Trial registration: This study was registered on July 7, 2009 at ClinicalTrials.gov, NCT00936065 .
期刊介绍：
BMC Dermatology is an open access journal publishing original peer-reviewed research articles in all aspects of the prevention, diagnosis and management of skin disorders, as well as related molecular genetics, pathophysiology, and epidemiology. BMC Dermatology (ISSN 1471-5945) is indexed/tracked/covered by PubMed, MEDLINE, CAS, EMBASE, Scopus and Google Scholar.
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