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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  This study was registered on July 7, 2009 at ClinicalTrials.gov, NCT00936065 .
authors.affiliation: Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul, Korea. joosoo@skku.edu.
authors.forename: Joo-Heung
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Dermatology, National Medical Center, Seoul, Korea.
authors.forename: Jai-Il
authors.initials: JI
authors.lastname: Youn
authors.affiliation: Department of Dermatology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Tae-Yoon
authors.initials: TY
authors.lastname: Kim
authors.affiliation: Department of Dermatology, Asian Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Jee-Ho
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Department of Dermatology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Chul-Jong
authors.initials: CJ
authors.lastname: Park
authors.affiliation: Department of Dermatology, Konkuk University School of Medicine, Seoul, Korea.
authors.forename: Yong-Beom
authors.initials: YB
authors.lastname: Choe
authors.affiliation: Department of Dermatology, College of Medicine, Korea University, Seoul, Korea.
authors.forename: Hae-Jun
authors.initials: HJ
authors.lastname: Song
authors.affiliation: Department of Dermatology, College of Medicine, Kyung Hee University, Seoul, Korea.
authors.forename: Nack-In
authors.initials: NI
authors.lastname: Kim
authors.affiliation: Department of Dermatology, Hallym University Sacred Heart Hospital, Seoul, Korea.
authors.forename: Kwang-Joong
authors.initials: KJ
authors.lastname: Kim
authors.affiliation: Department of Dermatology, School of Medicine, Chungnam National University, Daejeon, Korea.
authors.forename: Jeung-Hoon
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Pfizer Pharmaceuticals Korea Limited, Seoul, Korea.
authors.forename: Hyun-Jeong
authors.initials: HJ
authors.lastname: Yoo
mesh_terms: D017255:Acitretin / Q000008:administration & dosage*; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068800:Etanercept / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007641:Keratolytic Agents / Q000008:administration & dosage*; D007723:Korea; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011565:Psoriasis / Q000188:drug therapy*; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use; D012720:Severity of Illness Index
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D007641:Keratolytic Agents; D018124:Receptors, Tumor Necrosis Factor; D017255:Acitretin; D000068800:Etanercept
keywords: Acitretin; Combination therapy; Efficacy; Etanercept; Korean patients; Psoriasis; Safety