title: A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis.
abstract: BACKGROUND
  Few clinical trials have evaluated the combination of topical corticosteroids plus systemic therapies for psoriasis.
  
  
  OBJECTIVE
  We sought to evaluate efficacy and safety of etanercept plus topical clobetasol propionate (CP) foam versus etanercept monotherapy for treatment of moderate to severe plaque psoriasis.
  
  
  METHODS
  Adults with Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and psoriasis-affected body surface area greater than or equal to 10% were randomized to etanercept with CP as needed to clear (2 up-to-2-week courses, weeks 11-12 and 23-24) or etanercept alone (each arm at 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks).
  
  
  RESULTS
  A total of 592 patients enrolled (295 etanercept + CP arm; 297 etanercept arm). At week 12, significant differences were observed for response of 75% improvement in PASI score (primary end point, 65.2% vs 48.3% in the etanercept + CP vs etanercept arms, respectively; P < .001), response of 90% improvement in PASI score (29.7% vs 19.4%; P = .009), percentage PASI score improvement (76.5% vs 68.2%; P < .001), static physician global assessment of clear/almost clear (63.1% vs 47.3%; P < .001), and patient satisfaction with treatment (P = .006). Response of 75% improvement in PASI score and static physician global assessment of clear/almost clear were not significantly different between arms at week 24. Patient satisfaction with treatment (P = .001) and percentage improvement in PASI score (P = .031) were also greater in the etanercept + CP arm compared with etanercept only at week 24. Comparable numbers of adverse events occurred in each arm.
  
  
  CONCLUSIONS
  No placebo for CP foam was provided in the etanercept arm.
  
  
  CONCLUSIONS
  Addition of CP to etanercept yielded increased efficacy compared with etanercept alone at week 12 without an increase in treatment-related adverse events.
authors: Mount Sinai Medical Center, New York, New York, USA.
authors: Mark G
authors: MG
authors: Lebwohl
authors: Leon
authors: L
authors: Kircik
authors: Kristina
authors: K
authors: Callis Duffin
authors: David
authors: D
authors: Pariser
authors: Michele
authors: M
authors: Hooper
authors: Deborah
authors: D
authors: Wenkert
authors: Elizabeth H Z
authors: EH
authors: Thompson
authors: Jun
authors: J
authors: Yang
authors: Greg
authors: G
authors: Kricorian
authors: John
authors: J
authors: Koo
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001830:Body Surface Area; D002990:Clobetasol / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011565:Psoriasis / Q000188:drug therapy*; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D002990:Clobetasol; D000068800:Etanercept
keywords: BSA; CP; PASI; PASI 100; PASI 50; PASI 75; PASI 90; Psoriasis Area and Severity Index; TNF; body surface area; clobetasol propionate; combination therapy; efficacy; etanercept; plaque psoriasis; response of 100% improvement in Psoriasis Area and Severity Index score; response of 50% improvement in Psoriasis Area and Severity Index score; response of 75% improvement in Psoriasis Area and Severity Index score; response of 90% improvement in Psoriasis Area and Severity Index score; sPGA; safety; static physician global assessment; tumor necrosis factor