title: The efficacy and safety of etanercept when used with as-needed adjunctive topical therapy in a randomised, double-blind study in subjects with moderate-to-severe psoriasis (the PRISTINE trial).
abstract: OBJECTIVE
  To assess the efficacy and safety of two etanercept dose regimens for psoriasis treatment.
  
  
  METHODS
  Subjects were ≥18 years old with stable moderate-to-severe plaque psoriasis. Subjects were randomised to etanercept 50 mg once weekly (QW) or 50 mg twice weekly (BIW) double-blind for 12 weeks, followed by 50 mg QW open label in all subjects through week 24. Only mild topical corticosteroids were permitted on scalp, axillae and groin for first 12 weeks; topical medications (corticosteroids of all potencies, vitamin D analogues and combination products) were allowed as needed for second 12 weeks at physicians' discretion, consistent with "real-world" therapeutic practice. An independent ethics committee reviewed and approved the study protocol.
  
  
  RESULTS
  At week 24, 59.9% and 78.2% in the QW/QW and BIW/QW groups achieved PASI 75 improvement. Mean percentage PASI improvement in these groups was 58.5% and 74.1% at week 12 and 70.7% and 81.3% at week 24. Although permitted from weeks 12 to 24, topical agents were used in only 27.7% and 22.6% in the QW/QW and BIW/QW groups by week 24.
  
  
  CONCLUSIONS
  Both etanercept regimens were efficacious in moderate-to-severe psoriasis, although the BIW/QW regimen consistently provided higher response rates than the QW/QW regimen. More potent topical medications were used electively in <25% of subjects in each group.
authors.affiliation: Federal University Teaching Hospital Feldkirch, Feldkirch, Austria. robert.strohal@lkhf.at
authors.forename: Robert
authors.initials: R
authors.lastname: Strohal
authors.forename: Luis
authors.initials: L
authors.lastname: Puig
authors.forename: Edgardo
authors.initials: E
authors.lastname: Chouela
authors.forename: Tsen-Fang
authors.initials: TF
authors.lastname: Tsai
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Melin
authors.forename: Bruce
authors.initials: B
authors.lastname: Freundlich
authors.forename: Charles T
authors.initials: CT
authors.lastname: Molta
authors.forename: Joanne
authors.initials: J
authors.lastname: Fuiman
authors.forename: Ronald
authors.initials: R
authors.lastname: Pedersen
authors.forename: Deborah
authors.initials: D
authors.lastname: Robertson
mesh_terms: D000279:Administration, Cutaneous; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000875:Anthralin / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D014807:Vitamin D / Q000031:analogs & derivatives / Q000627:therapeutic use
chemical_list: D000305:Adrenal Cortex Hormones; D003879:Dermatologic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D014807:Vitamin D; D000068800:Etanercept; D000875:Anthralin