title: Improvement in aspects of sleep with etanercept and optional adjunctive topical therapy in patients with moderate-to-severe psoriasis: results from the PRISTINE trial.
abstract: BACKGROUND
  Impaired sleep in patients with moderate-to-severe psoriasis and improvement on therapy has not been widely studied.
  
  
  OBJECTIVE
  Quantify baseline aspects of sleep and improvement in patients with psoriasis receiving etanercept (ETN) when allowed concomitant topical medications (PRISTINE study).
  
  
  METHODS
  Patients with moderate-to-severe psoriasis were randomized to 50 mg ETN once weekly (QW/QW) or 50 mg ETN twice weekly (BIW/QW) for weeks 1-12, followed by 50 mg QW for weeks 13-24; a broad range of topical therapies were permitted during weeks 13-24. Sleep impairment was measured by the Medical Outcomes Study (MOS) sleep questionnaire Index II (population norm = 25.8; minimum clinically important difference = 5.1); quality of life (QoL) measures included Dermatology Life Quality Index (DLQI), EuroQoL 5 Dimension (EQ-5D) Utility Index and Visual Analogue Scale (VAS) and Functional Activity in Chronic Therapy-Fatigue (FACIT-Fatigue). ancova and Fisher's exact test or chi-squared tests were used for between-group testing.
  
  
  RESULTS
  Mean baseline MOS-Sleep scores were 34.0 for both groups indicating impairment (N = 270; QW/QW n = 137; BIW/QW n = 133, approximately 64% had impaired sleep). At week 12 of treatment, MOS-Sleep scores improved to 30.8 and 30.1, and at week 24, to 28.4 and 28.2 respectively. Poor sleep was significantly associated with clinically important problems in EQ-5D utility, VAS and FACIT-Fatigue; sleep improvement was associated with improved EQ-5D utility and FACIT-Fatigue (P < 0.001).
  
  
  CONCLUSIONS
  This study confirms that most patients with moderate-to-severe psoriasis have impaired sleep which is associated with impaired QoL. Treatment with etanercept significantly improved sleep, with most improvement occurring before a broad range of topicals were allowed. Sleep improvement was associated with improved QoL.
authors.affiliation: Excellence Center for Inflammation Medicine, University Hospital Schleswig-Holstein, University of Lübeck, Lübeck, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Thaçi
authors.forename: R
authors.initials: R
authors.lastname: Galimberti
authors.forename: M
authors.initials: M
authors.lastname: Amaya-Guerra
authors.forename: T
authors.initials: T
authors.lastname: Rosenbach
authors.forename: D
authors.initials: D
authors.lastname: Robertson
authors.forename: R
authors.initials: R
authors.lastname: Pedersen
authors.forename: S
authors.initials: S
authors.lastname: Yang
authors.forename: M
authors.initials: M
authors.lastname: Kuligowski
authors.forename: R
authors.initials: R
authors.lastname: Boggs
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life / Q000523:psychology; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012890:Sleep / Q000187:drug effects / Q000502:physiology; D012893:Sleep Wake Disorders / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept