title: Treating psoriasis with etanercept in italian clinical practice: prescribing practices and duration of remission following discontinuation.
abstract: BACKGROUND
  conventional antipsoriatic therapies are often administered until remission, with treatment resumed in the case of relapse, in order to reduce the likelihood of cumulative, dose-dependent toxicities. Biological agents have been safely used in continuous therapy.
  
  
  OBJECTIVE
  to assess the use of etanercept for psoriasis in clinical practice in Italy.
  
  
  METHODS
  this was an observational study carried out in 13 dermatological centres across Italy in patients with plaque psoriasis (with a Psoriasis Area and Severity Index [PASI] score >or=10) treated with etanercept. The study comprised a treatment and subsequent discontinuation period. Patients were eligible if they had plaque psoriasis and had begun treatment with etanercept between 1 September 2007 and 1 April 2008. Patients were evaluable for the duration of discontinuation analysis if they achieved a PASI reduction >or=50% (PASI50) and a PASI score <10 at the end of treatment. Etanercept treatment was restarted if the PASI score reached >or=10 or the patient had a clinical relapse. Data were collected retrospectively up to June 2008 and prospectively between July 2008 and January 2009. Patients received etanercept during the treatment period, followed by no etanercept treatment (other psoriasis treatment permitted) during the discontinuation period, and etanercept again during re-treatment. The main outcome measures were: PASI scores (type A responders: PASI reduction >or=75% [PASI75]; type B responders: PASI50 and PASI final score <10), Dermatology Life Quality Index (DLQI) scores and body surface area (BSA) involvement. Time from discontinuation to re-treatment was evaluated. Use of other antipsoriatic medications was recorded throughout.
  
  
  RESULTS
  eighty-five patients were evaluable for the treatment period. Overall, 55 (64.7%) of these patients were prescribed etanercept 50 mg twice weekly. The mean treatment duration was approximately 25 weeks. In total, 79 patients (92.9%) were considered type B responders and 77 of these patients were evaluable for the duration of discontinuation analysis. Overall, 68/85 (80%) were type A responders. During the treatment period, 7/85 (8.2%) patients received other antipsoriatic therapies. Improvements in mean DLQI score (-71.5%) and mean BSA involvement (-79.2%) were also observed. Etanercept was well tolerated. During the discontinuation period, 40/77 (51.9%) patients used other antipsoriatic medications (group 1) and 37/77 (48.1%) did not (group 2). The mean duration of discontinuation was significantly longer in group 1 (174 days) than in group 2 (117 days, log-rank test: p = 0.0013).
  
  
  CONCLUSIONS
  in clinical practice, the duration of discontinuation from etanercept was in accordance with previously reported data, and was longer in patients who received other antipsoriatic drugs during discontinuation of etanercept than in those who did not. High rates of PASI50 and PASI75 response were obtained with etanercept, and these rates were higher than those observed in controlled clinical studies. Etanercept treatment was flexible, effective and well tolerated, and was associated with improved quality of life.
authors.affiliation: Dermatological Unit, 'Sapienza' University of Rome AO Sant'Andrea, Rome, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Arcese
authors.forename: Nicola
authors.initials: N
authors.lastname: Aste
authors.forename: Alberta
authors.initials: A
authors.lastname: Bettacchi
authors.forename: Germana
authors.initials: G
authors.lastname: Camplone
authors.forename: Franca
authors.initials: F
authors.lastname: Cantoresi
authors.forename: Marzia
authors.initials: M
authors.lastname: Caproni
authors.forename: Domenico
authors.initials: D
authors.lastname: D'Amico
authors.forename: Paolo
authors.initials: P
authors.lastname: Fabbri
authors.forename: Giorgio
authors.initials: G
authors.lastname: Filosa
authors.forename: Antonia
authors.initials: A
authors.lastname: Galluccio
authors.forename: Katharina
authors.initials: K
authors.lastname: Hansel
authors.forename: Paolo
authors.initials: P
authors.lastname: Lisi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Micali
authors.forename: Maria Letizia
authors.initials: ML
authors.lastname: Musumeci
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Nicolini
authors.forename: Aurora
authors.initials: A
authors.lastname: Parodi
authors.forename: Mario
authors.initials: M
authors.lastname: Patania
authors.forename: Michele
authors.initials: M
authors.lastname: Pezza
authors.forename: Concetta
authors.initials: C
authors.lastname: Potenza
authors.forename: Antonio
authors.initials: A
authors.lastname: Richetta
authors.forename: Marco
authors.initials: M
authors.lastname: Simonacci
authors.forename: Piergiusto
authors.initials: P
authors.lastname: Trevisan
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Valenti
authors.forename: Stefano
authors.initials: S
authors.lastname: Calvieri
mesh_terms: D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D011565:Psoriasis / Q000188:drug therapy*; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors
chemical_list: D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept