title: [Clinical characteristics and disease course in patients treated with efalizumab following suspension of marketing authorization by the European medicines agency: a multicenter observational study].
abstract: OBJECTIVE
  The withdrawal of marketing authorization for efalizumab by the European Medicines Agency in February, 2009 provided a unique opportunity to assess the course of disease in patients who were not subject to the selection criteria and biases that were common in the pivotal trials. The aim of this study was to evaluate the course of psoriasis following forced suspension of efalizumab in a group of patients treated in normal clinical practice. As secondary objectives, we sought to assess the relationships between clinical characteristics, treatment response, and disease course during efalizumab treatment and 12 and 24 weeks after suspension.
  
  
  METHODS
  Information on the epidemiological profile and disease course during treatment and following suspension of the drug was collected from a group of patients treated with efalizumab. Statistical analyses were performed to identify predictive factors.
  
  
  RESULTS
  One hundred forty-seven patients from 12 Spanish hospitals were included in the study. During treatment, 4% of patients were diagnosed with generalized inflammatory flares. Most patients could be classified as having a good (55%) or moderate (18%) response to treatment. Rebound following withdrawal of efalizumab was observed in 30% of patients. The likelihood of rebound was independent of clinical characteristics, treatment response, or therapeutic approach used by the dermatologist following suspension.
  
  
  CONCLUSIONS
  There was a high frequency of rebound following suspension of efalizumab, exceeding the rate reported in pivotal trials. This is particularly noteworthy given the large proportion of patients with a good response to treatment and therefore believed to have a better prognosis. Other significant findings were the higher frequency of positive treatment response than observed in previous studies (possibly influenced by the mean treatment duration) and the high frequency of generalized inflammatory flares.
authors.affiliation: Servicio de Dermatología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España. laiamorell@hotmail.com
authors.forename: L
authors.initials: L
authors.lastname: Morell
authors.forename: J M
authors.initials: JM
authors.lastname: Carrascosa
authors.forename: C
authors.initials: C
authors.lastname: Ferrándiz
authors.forename: M
authors.initials: M
authors.lastname: García-Bustinduy
authors.forename: E
authors.initials: E
authors.lastname: Fonseca
authors.forename: G
authors.initials: G
authors.lastname: Carretero
authors.forename: E
authors.initials: E
authors.lastname: Daudén
authors.forename: S E
authors.initials: SE
authors.lastname: Marrón
authors.forename: J L
authors.initials: JL
authors.lastname: López-Estebaranz
authors.forename: M
authors.initials: M
authors.lastname: Ferrán
authors.forename: M
authors.initials: M
authors.lastname: Sánchez-Regaña
authors.forename: C
authors.initials: C
authors.lastname: Muñoz-Santos
authors.forename: I
authors.initials: I
authors.lastname: Belinchón
authors.forename: Luis
authors.initials: L
authors.lastname: Puig
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018450:Disease Progression; D005060:Europe; D006801:Humans; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D012189:Retrospective Studies; D056737:Safety-Based Drug Withdrawals; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C472181:efalizumab