title: High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study).
abstract: OBJECTIVE
  Etanercept 50 mg a week is approved in the treatment of AS. Increasing the etanercept dose to 100 mg/week improves efficacy in cutaneous psoriasis, a clinical manifestation related to the spondylarthritis family, while maintaining its safety profile. The purpose of this study was to evaluate the efficacy and safety of etanercept 100 vs 50 mg/week in patients with AS.
  
  
  METHODS
  Adult patients with AS were randomized to receive etanercept 50 mg twice a week (biw), or etanercept 50 mg once a week (qw) for 12 weeks. The primary efficacy endpoint was Ankylosing Spondylitis Assessment Study (ASAS20) response at Week 12; secondary endpoints included ASAS40, ASAS50, ASAS70 and ASAS5/6 responses, partial remission and quality of life. Safety was assessed until 15 days after the last visit.
  
  
  RESULTS
  A total of 108 patients were randomly selected and treated, 54 in each arm. At 12 weeks, ASAS20 response was achieved by 34 (71%) out of 48 patients of the etanercept 50 mg biw group and by 37 (76%) out of 49 patients of the etanercept 50 mg qw group (not statistically significant differences). Other efficacy variables improved significantly over time, but not between treatment groups. Fifty-six patients experienced at least one adverse event (generally, infections and infestations, gastrointestinal disorders and injection site reactions), most of them mild or moderate.
  
  
  CONCLUSIONS
  High-dose (100 mg/week) etanercept in the treatment of AS for 12 weeks is as safe as the standard dose (50 mg/week). However, it does not significantly increase its efficacy. Trial Registration. Clinicaltrials.gov, http://clinicaltrials.gov/, NCT00873730.
authors.affiliation: Rheumatology Department, Hospital Universitario Virgen Macarena, Avenida Dr Fedriani 3, 41009 Sevilla, Spain. federico.navarro.sarabia@juntadeandalucia.es
authors.forename: Federico
authors.initials: F
authors.lastname: Navarro-Sarabia
authors.forename: José L
authors.initials: JL
authors.lastname: Fernández-Sueiro
authors.forename: Juan C
authors.initials: JC
authors.lastname: Torre-Alonso
authors.forename: Jordi
authors.initials: J
authors.lastname: Gratacos
authors.forename: Rubén
authors.initials: R
authors.lastname: Queiro
authors.forename: Carlos
authors.initials: C
authors.lastname: Gonzalez
authors.forename: Eduardo
authors.initials: E
authors.lastname: Loza
authors.forename: Luis
authors.initials: L
authors.lastname: Linares
authors.forename: Pedro
authors.initials: P
authors.lastname: Zarco
authors.forename: Xavier
authors.initials: X
authors.lastname: Juanola
authors.forename: José
authors.initials: J
authors.lastname: Román-Ivorra
authors.forename: Emilio
authors.initials: E
authors.lastname: Martín-Mola
authors.forename: Raimon
authors.initials: R
authors.lastname: Sanmartí
authors.forename: Juan
authors.initials: J
authors.lastname: Mulero
authors.forename: Gema
authors.initials: G
authors.lastname: Diaz
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Armendáriz
authors.forename: Eduardo
authors.initials: E
authors.lastname: Collantes
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000068800:Etanercept; D005260:Female; D006304:Health Status; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D011788:Quality of Life; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012074:Remission Induction; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D000068800:Etanercept