title: Clinical trial of a leucotriene B4 receptor antagonist, BIIL 284, in patients with rheumatoid arthritis.
abstract: BACKGROUND
  Several clinical and experimental lines of evidence suggest that leucotriene B4 (LTB4), an arachidonic acid derivative with potent proinflammatory properties, plays a key role in the pathophysiology of rheumatoid arthritis (RA).
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of BIIL 284, an oral long-acting LTB4 receptor antagonist, as monotherapy for the treatment of patients with active RA.
  
  
  METHODS
  This was a multi-centre, randomised, double-blind, placebo-controlled trial of patients with active RA of 3 months' duration. A total of 342 patients were randomised to receive 5 mg, 25 mg or 75 mg of BIIL 284 or placebo. The primary end point was the percentage of patients achieving an American College of Rheumatology (ACR) 20.
  
  
  RESULTS
  Although a higher percentage of ACR 20 responders was observed in the groups treated with 25 mg and 75 mg of BIIL 284 compared with those treated with placebo, no statistically significant differences were found between any of the three active treatment groups compared with the placebo group with regard to the primary or secondary end points. All trial treatments were safe and well tolerated.
  
  
  CONCLUSIONS
  This clinical trial demonstrates that treatment of patients with active RA with a potent oral long-acting LTB4 receptor antagonist produced only modest improvements in disease activity. The results of this trial support the conclusion that LTB4 is not a major contributor to the inflammatory process in RA.
authors.affiliation: Service of Rheumatology, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Canary Islands, Spain.
authors.forename: Federico
authors.initials: F
authors.lastname: Díaz-González
authors.forename: Rieke H E
authors.initials: RH
authors.lastname: Alten
authors.forename: William G
authors.initials: WG
authors.lastname: Bensen
authors.forename: Jacques P
authors.initials: JP
authors.lastname: Brown
authors.forename: John T
authors.initials: JT
authors.lastname: Sibley
authors.forename: Maxime
authors.initials: M
authors.lastname: Dougados
authors.forename: Stefano
authors.initials: S
authors.lastname: Bombardieri
authors.forename: Patrick
authors.initials: P
authors.lastname: Durez
authors.forename: Pablo
authors.initials: P
authors.lastname: Ortiz
authors.forename: Gonzalo
authors.initials: G
authors.lastname: de-Miquel
authors.forename: Alexander
authors.initials: A
authors.lastname: Staab
authors.forename: Ralf
authors.initials: R
authors.lastname: Sigmund
authors.forename: Laurence
authors.initials: L
authors.lastname: Salin
authors.forename: Caroline
authors.initials: C
authors.lastname: Leledy
authors.forename: Stephen H
authors.initials: SH
authors.lastname: Polmar
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000578:Amidines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002219:Carbamates / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018102:Receptors, Leukotriene B4 / Q000037:antagonists & inhibitors*; D016896:Treatment Outcome
chemical_list: D000578:Amidines; D002219:Carbamates; D018102:Receptors, Leukotriene B4; C424425:amelubant