title: Infliximab treatment of intravenous immunoglobulin-resistant Kawasaki disease.
abstract: OBJECTIVE
  To investigate the safety, tolerability, and pharmacokinetics of the anti-tumor necrosis factor-alpha monoclonal antibody infliximab in subjects with intravenous immunoglobulin (IVIG)-resistant Kawasaki disease (KD).
  
  
  METHODS
  We conducted a multicenter, randomized, prospective trial of second IVIG infusion (2 g/kg) versus infliximab (5 mg/kg) in 24 children with acute KD and fever after initial treatment with IVIG. Primary outcome measures were the safety, tolerability, and pharmacokinetics of infliximab. Secondary outcome measures were duration of fever and changes in markers of inflammation.
  
  
  RESULTS
  Study drug infusions were associated with cessation of fever within 24 hours in 11 of 12 subjects treated with infliximab and in 8 of 12 subjects retreated with IVIG. No infusion reactions or serious adverse events were attributed to either study drug. No significant differences were observed between treatment groups in the change from baseline for laboratory variables, fever, or echocardiographic assessment of coronary arteries.
  
  
  CONCLUSIONS
  Both infliximab and a second IVIG infusion were safe and well tolerated in the subjects with KD who were resistant to standard IVIG treatment. The optimal management of patients resistant to IVIG remains to be determined.
authors.affiliation: Department of Pediatrics, University of California San Diego School of Medicine and Rady Children's Hospital San Diego, La Jolla, CA, USA.
authors.forename: Jane C
authors.initials: JC
authors.lastname: Burns
authors.forename: Brookie M
authors.initials: BM
authors.lastname: Best
authors.forename: Asuncion
authors.initials: A
authors.lastname: Mejias
authors.forename: Lynn
authors.initials: L
authors.lastname: Mahony
authors.forename: David E
authors.initials: DE
authors.lastname: Fixler
authors.forename: Hasan S
authors.initials: HS
authors.lastname: Jafri
authors.forename: Marian E
authors.initials: ME
authors.lastname: Melish
authors.forename: Mary Anne
authors.initials: MA
authors.lastname: Jackson
authors.forename: Basim I
authors.initials: BI
authors.lastname: Asmar
authors.forename: David J
authors.initials: DJ
authors.lastname: Lang
authors.forename: James D
authors.initials: JD
authors.lastname: Connor
authors.forename: Edmund V
authors.initials: EV
authors.lastname: Capparelli
authors.forename: Monica L
authors.initials: ML
authors.lastname: Keen
authors.forename: Khalid
authors.initials: K
authors.lastname: Mamun
authors.forename: Gregory F
authors.initials: GF
authors.lastname: Keenan
authors.forename: Octavio
authors.initials: O
authors.lastname: Ramilo
mesh_terms: D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D002648:Child; D002675:Child, Preschool; D003323:Coronary Aneurysm / Q000000981:diagnostic imaging; D018592:Cross-Over Studies; D004351:Drug Resistance; D005260:Female; D005334:Fever / Q000188:drug therapy; D006207:Half-Life; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D007223:Infant; D000069285:Infliximab; D007262:Infusions, Intravenous; D008297:Male; D008657:Metabolic Clearance Rate; D009080:Mucocutaneous Lymph Node Syndrome / Q000188:drug therapy*; D014463:Ultrasonography
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D016756:Immunoglobulins, Intravenous; D000069285:Infliximab