- 作者：Jane C. Burns ; Brookie M. Best ; Asuncion Mejias ; Lynn Mahony ; David E. Fixler ; Hasan S. Jafri ; Marian E. Melish ; Mary Anne Jackson ; Basim I. Asmar ; David J. Lang ; James D. Connor ; Edmund V. Capparelli ; Monica L. Keen ; Khalid Mamun ; Gregory F. Keenan ; Octavio Ramilo
- 刊名：The Journal of Pediatrics
- 出版年：2008
- 出版时间：December 2008
- 年：2008
- 卷：153
- 期：6
- 页码：833-838.e6
- 全文大小：341 K
Objective
To investigate the safety, tolerability, and pharmacokinetics of the anti–tumor necrosis factor-α monoclonal antibody infliximab in subjects with intravenous immunoglobulin (IVIG)-resistant Kawasaki disease (KD).Study design
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.