- A prospective, single-center (Children’s Hospital Boston), pilot, randomized trial between February 1998 through November 2000.1
- 39 subjects meeting the criteria for KD were entered in the study, and were randomly assigned (stratified by sex and age [<1yr,>1yr]), to receive intravenous methylprednisolone (IVMP), 30mg/kg, prior to IVIG and aspirin or IVIG and aspirin alone.
- Effectiveness of treatment was assessed by duration of fever (T≥38.3), length of hospitalization, need for IVIG retreatment, laboratory measures of systemic inflammation (including ESR, CRP), and coronary Z scores and incidence of aneurysms.
- Laboratory tests and Echocardiograms were preformed on all subjects at 3 standard times: baseline, on illness day 14 (range 11-21), and on illness day 42 (range 22-63).
- The IVMP group had shorter mean duration of fever (P=0.012), shorter hospital stays (P=.010), and at 6 weeks had lower ESR, CRP and IgA (P=.027, P=.011, P=.017 respectively). No statistical significance was noted in coronary dimensions.
- The IVMP group had fewer patients, 11%, requiring retreatment with IVIG compared to 25% in the standard group, resulting in NNT of 8.
- IVMP was well tolerated. The overall occurrence of at least one event during hospitalization (headaches, rigors, vomiting, CHF) was less frequent among children in IVMP group (P=.049), but no individual event differed significantly in its frequency between treatment groups.
- Neither patients or physicians were blinded to treatment, but outcome markers were measured objectively and echo readers were unaware of the patient’s treatment status.
- Other limitations of the study included: small sample size does not provide enough power, inconsistent definition of fever and the use of acetaminophen, the relatively older age of the subjects, and the possibility that the IVIG and aspirin group was initially somewhat more ill based on initial laboratory evaluation.2