44 - A PILOT STUDY ON CLINICAL SAFETY AND EFFICACY OF COMBINATION THERAPY WITH COLCHICINE AND INTRAVENOUS IMMUNOGLOBULIN FOR KAWASAKI DISEASE

BACKGROUND: Colchicine is an orally administered potent anti-inflammatory drug used to treat inflammatory diseases such as gout, pericarditis, Behcet's disease. It has broad cellular effects that include inhibition of NLRP3 inflammasome, IL-1b release, tubulin polymerization and leukocyte responsiveness, mechanisms that participate in the immunopathogenesis of Kawasaki disease (KD). It has recently been approved by the FDA as the first oral anti-inflammatory agent as an atheroprotective cardiovascular treatment.

Methods: We conducted a pilot clinical study to investigate the safety and efficacy of colchicine and IVIG combination therapy for children with KD. The study population consisted of KD patients aged ≥6 months and < 7 years. 2 g/kg IVIG was administered over 24 hours. Colchicine was administered orally at a dose of 0.5 mg/day for children aged 6 months to < 5 years and 1 mg/day for children aged 5 years and older. Colchicine was given for 10 days from the day IVIG was started. The occurrence of adverse events, need for additional treatment, and coronary artery measurements were evaluated within 24 hours before the start of IVIG, within 24 hours after the end of IVIG, and at days 28 to 35 of illness.

Results: A total of 54 KD patients were included. Twelve KD patients were treated with IVIG and colchicine and 42 patients only with IVIG. Gender, age, Kobayashi score, date of treatment initiation, white blood cell count before treatment, albumin, sodium, and CRP levels were similar between two groups. No difference was observed in coronary artery Z-score before the start of treatment. One patient in each group was evaluated for coronary artery involvement before treatment. There was no difference between the two groups in the number of patients requiring additional treatment: 6 in the IVIG + colchicine group and 14 in the IVIG group (p=0.42). There was no significant difference in the number of patients with coronary sequelae at days 28-35 of illness: 0 in the IVIG + colchicine group and 8 in the IVIG only group (p=0.064).There were no adverse event in the group that received IVIG + colchicine.

CONCLUSIONS: Addition of colchicine to IVIG was safe in this small study as no adverse events occurred. Colchicine, is an oral drug that is relatively inexpensive and given its various anti-inflammatory mechanisms of action, its role in treatment of IVIG-resistant KD or in preventing long-term ongoing vascular remodeling seen in KD patients should be further investigated in larger studies.