Infliximab for intensification of primary therapy for Kawasaki disease: a phase 3 randomised, double-blind, placebo-controlled trial

Abstract

SummaryBackground Kawasaki disease, the most common cause of acquired heart disease in developed countries, is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin. Resistance to intravenous immunoglobulin in Kawasaki disease increases the risk of coronary artery aneurysms. We assessed whether the addition of infl iximab to standard therapy (intravenous immunoglobulin and aspirin) in acute Kawasaki disease reduces the rate of treatment resistance.

Adjunctive therapies for Kawasaki disease

“…27 The addition of infliximab to primary treatment in acute KD did not reduce the incidence of coronary artery abnormalities, but was safe and reduced fever duration and left anterior descending coronary artery Z scores by two-fold. 27 In a two-center retrospective study comparing second IVIG infusion versus infliximab for IVIG-resistant KD patients, administration of infliximab was associated with a more rapid decrease in CRP, fewer days of fever, reduced cost, and shortened hospitalization. 4 These data support the use of infliximab for refractory KD, but randomized, controlled trials are needed.…”

“…etanercept) could be an effective adjunctive therapy in children with acute KD. 4,27 A trial was conducted involving 196 children randomized to a single intravenous infusion of infliximab (5 mg/kg) versus placebo, in addition to standard initial therapy with IVIG and aspirin. 27 The addition of infliximab to primary treatment in acute KD did not reduce the incidence of coronary artery abnormalities, but was safe and reduced fever duration and left anterior descending coronary artery Z scores by two-fold.…”

“…4,27 A trial was conducted involving 196 children randomized to a single intravenous infusion of infliximab (5 mg/kg) versus placebo, in addition to standard initial therapy with IVIG and aspirin. 27 The addition of infliximab to primary treatment in acute KD did not reduce the incidence of coronary artery abnormalities, but was safe and reduced fever duration and left anterior descending coronary artery Z scores by two-fold. 27 In a two-center retrospective study comparing second IVIG infusion versus infliximab for IVIG-resistant KD patients, administration of infliximab was associated with a more rapid decrease in CRP, fewer days of fever, reduced cost, and shortened hospitalization.…”

Use of Anti TNF-α Therapy in Systemic Vasculitis

“…Another 2 studies addressed the effect of adding infliximab to the standard therapy. In 2014 [55] a phase 3, randomised, double-blind, placebo-controlled trial was conducted on 196 patients to assess the benefit adding of infliximab to the conventional therapy. The results came to show infliximab didn`t reduce the disease resistance rate.…”

“…No complications or side effects have occurred in all 15 patients. Table 6 shows a summary of studies that addressed the use of anti TNF-α agents in patients with Kawasaki disease [57][58][59][60][61][62][63]. …”