The quality of evidence is downgraded by study limitations (unclear allocation concealment and lack of blinding), and by imprecise results (few patients and outcome events).
A Cochrane review [Abstract] 1 included 5 studies with a total of 494 subjects. Four included studies used infliximab and one study used etanercept. One study used TNF-α blocker as an initial treatment and 4 used it as an additional treatment to initial intravenous immunoglobulin (IVIG) therapy for non-responders. Two studies compared the intervention with a second dose of IVIG, 1 study compared the intervention with an additional single dose of polyethylene glycol-treated human immunoglobulin (IVIG), and 2 studies used a placebo control.
TNF-α blockers reduced the incidence of treatment resistance, but there was no clear difference between groups in the incidence of coronary artery abnormalities (CAAs).TNF-α blocker intervention decreased infusion reactions.There was no clear difference in adverse effect 'infections', incidence of rash, or incidence of contact dermatitis (table T1). Subgroup analyses according to the timing and type of TNF-α blocker used showed no differences between groups.
Outcome | Relative effect(95% CI) | Risk with placebo or additional treatment | Risk with TNF-α blockers intervention (95% CI) | Participants(studies) |
---|---|---|---|---|
Treatment resistance | RR 0.57(0.38 to 0.86) | 226 per 1000 | 129 per 1000(86 to 194) | 494(5) |
Incidence of coronary artery abnormalities | RR 1.18(0.45 to 3.12) | 62 per 1000 | 73 per 1000(28 to 194) | 270 (3) |
Adverse effects after treatment initiation: infusion reactions | RR 0.06(0.01 to 0.45) | 121 per 1000 | 7 per 1000(1 to 54) | 250 (3) |
Adverse effects after treatment initiation: infections | RR 0.68(0.33 to 1.37) | 88 per 1000 | 60 per 1000(29 to 121) | 227 (2) |
Adverse effects after treatment initiation: rash | RR 4.71(0.24 to 90.69) | 7 per 1000 | 31 per 1000(2 to 605) | 31 (1) |
Adverse effects after treatment initiation: contact dermatitis | RR 0.31(0.04 to 2.68) | 200 per 1000 | 62 per 1000(8 to 536) | 31 (1) |
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