BACKGROUND: There is a need for alternative therapy in severe adult atopic dermatitis (AD). Intravenous immunoglobulin (IVIG) treatment has been shown to be beneficial in a few open observations, but evidence of effectiveness is still lacking. OBJECTIVE: To investigate whether treatment with IVIG is effective in adults with severe AD. METHODS: In a randomized evaluator-blinded trial, 10 patients with severe AD were randomized to immediate or delayed (by 1 month) treatment with IVIG 2 g kg-1. Patients received an 8-h infusion of 1 g kg-1 daily for two consecutive days. They were assessed clinically at days 15, 30, 60 and 90. The primary efficacy criterion was measurement of the severity scoring of AD (SCORAD) index at day 30. RESULTS: The SCORAD values were not significantly different between the two groups at day 30. Similarly, global evaluation of disease severity by patients did not show any clinically significant change at day 30. In the cohort of 10 patients, the mean percentage decrease in SCORAD as compared with baseline was, respectively, 15%[95% confidence interval (CI) 6-24%] and 22% (95% CI 5-39%) at 30 and 60 days after IVIG infusion. CONCLUSIONS:IVIG treatment was not associated with clinically significant improvement of AD signs and symptoms in this randomized study. Although this study may have been too small to detect a beneficial effect in a small subset of patients, the results do not support the common use of IVIG in refractory AD.
RCT Entities:
BACKGROUND: There is a need for alternative therapy in severe adult atopic dermatitis (AD). Intravenous immunoglobulin (IVIG) treatment has been shown to be beneficial in a few open observations, but evidence of effectiveness is still lacking. OBJECTIVE: To investigate whether treatment with IVIG is effective in adults with severe AD. METHODS: In a randomized evaluator-blinded trial, 10 patients with severe AD were randomized to immediate or delayed (by 1 month) treatment with IVIG 2 g kg-1. Patients received an 8-h infusion of 1 g kg-1 daily for two consecutive days. They were assessed clinically at days 15, 30, 60 and 90. The primary efficacy criterion was measurement of the severity scoring of AD (SCORAD) index at day 30. RESULTS: The SCORAD values were not significantly different between the two groups at day 30. Similarly, global evaluation of disease severity by patients did not show any clinically significant change at day 30. In the cohort of 10 patients, the mean percentage decrease in SCORAD as compared with baseline was, respectively, 15%[95% confidence interval (CI) 6-24%] and 22% (95% CI 5-39%) at 30 and 60 days after IVIG infusion. CONCLUSIONS: IVIG treatment was not associated with clinically significant improvement of AD signs and symptoms in this randomized study. Although this study may have been too small to detect a beneficial effect in a small subset of patients, the results do not support the common use of IVIG in refractory AD.