A randomized double-blind trial of intravenous immunoglobulin for bullous pemphigoid

Abstract

Background: Patients with steroid-resistant bullous pemphigoid (BP) require an appropriate treatment option.

Objective: A multicenter, randomized, placebo-controlled, double-blind trial was conducted to investigate the therapeutic effect of high-dose intravenous immunoglobulin (IVIG; 400mg/kg/day for 5days) in BP patients who showed no symptomatic improvement with prednisolone (≥0.4mg/kg/day) administered.

Methods: We evaluated the efficacy using the disease activity score on day15 (DAS15) as a primary endpoint, and changes in the DAS over time, the anti-BP180 antibody titer, and safety for a period of 57days as secondary endpoints.

Results: We enrolled 56 patients in this study. The DAS15 was 12.5 points lower in the IVIG group than in the placebo group (p=0.089). The mean DAS of the IVIG group was constantly lower than that of the placebo group throughout the course of observation, and a post hoc analysis of covariance revealed a significant difference (p=0.041). Furthermore, when analyzed only in severe cases (DAS≥40), the DAS15 differed significantly (p=0.046). The anti-BP180 antibody titers showed no difference between the two groups.

Conclusion: IVIG provides a beneficial therapeutic outcome for patients with BP who are resistant to steroid therapy.

Keywords: Autoantibody; Autoimmune disease; Bullous pemphigoid; IgG; Intravenous immunoglobulin; Treatment.