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

- IVIG is an effective treatment for pemphigus.
- IVIG has some therapeutic benefits for bullous pemphigoid, although the effect is not as dramatic as in pemphigus.
- IVIG provides a therapeutic option for steroid-resistant patients with bullous pemphigoid without immune suppression.

BackgroundPatients with steroid-resistant bullous pemphigoid (BP) require an appropriate treatment option.ObjectiveA multicenter, randomized, placebo-controlled, double-blind trial was conducted to investigate the therapeutic effect of high-dose intravenous immunoglobulin (IVIG; 400 mg/kg/day for 5 days) in BP patients who showed no symptomatic improvement with prednisolone (≥0.4 mg/kg/day) administered.MethodsWe 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 57 days as secondary endpoints.ResultsWe 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.ConclusionIVIG provides a beneficial therapeutic outcome for patients with BP who are resistant to steroid therapy.