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

作者：Amagai Masayuki^*; Ikeda Shigaku; Hashimoto Takashi; Mizuashi Masato; Fujisawa Akihiro; Ihn Hironobu; Matsuzaki Yasushi; Ohtsuka Mikio; Fujiwara Hiroshi; Furuta Junichi; Tago Osamu; Yamagami Jun; Tanikawa Akiko; Uhara Hisashi; Morita Akimichi; Nakanishi Gen; Tani Mamori; Aoyama Yumi; Makino Eiichi; Muto Masahiko; Manabe Motomu; Konno Takayuki; Murata Satoru; Izaki Seiichi; Watanabe Hideaki; Yamaguchi Yukie; Matsukura Setsuko; Seishima Mariko; Habe Koji

来源：Journal of Dermatological Science, 2017, 85(2): 77-84.

DOI：10.1016/j.jdermsci.2016.11.003

• Bullous pemphigoid
• Intravenous immunoglobulin
• Autoimmune disease
• IgG
• Autoantibody
• Treatment

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; 400 mg/kg/day for 5 days) in BP patients who showed no symptomatic improvement with prednisolone (>= 0.4 mg/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 57 days 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.

• 出版日期2017-2