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

Bullous Pemphigoid Study Group

Research output: Contribution to journalArticle

27 Citations (Scopus)

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; 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.

Original languageEnglish
Pages (from-to)77-84
Number of pages8
JournalJournal of Dermatological Science
Volume85
Issue number2
DOIs
Publication statusPublished - 2017 Feb 1

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Bullous Pemphigoid
Intravenous Immunoglobulins
amsonic acid
Placebos
Anti-Idiotypic Antibodies
Steroids
Antibodies
Therapeutic Uses
Prednisolone
Therapeutics
Observation
Safety

Keywords

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

ASJC Scopus subject areas

  • Biochemistry
  • Molecular Biology
  • Dermatology

Cite this

A randomized double-blind trial of intravenous immunoglobulin for bullous pemphigoid. / Bullous Pemphigoid Study Group.

In: Journal of Dermatological Science, Vol. 85, No. 2, 01.02.2017, p. 77-84.

Research output: Contribution to journalArticle

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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; 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.",
keywords = "Autoantibody, Autoimmune disease, Bullous pemphigoid, IgG, Intravenous immunoglobulin, Treatment",
author = "{Bullous Pemphigoid Study Group} and Masayuki Amagai and Shigaku Ikeda and Takashi Hashimoto and Masato Mizuashi and Akihiro Fujisawa and Hironobu Ihn and Yasushi Matsuzaki and Mikio Ohtsuka and Hiroshi Fujiwara and Junichi Furuta and Osamu Tago and Jun Yamagami and Akiko Tanikawa and Hisashi Uhara and Akimichi Morita and Gen Nakanishi and Mamori Tani and Yumi Aoyama and Eiichi Makino and Masahiko Muto and Motomu Manabe and Takayuki Konno and Satoru Murata and Seiichi Izaki and Hideaki Watanabe and Yukie Yamaguchi and Setsuko Matsukura and Mariko Seishima and Koji Habe and Yuichi Yoshida and Sakae Kaneko and Hajime Shindo and Kimiko Nakajima and Takuro Kanekura and Kenzo Takahashi and Yasuo Kitajima and Koji Hashimoto",
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T1 - A randomized double-blind trial of intravenous immunoglobulin for bullous pemphigoid

AU - Bullous Pemphigoid Study Group

AU - Amagai, Masayuki

AU - Ikeda, Shigaku

AU - Hashimoto, Takashi

AU - Mizuashi, Masato

AU - Fujisawa, Akihiro

AU - Ihn, Hironobu

AU - Matsuzaki, Yasushi

AU - Ohtsuka, Mikio

AU - Fujiwara, Hiroshi

AU - Furuta, Junichi

AU - Tago, Osamu

AU - Yamagami, Jun

AU - Tanikawa, Akiko

AU - Uhara, Hisashi

AU - Morita, Akimichi

AU - Nakanishi, Gen

AU - Tani, Mamori

AU - Aoyama, Yumi

AU - Makino, Eiichi

AU - Muto, Masahiko

AU - Manabe, Motomu

AU - Konno, Takayuki

AU - Murata, Satoru

AU - Izaki, Seiichi

AU - Watanabe, Hideaki

AU - Yamaguchi, Yukie

AU - Matsukura, Setsuko

AU - Seishima, Mariko

AU - Habe, Koji

AU - Yoshida, Yuichi

AU - Kaneko, Sakae

AU - Shindo, Hajime

AU - Nakajima, Kimiko

AU - Kanekura, Takuro

AU - Takahashi, Kenzo

AU - Kitajima, Yasuo

AU - Hashimoto, Koji

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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.

AB - 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.

KW - Autoantibody

KW - Autoimmune disease

KW - Bullous pemphigoid

KW - IgG

KW - Intravenous immunoglobulin

KW - Treatment

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