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A randomized double-blind trial of intravenous immunoglobulin for pemphigus - 08/08/11

Doi : 10.1016/j.jaad.2008.09.052 
Masayuki Amagai, MD a, Shigaku Ikeda, MD b, Hiroshi Shimizu, MD c, Hajime Iizuka, MD d, Katsumi Hanada, MD e, Setsuya Aiba, MD f, Fumio Kaneko, MD g, Seiichi Izaki, MD h, Kunihiko Tamaki, MD i, Zenro Ikezawa, MD j, Masahiro Takigawa, MD k, Mariko Seishima, MD l, Toshihiro Tanaka, MD m, Yoshiki Miyachi, MD n, Ichiro Katayama, MD o, Yuji Horiguchi, MD p, Sachiko Miyagawa, MD q, Fukumi Furukawa, MD r, Keiji Iwatsuki, MD s, Michihiro Hide, MD t, Yoshiki Tokura, MD u, Masutaka Furue, MD v, Takashi Hashimoto, MD w, Hironobu Ihn, MD x, Sakuhei Fujiwara, MD y, Takeji Nishikawa, MD a, Hideoki Ogawa, MD b, Yasuo Kitajima, MD z, Koji Hashimoto, MD aa,

Pemphigus Study Group

a Department of Dermatology, Keio University School of Medicine, Tokyo, Japan 
b Department of Dermatology, Juntendo University School of Medicine, Tokyo, Japan 
c Department of Dermatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan 
d Department of Dermatology, Asahikawa Medical College, Asahikawa, Japan 
e Department of Dermatology, Hirosaki University School of Medicine, Hirosaki, Japan 
f Department of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan 
g Department of Dermatology, Fukushima Medical University, Fukushima, Japan 
h Department of Dermatology, Saitama Medical Center, Kawagoe, Japan 
i Department of Dermatology, University of Tokyo School of Medicine, Tokyo, Japan 
j Department of Dermatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan 
k Department of Dermatology, Hamamatsu University School of Medicine, Hamamatsu, Japan 
l Department of Dermatology, Ogaki Municipal Hospital, Ogaki, Japan 
m Department of Dermatology, Shiga University of Medical Science, Ohtsu, Japan 
n Department of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan 
o Department of Dermatology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan 
p Department of Dermatology, Osaka Red Cross Hospital, Osaka, Japan 
q Department of Dermatology, Nara Medical University, Kashihara, Japan 
r Department of Dermatology, Wakayama Medical University, Wakayama, Japan 
s Department of Dermatology, Okayama University Graduate School of Medicine, Okayama, Japan 
t Department of Dermatology, Hiroshima University Graduate School of Medicine, Hiroshima, Japan 
u Department of Dermatology, University of Occupational and Environment Health, Kitakyusyu, Japan 
v Department of Dermatology, Kyushu University Graduate School of Medicine, Fukuoka, Japan 
w Department of Dermatology, Kurume University School of Medicine, Kurume, Japan 
x Department of Dermatology, Faculty of Medical and Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan 
y Department of Dermatology, Oita University Faculty of Medicine, Yufu, Japan 
z Department of Dermatology, Gifu University Graduate School of Medicine, Gifu, Japan 
aa Department of Dermatology, Ehime University Graduate School of Medicine, Toon, Japan 

Reprint requests: Koji Hashimoto, MD, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime 791-0295, Japan.

Abstract

Background

Pemphigus is a rare life-threatening intractable autoimmune blistering disease caused by IgG autoantibodies to desmogleins. It has been difficult to conduct a double-blind clinical study for pemphigus partly because, in a placebo group, appropriate treatment often must be provided when the disease flares.

Objective

A multicenter, randomized, placebo-controlled, double-blind trial was conducted to investigate the therapeutic effect of a single cycle of high-dose intravenous immunoglobulin (400, 200, or 0 mg/kg/d) administered over 5 consecutive days in patients relatively resistant to systemic steroids.

Methods

We evaluated efficacy with time to escape from the protocol as a novel primary end point, and pemphigus activity score, antidesmoglein enzyme-linked immunosorbent assay scores, and safety as secondary end points.

Results

We enrolled 61 patients with pemphigus vulgaris or pemphigus foliaceus who did not respond to prednisolone (≥20 mg/d). Time to escape from the protocol was significantly prolonged in the 400-mg group compared with the placebo group (P < .001), and a dose-response relationship among the 3 treatment groups was observed (P < .001). Disease activity and enzyme-linked immunosorbent assay scores were significantly lower in the 400-mg group than in the other groups (P < .05 on day 43, P < .01 on day 85). There was no significant difference in the safety end point among the 3 treatment groups.

Limitation

Prednisolone at 20 mg/d or more may not be high enough to define steroid resistance.

Conclusion

Intravenous immunoglobulin (400 mg/kg/d for 5 d) in a single cycle is an effective and safe treatment for patients with pemphigus who are relatively resistant to systemic steroids. Time to escape from the protocol is a useful indicator for evaluation in randomized, placebo-controlled, double-blind studies of rare and serious diseases.

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Abbreviations used : ADRs, Dsg, HD, IVIG, PAS, PF, PV, TEP


Plan


 Other investigators in the Pemphigus Study Group are listed in the Appendix.
 Supported by Nihon Pharmaceutical Co Ltd, but no financial support was provided to any individual investigator for performing this trial.
 Disclosure: Drs Amagai, Ikeda, Kitajima, Nishikawa, and Hashimoto report receiving consulting and lecture fees from Nihon Pharmaceutical Co Ltd. Drs Shimizu, Iizuka, Hanada, Aiba, Kaneko, Izaki, Tamaki, Ikezawa, Takigawa, Seishima, Tanaka, Miyachi, Katayama, Horiguchi, Miyagawa, Furukawa, Iwatsuki, Hide, Tokura, Furue, Ihn, Fujiwara, Ogawa, and Hashimoto have no conflicts of interest to declare.
 Presented in part at the Post International Investigative Dermatology Satellite International Meeting on Autoimmune Bullous Diseases at Ohtsu, Japan on May 19, 2008 and the Annual Meeting of the Japanese Dermatological Association at Kyoto, Japan on April 20, 2008.


© 2008  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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