Masayuki Amagai1, Shigaku Ikeda2, Takashi Hashimoto3, Masato Mizuashi4, Akihiro Fujisawa5, Hironobu Ihn6, Yasushi Matsuzaki7, Mikio Ohtsuka8, Hiroshi Fujiwara9, Junichi Furuta10, Osamu Tago11, Jun Yamagami12, Akiko Tanikawa12, Hisashi Uhara13, Akimichi Morita14, Gen Nakanishi15, Mamori Tani16, Yumi Aoyama17, Eiichi Makino18, Masahiko Muto19, Motomu Manabe20, Takayuki Konno21, Satoru Murata22, Seiichi Izaki23, Hideaki Watanabe24, Yukie Yamaguchi25, Setsuko Matsukura26, Mariko Seishima27, Koji Habe28, Yuichi Yoshida29, Sakae Kaneko30, Hajime Shindo31, Kimiko Nakajima32, Takuro Kanekura33, Kenzo Takahashi34, Yasuo Kitajima35, Koji Hashimoto36. 1. Department of Dermatology, Keio University School of Medicine, 35 Shinano-machi, Shinjuku-ku, Tokyo 160-8582, Japan. Electronic address: amagai@med.keio.ac.jp. 2. Department of Dermatology, Juntendo University School of Medicine, 3-1-3 Hongo, Bunkyou-ku, Tokyo 113-8431, Japan. 3. Department of Dermatology, Kurume University School of Medicine, 67 Asahi-cho, Kurume, Fukuoka 830-0011, Japan. 4. Department of Dermatology, Tohoku University School of Medicine, 1-1 Seiryou-cho, aoba-ku, Sendai, Miyagi 980-8574, Japan. 5. Department of Dermatology, Kyoto University School of Medicine, 54 Shougoin Kawahara-cho, Sakyou-ku, Kyoto-shi, Kyoto 606-8507, Japan. 6. Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto 860-8556, Japan. 7. Department of Dermatology, Hirosaki University School of Medicine, 53 Hon-cho, Hirosaki, Aomori 036-8563, Japan. 8. Department of Dermatology, Fukushima Medical University, 1 Hikarigaoka, Fukushima-shi, Fukushima 960-1295, Japan. 9. Department of Dermatology, Niigata University School of Medicine, 1-754 Asahimachidori, Chuo-ku, Niigata-shi, Niigata, 951-8510, Japan. 10. Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan. 11. Department of Dermatology, Gunma University School of Medicine, 3-39-15 Shouwa-machi, Maebashi, Gunma 371-8511, Japan. 12. Department of Dermatology, Keio University School of Medicine, 35 Shinano-machi, Shinjuku-ku, Tokyo 160-8582, Japan. 13. Department of Dermatology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan. 14. Department of Dermatology, Nagoya city University School of Medicine, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-860, Japan. 15. Department of Dermatology, Shiga University of Medical Science, Setatsukinowa-cho, Otsu, Shiga 520-2192, Japan. 16. Department of Dermatology, Osaka University School of Medicine, Setatsukinowa-cho, Otsu, Shiga 520-2192, Japan. 17. Department of Dermatology, Okayama University School of Medicine, 2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama 700-8558, Japan. 18. Department of Dermatology, Kawasaki Medical University, 577 Matsushima, Kurashiki, Okayama 701-0192, Japan. 19. Department of Dermatology, Yamaguchi University School of Medicine, 1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan. 20. Department of Dermatology and Plastic Surgery, Akita University Graduate School of Medicine, 1-1-1 Hondo, Akita City, Akita 010-8543, Japan. 21. Department of Dermatology, Yamagata University School of Medicine, 2-2-2 Iidanishi, Yamagata-shi, Yamagata 990-9585, Japan. 22. Department of Dermatology, Jichi Medical University, 3311-1 Yakushiji, Shimono, Tochigi 329-0498, Japan. 23. Department of Dermatology, Saitama Medical Center, 1981 Kamoda, Kawagoe, Saitama 350-8550, Japan. 24. Department of Dermatology, Showa University East Hospital, 2-14-19 Nishinakanobu, Shinagawa-ku, Tokyo 142-0054, Japan. 25. Department of Dermatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0064, Japan. 26. Department of Dermatology, Yokohama city University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa 232-0024, Japan. 27. Department of Dermatology, Gifu University School of Medicine, 1-1 Yanagito, Gifu-shi, Gifu 501-1194, Japan. 28. Department of Dermatology, Mie University School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507, Japan. 29. Department of Dermatology, Tottori University School of Medicine, 36-1 Nishi-cho, Yonago, Tottori 683-8504, Japan. 30. Department of Dermatology, Shimane University Faculty of Medicine, 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan. 31. Department of Dermatology, Hiroshima University School of Medicine, 1-2-3 Kasumi, Minami-ku, Hiroshima-shi, Hiroshima 734-8551, Japan. 32. Department of Dermatology, Kochi University School of Medicine, 185-1 Kohasu, Okou-cho, Nankoku, Kochi 783-8505, Japan. 33. Department of Dermatology, Kagoshima University School of Medicine and Dentistry, 8-35-1 Sakuragaoka, Kagosima-shi, Kagoshima 890-8520, Japan. 34. Department of Dermatology, Ryukyu University School of Medicine, 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa 903-0215, Japan. 35. Kizawa memorial hospital, 590, Shimokobi, Kobicho, Minokamo-shi, Japan. 36. Ehime Prefectural University of Health Sciences, 543, Takoda, Tobe-cho, Iyo-gun, Ehime 791-2101, Japan.
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.
RCT Entities:
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.
Authors: Michela Ileen Biondo; Chiara Fiorentino; Severino Persechino; Antonella Tammaro; Angela Koverech; Armando Bartolazzi; Salvatore Raffa; Marco Canzoni; Andrea Picchianti-Diamanti; Roberta Di Rosa; Giovanni Di Zenzo; Enrico Scala; Giorgia Meneguzzi; Claudia Ferlito; Milica Markovic; Sara Caporuscio; Maria Laura Sorgi; Simonetta Salemi; Bruno Laganà Journal: Microorganisms Date: 2021-06-07