Rituximab therapy for refractory autoimmune bullous diseases: A multicenter, open‐label, single‐arm, phase 1/2 study on 10 Japanese patients
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- Yuichi Kurihara
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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- Jun Yamagami
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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- Takeru Funakoshi
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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- Maki Ishii
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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- Julia Miyamoto
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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- Yumi Fujio
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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- Risa Kakuta
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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- Akiko Tanikawa
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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- Yumi Aoyama
- Department of Dermatology Okayama University School of Medicine Okayama Japan
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- Keiji Iwatsuki
- Department of Dermatology Okayama University School of Medicine Okayama Japan
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- Norito Ishii
- Department of Dermatology Kurume University School of Medicine Kurume Japan
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- Takashi Hashimoto
- Department of Dermatology Kurume University School of Medicine Kurume Japan
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- Wataru Nishie
- Department of Dermatology Hokkaido University School of Medicine Sapporo Japan
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- Hiroshi Shimizu
- Department of Dermatology Hokkaido University School of Medicine Sapporo Japan
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- Keisuke Kouyama
- Clinical and Translational Research Center Keio University Hospital and Keio University School of Medicine Tokyo Japan
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- Masayuki Amagai
- Department of Dermatology Keio University School of Medicine Tokyo Japan
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説明
<jats:title>Abstract</jats:title><jats:p>This was a multicenter study of rituximab, a chimeric monoclonal immunoglobulin G antibody directed against <jats:styled-content style="fixed-case">CD</jats:styled-content>20, for the treatment of refractory autoimmune bullous diseases (pemphigus and pemphigoid). Ten patients (three with pemphigus vulgaris, six with pemphigus foliaceus and one with bullous pemphigoid) were treated with a single cycle of rituximab (four weekly infusions at a dose of 375 mg/m<jats:sup>2</jats:sup> of body surface area). The primary end‐points were the number of serious adverse events and rate of complete remission at 40 weeks. Five patients (50%) achieved complete remission with minimal therapy (defined as no active lesions with lower doses of systemic corticosteroids compared to that with prednisolone 10 mg/day). Improvements in clinical scores (Pemphigus Disease Area Index) and decreases in autoantibody titers in the sera were observed in the four pemphigus patients who failed to achieve complete remission. This suggests that rituximab was effective in nine of 10 cases. Two serious adverse events (<jats:italic>Pneumocystis carinii</jats:italic> pneumonia and septic shock due to infectious arthritis) were observed and adequately treated with hospitalization. <jats:styled-content style="fixed-case">CD</jats:styled-content>19‐positive B lymphocytes in the peripheral blood decreased on day 29 following rituximab treatment, and remained at low levels throughout the observation period (280 days). Our results confirmed the efficacy of rituximab therapy for refractory autoimmune bullous diseases in Japan.</jats:p>
収録刊行物
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- The Journal of Dermatology
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The Journal of Dermatology 46 (2), 124-130, 2018-12-26
Wiley
