Rituximab therapy for intractable pemphigus: A multicenter, open-label, single-arm, prospective study of 20 Japanese patients.
Rituximab therapy for intractable pemphigus: A multicenter, open-label, single-arm, prospective study of 20 Japanese patients.
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DOI：
10.1111/1346-8138.16597
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发表时间：
2023-02
影响因子：
3.1
通讯作者：
Amagai, Masayuki
中科院分区：
文献类型：
--
作者：
Yamagami, Jun;Kurihara, Yuichi;Funakoshi, Takeru;Saito, Yasuko;Tanaka, Ryo;Takahashi, Hayato;Ujiie, Hideyuki;Iwata, Hiroaki;Hirai, Yoji;Iwatsuki, Keiji;Ishii, Norito;Sakurai, Jun;Abe, Takayuki;Takemura, Ryo;Mashino, Naomi;Abe, Masahiro;Amagai, Masayuki
这是一项利妥昔单抗（一种针对CD 20的嵌合单克隆IgG抗体）治疗难治性寻常型天疱疮和落叶型天疱疮的多中心临床试验。总共有20名患者在第0天和第14天接受了两剂利妥昔单抗（1000 mg;间隔2周）治疗。主要终点是在第一次利妥昔单抗给药后第168天达到完全或部分缓解的患者比例。在20例入组患者中，分别有11例（55%）和4例（20%）患者达到完全缓解和部分缓解;因此，共有15例患者达到缓解（75.0% [95%置信区间，50.9%-91.3%]）。结果表明，缓解率大于预定阈值（5%）。此外，随着时间的推移，观察到临床评分（天疱疮疾病面积指数）显著改善和血清抗桥粒芯糖蛋白抗体水平降低。在2例患者中记录了4例严重不良事件（心力衰竭、肺炎、桡骨骨折和骨坏死），其中仅肺炎被认为与利妥昔单抗有因果关系。外周血CD 19阳性B淋巴细胞水平在利妥昔单抗治疗后第28天降低，并在整个研究期间保持较低水平，直至第168天。我们的研究结果证实了利妥昔单抗治疗日本难治性天疱疮患者的疗效和安全性。
This was a multicenter clinical trial of rituximab, a chimeric monoclonal IgG antibody directed against CD20, for the treatment of refractory pemphigus vulgaris and pemphigus foliaceus. In total, 20 patients were treated with two doses of rituximab (1000 mg; 2 weeks apart) on days 0 and 14. The primary end point was the proportion of patients who achieved complete or partial remission on day 168 following the first rituximab dose. Of the 20 enrolled patients, 11 (55%) and four (20%) achieved complete and partial remission, respectively; therefore, remission was achieved in a total of 15 patients (75.0% [95% confidence interval, 50.9%–91.3%]). It was demonstrated that the remission rate was greater than the prespecified threshold (5%). In addition, a significant improvement in clinical score (Pemphigus Disease Area Index) and decrease in serum anti‐desmoglein antibody level were observed over time. Four serious adverse events (heart failure, pneumonia, radial fracture, and osteonecrosis) were recorded in two patients, of which only pneumonia was considered causally related with rituximab. The level of peripheral blood CD19‐positive B lymphocytes was decreased on day 28 after rituximab treatment and remained low throughout the study period until day 168. Our results confirm the efficacy and safety of rituximab therapy for refractory pemphigus in Japanese patients.
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DOI：
10.1038/jid.2009.72
发表时间：
2009-10
期刊：
The Journal of investigative dermatology
影响因子：
--
作者：
通讯作者：
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影响因子：
--
作者：
Lunardon L;Tsai KJ;Propert KJ;Fett N;Stanley JR;Werth VP;Tsai DE;Payne AS
通讯作者：
Payne AS
影响因子：
3.1
作者：
Kurihara, Yuichi;Yamagami, Jun;Amagai, Masayuki
通讯作者：
Amagai, Masayuki
影响因子：
2.1
作者：
Goto, Shoko;Goto, Hiroaki;Kai, Sumio
通讯作者：
Kai, Sumio
影响因子：
10.3
作者：
Harman, K. E.;Brown, D.;Yesudian, P. D.
通讯作者：
Yesudian, P. D.