A multicentre randomized trial of the treatment of patients with pemphigus vulgaris with infliximab and prednisone compared with prednisone alone.
A multicentre randomized trial of the treatment of patients with pemphigus vulgaris with infliximab and prednisone compared with prednisone alone.
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DOI：
10.1111/bjd.13350
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发表时间：
2015-03
期刊：
影响因子：
--
通讯作者：
Welch B
中科院分区：
文献类型：
--
作者：
Hall RP 3rd;Fairley J;Woodley D;Werth VP;Hannah D;Streilein RD;McKillip J;Okawa J;Rose M;Keyes-Elstein LL;Pinckney A;Overington A;Wedgwood J;Ding L;Welch B
寻常型天疱疮 (PV) 是一种水疱性疾病，TNF-α 在发病机制中发挥作用。目的是评估英夫利昔单抗 (IFX) 联合泼尼松与单独泼尼松治疗 PV 的安全性。此外，还评估了治疗反应并进行了机制研究。在维持泼尼松治疗期间患有持续疾病活动的 PV 受试者被随机分配接受 IFX 或安慰剂以及泼尼松治疗。在第 18 周和第 26 周评估反应状态以及 IgG 抗 DSG1 和 DSG3 抗体。 。每组有 10 名受试者被随机分配。研究过程中没有出现安全信号。第 18 周时，每组有 1 名受试者做出了反应。第 26 周时，3 名 IFX 治疗受试者做出了反应，而安慰剂组则没有人做出反应 (p = 0 .21)。在第 18 周和第 26 周，IFX 治疗患者的中位 IgG 抗 DSG1 和抗 DSG3 水平较低（IgG 抗 DSG-1：第 18 周 p = 0.035，第 26 周 p = 0.022；IgG 抗 DSG3；第 18 周 p = 0.035，第 26 周 p = 0.05））。这项研究受到样本量相对较小的限制。研究组之间出现治疗相关不良事件 > 3 级的受试者比例没有显着差异。在这项随机、安慰剂对照试验中，IFX 治疗并未显示对治疗 PV 患者有效，尽管 IFX 治疗可能与抗 DSG1 和 DSG3 抗体的减少有关。
Pemphigus vulgaris (PV) is a blistering disease in which TNF-α has a role in the pathogenesis. The objective was to evaluate the safety of infliximab (IFX) with prednisone compared to prednisone alone in the treatment of PV. In addition, treatment response was assessed and mechanistic studies were performed. PV subjects who had ongoing disease activity while maintained on prednisone were randomized to receive either IFX or placebo in addition to prednisone. Response status and IgG anti-DSG1 and DSG3 antibodies were assessed at 18 and 26 weeks. . 10 subjects were randomized to each group. There were no safety signals during the course of the study. At week 18, 1 subject in each group had responded. At week 26, 3 IFX treated subjects vs. none in the placebo group had responded (p =0 .21). At weeks 18 and 26, the median IgG anti-DSG1 and anti-DSG3 levels were lower in the IFX treated-patients (IgG anti DSG-1: week 18 p =0.035, week 26 p = 0.022; IgG anti-DSG3; week 18 p=0.035, week 26 p = 0.05)). This study is limited by the relative small sample size. There was no significant difference between study arms in the proportion of subjects with treatment-related Adverse Events > Grade 3. IFX therapy was not shown to be effective for the treatment of patients with PV in this randomized, placebo-controlled trial, although IFX treatment may be associated with a decrease in anti-DSG1 and DSG3 antibodies.
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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：
--
影响因子：
4.9
作者：
Delabaye I;De Keyser F;REMITRACT study group
通讯作者：
REMITRACT study group
影响因子：
6.5
作者：
Beissert, Stefan;Mimouni, Daniel;Anhalt, Grant J.
通讯作者：
Anhalt, Grant J.
影响因子：
--
作者：
Lin, MH;Hsu, CK;Lee, JYY
通讯作者：
Lee, JYY
影响因子：
27.4
作者：
Salmon-Ceron, D.;Tubach, F.;Mariette, X.
通讯作者：
Mariette, X.