Secukinumab improves psoriasis symptoms in patients with inadequate response to cyclosporine A: A prospective study to evaluate direct switch.
Secukinumab improves psoriasis symptoms in patients with inadequate response to cyclosporine A: A prospective study to evaluate direct switch.
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DOI：
10.1111/1346-8138.13911
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发表时间：
2017-10
期刊：
影响因子：
--
通讯作者：
Nakagawa H
中科院分区：
文献类型：
--
作者：
Ohtsuki M;Morita A;Igarashi A;Imafuku S;Tada Y;Fujita H;Fujishige A;Yamaguchi M;Teshima R;Tani Y;Nakagawa H
关于银屑病患者从环孢菌素A（CyA）转换为阿基诺单抗的安全性和疗效的数据有限。本研究的目的是评估在中重度银屑病患者中，从CyA直接转换后，阿基诺单抗治疗16周的疗效和安全性。在这项多中心、开放标签、IV期研究中，34例中重度银屑病患者和CyA疗效不佳患者接受了阿基诺单抗300 mg s.c.在基线和第1、2、3、4、8和12周。主要终点为第16周时银屑病面积和严重程度指数评分（PASI 75）较基线改善≥75%。评价了直至第16周的阿基诺单抗治疗的疗效，并在研究期间监测了不良事件（AE）。82.4%（n = 28）接受阿伐奴单抗治疗的患者达到了第16周PASI 75应答的主要终点。使用阿伐单抗观察到早期改善，第2周PASI 50应答为41.2%，第4周PASI 75应答为44.1%。在70.6%（n = 24）的患者中观察到AE，整个研究期间未报告严重AE或死亡。苏金单抗显示出有利的安全性特征，与既往数据一致，无新的或非预期的安全性信号。本研究的结果表明，克林单抗对银屑病患者有效，能够顺利安全地从CyA直接转换为生物治疗。
There are limited data on the safety and efficacy of switching to secukinumab from cyclosporine A (CyA) in patients with psoriasis. The purpose of the present study was to assess the efficacy and safety of secukinumab for 16 weeks after direct switching from CyA in patients with moderate‐to‐severe psoriasis. In this multicenter, open‐label, phase IV study, 34 patients with moderate‐to‐severe psoriasis and inadequate response to CyA received secukinumab 300 mg s.c. at baseline and weeks 1, 2, 3, 4, 8 and 12. The primary end‐point was ≥75% improvement from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 16. The efficacy of secukinumab treatment was evaluated up to week 16, and adverse events (AE) were monitored during the study. The primary end‐point of the PASI 75 response at week 16 was achieved by 82.4% (n = 28) of patients receiving secukinumab. Early improvements were observed with secukinumab, with PASI 50 response of 41.2% at week 2 and PASI 75 response of 44.1% at week 4. AE were observed in 70.6% (n = 24) of patients, and there were no serious AE or deaths reported in the entire study period. Secukinumab showed a favorable safety profile consistent with previous data with no new or unexpected safety signals. The results of the present study show that secukinumab is effective in patients with psoriasis enabling a smooth and safe direct switch from CyA to biological therapy.
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影响因子：
158.5
作者：
Baeten, Dominique;Sieper, Joachim;Richards, Hanno B.
通讯作者：
Richards, Hanno B.
影响因子：
3.1
作者：
Ohtsuki, Mamitaro;Terui, Tadashi;Nakagawa, Hidemi
通讯作者：
Nakagawa, Hidemi
影响因子：
13.8
作者：
Menter, Alan;Korman, Neil J.;Bhushan, Reva
通讯作者：
Bhushan, Reva
影响因子：
168.9
作者：
McInnes, Iain B.;Mease, Philip J.;Mpofu, Shephard
通讯作者：
Mpofu, Shephard
DOI：
10.1111/j.1468-3083.2011.03992.x
发表时间：
2011-05-01
影响因子：
9.2
作者：
Maza, A.;Montaudie, H.;Paul, C.
通讯作者：
Paul, C.