Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.
Br J Dermatol. 2018 Feb;178(2):509-519. doi: 10.1111/bjd.16102. Epub 2018 Jan 9.
Real-life data on newer biological and biosimilar agents for moderate-to-severe psoriasis are lacking.
To examine safety, efficacy and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab and ustekinumab) and compare originators with biosimilars (i.e. Enbrel with Benepali, and Remicade with Remsima).
The DERMBIO registry contains data on all Danish patients with moderate-to-severe plaque psoriasis treated with biologics. We examined patients treated between 1 January 2007 and 31 March 2017. We used Kaplan-Meier survival curves and Cox regression to examine drug survival patterns.
A total of 3495 treatment series (2161 patients) were included (adalimumab n = 1332; etanercept n = 579; infliximab n = 333; ustekinumab n = 1055 and secukinumab n = 196). Secukinumab had the highest number of PASI 100 (100% improvement from baseline Psoriasis Area and Severity Index) respondents, but also the lowest drug survival among all the biologics. Ustekinumab had the highest drug survival overall. There were no significant differences in discontinuation risk between originator and biosimilar versions of infliximab or etanercept. Treatment with higher than approved dosages was frequent for all drugs except for adalimumab and secukinumab. Adverse events (predominantly infections) were most frequent for secukinumab compared with the other agents.
Ustekinumab was associated with the highest drug survival, and secukinumab with the lowest, although most patients on secukinumab were non-naïve. Switching from originator to biosimilar had no significant impact on drug survival, and the safety profiles were comparable. Adverse events occurred most frequently with secukinumab. Future studies are warranted to assess the long-term safety of novel biologics for psoriasis.
关于中度至重度银屑病的新型生物制剂和生物类似药的真实数据尚缺乏。
评估生物制剂（阿达木单抗、依那西普、英夫利昔单抗、司库奇尤单抗和乌司奴单抗）的安全性、疗效和停药时间（药物存续时间），并比较原研药与生物类似药（即恩利与倍利美，类克与雷莫芦单抗）。
DERMBIO 登记处包含所有丹麦中重度斑块状银屑病患者使用生物制剂治疗的数据。我们研究了 2007 年 1 月 1 日至 2017 年 3 月 31 日期间接受治疗的患者。我们使用 Kaplan-Meier 生存曲线和 Cox 回归来评估药物存续时间模式。
共纳入 3495 个治疗系列（2161 例患者），包括阿达木单抗 1332 例、依那西普 579 例、英夫利昔单抗 333 例、乌司奴单抗 1055 例和司库奇尤单抗 196 例。司库奇尤单抗的 PASI100（基线时银屑病面积和严重程度指数改善 100%）应答者比例最高，但所有生物制剂中药物存续时间最短。乌司奴单抗总体药物存续时间最长。英夫利昔单抗和依那西普的原研药和生物类似药版本之间停药风险无显著差异。除阿达木单抗和司库奇尤单抗外，所有药物的高剂量治疗均很常见。与其他药物相比，司库奇尤单抗的不良反应（主要是感染）最常见。
乌司奴单抗的药物存续时间最长，司库奇尤单抗最短，尽管司库奇尤单抗的大多数患者并非初治。从原研药转换为生物类似药对药物存续时间没有显著影响，且安全性相当。司库奇尤单抗的不良反应最常见。需要进一步研究评估新型生物制剂治疗银屑病的长期安全性。
