Shear Neil H, Paul Carle, Blauvelt Andrew, Gooderham Melinda, Leonardi Craig, Reich Kristian, Ohtsuki Mamitaro, Pangallo Beth, Xu Wen, Ball Susan, Ridenour Terri, Torisu-Itakura Hitoe, Agada Noah, Mallbris Lotus
J Drugs Dermatol. 2018 Feb 1;17(2):200-206.
BACKGROUND: Injection-site reactions (ISRs) are reported with biologic therapies. The objective of this study was to comprehensively characterize ISRs among moderate-to-severe psoriasis patients treated with ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A.
METHODS: ISRs are presented from UNCOVER-1, UNCOVER-2, and UNCOVER-3 (12 weeks) and all ixekizumab-exposed patients in 11 controlled and uncontrolled trials (156 weeks).
RESULTS: At week 12, reported ISR frequency with 80 mg ixekizumab every 2 weeks (IXE Q2W, 16.8%) was comparable with etanercept twice weekly (16.4%); both were significantly higher than placebo (3.3%). With IXE Q2W, ISRs were mild (12.3%), moderate (3.9%), or severe (0.7%), typically reported in the first 2 weeks (median onset, 6.6 days), and most commonly characterized as nonspecified, erythema, and pain. Generally, erythema onset was delayed, whereas pain occurred around drug administration. Discontinuation from ixekizumab due to ISRs (0.4%) occurred in the first 12 weeks. After 2 weeks, ISR frequency decreased and remained stable (≤4.2%) through week 156. No ISR-related serious adverse events were reported in ixekizumab-treated patients. ISR data were solicited if patients reported injection-associated events. Since nonspecified ISR was the most commonly reported term, specific types might be underreported.
CONCLUSIONS: ISRs have been reported with ixekizumab during clinical trials. These reactions are typically tolerable, manageable, and decrease over time.
Clinicaltrials.gov: NCT01474512 (UNCOVER-1); NCT01597245 (UNCOVER-2); NCT01646177 (UNCOVER-3); NCT01777191 (UNCOVER-A); NCT01624233 (UNCOVER-J); NCT01107457 (I1F-MC-RHAJ); NCT02561806 (I1F-MC-RHBS); NCT02387801 (I1F-US-RHBO);NCT02513550 (I1F-MC-RHBP); NCT02634801 (I1F-EW-RHBZ)
J Drugs Dermatol. 2018;17(2):200-206.
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.生物疗法会出现注射部位反应（ISR）。本研究的目的是全面描述接受ixekizumab（一种选择性靶向白细胞介素（IL）-17A的高亲和力单克隆抗体）治疗的中重度银屑病患者的ISR情况。
呈现了来自UNCOVER-1、UNCOVER-2和UNCOVER-3（12周）以及11项对照和非对照试验（156周）中所有接受ixekizumab治疗患者的ISR情况。
在第12周时，每2周注射80mg ixekizumab（IXE Q2W，16.8%）的ISR发生率与每周两次注射依那西普（16.4%）相当；两者均显著高于安慰剂（3.3%）。使用IXE Q2W时，ISR为轻度（12.3%）、中度（3.9%）或重度（0.7%），通常在前2周报告（中位发病时间为6.6天），最常见的表现为未明确说明、红斑和疼痛。一般来说，红斑出现较晚，而疼痛在给药时出现。在最初12周内，因ISR而停用ixekizumab的情况（0.4%）。2周后，ISR发生率下降并在第156周时保持稳定（≤4.2%）。接受ixekizumab治疗的患者未报告与ISR相关的严重不良事件。如果患者报告了与注射相关的事件，则会收集ISR数据。由于未明确说明的ISR是最常报告的类型，特定类型可能报告不足。
临床试验期间已报告了ixekizumab的ISR。这些反应通常是可耐受、可管理的，并且会随着时间的推移而减少。
Clinicaltrials.gov：NCT01474512（UNCOVER-1）；NCT01597245（UNCOVER-2）；NCT01646177（UNCOVER-3）；NCT01777191（UNCOVER-A）；NCT01624233（UNCOVER-J）；NCT01107457（I1F-MC-RHAJ）；NCT02561806（I1F-MC-RHBS）；NCT02387801（I1F-US-RHBO）；NCT02513550（I1F-MC-RHBP）；NCT（I1F-EW-RHBZ）
《皮肤药物学杂志》。2018年；17（2）：200 - 206。
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