K. Papp Clinical Research, Waterloo, ON, Canada.
Probity Medical Research, Waterloo, ON, Canada.
Br J Dermatol. 2017 Dec;177(6):1537-1551. doi: 10.1111/bjd.15723. Epub 2017 Nov 16.
Infections are associated with biological therapies in psoriasis.
To summarize the incidence of infections in patients with moderate-to-severe psoriasis treated with ixekizumab, an anti-interleukin-17A monoclonal antibody.
Infections are summarized from an integrated database of seven controlled and uncontrolled ixekizumab psoriasis trials. Data are presented from placebo-controlled induction (weeks 0-12; UNCOVER-1, UNCOVER-2 and UNCOVER-3) and maintenance periods (weeks 12-60; UNCOVER-1 and UNCOVER-2), and all patients exposed to ixekizumab pooled from all seven trials. Comparisons with etanercept were made during the induction period of two trials (UNCOVER-2 and UNCOVER-3). Incidence and exposure-adjusted incidence rates (IRs) per 100 patient-years (PYs) are reported.
Overall, 4209 patients were treated with ixekizumab (6480 PY). During induction (weeks 0-12), overall infection rates were higher in patients treated with ixekizumab (27%) vs. placebo (23%, P < 0·05); however, specific infection rates were comparable overall across treatment groups. IRs of infections did not increase with longer-term exposure. For all patients treated with ixekizumab (all seven trials), the incidence of serious infections was low (2%, IR 1·3). Candida infections, including eight cases of oesophageal candidiasis, were adequately managed with antifungal therapy, were noninvasive and did not lead to discontinuation.
Overall, infections occurred in a higher percentage of patients treated with ixekizumab vs. placebo during the first 12 weeks of treatment; however, specific infection rates were comparable overall across treatment groups. Incidences of serious infections were low and similar across treatment groups.
感染与银屑病的生物治疗有关。
总结接受抗白细胞介素-17A 单克隆抗体依奇珠单抗治疗的中重度银屑病患者的感染发生率。
从 7 项依奇珠单抗治疗银屑病的对照和非对照临床试验的综合数据库中总结感染情况。数据来自安慰剂对照诱导期（第 0-12 周；UNCOVER-1、UNCOVER-2 和 UNCOVER-3）和维持期（第 12-60 周；UNCOVER-1 和 UNCOVER-2），所有患者均来自 7 项试验的依奇珠单抗暴露组。在两项试验（UNCOVER-2 和 UNCOVER-3）的诱导期与依那西普进行比较。报告每 100 患者-年（PY）的发生率和暴露调整发生率（IR）。
共有 4209 例患者接受依奇珠单抗治疗（6480 PY）。在诱导期（第 0-12 周），依奇珠单抗治疗患者的总体感染率高于安慰剂（27% vs. 23%，P<0·05）；然而，总体来看，各治疗组的特定感染率相当。随着长期暴露，感染的 IR 并未增加。对于所有接受依奇珠单抗治疗的患者（所有 7 项试验），严重感染的发生率较低（2%，IR 1·3）。念珠菌感染，包括 8 例食管念珠菌病，用抗真菌治疗得到了很好的控制，是无侵袭性的，不会导致停药。
在治疗的前 12 周，接受依奇珠单抗治疗的患者感染率高于安慰剂组，但各治疗组的特定感染率总体相当。严重感染的发生率较低，且各组间相似。
