GSK, Rockville, MD, USA.
GSK, Philadelphia, PA, USA.
Rheumatology (Oxford). 2021 Mar 2;60(3):1226-1233. doi: 10.1093/rheumatology/keaa424.
In the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials, the adjuvanted recombinant zoster vaccine (RZV) demonstrated ≥90% efficacy in preventing herpes zoster (HZ) in all age groups ≥50 years. Given the increased HZ risk associated with certain underlying autoimmune diseases or their treatment regimes, we conducted a post hoc analysis of RZV's efficacy against HZ and safety profile [specifically, the occurrence of serious adverse events (SAEs)] in ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies.
Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomized to receive two doses of RZV or placebo 2 months apart. In this subgroup analysis of participants with at least one pIMD at enrolment, the efficacy was calculated for two-dose recipients who did not develop confirmed HZ before 30 days post-dose 2. SAE occurrence was evaluated for all participants who received at least one dose.
Of the 14 645 RZV and 14 660 placebo recipients from the ZOE-50/70 studies, 983 and 960, respectively, reported at least one pre-existing pIMD at enrolment and were included in these analyses. The most frequent pre-existing conditions were psoriasis, spondyloarthropathy and RA. Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70-79-year-old age group. SAEs and fatal SAEs were similar between RZV and placebo recipients.
In ZOE-50/70 participants with pre-existing pIMDs, RZV was highly efficacious against HZ and SAE incidence was similar between RZV and placebo recipients.
ClinicalTrials.gov, https://clinicaltrials.gov, NCT01165177 (ZOE-50), NCT01165229 (ZOE-70).
摘要 目的：在 ZOE-50（NCT01165177）和 ZOE-70（NCT01165229）三期临床试验中，佐剂重组带状疱疹疫苗（RZV）在所有 50 岁及以上年龄组中预防带状疱疹（HZ）的有效性均≥90%。鉴于某些潜在自身免疫性疾病或其治疗方案与 HZ 风险增加相关，我们对 ZOE-50/70 参与者中报告存在预先存在的潜在免疫介导性疾病（pIMD）且未接受免疫抑制治疗的 RZV 预防 HZ 的疗效和安全性概况（具体为严重不良事件（SAE）的发生）进行了事后分析。
年龄≥50 岁的成年人（ZOE-50）和≥70 岁的成年人（ZOE-70）被随机分为两组，两组均在 2 个月内接受两剂 RZV 或安慰剂。在这项对入组时至少有一种 pIMD 的参与者的亚组分析中，计算了两剂 RZV 未在第二次给药后 30 天内发生确诊 HZ 的接受者的疗效。对至少接受一剂的所有参与者评估 SAE 的发生情况。
在 ZOE-50/70 研究中，14645 名 RZV 和 14660 名安慰剂接受者中，分别有 983 名和 960 名报告入组时至少有一种预先存在的 pIMD，并且被纳入了这些分析。最常见的预先存在的疾病是银屑病、脊柱关节病和 RA。总体上，RZV 预防 HZ 的疗效为 90.5%（95%CI：73.5，97.5%），年龄在 70-79 岁的最低疗效为 84.4%（95%CI：30.8，98.3%）。RZV 和安慰剂接受者的 SAE 和致命 SAE 发生率相似。
在 ZOE-50/70 中存在预先存在的 pIMD 的参与者中，RZV 对 HZ 高度有效，RZV 和安慰剂接受者的 SAE 发生率相似。
ClinicalTrials.gov，https://clinicaltrials.gov，NCT01165177（ZOE-50），NCT01165229（ZOE-70）。
