重组带状疱疹疫苗在自身免疫性风湿病中的前瞻性对照研究：尽管使用静脉注射环磷酰胺，仍出现强效血清学转换。
完整摘要 · 中文译文
背景：重组带状疱疹疫苗（RZV）可预防自身免疫性风湿病（ARD）患者的带状疱疹，但静脉注射环磷酰胺（IVCYC）对免疫原性的影响尚不清楚。鉴于其导致细胞耗竭/细胞毒性，预期IVCYC会诱导严重的免疫原性损害，因此我们评估了其影响。 方法：这项前瞻性、随机、安慰剂对照试验的亚分析纳入了接受IVCYC的ARD患者（ARD-IVCYC），与未接受IVCYC的患者（ARD-no IVCYC）及健康对照组进行比较。RZV分两剂接种。在第二剂后评估体液免疫应答（≥4倍）、几何平均滴度（GMT）和细胞免疫应答。记录疾病活动度和不良事件（AEs）。 结果：共纳入41例ARD-IVCYC、164例ARD-no IVCYC和164例对照。血清转化率在ARD-IVCYC组与ARD-no IVCYC组之间无差异（91.9% vs. 91.5%），但均低于对照组（99.4%，p = 0.022）。接种后GMT在ARD两组间相当（p > 0.999），但低于对照组（p = 0.006）。细胞免疫应答和ARD疾病复发在组间无差异（p > 0.05），且无严重不良事件。 结论：RZV在接受IVCYC治疗的患者中诱发了>90%的体液免疫应答，支持在需要时于IVCYC治疗期间接种该疫苗（NCT05879419）。
完整摘要 · 英文原文
BACKGROUND: Recombinant zoster vaccine (RZV) prevents shingles in autoimmune rheumatic diseases (ARD), but intravenous cyclophosphamide (IVCYC) impact on immunogenicity is unknown. Given cell depletion/cytotoxicity, IVCYC is expected to induce profound immunogenicity impairment, we therefore evaluated its impact. METHODS: This subanalysis of prospective, randomized, placebo-controlled trial included ARD patients receiving IVCYC (ARD-IVCYC) compared with patients without IVCYC (ARD-no IVCYC) and healthy-controls. RZV was administered in two doses. Humoral response (≥4-fold), geometric mean titers (GMT) and cellular response were assessed after second dose. Disease activity and adverse events (AEs) were recorded. RESULTS: Forty-one ARD-IVCYC, 164 ARD-no IVCYC, and 164 controls were included. Seroconversion did not differ between ARD-IVCYC and ARD-no IVCYC (91.9% vs. 91.5%) and were lower than controls (99.4%, p = 0.022). Post-vaccination GMTs were comparable between ARD groups (p > 0.999), but lower than controls (p = 0.006). Cellular response and ARDs flares did not differ between groups (p > 0.05), with no severe AEs. CONCLUSION: RZV elicited >90% humoral response in IVCYC-treated patients, supporting it during IVCYC when warranted (NCT05879419).