Desai Aakash, Hashash Jana G, Kochhar Gursimran S, Farraye Francis A
Division of Gastroenterology and Hepatology, MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA.
Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA.
Crohns Colitis 360. 2023 Sep 6;5(3):otad047. doi: 10.1093/crocol/otad047. eCollection 2023 Jul.
Tixagevimab and cilgavimab (Evusheld) are 2 fully human monoclonal antibodies that received emergency-use authorization on December 21, 2021, for pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in patients who are moderate-severely immunocompromised. The real-world efficacy of Evusheld in patients with inflammatory bowel disease (IBD) is not known.
We conducted a retrospective cohort study using TriNetX, a multi-institutional database in patients with IBD who received Evusheld compared to patients with IBD who did not receive Evusheld (12.1.2021-10.28.2022). The primary outcome was to assess the risk of COVID-19 within 6 months. One-to-one propensity score matching (PSM) was performed for demographic parameters, comorbid conditions, IBD medications, and history of COVID-19. Risk was expressed as adjusted odds ratio (aOR) with 95% confidence interval (CI).
Four hundred and eight patients (0.19%) with IBD received Evusheld (mean age 58.6 ± 15.4 years old, female 47.7%) during the study period. After PSM, there was no difference in the risk (aOR 0.88, 95% CI, 0.33-2.35) of COVID-19 in the Evusheld cohort compared to the IBD control cohort. No patients required ICU care or intubation/respiratory support or were deceased in the Evusheld cohort.
Our study did not show that Evusheld decreases the risk of COVID-19 in patients with IBD. Prevention of moderate-severe COVID-19 in these patients should focus on vaccination strategies and early COVID-19 therapies.
替沙格维单抗和西加维单抗（恩适得）是两种全人源单克隆抗体，于2021年12月21日获得紧急使用授权，用于中度至重度免疫功能低下患者的新型冠状病毒肺炎（COVID-19）暴露前预防。恩适得在炎症性肠病（IBD）患者中的真实疗效尚不清楚。
我们使用TriNetX进行了一项回顾性队列研究，TriNetX是一个多机构数据库，纳入接受恩适得的IBD患者，并与未接受恩适得的IBD患者进行比较（2021年1月12日至2022年10月28日）。主要结局是评估6个月内发生COVID-19的风险。对人口统计学参数、合并症、IBD药物治疗和COVID-19病史进行一对一倾向评分匹配（PSM）。风险以调整优势比（aOR）和95%置信区间（CI）表示。
在研究期间，408例（0.19%）IBD患者接受了恩适得治疗（平均年龄58.6±15.4岁，女性占47.7%）。PSM后，与IBD对照队列相比，恩适得队列中COVID-19的风险（aOR 0.88，95%CI，0.33-2.35）没有差异。恩适得队列中没有患者需要重症监护或插管/呼吸支持，也没有患者死亡。
我们的研究未显示恩适得可降低IBD患者发生COVID-19的风险。预防这些患者的中度至重度COVID-19应侧重于疫苗接种策略和早期COVID-19治疗。
