Dluzynski Daniela, Al-Shaikhly Taha, Paules Catharine I, Henao Maria Paula
Penn State College of Medicine, Hershey, Pa.
Section of Asthma, Allergy, and Immunology, Penn State College of Medicine, Hershey, Pa.
J Allergy Clin Immunol Glob. 2024 Jun 13;3(3):100293. doi: 10.1016/j.jacig.2024.100293. eCollection 2024 Aug.
Tixagevimab-cilgavimab is a combination of 2 mAbs against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In December 2021, the Food and Drug Administration issued Emergency Use Authorization for intramuscular injection of tixagevimab-cilgavimab for prophylaxis against SARS-CoV-2 in immunocompromised patients. Shortly thereafter, our clinic distributed tixagevimab-cilgavimab to patients with common variable immunodeficiency.
We sought to evaluate the effectiveness and tolerability of tixagevimab-cilgavimab in a common variable immunodeficiency clinic.
A retrospective chart review from February 1, 2022, to August 1, 2022, of 47 patients with common variable immunodeficiency who were offered tixagevimab-cilgavimab was carried out. Comparative outcomes of treatment and nontreatment groups examined the occurrence of SARS-CoV-2 infection, severity of SARS-CoV-2 infection, and other non-SARS-CoV-2 infections.
Seventy percent of the patients were female; mean age was 49 years. Twenty-three patients received tixagevimab-cilgavimab, and 24 did not receive prophylaxis. In the tixagevimab-cilgavimab group, all were vaccinated for SARS-CoV-2 and 22 were receiving immunoglobulin replacement. One patient was infected with SARS-CoV-2, no patients required emergency care, and 7 patients had non-SARS-CoV-2 infection. In the cohort that did not receive prophylaxis, 21 were vaccinated, and all received immunoglobulin replacement. Two patients tested positive for SARS-CoV-2, 1 patient required emergency care due to SARS-CoV-2 disease severity, and 4 patients had a non-SARS-CoV-2 infection. None of the results showed statistical significance.
Although there is evidence that tixagevimab-cilgavimab can be protective against SARS-CoV-2 in immunocompromised individuals, our data suggest that this benefit may be blunted in patients with common variable immunodeficiency on immunoglobulin replacement. The additional benefit of tixagevimab-cilgavimab in immunocompromised patients already receiving replacement therapy requires further exploration.
替沙格韦单抗-西加韦单抗是两种针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的单克隆抗体的组合。2021年12月，美国食品药品监督管理局发布了替沙格韦单抗-西加韦单抗肌肉注射用于免疫功能低下患者预防SARS-CoV-2的紧急使用授权。此后不久，我们的诊所将替沙格韦单抗-西加韦单抗分发给了常见可变免疫缺陷患者。
我们试图评估替沙格韦单抗-西加韦单抗在常见可变免疫缺陷诊所中的有效性和耐受性。
对2022年2月1日至2022年8月1日期间47例接受替沙格韦单抗-西加韦单抗治疗的常见可变免疫缺陷患者进行回顾性病历审查。治疗组和未治疗组的比较结果考察了SARS-CoV-2感染的发生情况、SARS-CoV-2感染的严重程度以及其他非SARS-CoV-2感染情况。
70%的患者为女性；平均年龄为49岁。23例患者接受了替沙格韦单抗-西加韦单抗治疗，24例未接受预防治疗。在替沙格韦单抗-西加韦单抗组中，所有患者均接种了SARS-CoV-2疫苗，22例患者接受免疫球蛋白替代治疗。1例患者感染了SARS-CoV-2，无患者需要急诊治疗，7例患者发生了非SARS-CoV-2感染。在未接受预防治疗的队列中，21例患者接种了疫苗，所有患者均接受免疫球蛋白替代治疗。2例患者SARS-CoV-2检测呈阳性，1例患者因SARS-CoV-2疾病严重程度需要急诊治疗，4例患者发生了非SARS-CoV-2感染。所有结果均无统计学意义。
虽然有证据表明替沙格韦单抗-西加韦单抗可保护免疫功能低下个体免受SARS-CoV-2感染，但我们的数据表明，对于接受免疫球蛋白替代治疗的常见可变免疫缺陷患者，这种益处可能会减弱。替沙格韦单抗-西加韦单抗在已经接受替代治疗的免疫功能低下患者中的额外益处需要进一步探索。
