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논문분류	춘계학술대회 초록집
제목	Humoral Response to COVID Vaccine and Infection is Intact During Sibeprenlimab Treatment of IgAN: Data From the ENVISION Trial
저자	Adrian Liew
출판정보	2024; 2024(1):
키워드
초록	Objectives: In the ENVISION trial, the APRIL (A Proliferation Inducing Ligand) inhibitor, sibeprenlimab, decreased proteinuria and stabilized eGFR decline in patients with immunoglobulin A nephropathy (IgAN). The substudy reported here evaluated humoral response to SARS-CoV-2 mRNA vaccination and infection. Methods: Patients enrolled in ENVISION received 12 monthly intravenous infusions of sibeprenlimab or placebo. Recognized COVID infection (AE) and vaccination data were recorded for all patients; for substudy patients, serum SARS-CoV-2 spike and nucleocapsid antibody responses were measured monthly. Response following primary two-dose mRNA COVID vaccination was evaluated. Peak vaccine-induced serum receptor-binding domain (RBD) IgG titers were reported in World Health Organization binding antibody units (BAU)/mL. Retrospective serologic diagnosis of COVID infection required simultaneous elevation of nucleocapsid and spike antibody titers, unexplained by vaccine history. Results: Among 155 patients who received sibeprenlimab (n=117) or placebo (n=38), 56 (36.1%) had COVID reported as an AE [sibeprenlimab (33.3%), placebo (44.7%)], most of mild severity (Table 1). Two patients (one sibeprenlimab and one placebo recipient) were hospitalized per local protocol, thus considered COVID SAEs. There were no COVID-related deaths, ICU admissions or mechanical ventilation. In the substudy (n=74), symptomatic COVID (reported as an AE) occurred in 47.3% of patients, increasing to 68.9% with addition of retrospective serologic diagnoses. In the substudy cohort, COVID was reported as an AE in 14/15 (93%) of placebo recipients with serologic diagnosis, versus 21/36 (58%) of sibeprenlimab recipients. COVID vaccine seroconversion rates were 100% and peak RBD IgG antibody titers following primary mRNA vaccination exceeded 300 BAU/mL (Fig 1a). Durability of protective RBD IgG titers following vaccination was similar between groups (Fig 1b) Conclusions: COVID-specific antibody responses to vaccination and infection were preserved in patients with IgAN treated with sibeprenlimab.
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