Abstract

GLP-1 RAs are peptides used to treat patients with T2D. Anaphylaxis has been observed with these treatments, and in the lixisenatide development program, more cases of anaphylaxis were reported for lixisenatide than placebo (0.2% vs 0.1%). The aim was to assess anaphylaxis incidence rates (IRs) among patients with T2D initiating GLP-1 RAs, with a focus on lixisenatide. We conducted a cohort study in 3 large US claims databases using data from 2017-2021. We included new users of GLP-1 RAs with T2D aged ≥18 years and enrolled ≥6 months in the database before GLP-1 RA initiation (start of follow-up). Medications included were: lixisenatide and insulin glargine/lixisenatide, exenatide, liraglutide and insulin degludec/liraglutide, dulaglutide, and semaglutide. We identified the first anaphylaxis event during follow-up using a validated algorithm. We report anaphylaxis crude IRs and 95% confidence intervals (CIs) for each medication cohort, pooled across data sources. There were 696,089 new users with 456,612 person-years (p-y) of exposure to GLP-1 RAs. Baseline characteristics (demographics, medications, medical conditions) were similar across the medication cohorts. IRs ranged from 1.0 (lixisenatide) to 6.0 (exenatide) per 10,000 p-y with wide 95% confidence intervals (Figure). Anaphylaxis is rare with GLP-1 RA treatments. Lixisenatide is unlikely to confer higher risk of anaphylaxis than other GLP-1 RAs.