PURPOSE: Immune globulin infusion (human), 10% solution (GAMMAGARD LIQUID; GGL), an intravenous immunoglobulin (IVIG), has recently received US approval for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). We evaluated rates of thrombotic events, acute kidney injury (AKI), and hemolytic events among patients with CIDP initiating IVIG treatment with GGL, versus a US-approved IVIG comparator for CIDP, in individual and combined cohorts of immunoglobulin (Ig)-naive and Ig-experienced participants.
METHODS: This active-comparator, new-user, cohort study of patients with CIDP used the Merative MarketScan Research and Optum Clinformatics Data Mart databases (2008–2019). Outcomes were compared between adults receiving GGL and comparator IVIGs within propensity score-weighted samples using hazard ratios (HRs) and time period-specific risk ratios (RRs) and risk differences (RDs) with 95% confidence intervals. Results were meta-analyzed across data sources, where appropriate.
RESULTS: Data from eligible patients in MarketScan (GGL, n=1441; comparators, n=2708) and Optum (GGL, n=644; comparators, n=1293) were analyzed. Across both databases, HRs, 1-year RRs, and 1-year RDs for thrombotic events did not suggest consistent differences in risk across treatment groups (e.g. Optum combined cohort: RR 0.60 [95% CI, 0.25 to 1.54], RD −0.0194 [95% CI, −0.0520 to 0.0137]). Similarly, there was no difference in AKI risk between treatment groups (e.g. Optum combined cohort: RR 0.65 [95% CI, 0.22 to 1.94], RD −0.0103 [95% CI, −0.0322 to 0.0140]). Hemolytic events were rare.
CONCLUSIONS: Thrombotic events, AKI, and hemolytic events were rare among patients with CIDP receiving IVIG. There were no consistently different outcome risks between patients receiving GGL versus other IVIGs with US approval for CIDP.
