A Comparative Real-World Study Evaluating the Safety of Immune Globulin Infusion (Human) 10% Solution and Other Intravenous Immunoglobulin Therapies for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-03-01 DOI:10.1002/pds.70124

J Bradley Layton, Colin Anderson-Smits, Zhongwen Huang, Hakan Ay, William Spalding, Bilal Khokhar, Jie Zhou, Lee Bennett, Mary S Anthony

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引用次数: 0

Abstract

Purpose: Immune globulin infusion (human) 10% solution (GAMMAGARD LIQUID; GGL), an intravenous immunoglobulin (IVIG), has recently received U.S. approval for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). We evaluated thrombotic events, acute kidney injury (AKI), and hemolytic events among patients with CIDP initiating IVIG treatment with GGL, versus a U.S.-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 (CI). Database-specific results were meta-analyzed and 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., MarketScan combined cohort: RR 1.14 [95% CI, 0.50 to 2.55]; Optum combined cohort: 0.60 [0.25 to 1.54]). Similarly, there was no difference in AKI risk between groups (e.g., MarketScan combined cohort: RR 1.25 [95% CI, 0.65 to 2.54]; Optum combined cohort: 0.65 [0.22 to 1.94]). 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.

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.