J Bradley Layton, Colin Anderson-Smits, Zhongwen Huang, Hakan Ay, William Spalding, Bilal Khokhar, Jie Zhou, Lee Bennett, Mary S Anthony
{"title":"一项评估免疫球蛋白输注（人）10%溶液和其他静脉注射免疫球蛋白治疗慢性炎症性脱髓鞘性多根神经病变安全性的比较现实世界研究。","authors":"J Bradley Layton, Colin Anderson-Smits, Zhongwen Huang, Hakan Ay, William Spalding, Bilal Khokhar, Jie Zhou, Lee Bennett, Mary S Anthony","doi":"10.1002/pds.70124","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70124"},"PeriodicalIF":2.4000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11912303/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"J Bradley Layton, Colin Anderson-Smits, Zhongwen Huang, Hakan Ay, William Spalding, Bilal Khokhar, Jie Zhou, Lee Bennett, Mary S Anthony\",\"doi\":\"10.1002/pds.70124\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>Thrombotic events, AKI, and hemolytic events were rare among patients with CIDP receiving IVIG. 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引用次数: 0
摘要
目的：免疫球蛋白输注（人）10%溶液(GAMMAGARD LIQUID；GGL是一种静脉注射免疫球蛋白（IVIG），最近获得美国批准用于治疗慢性炎症性脱髓鞘性多神经根神经病变（CIDP）。我们在单独和联合免疫球蛋白（Ig）初始和有igg经验的参与者中，评估了CIDP患者中使用GGL进行IVIG治疗的血栓事件、急性肾损伤（AKI）和溶血事件，并与美国批准的CIDP IVIG比较物进行比较。方法：使用Merative MarketScan Research和Optum Clinformatics Data Mart数据库（2008-2019）对CIDP患者进行主动比较、新用户、队列研究。使用95%置信区间（CI）的风险比（hr）、时间段特定风险比（rr）和风险差异（rd）比较倾向评分加权样本中接受GGL和比较IVIGs的成人的结果。对数据库特定的结果进行了meta分析和适当的分析。结果：来自MarketScan (GGL, n = 1441；comparators, n = 2708)和Optum (GGL, n = 644；比较者（n = 1293）进行分析。在这两个数据库中，血栓形成事件的hr、1年RRs和1年RDs在治疗组之间没有一致的风险差异(例如，MarketScan联合队列：RR 1.14 [95% CI， 0.50至2.55]；Optum联合队列：0.60[0.25至1.54])。同样，组间AKI风险无差异(例如，MarketScan联合队列：RR 1.25 [95% CI， 0.65至2.54]；Optum联合队列：0.65[0.22至1.94])。溶血事件罕见。结论：在接受IVIG治疗的CIDP患者中，血栓形成事件、AKI和溶血事件是罕见的。在接受GGL的患者与美国批准CIDP的其他ivig患者之间，没有一致的不同的结局风险。
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.
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.
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.
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