Maureen Dubreuil, Jessica A Walsh, Atul Deodhar, Lianne S Gensler, Jeffrey R Curtis, Sarah Welby, Olga Pilipczuk, Silky Beaty, Michael F Mørup, Vanessa Taieb, Suzanne Anjohrin
{"title":"在美国，生物制剂和靶向合成抗风湿药物在轴性脊柱炎患者中的实际应用：持久性、持久性相关变量和剂量变化","authors":"Maureen Dubreuil, Jessica A Walsh, Atul Deodhar, Lianne S Gensler, Jeffrey R Curtis, Sarah Welby, Olga Pilipczuk, Silky Beaty, Michael F Mørup, Vanessa Taieb, Suzanne Anjohrin","doi":"10.1002/pds.70197","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to evaluate 12-month persistence of biologic and targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) treatment in US patients with axial spondyloarthritis (axSpA) using real-world data, and patient baseline characteristics associated with increased or decreased persistence probability.</p><p><strong>Methods: </strong>Anonymized US claims from Merative MarketScan provided patient data relative to an index date (initiation of a new b/tsDMARD of interest for axSpA), from which patients were followed for 12 months or until b/tsDMARD non-persistence (≥ 90-day gap or b/tsDMARD switch) or MarketScan disenrollment. Persistence probabilities were estimated using Kaplan-Meier survival curves. Association of variables with persistence was estimated using multivariable Cox regression analyses.</p><p><strong>Results: </strong>Of the 5970 adults with axSpA, 76.7% were prescribed a TNFi as their index b/tsDMARD, and 55.1% were b/tsDMARD-unexposed while 44.9% were b/tsDMARD-exposed before index b/tsDMARD. b/tsDMARD persistence probability was 67.8%, 57.7%, and 54.4% at 6, 9, and 12 months, respectively. 12-month persistence probabilities stratified by index b/tsDMARD mode of action or history of b/tsDMARD treatment ranged from 51.8% to 55.7%. Female sex and history of dactylitis were associated with decreased b/tsDMARD persistence, while history of inflammatory bowel disease, uveitis, and obesity were associated with increased persistence probability.</p><p><strong>Conclusions: </strong>Around half of patients studied were non-persistent with any given b/tsDMARD within a year of initiating therapy. Persistence was not considerably affected by index b/tsDMARD mode of action or history of b/tsDMARD treatment. Patient characteristics associated with decreased persistence probability, including female sex and dactylitis, may help clinicians recognize patients who may benefit from additional support to improve long-term treatment outcomes.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70197"},"PeriodicalIF":2.4000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Use of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Patients With Axial Spondyloarthritis in the United States: Persistence, Variables Associated With Persistence, and Dosing Variations.\",\"authors\":\"Maureen Dubreuil, Jessica A Walsh, Atul Deodhar, Lianne S Gensler, Jeffrey R Curtis, Sarah Welby, Olga Pilipczuk, Silky Beaty, Michael F Mørup, Vanessa Taieb, Suzanne Anjohrin\",\"doi\":\"10.1002/pds.70197\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The objective of this study was to evaluate 12-month persistence of biologic and targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) treatment in US patients with axial spondyloarthritis (axSpA) using real-world data, and patient baseline characteristics associated with increased or decreased persistence probability.</p><p><strong>Methods: </strong>Anonymized US claims from Merative MarketScan provided patient data relative to an index date (initiation of a new b/tsDMARD of interest for axSpA), from which patients were followed for 12 months or until b/tsDMARD non-persistence (≥ 90-day gap or b/tsDMARD switch) or MarketScan disenrollment. Persistence probabilities were estimated using Kaplan-Meier survival curves. Association of variables with persistence was estimated using multivariable Cox regression analyses.</p><p><strong>Results: </strong>Of the 5970 adults with axSpA, 76.7% were prescribed a TNFi as their index b/tsDMARD, and 55.1% were b/tsDMARD-unexposed while 44.9% were b/tsDMARD-exposed before index b/tsDMARD. b/tsDMARD persistence probability was 67.8%, 57.7%, and 54.4% at 6, 9, and 12 months, respectively. 12-month persistence probabilities stratified by index b/tsDMARD mode of action or history of b/tsDMARD treatment ranged from 51.8% to 55.7%. Female sex and history of dactylitis were associated with decreased b/tsDMARD persistence, while history of inflammatory bowel disease, uveitis, and obesity were associated with increased persistence probability.</p><p><strong>Conclusions: </strong>Around half of patients studied were non-persistent with any given b/tsDMARD within a year of initiating therapy. Persistence was not considerably affected by index b/tsDMARD mode of action or history of b/tsDMARD treatment. Patient characteristics associated with decreased persistence probability, including female sex and dactylitis, may help clinicians recognize patients who may benefit from additional support to improve long-term treatment outcomes.</p>\",\"PeriodicalId\":19782,\"journal\":{\"name\":\"Pharmacoepidemiology and Drug Safety\",\"volume\":\"34 9\",\"pages\":\"e70197\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacoepidemiology and Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/pds.70197\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70197","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Real-World Use of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Patients With Axial Spondyloarthritis in the United States: Persistence, Variables Associated With Persistence, and Dosing Variations.
Objective: The objective of this study was to evaluate 12-month persistence of biologic and targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) treatment in US patients with axial spondyloarthritis (axSpA) using real-world data, and patient baseline characteristics associated with increased or decreased persistence probability.
Methods: Anonymized US claims from Merative MarketScan provided patient data relative to an index date (initiation of a new b/tsDMARD of interest for axSpA), from which patients were followed for 12 months or until b/tsDMARD non-persistence (≥ 90-day gap or b/tsDMARD switch) or MarketScan disenrollment. Persistence probabilities were estimated using Kaplan-Meier survival curves. Association of variables with persistence was estimated using multivariable Cox regression analyses.
Results: Of the 5970 adults with axSpA, 76.7% were prescribed a TNFi as their index b/tsDMARD, and 55.1% were b/tsDMARD-unexposed while 44.9% were b/tsDMARD-exposed before index b/tsDMARD. b/tsDMARD persistence probability was 67.8%, 57.7%, and 54.4% at 6, 9, and 12 months, respectively. 12-month persistence probabilities stratified by index b/tsDMARD mode of action or history of b/tsDMARD treatment ranged from 51.8% to 55.7%. Female sex and history of dactylitis were associated with decreased b/tsDMARD persistence, while history of inflammatory bowel disease, uveitis, and obesity were associated with increased persistence probability.
Conclusions: Around half of patients studied were non-persistent with any given b/tsDMARD within a year of initiating therapy. Persistence was not considerably affected by index b/tsDMARD mode of action or history of b/tsDMARD treatment. Patient characteristics associated with decreased persistence probability, including female sex and dactylitis, may help clinicians recognize patients who may benefit from additional support to improve long-term treatment outcomes.
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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