Implementing Negative Control Outcomes to Assess Comparability of Treatments for Psoriasis and Psoriatic Arthritis.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-05-01 DOI:10.1002/pds.70156

Mary E Horner, Alexis Ogdie, Kate K Orroth, Shia T Kent, Kathy V Tran, Cynthia Deignan, Myriam Cordey, M Alan Brookhart

{"title":"Implementing Negative Control Outcomes to Assess Comparability of Treatments for Psoriasis and Psoriatic Arthritis.","authors":"Mary E Horner, Alexis Ogdie, Kate K Orroth, Shia T Kent, Kathy V Tran, Cynthia Deignan, Myriam Cordey, M Alan Brookhart","doi":"10.1002/pds.70156","DOIUrl":null,"url":null,"abstract":"Purpose: Treatment selection is typically associated with prognosis, leading to potential confounding in comparative studies. We used negative control outcomes (NCOs) to identify potential residual confounding when comparing apremilast initiators to other psoriasis (PsO) or psoriatic arthritis (PsA) treatment initiators.Methods: Adults with PsO/PsA who initiated treatment from September 23/March 21, 2016, respectively, with apremilast, topicals, methotrexate, interleukin (IL)-17 inhibitor (i), IL-12/23i, or tumor necrosis factor inhibitor (TNFi) were identified in the OPTUM Clinformatics DataMart database. Follow-up ended at treatment switch/discontinuation, NCO, end of enrollment, or September 30, 2022. NCOs addressed confounding for healthy users (wellness visit, herpes zoster vaccine, colon cancer screening, pelvic screening), functional status (accidents), and channeling. The 1-year relative risk (RR) for each NCO was estimated for all treatment comparisons using an inverse probability of treatment and censoring weighted estimator.Results: In PsO, potential healthy user bias was detected in apremilast vs. IL-17i initiators, with a higher likelihood of herpes zoster vaccine and colon cancer screening (RR [95% CI]: 2.01 [1.41, 2.88] and 1.42 [1.13, 1.77], respectively). Wellness visits and pelvic exams were less likely among apremilast vs. topical initiators (0.84 [0.72, 0.98] and 0.83 [0.70, 0.98], respectively). The wellness visit RR was attenuated in individuals with ≥ 1 pre-index topical prescription (0.90 [0.78, 1.04]). In PsA, minimal residual confounding was observed between apremilast and other treatments.Conclusions: Eligibility criteria (prior topicals) and weighting reduced residual confounding when comparing apremilast vs. other treatments for PsO and PsA. Integration of NCOs into comparative effectiveness/safety studies of PsO/PsA treatments may help identify unmeasured confounding.","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 5","pages":"e70156"},"PeriodicalIF":2.4000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087269/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70156","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

Abstract

Purpose: Treatment selection is typically associated with prognosis, leading to potential confounding in comparative studies. We used negative control outcomes (NCOs) to identify potential residual confounding when comparing apremilast initiators to other psoriasis (PsO) or psoriatic arthritis (PsA) treatment initiators.

Methods: Adults with PsO/PsA who initiated treatment from September 23/March 21, 2016, respectively, with apremilast, topicals, methotrexate, interleukin (IL)-17 inhibitor (i), IL-12/23i, or tumor necrosis factor inhibitor (TNFi) were identified in the OPTUM Clinformatics DataMart database. Follow-up ended at treatment switch/discontinuation, NCO, end of enrollment, or September 30, 2022. NCOs addressed confounding for healthy users (wellness visit, herpes zoster vaccine, colon cancer screening, pelvic screening), functional status (accidents), and channeling. The 1-year relative risk (RR) for each NCO was estimated for all treatment comparisons using an inverse probability of treatment and censoring weighted estimator.

Results: In PsO, potential healthy user bias was detected in apremilast vs. IL-17i initiators, with a higher likelihood of herpes zoster vaccine and colon cancer screening (RR [95% CI]: 2.01 [1.41, 2.88] and 1.42 [1.13, 1.77], respectively). Wellness visits and pelvic exams were less likely among apremilast vs. topical initiators (0.84 [0.72, 0.98] and 0.83 [0.70, 0.98], respectively). The wellness visit RR was attenuated in individuals with ≥ 1 pre-index topical prescription (0.90 [0.78, 1.04]). In PsA, minimal residual confounding was observed between apremilast and other treatments.

Conclusions: Eligibility criteria (prior topicals) and weighting reduced residual confounding when comparing apremilast vs. other treatments for PsO and PsA. Integration of NCOs into comparative effectiveness/safety studies of PsO/PsA treatments may help identify unmeasured confounding.

查看原文本刊更多论文

实施阴性对照结果评估银屑病和银屑病关节炎治疗的可比性。

目的：治疗选择通常与预后相关，在比较研究中导致潜在的混淆。我们使用阴性对照结果（NCOs）来确定在比较阿普米司特与其他银屑病（PsO）或银屑病关节炎（PsA）治疗起始剂时潜在的残留混淆。方法：在OPTUM Clinformatics DataMart数据库中，分别于2016年9月23日至3月21日开始使用阿普米司特、外用药物、甲氨蝶呤、白细胞介素(IL)-17抑制剂(i)、IL-12/23i或肿瘤坏死因子抑制剂（TNFi）治疗的成年PsO/PsA患者。随访结束于治疗切换/停止、NCO、入组结束或2022年9月30日。非政府组织解决了健康用户的混淆问题（健康访问、带状疱疹疫苗、结肠癌筛查、盆腔筛查）、功能状态（意外）和渠道。使用治疗逆概率和审查加权估计值估计所有治疗比较中每个NCO的1年相对风险（RR）。结果：在PsO中，阿普雷米司特与IL-17i启动剂中检测到潜在的健康用户偏差，带状疱疹疫苗和结肠癌筛查的可能性更高（RR [95% CI]: 2.01[1.41, 2.88]和1.42[1.13,1.77]）。阿普米司特与局部用药相比，健康访问和盆腔检查的可能性更低（分别为0.84[0.72,0.98]和0.83[0.70,0.98]）。指数前外用处方≥1个个体的健康访视RR降低（0.90[0.78,1.04]）。在PsA中，阿普米司特和其他治疗之间的残留混淆最小。结论：在比较阿普雷米司特与其他治疗PsO和PsA时，资格标准（既往局部）和权重减少了残留混淆。将非政府组织纳入PsO/PsA治疗的比较有效性/安全性研究可能有助于识别未测量的混杂因素。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.