{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T13:20:16Z","timestamp":1783948816085,"version":"3.55.0"},"reference-count":36,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T00:00:00Z","timestamp":1768867200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T00:00:00Z","timestamp":1768867200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp;amp; Syst Pharma"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Model\u2010based meta\u2010analysis (MBMA) utilizes aggregate data (AD) and allows integration of information from multiple studies, which may provide more statistical power to detect clinically relevant treatment effects than an individual randomized controlled trial alone. Access to individual patient data (IPD) is often limited due to confidentiality; therefore, obtaining IPD associated with published literature data is challenging. Thus, to probe predictive covariates, one must rely on an adequate range of aggregate covariate data, or published stratified results could also be used. With access to IPD, or with access to published stratified results, estimates for predictive covariates could be improved. This work is primarily centered on quantifying the potential benefits of having access to IPD when performing MBMA. This was assessed using a 3\u2010step approach. Two scenarios were explored: one to compare MBMAs with and without access to IPD, assuming no predictive covariates; and another to compare MBMAs with and without access to IPD, where a specific predictive covariate was known to be influential and was used to stratify IPD accordingly. The performance of the method was evaluated for different ratios of IPD studies versus AD studies. In the scenario where an MBMA with covariate was used, instead, the performance of the method was evaluated for different ratios of covariate stratified AD studies versus AD studies. Overall, the benefit of IPD over AD was not evident in the model without covariates, whereas including stratified IPD led to improved covariate model performance.<\/jats:p>","DOI":"10.1002\/psp4.70159","type":"journal-article","created":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T11:47:53Z","timestamp":1768909673000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Combining Aggregate Data and Individual Patient Data in Model\u2010Based Meta\u2010Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients"],"prefix":"10.1002","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-9342-6464","authenticated-orcid":false,"given":"Thao\u2010Nguyen","family":"Pham","sequence":"first","affiliation":[{"name":"Normandie Univ, UNICAEN, CNRS, ISTCT, GIP CYCERON  Caen France"},{"name":"Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8034-5567","authenticated-orcid":false,"given":"Anna","family":"Largajolli","sequence":"additional","affiliation":[{"name":"Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Luisa","family":"Sardu","sequence":"additional","affiliation":[{"name":"Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Maringwa","sequence":"additional","affiliation":[{"name":"Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5221-9157","authenticated-orcid":false,"given":"Matthew L.","family":"Zierhut","sequence":"additional","affiliation":[{"name":"Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5138-7688","authenticated-orcid":false,"given":"S. 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Amy","family":"Cheung","sequence":"additional","affiliation":[{"name":"Certara  Radnor Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,1,20]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1462"},{"key":"e_1_2_9_3_1","volume-title":"BEST (Biomarkers, EndpointS, and other Tools)","author":"FDA\u2010NIH Biomarker Working Group","year":"2016"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2022.103908"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12471"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.668"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12227"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/jrsm.1721"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/jrsm.1576"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jrsm.1119"},{"key":"e_1_2_9_11_1","unstructured":"R Core Team \u201cR: A Language and Environment for Statistical Computing 2021 \u201dhttps:\/\/www.R\u2010project.org\/."},{"key":"e_1_2_9_12_1","unstructured":"J.Pinheiro D.Bates andR Core Team \u201cnlme: Linear and Nonlinear Mixed Effects Models 2023 \u201dhttps:\/\/CRAN.R\u2010project.org\/package=nlme."},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0835-9"},{"key":"e_1_2_9_14_1","doi-asserted-by":"crossref","first-page":"2120","DOI":"10.2146\/news120088","article-title":"FDA Approves Tofacitinib for Rheumatoid Arthritis","volume":"69","author":"Traynor K.","year":"2012","journal-title":"American Journal of Health\u2010System Pharmacy"},{"key":"e_1_2_9_15_1","unstructured":"\u201cCertara Rheumatoid Arthritis Clinical Outcomes Database version 20221215 \u201dhttps:\/\/codex.certara.com\/codex\/atopic\u2010dermatitis."},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.576"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40744-021-00284-1"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOR.0000000000000782"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.33419"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.33383"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2020-001395"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.3109\/14397595.2014.995875"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2014-206028"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-015-0612-7"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61424-X"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.37816"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1112072"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1109071"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-159-4-201308200-00006"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-022-03201-5"},{"key":"e_1_2_9_31_1","unstructured":"W. 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