{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T14:24:08Z","timestamp":1787408648911,"version":"build-2736575974"},"reference-count":38,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T00:00:00Z","timestamp":1786665600000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"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":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    The exclusion of pregnant individuals from clinical trials has resulted in a significant medical knowledge gap for this population. Leveraging real\u2010world data (RWD) provides a critical window into the prevalence and use of medications during pregnancy. Using the health plan claims database IQVIA PharMetrics(R) Plus, we evaluated the use of disease\u2010modifying therapies (DMTs) and concomitant medications in pregnant individuals. We focused on two case examples\u2014Crohn's Disease (CD) and Multiple Sclerosis (MS)\u2014analyzing patients with a history of DMT use before, during, and after pregnancy between 2021 and 2024. In the CD cohort, we found that 47% (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20091187) of individuals used a DMT during pregnancy. Among these patients, 67% (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009694) were prescribed a monoclonal antibody (e.g., adalimumab, ustekinumab). In the MS cohort, 27% (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009300) of individuals used a DMT during pregnancy, of which the predominant medication used was glatiramer acetate, a well\u2010established immunomodulator. Across both cohorts, a targeted concomitant medication analysis focusing on major metabolic and efflux pathways revealed that several medications taken during pregnancy interact with CYP3A4, P\u2010gp, or BCRP. Other potential DDI pathways were not assessed. These RWD analyses confirm that pregnant individuals are often exposed to complex medication regimens, highlighting the need to understand drug use and disposition in this vulnerable population.\n                  <\/jats:p>","DOI":"10.1111\/cts.70695","type":"journal-article","created":{"date-parts":[[2026,8,15]],"date-time":"2026-08-15T02:41:54Z","timestamp":1786761714000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bridging the Pregnancy Knowledge Gap: A Real\u2010World Analysis of Medication Use and Drug\u2013Drug Interaction Risk in Crohn's Disease and Multiple Sclerosis"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5978-5672","authenticated-orcid":false,"given":"Jacqueline","family":"Williams","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Genentech, Inc.  South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9043-5336","authenticated-orcid":false,"given":"Rucha","family":"Sane","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Genentech, Inc.  South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-0017-2971","authenticated-orcid":false,"given":"Amita","family":"Joshi","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Genentech, Inc.  South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5541-3617","authenticated-orcid":false,"given":"Kit Wun Kathy","family":"Cheung","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Genentech, Inc.  South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0501-1804","authenticated-orcid":false,"given":"Bianca","family":"Vora","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Genentech, Inc.  South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.whi.2012.10.003"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2022.07.009"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2011.02.029"},{"key":"e_1_2_9_5_1","first-page":"325","article-title":"Pediatric Pharmacotherapy","volume":"261","author":"Donge T.","year":"2019","journal-title":"Handbook of Experimental Pharmacology"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002160"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.112.050245"},{"key":"e_1_2_9_8_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use \u201cE21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials \u201d(2025) https:\/\/database.ich.org\/sites\/default\/files\/ICH_E21EWG_Step2_Draft_Guideline_2025_0514.docx."},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(24)00512-6"},{"key":"e_1_2_9_10_1","unstructured":"IQVIA PharMetrics Plus(2025) https:\/\/www.iqvia.com\/locations\/united\u2010states\/library\/fact\u2010sheets\/iqvia\u2010pharmetrics\u2010plus."},{"key":"e_1_2_9_11_1","unstructured":"Certara Drug Interaction Database (DIDB)(2025) https:\/\/www.druginteractionsolutions.org\/."},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2023.07.003"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000001102"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2007.01355.x"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/17562848211016242"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.11.038"},{"key":"e_1_2_9_17_1","first-page":"221","article-title":"Managing Crohn's Disease During Pregnancy","volume":"11","author":"Cimpoca B. A.","year":"2016","journal-title":"Maedica"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/gastro\/goac055"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.rdc.2017.04.013"},{"key":"e_1_2_9_20_1","volume-title":"MotherToBaby | Fact Sheets","author":"Organization of Teratology Information Specialists (OTIS)","year":"2022"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4410"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002237"},{"key":"e_1_2_9_23_1","volume-title":"Mesalamine (PENTASA) Extended\u2010Release Capsules, for Oral Use","author":"Takeda Pharmaceuticals U.S.A., Inc","year":"2024"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000001023"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.71"},{"key":"e_1_2_9_26_1","doi-asserted-by":"crossref","unstructured":"K.Farrell J.Horton andAuthors \u201cMesalamine for the Treatment of Crohn Disease: Rapid Review [Internet] \u201d(2022) https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK603379\/.","DOI":"10.51731\/cjht.2022.411"},{"key":"e_1_2_9_27_1","unstructured":"J. K. J.Gaidos \u201cUpdates on the Safety of Using Newer IBD Medications During Pregnancy \u201d2020 https:\/\/www.crohnscolitisfoundation.org\/clinical\u2010pearls\/medication\u2010during\u2010pregnancy."},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000002553"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2025.04.005"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clim.2013.03.005"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000007044"},{"key":"e_1_2_9_32_1","unstructured":"M. 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