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This paper reviews the regulatory approval, mechanism of action, pharmacokinetics (PKs)\/pharmacodynamics, immunogenicity, and clinical efficacy and safety data for risankizumab, focusing on the three main approved indications. Risankizumab binds to the p19 subunit of IL\u201023 and inhibits IL\u201023 from interacting with the IL\u201023 receptor and subsequent signaling. Biomarker data obtained following treatment with risankizumab in multiple indications provided supportive evidence for downstream blockade of IL\u201023 signaling associated with disease pathology. The PKs of risankizumab is linear and time\u2010independent, consistent with typical IgG1 monoclonal antibodies, across all evaluated indications. Risankizumab exhibited positive exposure\u2010response relationships for efficacy with no apparent exposure\u2010dependent worsening in safety. Immunogenicity to risankizumab had no major clinical consequences for either efficacy or safety. Efficacy and safety of risankizumab have been established in PsO, PsA, and CD in the pivotal clinical trials where superior benefit\/risk profiles were demonstrated compared to placebo and\/or active comparators. Moreover, safety evaluations in open\u2010label extension studies following long\u2010term treatment with risankizumab showed stable and favorable safety profiles consistent with shorter\u2010term studies. These data formed the foundation for risankizumab's marketing approvals to treat multiple inflammatory diseases across the globe.<\/jats:p>","DOI":"10.1111\/cts.13706","type":"journal-article","created":{"date-parts":[[2024,1,10]],"date-time":"2024-01-10T11:20:27Z","timestamp":1704885627000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":50,"title":["Risankizumab: Mechanism of action, clinical and translational science"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9731-5118","authenticated-orcid":false,"given":"Yinuo","family":"Pang","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie, Inc.  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1317-9105","authenticated-orcid":false,"given":"Ronilda","family":"D'Cunha","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie, Inc.  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4015-7451","authenticated-orcid":false,"given":"Insa","family":"Winzenborg","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Deutschland GmbH &amp; Co. KG  Ludwigshafen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0076-7626","authenticated-orcid":false,"given":"Geertruida","family":"Veldman","sequence":"additional","affiliation":[{"name":"Discovery Research AbbVie, Inc.  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie","family":"Pivorunas","sequence":"additional","affiliation":[{"name":"Precision Medicine, Immunology AbbVie, Inc.  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kori","family":"Wallace","sequence":"additional","affiliation":[{"name":"Clinical Development, Immunology AbbVie, Inc.  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,1,10]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-065X.2008.00699.x"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1084\/jem.20030451"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/ar3817"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1189\/jlb.0810456"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjac038"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/19420862.2021.1964420"},{"key":"e_1_2_12_8_1","unstructured":"AbbVie Inc.Skyrizi\u00ae (risankizumab\u2010rzaa). 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