Risankizumab: Mechanism of action, clinical and translational science
Abstract Risankizumab is a high‐affinity neutralizing anti‐interleukin (IL)‐23 monoclonal antibody marketed in over 40 countries across the globe to treat several inflammatory diseases, such as plaque psoriasis (PsO), psoriatic arthritis (PsA), and Crohn's disease (CD). This paper reviews the r...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2024-01-01
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| Series: | Clinical and Translational Science |
| Online Access: | https://doi.org/10.1111/cts.13706 |
| _version_ | 1797347331996123136 |
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| author | Yinuo Pang Ronilda D'Cunha Insa Winzenborg Geertruida Veldman Valerie Pivorunas Kori Wallace |
| author_facet | Yinuo Pang Ronilda D'Cunha Insa Winzenborg Geertruida Veldman Valerie Pivorunas Kori Wallace |
| author_sort | Yinuo Pang |
| collection | DOAJ |
| description | Abstract Risankizumab is a high‐affinity neutralizing anti‐interleukin (IL)‐23 monoclonal antibody marketed in over 40 countries across the globe to treat several inflammatory diseases, such as plaque psoriasis (PsO), psoriatic arthritis (PsA), and Crohn's disease (CD). 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‐23 and inhibits IL‐23 from interacting with the IL‐23 receptor and subsequent signaling. Biomarker data obtained following treatment with risankizumab in multiple indications provided supportive evidence for downstream blockade of IL‐23 signaling associated with disease pathology. The PKs of risankizumab is linear and time‐independent, consistent with typical IgG1 monoclonal antibodies, across all evaluated indications. Risankizumab exhibited positive exposure‐response relationships for efficacy with no apparent exposure‐dependent 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‐label extension studies following long‐term treatment with risankizumab showed stable and favorable safety profiles consistent with shorter‐term studies. These data formed the foundation for risankizumab's marketing approvals to treat multiple inflammatory diseases across the globe. |
| first_indexed | 2024-03-08T11:46:14Z |
| format | Article |
| id | doaj.art-2606d68cf87141a79c6057e690d31f3c |
| institution | Directory Open Access Journal |
| issn | 1752-8054 1752-8062 |
| language | English |
| last_indexed | 2024-03-08T11:46:14Z |
| publishDate | 2024-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Science |
| spelling | doaj.art-2606d68cf87141a79c6057e690d31f3c2024-01-24T18:33:50ZengWileyClinical and Translational Science1752-80541752-80622024-01-01171n/an/a10.1111/cts.13706Risankizumab: Mechanism of action, clinical and translational scienceYinuo Pang0Ronilda D'Cunha1Insa Winzenborg2Geertruida Veldman3Valerie Pivorunas4Kori Wallace5Clinical Pharmacology AbbVie, Inc. North Chicago Illinois USAClinical Pharmacology AbbVie, Inc. North Chicago Illinois USAClinical Pharmacology AbbVie Deutschland GmbH & Co. KG Ludwigshafen GermanyDiscovery Research AbbVie, Inc. Worcester Massachusetts USAPrecision Medicine, Immunology AbbVie, Inc. Worcester Massachusetts USAClinical Development, Immunology AbbVie, Inc. North Chicago Illinois USAAbstract Risankizumab is a high‐affinity neutralizing anti‐interleukin (IL)‐23 monoclonal antibody marketed in over 40 countries across the globe to treat several inflammatory diseases, such as plaque psoriasis (PsO), psoriatic arthritis (PsA), and Crohn's disease (CD). 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‐23 and inhibits IL‐23 from interacting with the IL‐23 receptor and subsequent signaling. Biomarker data obtained following treatment with risankizumab in multiple indications provided supportive evidence for downstream blockade of IL‐23 signaling associated with disease pathology. The PKs of risankizumab is linear and time‐independent, consistent with typical IgG1 monoclonal antibodies, across all evaluated indications. Risankizumab exhibited positive exposure‐response relationships for efficacy with no apparent exposure‐dependent 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‐label extension studies following long‐term treatment with risankizumab showed stable and favorable safety profiles consistent with shorter‐term studies. These data formed the foundation for risankizumab's marketing approvals to treat multiple inflammatory diseases across the globe.https://doi.org/10.1111/cts.13706 |
| spellingShingle | Yinuo Pang Ronilda D'Cunha Insa Winzenborg Geertruida Veldman Valerie Pivorunas Kori Wallace Risankizumab: Mechanism of action, clinical and translational science Clinical and Translational Science |
| title | Risankizumab: Mechanism of action, clinical and translational science |
| title_full | Risankizumab: Mechanism of action, clinical and translational science |
| title_fullStr | Risankizumab: Mechanism of action, clinical and translational science |
| title_full_unstemmed | Risankizumab: Mechanism of action, clinical and translational science |
| title_short | Risankizumab: Mechanism of action, clinical and translational science |
| title_sort | risankizumab mechanism of action clinical and translational science |
| url | https://doi.org/10.1111/cts.13706 |
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