Upadacitinib Induction Therapy Shows Favorable Outcomes in Moderate to Severe Crohn Disease
The patient cohorts were well-balanced at baseline, and, overall, 45.4% had a history of biologic therapy failure.
The patient cohorts were well-balanced at baseline, and, overall, 45.4% had a history of biologic therapy failure.
Although ustekinumab is a common therapy used to treat CD, no serum concentrations that associate with outcomes have been established.
Biologics target inflammatory pathways, allowing for mucosal healing with the end goal of achieving clinical remission.
The data were compared with the 2018 ACG and 2020 AGA guidelines for UC and the 2019 ACG and 2021 AGA guidelines for CD.
Kaplan-Meier analyses were used to estimate the mean time to treatment switch, and all-cause health care resource use and costs (2020 $US) were compiled and compared for the 2 cohorts.
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The application is supported by data from the two phase 3 induction studies, U-EXCEED and U-EXCEL, and one phase 3 maintenance study, U-ENDURE.
The application is under review for relapsing forms of multiple sclerosis and Crohn disease.
The sBLA is supported by data from a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50mg/mL and citrate-free Hyrimoz HCF.
Skyrizi is now approved for the treatment of moderately to severely active Crohn disease in adults.