AbbVie has submitted an application to the Food and Drug Administration (FDA) for review of upadacitinib in the treatment of active psoriatic arthritis (PsA) in adults.
The application is supported by data from two phase 3 studies (SELECT-PsA 1 and SELECT-PsA 2) that assessed the efficacy and safety of upadacitinib (15mg and 30mg) in more than 2000 adults with active PsA. SELECT-PsA 1 compared upadacitinib with placebo and adalimumab; SELECT-PsA 2 compared upadacitinib with placebo. The primary end point for both studies was the proportion of patients who achieved an American College of Rheumatology (ACR) 20 response at week 12.
Results from SELECT-PsA 1 showed that upadacitinib 15mg and 30mg achieved noninferiority at week 12 compared with adalimumab, with the 30mg dose showing superiority. Both doses of upadacitinib achieved statistically significant ACR20, ACR50, and ACR70 responses at week 12 compared with placebo, along with significant improvements for key secondary end points, including the Health Assessment Questionnaire – Disability Index (HAQ-DI), Psoriasis Area Severity Index (PASI 75), and Minimal disease activity (MDA).
Additionally, findings from SELECT-PsA 2 demonstrated both doses of upadacitinib achieved statistically significant ACR 20, ACR50, and ACR70 responses at week 12 compared with placebo. Both doses of upadacitinib also achieved statistically significant responses for PASI 75 and MDA compared with placebo.
With regard to safety, upadacitinib demonstrated a profile consistent with that seen in previous clinical studies.
Upadacitinib, a selective and reversible Janus Kinase (JAK) inhibitor, is currently marketed under the brand name Rinvoq™ and is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.
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