The Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib) for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to 1 or more tumor necrosis factor (TNF) blockers.
The application is supported by data from two phase 3 studies, SELECT-PsA 1 (ClinicalTrials.gov Identifier: NCT03104400) and SELECT-PsA 2 (ClinicalTrials.gov Identifier: NCT03104374), which assessed the efficacy and safety of upadacitinib (15mg and 30mg) in adults with active PsA. SELECT-PsA 1 compared upadacitinib with placebo and adalimumab; SELECT-PsA 2 compared upadacitinib with placebo.
In both trials, patients treated with upadacitinib 15mg achieved significantly higher American College of Rheumatology (ACR) 20 responses compared with placebo at week 12 (SELECT-PsA 1: 71% vs 36%; SELECT-PsA 2: 57% vs 24%). Moreover, patients treated with upadacitinib 15mg achieved the following improvements at week 12 in SELECT-PsA 1 and SELECT-PsA 2, respectively, vs placebo:
- ACR50 response: 38% and 32% vs 13% and 5%;
- ACR70 response: 16% and 9% vs 2% and 1%;
- Proportion of Health Assessment Questionnaire – Disability Index (HAQ-DI) responders: 58% and 45% vs 33% and 27%.
Treatment with upadacitinib 15mg resulted in improvement in dactylitis and enthesitis in patients with pre-existing dactylitis or enthesitis, as well as improvements in skin manifestations and fatigue. Upadacitinib also significantly inhibited the progression of structural joint damage, as assessed by the change from baseline in modified Total Sharp Score (mTSS) at week 24.
The safety profile of upadacitinib in patients with active PsA was consistent with that seen in patients with rheumatoid arthritis. The most common adverse events included upper respiratory tract infection and blood creatine phosphokinase elevations.
The labeling for Rinvoq has also been updated to include additional warnings on the risks of serious cardiovascular-related events, malignancy, thrombosis, and death. The update follows the FDA’s Drug Safety Communication for certain JAK inhibitors issued on September 1, 2021.
Rinvoq is also approved for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to 1 or more TNF blockers.
- Rinvoq® (upadacitinib) receives US FDA approval for active psoriatic arthritis. News release. AbbVie. December 14, 2021. Accessed December 15, 2021. https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-receives-us-fda-approval-for-active-psoriatic-arthritis-301444790.html.
- Rinvoq. Package insert. AbbVie; 2021. Accessed December 15, 2021. https://www.rxabbvie.com/pdf/rinvoq_pi.pdf.