AbbVie announced positive topline data from the phase 3 SELECT-PsA 2 trial of upadacitinib (Rinvoq), a Janus Kinase (JAK) inhibitor, in patients with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to ≥1 biologic disease modifying anti-rheumatic drugs (bDMARDs).
In the multicenter, randomized, double-blind trial patients were randomized to receive upadacitinib 15mg, 30mg, or placebo followed by either upadacitinib 15mg or 30mg at week 24. The primary end point was the proportion of patients who achieved an American College of Rheumatology (ACR) 20 response at week 12. Key secondary end points included ACR50 and ACR70 responses, Psoriasis Area Severity Index (PASI 75), and the proportion of patients achieving minimal disease activity (MDA) at week 24.
Results showed patients treated with upadacitinib 15mg and 30mg achieved the following statistically significant ACR responses at week 12:
- ACR20 of 57% and 64%, respectively, vs 24% in the placebo group (P <.0001)
- ACR50 of 32% and 38%, respectively, vs 5% in the placebo group (P <.0001)
- ACR70 of 9% and 17%, respectively, vs 0.5% in the placebo group (P <.0001)
Additionally, PASI 75 was observed at week 16 in 52% and 57% of patients treated with upadacitinib 15mg and 30mg, respectively, compared with 16% in placebo at week 16 (P <.0001). At week 24, MDA was achieved by 25% and 29% of patients in the upadacitinib 15mg and 30mg groups, respectively, compared with 3% in placebo (P <.0001)
The safety profile of upadacitinib was consistent with that seen in previous clinical studies. Full detailed results from the SELECT-PsA 2 study will be presented at a future medical meeting and published in a peer-reviewed publication.
“Data from this Phase 3 study will support regulatory submissions for Rinvoq in psoriatic arthritis,” said Michael Severino, MD, vice chairman and president, AbbVie.
Rinvoq is currently approved for the treatment of moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate.
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