FDA Approves AbbVie’s Oral JAK1 Inhibitor Rinvoq (Upadacitinib) for Active Psoriatic Arthritis as Second U.S. Indication

December 14, 2021 /BioValleyBIOON/ -- AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has approved the oral JAK1 inhibitor Rinvoq (upadacitinib, 15mg, once daily) for the treatment of patients with one or moreTumorAdult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blockers.Rinvoq can help improve joint pain, swelling, and stiffness as well as fatigue in patients with active PsA, and prevent further joint damage.

This approval marks the second indication for Rinvoq in the United States.In 2019, Rinvoq was approved for the treatment of moderate to severe rheumatoid arthritis.Rheumatoid Arthritis(RA) adult patients.

AbbVie Vice Chairman and President Michael Severino stated, "The efficacy of Rinvoq in alleviating multiple manifestations of psoriatic arthritis has been well demonstrated in two large-scale, long-term clinical trials. This new approval underscores our mission to provide a range of therapies to help more patients with rheumatic diseases achieve disease control."

The new indication for Rinvoq in the treatment of PsA is supported by data from two Phase 3 clinical studies, SELECT-PsA-1 (NCT03104400) and SELECT-PsA-2 (NCT03104374). These two studies enrolled over 2000 patients with active PsA.

The results showed,In two studies, at week 12 of treatment, Rinvoq achieved the primary endpoint of ACR20 response.: The ACR20 response rate significantly increased in the Rinvoq 15mg dose group compared to the placebo group (SELECT-PsA-1 study: 71% vs 36%; SELECT-PsA-2 study: 57% vs 24%). In the SESECT-PsA 1 study, at week 12 of treatment, Rinvoq 15mg demonstrated non-inferiority to Humira (adalimumab) in terms of ACR20 response rate.

In addition, in two studies, the ACR50 response rate was significantly higher in the Rinvoq 15mg dose group compared to the placebo group (SELECT-PsA-1 study: 38% vs 13%; SELECT-PsA-2 study: 32% vs 5%), and the ACR70 response rate was also significantly higher (SELECT-PsA-1 study: 16% vs 2%; SELECT-PsA-2 study: 9% vs 1%).

In 2 studies, compared with the placebo group, patients in the Rinvoq 15mg dose group showed greater improvements in structural joint damage progression (mTSS), physical function (HAQ-DI), skin symptoms (PASI 75), and fatigue (FACIT-F), and a higher proportion of patients achieved minimal disease activity. In both studies, the safety profile of active PsA patients treated with 15mg dose of Rinvoq was consistent with that observed in the class.Rheumatoid Arthritis(RA) patients is consistent.

SELECT-PsA 1&2 Post Hoc Analysis Data

In November 2021, AbbVie at the 2021 American College of Rheumatology (ACR)MeetingNew post-hoc analysis results from the SELECT-PsA 1 and SELECT-PsA 2 studies were published. This analysis involved adult patients with active PsA and axial involvement. Axial involvement was assessed by investigators and determined based on patient-reported outcome criteria (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] ≥4 and BASDAI Question 2 ≥4 at baseline).

Analysis showed that: (1) In two studies, treatment for 24 weeks resulted in higher clinical responses in axial involvement in the Rinvoq group compared to the placebo group; (2) In the SESECT-PsA 1 study,At 24 weeks of treatment, patients in the Rinvoq group also showed a higher clinical response in axial involvement compared to the Humira (adalimumab) group.PsA patients with axial involvement often face significant functional challenges. These post-hoc analysis data highlight the potential of Rinvoq to help more patients control the disease, including those affected by axial symptoms.

Moreover, at Week 24, across all BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints,The Rinvoq group showed a numerically higher response compared to the Humira group.At week 24, a higher proportion of patients in the Rinvoq group achieved clinically important improvement (CII) in ASDAS compared with the Humira group (69.8% vs 54.1%, nominal p<0.05). The results of the post-hoc analysis were consistent with the previously reported data based solely on investigator assessment.

Psoriatic Arthritis (PsA) is a complex heterogeneous disease with hallmark manifestations spanning multiple domains, including joints and skin. In PsA, the immune system triggers inflammation, leading to psoriasis-related skin lesions, pain, fatigue, and joint stiffness. PsA affects approximately 30% of patients with psoriasis.

The active pharmaceutical ingredient in Rinvoq is upadacitinib, an oral, selective, and reversible JAK1 inhibitor discovered and developed by AbbVie. It is being developed for the treatment of several immune-mediated inflammatory diseases. JAK1 is a kinase that plays a crucial role in the pathophysiological processes of various inflammatory diseases.

As of now,In the EU, Rinvoq 15mg has been approved for four indications.: (1) Used to treat moderate to severe rheumatoidRheumatoid Arthritis(RA) adult patients; (2) for the treatment of active psoriatic arthritis (PsA) in adult patients; (3) for the treatment of active ankylosing spondylitis (AS) in adult patients; (4) for the treatment of moderate to severe atopic dermatitis (AD) in adult patients and pediatric patients aged 12 years and older. In the EU, Rinvoq 30mg has been approved for one indication: for the treatment of moderate to severe AD in adult patients.

In the United States, Rinvoq 15mg has been approved for two indications: for the treatment of adult patients with moderate to severe RA, and adult patients with active PsA.

Currently, Rinvoq is in Phase 3 trials for the treatment of rheumatoid arthritis (RA), atopic dermatitis (AD), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), Crohn's disease (CD), ulcerative colitis (UC), giant cell arteritis (GCA), and Takayasu arteritis.Clinical TrialIn progress. (Bioon.com)

Source of the original text:RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Active Psoriatic Arthritis