AbbVie's Oral JAK1 Inhibitor RINVOQ (Upadacitinib) Demonstrates Long-Term Sustained Response in Moderate-to-Severe Rheumatoid Arthritis
Nov 12, 2021 01:47
CST Updated
01:47
AbbVie
Innovative Drug Developer
RA-Rheumatoid Arthritis (Image Source: rheumatologyadvisor.com)
November 11, 2021 /BioValleyBIOON/ -- AbbVie recently announced the results of the Phase 3 SELECT-BEYOND study evaluating Rinvoq (upadacitinib, 15mg once daily), an oral JAK1 inhibitor, for the treatment of patients with rheumatoid arthritis (RA).Clinical TrialNew data from a post-hoc analysis. See details:Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs。
The SELECT-BEYOND trial enrolled patients with moderate to severe RA who were receiving stable treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and had previously shown an inadequate response or intolerance to at least one biologic DMARD (bDMARD).
The results showed,Among patients receiving Rinvoq + background csDMARD therapy, 34% achieved Clinical Disease Activity Index (CDAI) remission (CDAI ≤ 2.8) at their first response before Week 60, and 79% of patients reached CDAI low disease activity (LDA; CDAI ≤ 10).。Maintenance of response (defined as not losing response in two consecutive study visits) was observed in 39% and 61% of patients achieving CDAI remission and CDAI LDA, respectively, at week 60.
Among patients who lost CDAI remission while on Rinvoq, 58% maintained CDAI LDA, and 22% regained remission before the data cutoff. Similar sustained response patterns of remission and LDA were observed based on Simplified Disease Activity Index (SDAI) criteria and DAS28 (CRP) <2.6/≤3.2.
SELECT-BEYONDClinical TrialPost-hoc Analysis Data
Thomas Hudson, M.D., Chief Scientific Officer and Senior Vice President at AbbVie, stated: "Many patients with rheumatoid arthritis continue to experience joint pain and declining physical function despite receiving treatment. These data highlight the potential of Rinvoq as a significant treatment option to help patients facing the daily challenges of rheumatoid arthritis."
Dr. Ronald van Vollenhoven, Director of the Amsterdam Rheumatology Center (ARC) and Chair of Rheumatology, stated: "The primary treatment goal for patients with rheumatoid arthritis is to achieve remission or reduce disease activity. These data are encouraging, further demonstrating that Rinvoq can help more patients with rheumatoid arthritis control this chronic progressive disease and achieve these important treatment goals."
The active pharmaceutical ingredient in Rinvoq is upadacitinib, which was discovered and developed by AbbVie.Oral selective and reversible JAK1 inhibitor, is being developed to treat several immune-mediated inflammatory diseases.JAK1 is a kinase that plays a key role in the pathophysiological processes of various inflammatory diseases.
To date, in the European Union, Rinvoq 15mg has been approved for four indications: (1) for the treatment of moderate to severe rheumatoid arthritis...Rheumatoid 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 under 65 years of age.
In the United States, Rinvoq 15mg has been approved for only one indication: the treatment of moderate to severe rheumatoid arthritis.Rheumatoid Arthritis(RA) adult patients.
Currently, Rinvoq is used for the treatment of ulcerative colitis (UC),Rheumatoid Arthritis(RA), psoriatic arthritis (PsA), atopic dermatitis (AD), axial spondyloarthritis (axSpA), Crohn's disease (CD), and giant cell arteritis (GCA) are currently in Phase 3 clinical trials. (Bioon.com)
