AbbVie (ABBV) reported that RINVOQ® (upadacitinib), 15 mg once daily, has been approved by the U.S. Food and Drug Administration (FDA) to treat giant cell arteritis (GCA) in adults. This follows RINVOQ’s recent commercial authorization by the European Commission to treat GCA in adult patients.
Results from the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission* (46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen in week 12 to week 52, compared to 29.0% of patients receiving a placebo in combination with a 52-week steroid taper regimen; p=0.002), support the approvals.
RINVOQ’s safety profile during the 52-week, placebo-controlled trial was much in line with that seen in other authorized uses.
This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission,
With this new indication for RINVOQ, we are underscoring AbbVie’s commitment to exploring how we can identify and address unmet needs for patients with immune-mediated diseases.
Roopal Thakkar
The aorta, various big and medium arteries, and the temporal and other cranial arteries become inflamed due to GCA, an autoimmune illness. The illness can cause crippling symptoms and possibly serious consequences like blindness, an aortic aneurysm, or stroke if treatment is not received. 2 The risk of getting GCA is highest for Caucasian women over 50, usually between 70 and 80 years of age. Research indicates that men are more likely to experience ocular symptoms associated with GCA, despite the fact that women are more likely to get the condition than men.
Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities. Additionally, relapse remains common for patients with this disease,
We now have a new option to treat GCA. The results of this clinical trial show that upadacitinib offers patients the chance to reach sustained remission.
Peter A. Merkel
RINVOQ® (upadacitinib)
RINVOQ, a JAK inhibitor that was found and created by AbbVie researchers, is being investigated in a number of immune-mediated inflammatory disorders. RINVOQ more effectively suppressed cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 than JAK2/JAK2 in human leukocyte cellular tests. One It is still unknown how particular JAK enzyme inhibition relates to the safety and efficacy of treatment.
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