FDA approves RINVOQ® (upadacitinib) for the management of ankylosing spondylitis

RINVOQ® (upadacitinib; 15 mg, once daily) has gained the US Food and Drug Administration (FDA) approval for the treatment of patients with active ankylosing spondylitis (AS) who have had an insufficient response or intolerance to one or more tumour necrosis factor (TNF) blockers.

The approval was based on 2  pivotal trials  namely phase 3 SELECT-AXIS 2 clinical trial and phase 2/3 SELECT-AXIS 1 clinical trial. The former evaluated upadacitinib in patients who had inadequate response or intolerance to one or two biologic disease-modifying anti-rheumatic drugs (bDMARDs), and the latter in patients who were naive to bDMARDs and had an inadequate response or intolerance to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs).

At week 14, a significantly higher proportion of patients who received upadacitinib 15 mg (51% in SELECT-AXIS 1 and 44.5% in SELECT-AXIS 2) achieved a ASAS40 response than those  who received placebo (26% and 18.2% respectively) in both the studies. Moreover, the safety profile noted in patients with active AS treated with upadacitinib 15 mg was comparable to that seen in rheumatoid arthritis and psoriatic arthritis patients. Treatment with upadacitinib contributed to significant improvement in the signs and symptoms of AS including total back pain, physical function (Bath ankylosing spondylitis functional index, BASFI) and disease activity.

Upadacitinib, a second-generation selective Janus kinase (JAK) inhibitor targeting the JAK1 enzyme, acts by inhibiting the growth factor and cytokine-mediated signals transduced intracellularly by the JAK-STAT pathway. It also reduces the  inflammatory action by preventing the phosphorylation and intracellular activation of STATs. Earlier trials have also reported the drug to be safe and effective in children 12 years of age with moderate to severe eczema.


Reference: RINVOQ® (upadacitinib) approved by U.S. FDA as an oral treatment for adults with active ankylosing spondylitis. News release. AbbVie; April 29, 2022. Accessed May 2, 2022. https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-approved-by-us-fda-as-an-oral-treatment-for-adults-with-active-ankylosing-spondylitis.htm