AbbVie announced that the European Commission (EC) has approved RINVOQ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Axial spondyloarthritis (axSpA) is a chronic, progressive and disabling inflammatory rheumatic disease that causes joint inflammation, leading to back pain and stiffness. 3,4,5 AxSpA consists of two subsets that have been clinically defined as ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA), and non-radiographic axial spondyloarthritis (nr-axSpA).

6 Approximately 10%-40% of patients eventually progress from nr-axSpA to r-axSpA over a 2- to 10-year period. The company previously disclosed topline results [1] from the Phase 3 SELECT-AXIS 2 nr-axSpA clinical trial and the full results have been published in The Lancet [2]. Study results show a significantly greater proportion of patients receiving RINVOQ 15 mg achieved an Assessment of SpondyloArthritis international Society 40% (ASAS40) response at week 14 (45% versus 23%; pAbout the SELECT-AXIS 1 and SELECT-AXIS 2 trial programs2,8,9 SELECT-AXIS 1 is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active AS who are bDMARD-naïve and had inadequate response to at least two NSAIDs or intolerance to/contraindication for NSAIDs.

Period 2 is an open-label extension period to evaluate the long-term safety and efficacy of RINVOQ in subjects who completed Period 1. SELECT-AXIS 2 (NCT04169373) was conducted under a master protocol and includes two separate studies (SELECT-AXIS 2 AS (bDMARD-IR) study, or Study 1 and SELECT-AXIS 2 nr-axSpA study, or Study 2). Study 1: SELECT-AXIS 2 AS (bDMARD-IR) study8: A randomized, double-blind, placebo-controlled Phase 3 trial, which evaluated the efficacy and safety of RINVOQ compared with placebo, in 420 patients with a clinical diagnosis of AS who fulfilled the modified New York criteria, had BASDAI score =4 and total back pain score =4 (based on a numerical scale of 0-10), and had an inadequate response to bDMARD therapy. Study 2: SELECT-AXIS 2 nr-axSpA study2: A randomized, double-blind, placebo-controlled, Phase 3 trial which evaluated the efficacy and safety of RINVOQ compared with placebo, in 314 patients with a clinical diagnosis of nr-axSpA.

Patients enrolled in the study had active signs of inflammation as indicated by MRI + sacroiliac joint inflammation, and/or high sensitivity C-reactive protein (hs-CRP) >upper limit of normal (2.87 mg/L) at screening, and who had BASDAI score =4 and a total back pain score =4 (based on a numerical scale of 0-10).