The U.S. Food and Drug Administration (FDA) has approved upadacitinib (RINVOQ) 15 mg orally once daily for the treatment of adults with difficult-to-treat conditions. non-radiographic active axial spondyloarthritis (nr-axSpA).
The indication granted to AbbVie makes the JAK inhibitor the first in its class of drugs approved for both nr-axSpA and active ankylosing spondylitis (AS), and marks its sixth FDA indication in inflammatory diseases.
As a selective JAK inhibitor, upadacitinib has been shown to positively treat and is indicated for rheumatoid arthritis, psoriatic arthritis, AS, and active ulcerative colitis. It is also being considered for the treatment of chronic immune-mediated inflammatory diseases, including plaque psoriasis and Crohn’s disease.
The latest FDA approval for upadacitinib was supported by results from the pivotal Phase 3 SELECT-AXIS 2 clinical study, in which the daily oral agent evaluated efficacy, safety and tolerability in adults with active nr-axSpA.
Investigators in the randomized, placebo-controlled, double-blind trial compared upadacitinib to placebo on outcomes, including reduction in some components of the composite AS Disease Activity Score (ASAS), a scale with infinite items rating disease activity from zero (0) at any level of disease severity. Components observed from the index included patient total low back pain, patient global assessment (PGA) of disease activity, morning stiffness, and physical function. The team measured the ASAS40 response as improvement in disease activity in patients by ≥40% from baseline.
The investigators also looked for multiplicity-controlled endpoints, including total back pain and the Bath Ankylosing Spondylitis Disease Activity Index (BASFI).
At 14 weeks, the team observed a significantly greater mean decrease in total back pain from baseline in those treated with upadacitinib compared to placebo, as well as a significantly greater improvement in physical function according to the BASFI.
Almost half of all patients in the upadacitinib arm achieved an ASAS40 response at week 14 (44.9%), compared to only 22.3% in the placebo arm.
Researchers observed a similar safety profile for upadacitinib in SELECT-AXIS 2, as seen in clinical trials evaluating patients with rheumatoid arthritis, psoriatic arthritis and AS.
In a statement accompanying the approval, principal investigator Atul Deodhar, MD, professor of medicine and medical director of rheumatology clinics for the division of arthritis and rheumatic diseases at Oregon Health & Science University, called the new indication from the FDA for JAK inhibitors offers “an important new treatment option for patients and their caregivers to help control their symptoms and disease.”
“Many patients living with nr-axSpA continue to experience symptoms and are unable to control the disease with current treatments,” Deodhar said. “In the SELECT-AXIS 2 trials, RINVOQ demonstrated efficacy in both nr-axSpA and AS with consistent safety across all indications.”