The Food and Drug Administration (FDA) has approved Rinvoq® (upadacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to 1 or more tumor necrosis factor (TNF) blockers.
The approval was based on data from the double-blind, placebo-controlled phase 2/3 SELECT-AXIS 1 trial (ClinicalTrials.gov Identifier: NCT03178487) and the randomized, double-blind, placebo-controlled phase 3 SELECT-AXIS 2 trial (ClinicalTrials.gov Identifier: NCT04169373). The SELECT-AXIS 1 trial included 187 treatment-naive AS patients with an inadequate response to or contraindication for NSAIDS. The SELECT-AXIS 2 trial included 420 AS patients with an inadequate response to 1 or 2 biologic disease-modifying anti-rheumatic drugs (DMARDs).
In both trials, patients were randomly assigned to receive either upadacitinib 15mg orally once daily or placebo. At week 14, all patients in the placebo arm were switched to upadacitinib 15mg once daily. The primary endpoint for both trials was the proportion of patients achieving an Assessment of SpondyloArthritis international Society 40 (ASAS40) response at week 14.
Results from SELECT-AXIS 1 and 2 showed 50.5% and 44.5% of patients treated with upadacitinib 15mg, respectively, achieved an ASAS40 response at week 14 compared with 25.5% and 18.2% of those who received placebo. Clinical responses were observed as early as week 4 with upadacitinib in SELECT-AXIS 2 for ASAS40.
In both trials, when compared with placebo, treatment with upadacitinib 15mg was associated with improvements at week 14 in the following secondary endpoints: Patient Global Assessment of Disease Activity, Bath Ankylosing Spondylitis Functional Index, Patient’s Assessment of Total Back Pain, Bath Ankylosing Spondylitis Functional Index, high sensitivity C-reactive protein, Ankylosing Spondylitis Quality of Life, Maastricht Ankylosing Spondylitis Enthesitis Score, and Bath Ankylosing Spondylitis Metrology Index.
“Many patients with ankylosing spondylitis do not achieve disease control with current biologic therapies and additional treatments are needed to help relieve the signs and symptoms of this disease,” said Atul Deodhar, MD, professor of medicine and medical director of the Rheumatology Clinics for the Division of Arthritis and Rheumatic Diseases at Oregon Health & Science University, and investigator of the SELECT-AXIS 1 trial. “With today’s FDA approval, patients who do not respond to a TNF inhibitor have an additional oral treatment option, in partnership with their rheumatologist, to help take control of this disease.”
The safety profile of upadacitinib in AS patients was consistent with that seen in previous studies. The most common adverse reactions reported were upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache. The JAK inhibitor also carries a Boxed Warning associated with risks of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Rinvoq is also indicated for the treatment of psoriatic arthritis, rheumatoid arthritis, atopic dermatitis, and ulcerative colitis.
- Rinvoq® (upadacitinib) approved by US FDA as an oral treatment for adults with active ankylosing spondylitis. News release. AbbVie. Accessed April 29, 2022. https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-approved-by-us-fda-as-an-oral-treatment-for-adults-with-active-ankylosing-spondylitis-301536539.html
- Rinvoq. Package insert. AbbVie; 2022. Accessed April 29, 2022. https://www.rxabbvie.com/pdf/rinvoq_pi.pdf