In patients with non-radiographic axial spondyloarthritis (nr-axSpA), upadacitinib significantly improved disease activity, pain, function, and quality of life compared with placebo and demonstrated a favorable safety profile, according to study results presented at European Alliance of Associations for Rheumatology (EULAR) 2022 Congress, held June 1 to 5 in Copenhagen, Demark.
The randomized, double-blind, placebo-controlled, phase 3 trial was part of the broader SELECT-AXIS 2 clinical trial (ClinicalTrials.gov Identifier: NCT04169373). Enrolled patients included adult patients with nr-axSpA who had axSpA-consistent inflammation of the sacroiliac joints on magnetic resonance imaging (MRI) and/or a high-sensitivity C-reactive protein (CRP) level higher than 2.87 mg/L, and Bath ankylosing spondylitis disease activity index (BASDAI) and total spinal pain scores of at least 4. Study patients were randomly assigned in a 1:1 ratio to receive other 15 mg oral upadacitinib once daily or placebo over 52 weeks.
The primary endpoint was a 40% improvement in the assessment in ankylosing spondylitis response criteria (ASAS40) at week 14. Multiplicity-controlled secondary endpoints at week 14 were:
- At least 50% improvement from baseline in BASDAI;
- Ankylosing spondylitis disease activity score (ASDAS) of inactive disease (<1.3);
- ASDAS low disease activity score (<2.1);
- ASDAS partial remission and change from baseline in ASDAS-CRP level;
- Spondyloarthritis Research Consortium of Canada MRI sacroiliac joint inflammation score;
- Total and nocturnal back pain;
- Bath ankylosing spondylitis functional index;
- Ankylosing spondylitis quality of life;
- Assessment of Spodyloarthritis International Society health index;
- Bath ankylosing spondylitis metrology index (BASMI);
- Maastricht ankylosing spondylitis enthesitis score (MASES); and
- Treatment emergent adverse events.
A total of 313 patients with nr-axSpA were in enrolled in the study. Of these patients, 156 patients received upadacitinib and 157 received placebo. Baseline demographics were similar between the treatment groups. The ASAS40 response rate was 45% with upadacitinib vs 23% with placebo (P <.0001). All secondary endpoints, except BASMI and MASES, were met (P <.01). Treatment emergent adverse events were similar between treatment groups (48% with upadacitinib vs 46% with placebo).
Serious treatment emergent adverse events in the upadacitinib and placebo groups were 2.6% and 1.3%, respectively. There were few reports of serious infection, herpes zoster, and uveitis, and no reports of malignancy (other than 1 basal cell carcinoma in the placebo group), major adverse cardiovascular events, venous thromboembolic events, inflammatory bowel disease, or death.
The study authors concluded, “These results support the potential use of UPA in patients with active nr-axSpA.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Deodhar A, Van den Bosch F, Poddubnyy D, et al. Efficacy and safety of upadacitinib in patients with active non-radiographic axial spondyloarthritis: A double-blind, randomized, placebo-controlled phase 3 trial. Presented at: EULAR Congress 2022; June 1-4, 2022; Copenhagen, Denmark. Abstract OP0016.