Impact of Upadacitinib on Reducing Pain in Patients Across the Axial Spondyloarthritis Spectrum: A Post Hoc Analysis of the Phase 2/3 SELECT-AXIS Studies.

INTRODUCTION

This post hoc analysis evaluates the efficacy of upadacitinib (UPA), a Janus kinase inhibitor, across multiple pain endpoints in patients with axial spondyloarthritis (axSpA) through 104 weeks from the phase 2/3 SELECT-AXIS studies.

METHODS

Adult patients with radiographic axSpA (r-axSpA; historically ankylosing spondylitis; two studies) who were naïve or had an inadequate response (IR) to biologic disease-modifying antirheumatic drugs (bDMARDs), or with non-radiographic axSpA (nr-axSpA; one study), were randomized to UPA 15 mg (UPA15) once daily or placebo (PBO). Patients treated with PBO were switched to UPA15 at week 14 in the r-axSpA studies and week 52 in the nr-axSpA study. Pain outcomes were assessed through week 104 and analyzed using nonresponder imputation or mixed-model repeated measures and as observed data. Safety data were not evaluated in this analysis but have been published previously.

RESULTS

Across axSpA, higher proportions of patients achieved ≥ 30%/50%/70% reduction from baseline in the patient's global assessment of pain with UPA15 versus PBO as early as week 1; reductions in pain were generally maintained through week 104 in the continuous UPA15 groups. Patients who switched from PBO to UPA15 showed generally similar responses to the continuous UPA15 groups through week 104. Additional pain endpoints, including minimal clinically important difference and total back pain, showed similar results. Numerically higher proportions of patients who reported early pain improvement (≥ 30% at week 2 or ≥ 50% at week 14) following UPA15 treatment achieved stringent disease control targets, including Assessment of SpondyloArthritis international Society (ASAS) partial remission, Ankylosing Spondylitis Disease Activity Score (ASDAS) low disease activity, or ASDAS inactive disease at week 104 versus patients who did not report early pain improvement.

CONCLUSIONS

These results from the SELECT-AXIS studies support the clinical benefit of UPA15 for reducing pain in patients with axSpA through 104 weeks (2 years). TRIAL REGISTRATION, CLINICALTRIALS.

GOV IDENTIFIER: NCT03178487 and NCT04169373.