Efficacy of upadacitinib in subgroups of patients with axial spondyloarthritis with early versus established disease.

OBJECTIVES

Early disease activity control with targeted therapies may improve long-term outcomes in axial spondyloarthritis (axSpA). Here, we evaluated the efficacy of upadacitinib in patients with axSpA with shorter versus longer symptom durations.

METHODS

SELECT-AXIS 1 and 2 studies enrolled patients with radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA) naïve to biologic disease-modifying antirheumatic drugs (bDMARD-naïve) and with an intolerance or inadequate response to bDMARD therapy. Patients were stratified by symptom duration (nr-axSpA: early vs established (≤2 vs >2 years=Assessment of SpondyloArthritis international Society (ASAS) definition) and shorter vs longer (≤5 vs >5 years); r-axSpA: ≤5 vs >5 years). Efficacy endpoints assessed through week 14 included the proportion of patients achieving Axial Spondyloarthritis Disease Activity Score and ASAS40 responses, among others. Across all endpoints, the efficacy of upadacitinib versus placebo was assessed by relative risk (RR), and the placebo-adjusted effect of upadacitinib between shorter versus longer symptom duration was assessed by the RR ratio.

RESULTS

At week 14, better responses were observed in patients treated with upadacitinib in all endpoints assessed compared with placebo, regardless of symptom duration. When comparing patients with early/shorter versus established/longer symptom durations, for all measures assessed, no statistically significant differences were observed except for the change from baseline in high-sensitivity C-reactive protein in the nr-axSpA group, with a better response in early disease (difference -8.2, 95% CI -14.9 to -1.6).

CONCLUSION

Regarding short-term outcomes, both subgroups of patients (shorter axSpA symptom duration (≤2 years) and longer symptom duration (>2 years)) achieved comparable results when treated with upadacitinib.

TRIAL REGISTRATION NUMBER: NCT03178487 (SELECT-AXIS 1) and NCT04169373 (SELECT-AXIS 2).