Why carry out this study?

In addition to reduced spinal mobility, impaired function, and presence of inflammation, patients with ankylosing spondylitis (AS) suffer from chronic back pain, fatigue, and reduced health-related quality of life (HRQoL).

Despite recent advancements in biologic therapies, there remains a significant, unmet need for the treatment of AS, highlighted by the high proportion of patients who do not achieve an adequate response to biologic disease-modifying antirheumatic drugs (bDMARDs).

This study evaluated the effect of upadacitinib versus placebo on response rates and clinically meaningful improvements in patient-reported outcomes (PROs) in patients with AS in SELECT-AXIS 2.

What has been learned from the study?

A higher proportion of patients reported clinically meaningful improvements at week 14 across PROs with upadacitinib 15 mg compared with placebo: BASDAI (73.9 vs. 47.8%), PtGA (82.9 vs. 63.2%), total back pain (80.1 vs. 65.1%), nocturnal back pain (82.9 vs. 65.1%), FACIT-F (57.7 vs. 43.0%), BASFI (74.4 vs. 53.6%), ASAS HI (46.4 vs. 23.0%), ASQoL (60.3 vs. 35.6%), SF-36 PCS (70.9 vs. 54.1%), and WPAI activity impairment (58.5 vs. 31.0%), nominal p ≤ 0.001.

Improvements in mean change in fatigue, disease-specific and general HRQoL patient-reported measures from baseline were seen as early as week 1 or 2 and continued through week 14 in bDMARD-IR patients with active AS who received upadacitinib 15 mg compared with placebo (ASQoL, ASAS HI and SF-36 PCS and MCS; p < 0.05).