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). |