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. 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. 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. 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). NCT03178487 and NCT04169373. This analysis looked at how well upadacitinib, a Janus kinase inhibitor, worked to reduce pain in people with a condition called axial spondyloarthritis (axSpA). AxSpA is a type of arthritis that mainly affects the spine and can cause severe pain and stiffness. This analysis included adults with either radiographic axSpA (r-axSpA, previously called ankylosing spondylitis) or non-radiographic axSpA (nr-axSpA) from three studies. People in the studies may or may not have used specific arthritis medicines before. People in the studies were randomly given either upadacitinib (15 mg once daily) or a placebo (a pill with no medicine). At week 14 or 52 of the studies, people treated with a placebo switched to upadacitinib. The researchers wanted to know how much pain improved over 2 years (104 weeks) using several different measures. They found that more people taking upadacitinib than placebo felt at least 30%, 50%, or 70% improvement in their pain compared to the start of the study, and this occurred as early as the first week of treatment. The people who switched from placebo to upadacitinib showed similar pain relief as those who took upadacitinib the entire time. Other measures of more specific types of pain, like total back pain, showed similar results. Also, people who experienced early pain relief were more likely to reach strict disease control goals, such as low disease activity, after 2 years. In summary, this analysis shows that upadacitinib helped reduce pain for people with axSpA for up to 2 years.
Baraliakos et al. (Fri,) studied this question.