Upadacitinib Improves Pain Associated with Ankylosing Spondylitis, PsA

Iain B McInnes, MD, PhD

Upadacitinib has already been found to be safe and effective in the phase 3 SELECT-PsA 1 and 2 studies on patients with active psoriatic arthritis (PsA), as well as among patients with active ankylosing spondylitis (AS) in the phase 2/3 SELECT-AXIS 1 study.

However, a new investigation compiled the data from all 3 randomized trials which brought more insight on upadacitinib's effect. Patients with active psoriatic arthritis or ankylosing spondylitis displayed rapid and sustained improvements in pain outcomes with upadacitinib for over a year.

The population included patients who have experienced either inadequate responses to non-biologic or biologic disease-modifying antirheumatic drugs (DMARDs), or were biologic-naive with inadequate response to non-steroidal anti-inflammatory drugs. Improvements were consistent and observed across several endpoints.

The Study

In all 3 studies, patients were randomized to receive either upadacitinib 15 mg once daily, or placebo. In SELECT-PsA 1, an additional group was administered adalimumab 40 mg every other week. Investigators, led by Iain B McInnes, MD, PhD, University of Glasgow, College of Medical, Veterinary and Life Sciences, evaluated pain outcomes based on increments.

In post hoc analyses, when compared with baseline, outcomes were measured by the proportion of patients who achieved ≥30%, ≥50% and ≥70% reduction using a patient global assessment of pain.

Also, changes from baseline were assessed at specific time points, as were particular questions from Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Additional end points that were unique to each study were looked at.

The Results

The research showed that a higher proportion of patients who received upadacitinib acheived ≥30%, ≥50% and ≥70% reduction in pain end points compared with placebo.

The improvements were observed as early as week 2 and were sustained or further increased through the first year (PsA 1/2 studies: 64%/48%, 58%/42% and 38%/22%, respectively; SELECT-AXIS 1 study: 76%, 72% and 54%). The data regarding adalimumab from the SELECT-PsA 1 study produced similar results (59%, 49% and 32%).

Patients who switched from placebo to upadacitinib 15 mg were able to improve to similar levels of the continuous upadacitinib group by the end of year 1 (PsA 1/2 studies: 46%–60%, 35%–49% and 15%–34%; AS study: 83%, 72% and 46%).

Investigators pointed to the importance of pain management in these populations a key component to the treatment of psoriatic arthritis and ankylosing spondylitis. Pain has an incredible impact on an individual's quality of life, fatigue, and functional work impairment.

The study "Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: post hoc analysis of three randomised clinical trials" was published in RMD Open Rheumatic & Musculoskeletal Diseases.