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Atul Deodhar, MD, MRCP, discusses his recent study investigating the efficacy and safety of upadacitinib in active ankylosing Spondylitis, including study design, results, and its clinical significance.
Rheumatology Network interviewed Atul Deodhar, MD, MRCP, Professor of Medicine, Division of Arthritis and Rheumatic Diseases, School of Medicine, at the Oregon Health and Science University (OHSU) Rheumatology Clinic. We discuss Deodhar’s recent study entitled, “Upadacitinib in Active Ankylosing Spondylitis: 1-Year Results From the Double-Blind, Placebo-Controlled SELECT-AXIS 1 Study and Open-Label Extension,” including the study design, the results of the study, and its clinical significance.
The SELECT-AXIS 1 study enrolled a total of 187 (178 of which completed week 14) adult patients with active ankylosing spondylitis (AS) with an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Participants received either upadacitinib 15 mg once a day or a placebo. After week 14, the study continued with all participants receiving upadacitinib up to week 104.
Results proved that upadacitinib 15 mg showed sustained efficacy over the course of 1 year. Additionally, those who switched from placebo to upadacitinib had similar efficacy when compared with participants who received continuous upadacitinib. While a total of 618 adverse events were reported, no serious infections or events were noted.
RN: What first sparked your interest in researching the efficacy and safety of upadacitinib for patients with ankylosing spondylitis?
Atul Deodhar, MD, MRCP: There are very limited treatment options available for AS, and outside of NSAIDs, there are no oral treatments. Upadacitinib had shown good efficacy in rheumatoid arthritis (RA), and with our previous experience with tofacitinib and filgotinib (other janus kinase [JAK] inhibitors) in AS, it was natural for us to study efficacy and safety of upadacitinib in AS.
RN: Can you tell me a bit about the study design?
AD: SELECT-AXIS-1 was a double-blind randomized controlled trial of upadacitinib 15 mg per day versus placebo (2-arms only) in patients with active AS. The primary endpoint was Assessment of SpondyloArthritis international Society (ASAS) 40 at week 14. There was a 90-week open label extension period after the double-blind period.
RN: What were the results of the study?
AD: Of 187 patients, 178 completed week 14 on study drug and entered the open-label extension. Similar proportions of patients in either group (continuous upadacitinib or placebo-to-upadacitinib) achieved ASAS 40 or Ankylosing Spondylitis Disease Activity Score (ASDAS) low-disease activity at week 64: ≥70% of patients achieved these endpoints based on non-responder imputation (NRI) and ≥81% based on as-observed analyses. Furthermore, ≥34% NRI and ≥39% as-observed (AO) of patients achieved ASDAS inactive disease or ASAS partial remission at week 64. Mean changes from baseline (week 0) to week 64 in pain, function, and inflammation showed consistent improvement or sustained maintenance through the study.
RN: Did these results surprise you?
AD: It did not surprise me that the drug works, but I was surprised with the effect size.
RN: What was the clinical significance of these results?
AD: This confirms that JAK inhibitors have a role to play as an effective treatment option in AS.
RN: Does your team plan on doing any further research on the topic?
AD: Yes, we are participating in a larger Phase 3 study in AS and also in Non-Radiographic Axial Spondyloarthritis (nr-axSpA).
RN: Is there anything else you’d like our audience to know about this study, upadacitinib, or AS?
AD: There is a lot of excitement in the field of axial spondyloarthritis (that includes AS and nr-axSpA), including understanding the pathogenesis better, finding these patients early, and finding new drugs to change the natural history of the disease. Watch this space!