doubleblind placebocontrolled study with openlabel extension Atul Deodhar MD Oregon Health amp Science University Portland OR USA Key message Upadacitinib a JAK1 inhibitor showed sustained and consistent efficacy over 1 year in AS patients ID: 1036103
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1. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis: 1-year results from a randomized,double-blind, placebo-controlled study with open-label extensionAtul Deodhar, MDOregon Health & Science UniversityPortland, OR, USA
2. Key messageUpadacitinib – a JAK1 inhibitor – showed sustained and consistent efficacy over 1 year in AS patients.No new safety findings were observed compared with data from other indications.
3. Background (1)What do we already know about this topic?Upadacitinib is an oral JAK inhibitor with selectivity for JAK1.Upadacitinib may be useful for the management of ankylosing spondylitis.
4. Background (2)How was this study conducted?SELECT-AXIS 1 was a randomized, placebo-controlled trial with a 14-week period followed by 90-week open-label extension.187 biologic-naïve patients with active AS and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) were randomized to upadacitinib 15 mg once daily (QD) or placebo; in the extension all patients received upadacitinib.
5. Findings (1)What does this study add?This study reports an interim analysis for SELECT-AXIS 1 data up to Week 64.Efficacy was maintained or improved in the continuous upadacitinib group: 85% achieved ASAS40 at Week 64 in the as-observed analysis and 72% in the NRI analysis.Patients who switched to upadacitinib at Week 14 showed similar speed of onset and magnitude of response compared with those initially randomized to upadacitinib: ASAS40 was achieved by 81% and 70% in the as-observed and NRI analyses at Week 64.Similar results were observed for other efficacy endpoints including low disease activity, partial remission and inactive disease, as measured by ASDAS in both as-observed and NRI datasets.
6. Findings (2)What does this study add?Throughout the 64-week period there was a significant decrease in continuous efficacy endpoints including ASDAS, BASFI, ptGA and hsCRP in both analyses.Over 237.6 patient-years (PY) of treatment, 618 adverse events were reported (260.1/100 PY).Adverse events leading to discontinuation and serious adverse events were low: 6.3/100 PY and 5.9/100 PY, respectively.No serious infections, active tuberculosis, venous thromboembolic events, gastrointestinal perforation, major adverse cardiovascular events, renal dysfunction, or deaths were reported.Laboratory results showed a slight initial decrease in neutrophils, but levels stabilized over time. Creatine phosphokinase levels increased by around 20%, but no patient experienced any related symptoms.
7. PerspectivesHow does this study impact clinical practice?In biologic-naïve patients with active AS, upadacitinib allowed to achieve significant improvement across a range of efficacy endpoints over 1 year.Patients switching from placebo to upadacitinib showed a similar efficacy response.
8. Related contentVan der Heijde D, Song I-H, Pangan A, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet 2019;394(10214):2108–17. Torgutalp M, Poddubnyy D. Emerging treatment options for spondyloarthritis. Best Pract Res Clin Rheumatol 2018;32(3):472–84. Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet 2018;391(10139):2513–24. Deodhar A, van der Heijde D, Sieper J, et al. Efficacy and Safety of Upadacitinib in Patients with Active Ankylosing Spondylitis: 1-Year Results from a Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension. Presented at ACR Convergence 2020; abstract 2023.