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Abstract Number: 0369

Effect of Upadacitinib on Reducing Pain in Patients with Active Ankylosing Spondylitis and Inadequate Response to Nonsteroidal Anti-inflammatory Drugs

Atul Deodhar1, Xenofon Baraliakos2, Iain McInnes3, Kurt de Vlam4, Louis Bessette5, Anna Maniccia6, Ralph Lippe7, Christopher Saffore6, Tianming Gao6, In-Ho Song6 and Andrew Östör8, 1Oregon Health & Science University, Portland, OR, 2Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, 3Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, 4Department of Rheumatology, University of Leuven, Belgium, Leuven, Belgium, 5Laval University, Quebec, Canada, 6AbbVie Inc., North Chicago, IL, 7AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany, 8Cabrini Medical Center, Monash University, Malvern, Victoria, Australia

Meeting: ACR Convergence 2020

Keywords: Ankylosing spondylitis (AS), Outcome measures, Randomized Trial

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Session Information

Date: Friday, November 6, 2020

Session Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster I

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Pain is a debilitating symptom of ankylosing spondylitis (AS) and negatively impacts patient (pt) lives. Upadacitinib (UPA), a Janus kinase (JAK) inhibitor engineered for increased selectivity for JAK1 over JAK2, JAK3, and tyrosine kinase 2, 1 showed significant efficacy vs placebo (PBO) in the randomized phase 2/3 SELECT-AXIS 1 study in active AS.2 The objective of this analysis was to evaluate the efficacy of UPA on multiple pain assessments through 64 weeks (wks).

Methods: SELECT-AXIS 1 (NCT03178487) enrolled adults with active AS, who had an inadequate response, intolerance or contraindications to ≥2 NSAIDs, were biologic DMARD naive and met the modified New-York Criteria. Pts were randomized 1:1 to UPA 15 mg once daily (QD, n=93) or PBO (n=94) for 14 wks  (Period 1), followed by open-label UPA 15 mg QD during 90-wk extension (Period 2); reported here are data through wk 64. Pain endpoints included the proportion of pts achieving ≥30%/≥50%/≥70% reduction in Pt’s Global Assessment (PGA) of pain on a 0–10 numeric rating scale (NRS), minimal clinically important difference (MCID, defined as ≥1 point reduction or ≥15% reduction from baseline [BL]) in PGA of pain, and much better improvement (MBI, defined as ≥2 point reduction and ≥33% reduction from BL) in PGA of pain. In addition, mean change from baseline in PGA of pain, BASDAI questions 2 (neck/back/hip pain) and 3 (peripheral pain/swelling), and pt’s assessment of total back pain and nocturnal back pain NRS scores (NRS 0–10) were assessed. Non-responder imputation (binary endpoints) and mixed-effects model for repeated measurements (continuous endpoints) were used for missing data/dropouts in Period 1; as-observed analysis was used for Period 2.

Results: A significantly higher proportion of pts receiving UPA vs PBO achieved reductions in all PGA of pain assessments as early as wk 2 that was sustained at all time points in Period 1; the only exception was ≥70% reduction in PGA of pain that was significant at wk 4 and sustained thereafter (Fig. 1). For ≥30%/≥50%/≥70% reduction and MBI, the response rate increased over time with UPA; the difference for UPA vs PBO also continued to increase over time for ≥50% and ≥70% reduction endpoints. For MCID, an increase from BL to wk 2 was observed and plateaued thereafter. The mean change from BL in PGA of pain, BASDAI Q2, total back pain, and nocturnal back pain NRS scores were significantly greater for UPA vs PBO at all time points in Period 1; BASDAI Q3 was significant at wk 8 and 14 (Figs 1-2). The effect of UPA on pain reduction was sustained through wk 64. PBO pts who switched to open-label UPA at wk 14 generally reached the same level of pain reduction as those initially randomized to UPA (Figs 1-2).

Conclusion: In pts with active AS and an inadequate response/contraindication to NSAIDs, a greater proportion of patients treated with UPA achieved rapid, significant, and clinically meaningful reductions in pain vs PBO through 14 wks across multiple pain assessments. The reductions in pain were sustained over time, and pts who switched from PBO to UPA reached the same level of improvement as the continuous UPA group. 

  1. Parmentier JM, et al. BMC Rheumatology. 2018;2(23).
  2. van der Heijde D, et al. Lancet. 2019;394(10214):2108-2117.

Figure 1

Figure 2


Disclosure: A. Deodhar, AbbVie, 2, 5, Eli Lilly, 2, 5, GlaxoSmithKline, 2, 5, Novartis, 2, 5, Janssen, 5, Pfizer, 2, 5, Boehringer Ingelheim, 5, UCB Pharma, 2, 5, Amgen Inc., 5, Celgene, 5, Galapagos, 5, Bristol-Myers Squibb, 2; X. Baraliakos, AbbVie, 2, 5, Celgene, 2, 5, Galapagos, 2, 5, Janssen, 2, 5, Eli Lilly, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5, Bristol-Myers Squibb, 2, 5, Chugai, 2, 5, MSD, 2, 5, Sandoz, 2, 5, Hexal, 2, 5; I. McInnes, Novartis, 9, AbbVie, 9, Celgene, 9, Janssen, 2, 9, UCB, 2, 9, Bristol Myers Squibb, 2, 9, AstraZeneca, 2, Boehringer Ingelheim, 2, Lilly, 9, LEO, 9; K. de Vlam, Eli Lilly and Company, 2, 5, 8, Novartis, 2, 5, 8, UCB, 2, 5, 8, Celgene, 2, 5, 8, Pfizer, 2, 5, 8; L. Bessette, Amgen, 1, 2, 3, BMS, 1, 2, 3, Janssen, 1, 2, 3, UCB, 1, 2, 3, AbbVie, 1, 2, 3, Pfizer, 1, 2, 3, Merck, 1, 2, 3, Celgene, 1, 2, 3, Sanofi, 1, 2, 3, Lilly, 1, 2, 3, Novartis, 1, 2, 3, Gilead, 2, 6, 8; A. Maniccia, AbbVie Inc., 1, 3, 4; R. Lippe, AbbVie Inc., 1, 3; C. Saffore, AbbVie Inc., 1, 3, 4; T. Gao, AbbVie Inc., 1, 3, 4; I. Song, AbbVie, 1, 3; A. Östör, AbbVie, 5, Roche, 5, Janssen, 5, Eli Lilly, 5, Novartis, 5, Pfizer, 5, Gilead, 5, Paradigm, 5, UCB Pharma, 5, Bristol-Myers Squibb, 5.

To cite this abstract in AMA style:

Deodhar A, Baraliakos X, McInnes I, de Vlam K, Bessette L, Maniccia A, Lippe R, Saffore C, Gao T, Song I, Östör A. Effect of Upadacitinib on Reducing Pain in Patients with Active Ankylosing Spondylitis and Inadequate Response to Nonsteroidal Anti-inflammatory Drugs [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/effect-of-upadacitinib-on-reducing-pain-in-patients-with-active-ankylosing-spondylitis-and-inadequate-response-to-nonsteroidal-anti-inflammatory-drugs/. Accessed March 27, 2023.
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