ACR Meeting Abstracts

ACR Meeting Abstracts

  • Home
  • Meetings Archive
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP Annual Meeting
    • 2017 ACR/ARHP PRSYM
    • 2016-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • Meeting Resource Center

Abstract Number: 1694

Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs

Ronald van Vollenhoven1, Stephen Hall2, Alvin Wells3, Sebastian Meerwein4, Yanna Song5, Jessica Suboticki5 and Roy Fleischmann6, 1Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 2Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, 3Rheumatology and Immunotherapy Center, Franklin, WI, 4AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, 5AbbVie Inc., North Chicago, IL, 6Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX

Meeting: ACR Convergence 2021

Keywords: clinical trial, Disease-Modifying Antirheumatic Drugs (Dmards), Randomized Trial, Response Criteria, rheumatoid arthritis

  • Tweet
  • Email
  • Print
Session Information

Date: Tuesday, November 9, 2021

Session Title: RA – Treatments Poster III: RA Treatments & Their Safety (1674–1710)

Session Type: Poster Session D

Session Time: 8:30AM-10:30AM

Background/Purpose: Sustained clinical remission (REM) is the primary treatment goal for patients with rheumatoid arthritis (RA), with low disease activity (LDA) being an appropriate target for treatment-refractory patients.1,2 This analysis evaluated the sustainability of response to the JAK inhibitor, upadacitinib (UPA) 15 mg once daily (QD), among patients with prior inadequate response or intolerance to biologic DMARDs.

Methods: Data come from the 12-week, phase 3 randomized, placebo (PBO)-controlled SELECT-BEYOND trial of UPA 15 mg or 30 mg QD in patients with moderate to severe RA on stable background conventional synthetic (cs) DMARDs. Initiation, change, or discontinuation of background RA medications, including ≤2 csDMARDs, was allowed starting at Week 24. Patients completing the 12-week trial were able to enter a long-term extension of up to 5 yrs with all PBO patients switching to UPA.3 This post hoc analysis evaluated REM (CDAI ≤2.8; SDAI ≤3.3), LDA (CDAI≤10; SDAI≤11), and DAS28(CRP) < 2.6/≤3.2 at first occurrence of response before Week 60, as well as at 3, 6, and 12 months following initial response in patients randomized to UPA 15 mg. For those patients who achieved REM/LDA, Kaplan-Meier was used to define the time from when the response was first achieved to the earliest date at which the response was lost at two consecutive visits or discontinuation of study drug. The predictive ability of time to REM/LDA was evaluated using Harrell’s concordance (c)-index (range: 0 to 1, where 0.5 indicates a model that is no better at predicting an outcome than random chance). The date of the last follow up was 16 April 2018, when all patients had reached the Week 60 visit. Non-responder imputation was used for missing data. Only data from the approved 15 mg dosage are reported here.

Results: In patients with active RA despite prior treatment with at least one bDMARD, 34% and 79% of those receiving UPA 15 mg + background csDMARD(s) achieved CDAI REM or LDA through Week 60, respectively. Sustained CDAI REM was attained by 30%, 26%, and 16% of patients randomized to UPA at 3, 6, and 12 months post initial response, while CDAI LDA was achieved by 68%, 61%, and 50% of patients during the same time points (Figure 1). Time to initial clinical response weakly predicted sustained REM but did not predict sustained LDA, with a c-index (95% CI) of 0.62 (0.49, 0.74) and 0.52 (0.44, 0.61), respectively. Through the last follow-up visit at Week 60, 39/61% of patients on UPA remained in CDAI REM/LDA (Figure 2). Of those who lost CDAI REM, 58% remained in CDAI LDA, and 22% recaptured REM by the cut-off date; 18% of patients who lost CDAI LDA recaptured response. Similar results were observed for REM and LDA based on SDAI and for DAS28(CRP) < 2.6/≤3.2.

Conclusion: Among patients with inadequate response or intolerance to bDMARDs, over three-quarters on UPA 15 mg achieved CDAI LDA, a relevant therapeutic target for these treatment-refractory patients, and nearly two-thirds of those maintained this response through 60 weeks. Additionally, about one-third of UPA-treated patients attained CDAI REM and maintained that response over 60 weeks.

1. Smolen et al. Ann Rheum Dis 2020;79:685–99.
2. Singh et al. Arthritis Rheumatol 2016;68:1–26.
3. Genovese, et al. Lancet 2018;391:2513–24.


Disclosures: R. van Vollenhoven, Bristol Myers Squibb, 2, 5, Eli Lilly, 5, UCB, 2, 5, 6, Pfizer, 2, 6, 12, Support for educational programs; institutional grants, Roche, 12, Support for educational programs; institutional grants, Janssen, 2, 6, AbbVie, 2, 6, AstraZeneca, 2, Biotest, 2, GlaxoSmithKline, 2, 6, Biogen, 2, Galapagos, 2, 6, Gilead, 2, Sanofi, 2, Servier, 2, Vielabio, 2; S. Hall, AbbVie, 2, 6, Eli Lilly, 2, 6, Janssen, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, UCB, 2, 6, Bristol-Myers Squibb, 2, 5, Merck, 2, 5, 6; A. Wells, AbbVie, 2, 5; S. Meerwein, AbbVie, 3, 11; Y. Song, AbbVie, 3, 11; J. Suboticki, AbbVie, 3, 11; R. Fleischmann, AbbVie, 2, 5, Amgen, 2, 5, Bristol-Myers Squibb, 2, 5, Celltrion, 2, 5, Eli Lilly, 2, 5, Genentech, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer Inc, 2, 5, Sanofi-Aventis, 2, 5, UCB, 2, 5, GSK, 2, 5, AstraZeneca, 2, 5, Bayer, 2, 5, Biogen, 5, Flexion, 2, 5, Galapagos, 5, Galvani, 2, 5, Gilead Sciences, 2, 5, Horizon, 5, Noven, 5, Samumed, 5, Scipher, 5, Selecta, 5, Teva Pharmaceuticals, 5, Viela, 5, Vorso, 5.

To cite this abstract in AMA style:

van Vollenhoven R, Hall S, Wells A, Meerwein S, Song Y, Suboticki J, Fleischmann R. Sustainability of Response to Upadacitinib Among Patients with Active Rheumatoid Arthritis Refractory to Biological Disease-Modifying Anti-Rheumatic Drugs [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/sustainability-of-response-to-upadacitinib-among-patients-with-active-rheumatoid-arthritis-refractory-to-biological-disease-modifying-anti-rheumatic-drugs/. Accessed July 4, 2022.
  • Tweet
  • Email
  • Print

« Back to ACR Convergence 2021

ACR Meeting Abstracts - https://acrabstracts.org/abstract/sustainability-of-response-to-upadacitinib-among-patients-with-active-rheumatoid-arthritis-refractory-to-biological-disease-modifying-anti-rheumatic-drugs/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

ACR Pediatric Rheumatology Symposium 2020

© COPYRIGHT 2022 AMERICAN COLLEGE OF RHEUMATOLOGY

Wiley

  • Home
  • Meetings Archive
  • Advanced Search
  • Meeting Resource Center
  • Online Journal
  • Privacy Policy
  • Permissions Policies