ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0832

Consistency in Time to Response with Upadacitinib as Monotherapy or Combination Therapy and Across Patient Populations with Rheumatoid Arthritis

Andrea Rubbert-Roth1, Bernard Combe2, Zoltan Szekanecz3, Stephen Hall4, Boulos Haraoui5, Suzan Mansour Hussein Attar6, Anna-Karin Ekwall7, Yanna Song8, Tim Shaw9, Orsolya Nagy8 and Ricardo Xavier10, 1Kantonspital St Gallen, St.Gallen, Switzerland, 2CHU Montpellier Montpellier University, Montpellier, France, 3Division of Rheumatology, University of Debrecen, Faculty of Medicine, Debrecen, Hungary, 4Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, 5Institut de Rhumatologie de Montréal, Montréal, QC, Canada, 6King Abdulaziz University, Jeddah, Saudi Arabia, Jeddah, Saudi Arabia, 7University of Gothenburg, Gothenburg, Sweden, 8AbbVie Inc., North Chicago, IL, 9AbbVie Inc., North Chicago, 10Departamento de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil

Meeting: ACR Convergence 2021

Keywords: ,

Session Information

Date: Sunday, November 7, 2021

Title: RA – Treatments Poster I: Comparative Effectiveness, Biosimilars, Withdrawal, & the Real World (0813–0845)

Session Type: Poster Session B

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

Background/Purpose: Upadacitinib (UPA) has demonstrated efficacy in patients with moderate-to-severe rheumatoid arthritis (RA) across various patient populations.1–4 This post hoc analysis aimed to evaluate the consistency in time to achieving meaningful clinical response with UPA 15 mg + conventional synthetic (cs) DMARDs in biologic (b) DMARD-inadequate responder (IR) versus csDMARD-IR patients with RA as well as with UPA 15 mg monotherapy versus UPA 15 mg + csDMARDs in csDMARD-IR patients.

Methods: Patients originally randomized to UPA 15 mg once daily from four Phase 3 trials were included in this analysis: SELECT-BEYOND1 and SELECT-CHOICE2 (UPA 15 mg + csDMARDs in bDMARD-IR patients), SELECT-NEXT3 (UPA 15 mg + csDMARDs in csDMARD-IR patients), and SELECT-MONOTHERAPY4 (UPA 15 mg monotherapy in methotrexate-IR patients). Time to response was estimated using the Kaplan–Meier method for clinical outcomes over 24 weeks (26 weeks in SELECT-MONOTHERAPY). Clinical outcomes included achievement of 28-joint Disease Activity Score with C-reactive protein (DAS28[CRP]) ≤3.2; low disease activity (LDA) defined as Clinical Disease Activity Index (CDAI) ≤10 and Simple Disease Activity Index (SDAI) ≤11; and 50% improvement in American College of Rheumatology (ACR) core components and morning stiffness (MS) duration/severity. Data presented were as observed.

Results: Overall, 905 patients were included (SELECT-BEYOND: n=164; SELECT-CHOICE: n=303; SELECT-NEXT: n=221; SELECT-MONOTHERAPY: n=217). csDMARD-IR patients had a mean disease duration of 7.3 (SELECT-NEXT) or 7.5 years (SELECT-MONOTHERAPY); bDMARD-IR patients had a mean disease duration of 12.4 years, with a more refractory population (≥3 prior bDMARDs) in SELECT-BEYOND (23%) than SELECT-CHOICE (10%). In general, the median time to DAS28(CRP) ≤3.2, CDAI LDA, 50% improvement in ACR core components, and 50% improvement in MS duration/severity were consistent across the studies in bDMARD-IR and csDMARD-IR patients. For SELECT-BEYOND, SELECT-CHOICE, SELECT-NEXT, and SELECT-MONOTHERAPY, the median (95% CI) time to achieve DAS28(CRP) ≤3.2 was 12 (12, 16), 12 (8, 12), 12 (8, 12), and 14 (8, 14) weeks, respectively (Figure 1), and the median time to achieve CDAI LDA was 20 (12, 24), 16 (12, 16), 16 (12, 16), and 20 (14, 20) weeks, respectively (Figure 2). A longer median (95% CI) time to achieve SDAI LDA was observed with UPA monotherapy (20 [14, 20] weeks) versus UPA + csDMARDs (12 [12, 16] weeks) in csDMARD-IR patients. Among bDMARD-IR patients, the median (95% CI) time to 50% improvement in pain was longer in SELECT-BEYOND versus SELECT-CHOICE (16 [12, 20] versus 8 [8, 12] weeks).

Conclusion: In diverse patient populations with RA, patients treated with UPA 15 mg, as monotherapy or with csDMARDs, generally demonstrated consistent time to achieving DAS28(CRP) ≤3.2, CDAI LDA, and 50% improvement in clinical outcomes.

  1. Genovese MC, et al. Lancet 2018;391:2513–24.
  2. Rubbert-Roth A, et al. N Engl J Med 2020;383:1511–21.
  3. Burmester GR, et al. Lancet 2018;391:2503–12.
  4. Smolen JS, et al. Lancet 2019;393:2303–11.

Figure 1. Kaplan–Meier plot of time to first achievement of DAS28(CRP) ≤3.2

Figure 2. Kaplan–Meier plot of time to first achievement of CDAI ≤10 (LDA)

Disclosures: A. Rubbert-Roth, AbbVie, 2, 6, Bristol-Myers Squibb, 2, 6, Chugai, 2, 6, Roche, 2, 6, Gilead, 2, 6, Janssen, 2, 6, Eli Lilly, 2, 6, Sanofi, 2, 6, Amgen, 2, 6, Novartis, 2, 6; B. Combe, AbbVie, 2, 4, 5, 6, Bristol-Myers Squibb, 6, Celltrion, 4, 6, Eli Lilly, 2, 4, 5, 6, Gilead/Galapagos, 2, 4, 6, Janssen, 4, Merck, 6, Pfizer, 5, 6, Roche/Chugai, 4, 6, Novartis, 4, 5, 6, Sanofi, 2, Novartis, 5, UCB, 6; Z. Szekanecz, AbbVie, 1, 2, 6, Eli Lilly, 1, 2, 6, Gedeon Richter, 1, Pfizer Inc, 1, 2, 5, 6, Roche, 1, 2, 6, Sanofi, 2, 6, Novartis, 1, 2, 6; 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; B. Haraoui, Amgen Inc., 2, 6, AbbVie, 2, 6, Bristol-Myers Squibb, 2, 6, Eli Lilly, 2, 6, Janssen, 2, 6, Merck, 2, 6, UCB, 2, 6, Celgene, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 2, 6, Sandoz, 2, 6, Sanofi-Genzyme, 2, 6; S. Attar, None; A. Ekwall, Pfizer, 2, AbbVie, 2; Y. Song, AbbVie, 3, 11; T. Shaw, AbbVie, 3, 11; O. Nagy, AbbVie, 3, 11; R. Xavier, Abbvie, 2, Janssen, 2, UCB, 2, Pfizer, 2, Novartis, 2, Amgen, 2, Bristol-Myers Squibb, 2, Eli Lilly, 2.

To cite this abstract in AMA style:

Rubbert-Roth A, Combe B, Szekanecz Z, Hall S, Haraoui B, Attar S, Ekwall A, Song Y, Shaw T, Nagy O, Xavier R. Consistency in Time to Response with Upadacitinib as Monotherapy or Combination Therapy and Across Patient Populations with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/consistency-in-time-to-response-with-upadacitinib-as-monotherapy-or-combination-therapy-and-across-patient-populations-with-rheumatoid-arthritis/. Accessed .

« Back to ACR Convergence 2021

ACR Meeting Abstracts - https://acrabstracts.org/abstract/consistency-in-time-to-response-with-upadacitinib-as-monotherapy-or-combination-therapy-and-across-patient-populations-with-rheumatoid-arthritis/