ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1237

Predictors of Response: Baseline Characteristics and Early Treatment Responses Associated with Achievement of Remission and Low Disease Activity Among Upadacitinib-Treated Patients with Rheumatoid Arthritis

Arthur Kavanaugh1, Zoltan Szekanecz2, Edward Keystone3, Andrea Rubbert-Roth4, Stephen Hall5, Ricardo Xavier6, Joaquim Pereira7, In-Ho Song8, Naomi Martin9, Yanna Song8, Samuel Anyanwu8 and Peter Nash10, 1Division of Rheumatology, Allergy and Immunology, Department of Medicine, University of California San Diego, La Jolla, CA, 2Division of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary, 3Keystone Consulting Enterprises Inc., Toronto, ON, Canada, 4Kantonspital St Gallen, St.Gallen, Switzerland, 5Emeritus Research and Monash University, Melbourne, Australia, Melbourne, Australia, 6Departamento de Reumatologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, 7Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte and Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon Academic Medical Centre, Lisbon, Portugal, 8AbbVie Inc., North Chicago, IL, 9AbbVie Inc., Saint-Laurent, QC, Canada, 10Griffith University, Brisbane, Australia

Meeting: ACR Convergence 2021

Keywords: , ,

Session Information

Date: Monday, November 8, 2021

Title: RA – Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation (1223–1256)

Session Type: Poster Session C

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

Background/Purpose: Early prediction of response to treatment with upadacitinib (UPA) 15 mg once daily (QD) could help optimize therapy in patients (pts) with RA.1-4 The objective of this analysis was to identify baseline (BL) characteristics or Week (Wk) 12 disease activity measures that may predict the achievement of remission (REM) or low disease activity (LDA) at 6 months in pts with RA.

Methods: This ad hoc analysis included pts randomized to UPA 15 mg QD, as monotherapy in MTX-naïve pts (SELECT-EARLY) or in combination with conventional synthetic DMARDs (csDMARDs), in pts with inadequate response (IR) to MTX (SELECT-COMPARE) or ≥1 tumor necrosis factor inhibitors (TNFis) (SELECT-BEYOND and SELECT-CHOICE). Association of BL characteristics (age, disease duration, prior/concomitant treatments, C-reactive protein [CRP], seropositivity, and disease activity) and Wk 12 disease activity parameters with achievement of Clinical Disease Activity Index (CDAI) REM (≤2.8) or LDA (≤10) at Wk 24 (or Wk 26 in SELECT-COMPARE) was assessed by concordance statistics (C-statistics), or area under the receiver operator characteristic curve. C-index values and 95% confidence intervals were calculated by fitting a univariate logistic regression model for: demographic and BL characteristics, Wk 12 disease activity measures, and change from BL at Wk 12 in disease activity measures. A multivariate logistic regression with stepwise model selection was also performed. Proportion of pts achieving Wk 24/26 CDAI REM/LDA was stratified by ≥50% improvement from BL in swollen and/or tender joint count in 66/68 joints (SJC66/TJC68).

Results: A total of 1377 pts were included. Across the 4 studies, CDAI REM and LDA were achieved in 11.0–28.4% and 50.0–58.6% of pts, respectively (Table). BL demographics and disease characteristics were weakly predictive (C-index < 0.70) of Wk 24/26 CDAI REM (C-index 0.49–0.69) or LDA (C-index 0.47–0.65), except for BL disability index of HAQ (HAQ-DI) in SELECT-BEYOND, which was moderately predictive of CDAI REM (C-index 0.73). Changes from BL in disease activity measures at Wk 12 were weakly or moderately predictive of Wk 24/26 CDAI REM (Figure) or LDA. CDAI value at Wk 12 was strongly predictive (C-index >0.80) of Wk 24/26 CDAI REM or LDA. Disease Activity Score in 28 joints using CRP and pain at Wk 12 were strongly predictive of Wk 24/26 CDAI REM (except in SELECT-CHOICE). Physician’s global assessment at Wk 12 was the only common predictor in multivariate regression models for CDAI REM/LDA at Wk 24/26 across studies. Greater proportion of pts achieving ≥50% improvement in SJC66 and TJC68 at Wk 12 achieved CDAI REM (16.5–37.8% vs 0–9.4%) or LDA (66.0–72.8% vs 20.9–35.7%) at Wk 24/26 than those who did not.

Conclusion: BL characteristics did not strongly predict response to UPA, but composite disease activity scores at Wk 12 predicted Wk 24/26 REM/LDA with UPA 15 mg QD across MTX-naïve, MTX-IR, and TNFi-IR pts. ≥50% improvement in SJC/TJC at Wk 12 was also associated with Wk 24/26 REM/LDA.

References:
1. van Vollenhoven R, et al. Arthritis Rheumatol 2020;72:1607–20.
2. Genovese MC, et al. Lancet 2018;391:2513–24.
3. Fleischmann R, et al. Arthritis Rheumatol 2019;71:1788–800.
4. Rubbert-Roth A, et al. N Engl J Med 2020;383:1511–21.

Disclosures: A. Kavanaugh, AbbVie, 2, 5, Amgen, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5; Z. Szekanecz, None; E. Keystone, AbbVie, 2, 6, Amgen, 2, 5, 6, Bristol-Myers Squibb Company, 2, Celltrion, 2, Gilead Sciences, 2, F. Hoffmann-La Roche, 2, 6, Janssen, 2, 6, Eli Lilly, 2, Merck, 2, 5, 6, Myriad Autoimmune, 2, Novartis, 6, Pfizer Inc, 2, 5, 6, PuraPharm, 5, Sandoz, 2, Sanofi-Genzyme, 2, 6, Samsung Bioepis, 2; 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; 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; R. Xavier, Abbvie, 2, Janssen, 2, UCB, 2, Pfizer, 2, Novartis, 2, Amgen, 2, Bristol-Myers Squibb, 2, Eli Lilly, 2; J. Pereira, AbbVie, 2, 5, 6, Medac, 2, 5, 6, MSD, 2, 5, 6, Pfizer, 2, 5, 6, Roche, 2, 5, 6; I. Song, AbbVie, 3, 11; N. Martin, AbbVie, 3, 11; Y. Song, AbbVie, 3, 11; S. Anyanwu, AbbVie, 3, 11; P. Nash, Janssen, 2, 5, 6, AbbVie, 2, 5, 6, Pfizer, 2, 5, 6, Novartis, 2, 5, 6, Eli Lilly, 2, 5, 6, Roche, 2, 5, 6, Bristol-Myers Squibb, 2, 5, 6, Sanofi, 2, 5, 6, Merck, 2, 5, 6, UCB, 2, 5, 6, Gilead/Galapagos, 2, 5, 6, Celgene, 2, 5, 6, Samsung, 2, 5, 6.

To cite this abstract in AMA style:

Kavanaugh A, Szekanecz Z, Keystone E, Rubbert-Roth A, Hall S, Xavier R, Pereira J, Song I, Martin N, Song Y, Anyanwu S, Nash P. Predictors of Response: Baseline Characteristics and Early Treatment Responses Associated with Achievement of Remission and Low Disease Activity Among Upadacitinib-Treated Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/predictors-of-response-baseline-characteristics-and-early-treatment-responses-associated-with-achievement-of-remission-and-low-disease-activity-among-upadacitinib-treated-patients-with-rheumatoid-art/. Accessed .

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/predictors-of-response-baseline-characteristics-and-early-treatment-responses-associated-with-achievement-of-remission-and-low-disease-activity-among-upadacitinib-treated-patients-with-rheumatoid-art/