ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1231

Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 Years

Charles Peterfy1, Vibeke Strand2, Mark Genovese3, Alan Friedman4, Jeffrey Enejosa4, Stephen Hall5, Eduardo Mysler6, Patrick Durez7, Xenofon Baraliakos8, Tim Shaw4, Yanna Song9, Yihan Li4 and In-Ho Song4, 1Spire Sciences, Inc., Boca Raton, FL, 2Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, 3Stanford University Medical Center, Palo Alto, CA, 4AbbVie Inc., North Chicago, IL, 5Cabrini Medical Centre, Monash University and Emeritus Research, Malvern, Victoria, Australia, 6Organización Medica de Investigación, Buenos Aires, Argentina, 7Division of Rheumatology, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium, 8Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, 9AbbVie Inc., North Chicago,, IL

Meeting: ACR Convergence 2020

Keywords: ,

Session Information

Date: Sunday, November 8, 2020

Title: RA – Treatments Poster III: PROs, Biomarkers, Systemic Inflammation & Radiographs

Session Type: Poster Session C

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

Background/Purpose: For patients with rheumatoid arthritis (RA), long‑term prevention of structural joint damage is a key treatment goal.1 In the SELECT-EARLY and SELECT-COMPARE trials, upadacitinib (UPA), an oral JAK inhibitor, inhibited the progression of structural joint damage at 6 months and 1 year when used either as monotherapy or in combination with methotrexate (MTX) in patients (pts) with active RA.2 We describe the radiographic progression up to 2 years (96 wks) among pts with RA receiving UPA either as monotherapy or in combination with MTX.

Methods: Both the SELECT-EARLY and SELECT-COMPARE phase 3, randomized controlled trials enrolled pts at high risk for progressive structural damage with baseline (BL) erosive joint damage and/or seropositivity.3,4 In SELECT-EARLY, MTX-naïve pts (N=945) were randomized to UPA 15 mg or 30 mg once daily (QD) or MTX monotherapy. In SELECT‑COMPARE, pts with an inadequate response to MTX (N=1629) were randomized to UPA 15 mg, placebo (PBO), or adalimumab (ADA) 40 mg every other wk, with all pts continuing background MTX; at wk 26, all pts receiving PBO were switched to UPA 15 mg, regardless of response. In both trials, mean changes from BL in modified Total Sharp Score (mTSS), joint space narrowing, and joint erosion as well as the proportion of pts with no radiographic progression (change in mTSS ≤0) were evaluated based on X-rays taken at wks 24/26, 48, and 96 for those patients in whom wk 96 X-rays were available. Data are reported as observed (AO).

Results: BL demographics have been reported previously.3,4 In the SELECT-EARLY study, at wk 96 UPA monotherapy (15 mg and 30 mg doses) significantly inhibited radiographic progression compared with MTX as measured by mean change in mTSS and by the proportion of patients with no radiographic progression (Figures 1 and 2). When patients who were rescued (MTX added to UPA or UPA added to MTX) were removed from the analysis, changes in mTSS from baseline remained similar. By the same measures, in SELECT‑COMPARE, the degree of inhibition of structural progression observed was comparable between UPA and ADA. Following the switch of all PBO patients to UPA, the rate of progression slowed and was comparable to that observed in pts receiving UPA from BL. Among pts from both studies that had no radiographic progression at wk 24/26, >90% remained without radiographic progression at wk 48 and 96.

Conclusion: UPA was effective in inhibiting the progression of structural joint damage through 2 years both in MTX-naïve patients receiving UPA monotherapy and MTX-inadequate responder patients receiving UPA in combination with MTX. 

References:
                   1. Smolen, et al. Ann Rheum Dis 2017;76(6):960-77.
                   2. Peterfy, et al. Ann Rheum Dis 2019;78(suppl 2):369-370.
                   3. Fleischmann, et al. Arthritis Rheumatol 2019;71(11):1788-1800.
                   4. van Vollenhoven, et al. Arthritis Rheumatol 2018;70(suppl 10).
                       Original abs: Ann Rheum Dis. 2020; 79(S1):326.

Disclosure: C. Peterfy, AbbVie, 1, Acerta, 1, Amgen, 1, 2, Astra Zeneca, 1, Bristol-Myers Squibb, 1, Centrexion, 1, Daiichi Sankyo, 1, Five Prime Therapeutics, 1, Genentech, 1, Gilead, 1, Hoffman-La Roche, 1, Janssen, 1, Lilly, 1, Medimmune, 1, Merck & Co, 1, Myriad, 1, Novartis, 1, Plexxikon, 1, Pfizer, 1, Sanofi, 1, Salix Santarus, 1, Samsung, 1, Samumed, 1, Setpoint, 1, Sorrento, 1, UCB, 1, Vorso, 1, Spire Sciences, 1, 2, 3; V. Strand, AbbVie, 5, Amgen, 5, Celltrion, 5, Janssen, 5, Merck, 5, Novartis, 5, Regeneron, 5, Sanofi, 5, UCB, 5, Genentech/Roche, 5, GSK, 5, Pfizer, 5, Bayer, 5, Bristol-Myers Squibb, 5, Boehringer Ingelheim, 5, Galapagos, 5, Lilly, 5, Gilead, 5, Samsung, 5, Servier, 5, Setpoint, 5, Arena, 5, AstraZeneca, 5, Horizon, 5, Ichnos, 5, Inmedix, 5, Sandoz, 5; M. Genovese, Abbvie, 2, 5, Eli Lilly and Company, 2, 5, Galapagos, 2, 5, Gilead Sciences Inc., 2, 5, Pfizer, 2, 5, EMD Merck Serono, 2, 5, Genentech/Roche, 2, 5, GlaxoSmithKline, 2, 5, Novartis, 2, 5, RPharm, 2, 5, Sanofi-Genzyme, 2, UCB, 5, Amgen, 5; A. Friedman, AbbVie, 1, 2; J. Enejosa, AbbVie, 1, 2; S. Hall, AbbVie, 1, 2, Bristol-Myers Squibb, 1, 2, Lilly, 1, 2, Janssen, 1, 2, Pfizer, 1, 2, UCB Pharma, 1, 2, Novartis, 1, 2; E. Mysler, AbbVie, 2, 5, Amgen, 2, 5, Bristol-Myers Squibb, 2, 5, Eli Lilly, 2, 5, Janssen, 2, 5, Pfizer, 2, 5, Roche, 2, 5, Sandoz, 2, 5; P. Durez, None; 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; T. Shaw, AbbVie, 1, 2; Y. Song, AbbVie, 1, 2; Y. Li, AbbVie, 1, 2; I. Song, AbbVie, 1, 3.

To cite this abstract in AMA style:

Peterfy C, Strand V, Genovese M, Friedman A, Enejosa J, Hall S, Mysler E, Durez P, Baraliakos X, Shaw T, Song Y, Li Y, Song I. Radiographic Outcomes in Patients with Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in Combination with Methotrexate: Results at 2 Years [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/radiographic-outcomes-in-patients-with-rheumatoid-arthritis-receiving-upadacitinib-as-monotherapy-or-in-combination-with-methotrexate-results-at-2-years/. Accessed .

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