Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 Weeks

Roy Fleischmann¹, In-Ho Song², Jeffrey Enejosa³, Eduardo Mysler⁴, Louis Bessette⁵, Patrick Durez⁶, Andrew Östör⁷, Jerzy Swierkot⁸, Yanna Song⁹ and Mark Genovese¹⁰, ¹Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, ²AbbVie Inc., North Chicago, IL, ³AbbVie Inc., Evanston, IL, ⁴Organización Medica de Investigación, Buenos Aires, Argentina, ⁵Laval University, Quebec, Canada, ⁶Division of Rheumatology, Cliniques Universitaires Saint-Luc, Bruxelles, Belgium, ⁷Cabrini Medical Center, Monash University, Malvern, Victoria, Australia, ⁸Wroclaw Medical University, Wroclaw, Poland, ⁹AbbVie Inc., North Chicago,, IL, ¹⁰Stanford University Medical Center, Palo Alto, CA

Meeting: ACR Convergence 2020

Keywords: clinical trial, rheumatoid arthritis

Session Information

Date: Friday, November 6, 2020

Title: RA – Treatments Poster I: RA Treatments & Their Safety

Session Type: Poster Session A

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

Background/Purpose: We report safety/efficacy of upadacitinib (UPA) vs adalimumab (ADA) up to 72 weeks (wks) in patients (pts) with rheumatoid arthritis from the ongoing long-term extension (LTE) of SELECT-COMPARE.

Methods: Pts were randomized to once-daily UPA 15mg, placebo (PBO), or ADA 40mg every other wk. Pts were rescued at Wks 14/18/22 from UPA to ADA, ADA to UPA or PBO to UPA if they met protocol-specified rescue criteria; at Wk26 all remaining patients with CDAI >10 were rescued as above with all remaining PBO pts switched to UPA. Pts continued UPA or ADA in a blinded manner until the last pt completed the Wk48 visit. Completers entered the LTE. Treatment-emergent adverse events (TEAEs)/100PY were summarized up to December 26 2018. Efficacy was analyzed by randomized group. NRI was used for binary endpoints for rescue prior to Wk26.LOCF was used for continuous and binary endpoints for rescue at Wk26.

Results: 1629 pts were randomized (UPA: 1209 [399 non-switched; 159 switched from ADA; 651 from PBO]; ADA: 420 [168 non-switched; 252 switched from UPA]); 1403 entered the LTE. Cumulative exposures were 1396.7 and 515.1 PYs for UPA and ADA, respectively. TEAEs/100PY of any AEs and serious AEs for UPA vs ADA were 266.3 vs 299.4 and 12.7 vs 15.9, respectively. AE of special interest (AESIs)/100PY for UPA vs ADA were 3.7 vs 4.3 for serious infections, 0.9 vs 0.6 for opportunistic infections, 0.7 vs 1.0 for malignancy, 0.4 vs 0.6 for adjudicated MACE, 0.3 vs 1.0 for VTE, and 0.6 vs 1.2 for deaths. The event rates were numerically higher with UPA vs ADA for herpes zoster (3.1 vs 1.2), hepatic disorder (17.3 vs 14.0), and CPK elevation (5.6 vs 2.1). At Wk72, ACR20/50/70 was achieved by 64/51/38% vs 53/38/25% of pts on UPA and ADA (p< .01/.001/.001), DAS28-CRP≤3.2/< 2.6 by 49/41% vs 32/26% (p< .001), and CDAI≤10/≤2.8 by 46/28% vs 33/17% (p< .001), respectively.

Conclusion: UPA continued to demonstrate a safety profile consistent with observations through 48 wks and durable clinical efficacy.¹

References:
1. Fleischmann R, et al. Annals of the Rheumatic Diseases 2019;78:744-745.
Original abs: Ann Rheum Dis. 2020; 79(S1):319.

Disclosure: R. Fleischmann, Pfizer, 2, 5; I. Song, AbbVie, 1, 3; J. Enejosa, AbbVie, 1, 3; 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; 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; P. Durez, None; 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; J. Swierkot, AbbVie, 2, 8, Sandoz, 2, 8, Pfizer, 2, 8, Roche, 2, 8, Bristol-Myers Squibb, 2, 8, UCB, 2, 8, MSD, 2, 8, Accord, 2, 8, Janssen, 2, 8; Y. Song, AbbVie, 1, 2; 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.

To cite this abstract in AMA style:

Fleischmann R, Song I, Enejosa J, Mysler E, Bessette L, Durez P, Östör A, Swierkot J, Song Y, Genovese M. Long-Term Safety and Effectiveness of Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis: Results at 72 Weeks [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-and-effectiveness-of-upadacitinib-or-adalimumab-in-patients-with-rheumatoid-arthritis-results-at-72-weeks/. Accessed .

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