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THU0201 LONG-TERM SAFETY AND EFFECTIVENESS OF UPADACITINIB OR ADALIMUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS AT 72 WEEKS FROM THE SELECT-COMPARE STUDY
  1. R. Fleischmann1,
  2. I. H. Song2,
  3. J. Enejosa2,
  4. E. Mysler3,
  5. L. Bessette4,
  6. P. Durez5,
  7. A. Ostor6,
  8. J. Swierkot7,
  9. Y. Song2,
  10. M. C. Genovese8
  1. 1Univ of Texas Southwestern Med Center, Metroplex Clinical Research Center, Dallas, United States of America
  2. 2AbbVie Inc., North Chicago, United States of America
  3. 3Organización Medica de Investigación, Buenos Aires, Argentina
  4. 4Laval Univ, Quebec, Canada
  5. 5Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, UCL Saint-Luc, Brussels, Belgium
  6. 6Cabrini Medical Center, Monash University, Malvern, Australia
  7. 7Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wrocław, Poland
  8. 8Stanford Univ School of Medicine, Palo Alto, United States of America

Abstract

Background: In the SELECT-COMPARE study in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX), upadacitinib (UPA), a Janus Kinase (JAK) 1-selective inhibitor, showed significant improvements in treatment of signs and symptoms when compared to placebo (PBO) and adalimumab (ADA) up to 48 weeks.1

Objectives: To report safety and efficacy of UPA vs ADA up to 72 weeks in patients with RA from the ongoing long-term extension (LTE) of SELECT-COMPARE.

Methods: Patients were randomized to once daily (QD) UPA 15 mg, PBO, or ADA 40 mg every other week, with all patients continuing background MTX. The study was double-blind for 48 weeks. Between Weeks 14-26, patients were rescued (from PBO to UPA, UPA to ADA, or ADA to UPA) if there was <20% improvement in tender/swollen joint count at Weeks 14/18/22 or if Clinical Disease Activity Index (CDAI) was >10 at Week 26; all PBO patients who were not rescued were switched to UPA at Week 26. Patients continued UPA or ADA in a blinded manner until the last patient completed the Week 48 visit; patients received open-label treatment thereafter. Study visits occurred at Week 60, 72, and every 12 weeks thereafter. Treatment-emergent adverse events (TEAEs) per 100 patient years (PY) were summarized up to December 26, 2018. Efficacy was analyzed by randomized group.

Results: In total, 651, 651 and 327 patients were randomized at baseline to receive UPA, PBO, and ADA, respectively. Subsequently, 252 patients were switched from UPA to ADA, 159 were switched from ADA to UPA, and all PBO patients were switched to UPA. 1403 patients entered the LTE at Week 48 (UPA: 1091 [565 switched from PBO; 66 rescued from ADA; 460 on continued UPA]; ADA: 312 [110 rescued from UPA; 202 on continued ADA]). The cumulative exposures were 1396.7 and 515.1 PYs for UPA and ADA, respectively. UPA + MTX was generally well-tolerated as assessed by the frequency of AEs, including serious AEs, AEs leading to discontinuation of study drug, and AEs of special interest ([AESIs] including serious and opportunistic infections, malignancy, adjudicated major adverse cardiac events or venous thromboembolism; Figure 1). The event rates of AESIs were generally comparable between UPA + MTX and ADA + MTX, except for herpes zoster, lymphopenia, hepatic disorder, and CPK elevation, which were numerically higher with UPA + MTX. At both Weeks 60 and 72, significantly greater proportions of patient receiving UPA + MTX achieved ACR20/50/70 (P ≤.01/.001/.001), low disease activity (P ≤.001) and remission (P ≤.001) compared to those receiving ADA + MTX; Figure 2). Similarly, improvements in pain and function were significantly greater in the UPA vs ADA group through Week 72 (P ≤.01).

Conclusion: The safety profile for UPA + MTX was consistent with that reported previously and with the integrated Phase 3 safety analysis.1,2 UPA + MTX maintained significantly higher levels of clinical response, including remission compared to ADA + MTX through Week 72.

References: [1]Fleischmann R, et al. Annals of the Rheumatic Diseases. 2019;78:744-745.

[2]Cohen SB, et al. Thu0167. Annals of the Rheumatic Diseases. 2019;78:357.

Disclosure of Interests: : Roy Fleischmann Grant/research support from: AbbVie, Akros, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer, IngelhCentrexion, Eli Lilly, EMD Serono, Genentech, Gilead, Janssen, Merck, Nektar, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Samsung, Sandoz, Sanofi Genzyme, Selecta, Taiho, UCB, Consultant of: AbbVie, ACEA, Amgen, Bristol-Myers Squibb, Eli Lilly, Gilead, GlaxoSmithKline, Novartis, Pfizer, Sanofi Genzyme, UCB, In-Ho Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Jeffrey Enejosa Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Eduardo Mysler Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Roche, Eli Lilly, Novartis, Janssen, Sanofi, and Pfizer., Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Roche, Eli Lilly, Novartis, Janssen, Sanofi, and Pfizer, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Patrick Durez Speakers bureau: AbbVie, Bristol-Myers Squibb, Celltrion, Eli Lilly, Pfizer, Sanofi, Andrew Ostor Consultant of: MSD, Pfizer, Lilly, Abbvie, Novartis, Roche, Gilead and BMS, Speakers bureau: MSD, Pfizer, Lilly, Abbvie, Novartis, Roche, Gilead and BMS, Jerzy Swierkot Grant/research support from: AbbVie, Sandoz, Pfizer, Roche, BMS, UCB, MSD, Accord, Janssen, Consultant of: AbbVie, Sandoz, Pfizer, Roche, BMS, UCB, MSD, Accord, Janssen, Speakers bureau: AbbVie, Sandoz, Pfizer, Roche, BMS, UCB, MSD, Accord, Janssen, Yanna Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Mark C. Genovese Grant/research support from: Abbvie, Eli Lilly and Company, EMD Merck Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, Pfizer Inc., RPharm, Sanofi Genzyme, Consultant of: Abbvie, Eli Lilly and Company, EMD Merck Serono, Genentech/Roche, Gilead Sciences, Inc., GSK, Novartis, RPharm, Sanofi Genzyme

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