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Abstract Number: 2907

Clinical and Functional Outcomes Among Rheumatoid Arthritis Patients Switching Between JAK1-Selective Inhibitor Upadacitinib and Adalimumab Following Insufficient Response

Roy Fleischmann1, Mark Genovese 2, Ricardo Blanco 3, Stephen Hall 4, Glen Thomson 5, Filip Van den Bosch 6, Cristiano A. Zerbini 7, Jose Jeffrey Enejosa 8, Yihan Li 9, Ryan DeMasi 9 and In-Ho Song 8, 1Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, 2Stanford University, Stanford, CA, 3Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, IDIVAL, Santander, Spain, 4Monash University and Emeritus Research, Melbourne, Australia, 5CIADS Research, Winnipeg, Canada, 6Ghent University Hospital, Ghent, Belgium, 7Centro Paulista de Investigação Clinica, São Paulo, Brazil, 8AbbVie Inc., North Chicago, IL, USA, North Chicago, IL, 9AbbVie Inc., North Chicago, IL

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Adalimumab, Janus kinase (JAK), rheumatoid arthritis (RA) and Treatment Switch, Upadacitinib

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Session Information

Date: Wednesday, November 13, 2019

Session Title: 6W021: RA – Treatments V: Switching & Tapering RA Medications (2906–2911)

Session Type: ACR Abstract Session

Session Time: 11:00AM-12:30PM

Background/Purpose: The goal of RA treatment is to achieve clinical remission or, at minimum, low disease activity (LDA). Modification of initial csDMARD therapy with the addition of a biologic (b) DMARD, such as a tumor necrosis factor inhibitor (TNFi), or Janus Kinase inhibitor (JAKi) may be needed following an inadequate response (IR).1 Switches in mechanism of action have been advocated in TNF- and JAK-IR patients (pts); however, controlled data describing switches between JAKi and TNFi are lacking.

Methods: In a phase 3, double-blind study of the JAK1-selective inhibitor upadacitinib (UPA) 15 mg once daily vs PBO or adalimumab (ADA) 40 mg every other week in MTX-IR pts (all on background MTX), pts without ≥20% improvements from baseline (BL) in tender or swollen joint counts by wks 14, 18, or 22 [non-responders (NR)] were switched from UPA to ADA and vice versa in a blinded fashion and without washout. Pts who did not achieve LDA according to CDAI (CDAI ≤10) at wk 26 [partial-responders (PR)] were switched to the alternate treatment as above. Post-hoc analyses assessed clinical outcomes (Table 1) at 3m(onth) and 6m (±2 wks) post-switch. Adverse events (AEs) were summarized as n% through 3m and 6m post-switch. Data were as observed.

Results: In total, 651 and 327 pts were randomized to receive UPA and ADA. 252 pts were switched from UPA to ADA (39%, NR:126; PR:126), and 159 were switched from ADA to UPA (49%, NR:77; PR:82) (Figure). At 6m post-switch, DAS28(CRP) < 2.6/CDAI ≤2.8 were achieved by 21%/5% of UPA to ADA pts, and 40%/41% achieved DAS28(CRP) ≤3.2/CDAI ≤10. In pts who switched from ADA to UPA, 35%/15% achieved DAS28(CRP) < 2.6/CDAI ≤2.8 and 56%/53% achieved DAS28(CRP) ≤3.2/CDAI ≤10 at 6m post-switch. ACR20/50/70 (based on original BL) after switch are shown in Table 1. Mean change from the original BL in HAQ-DI were -0.58 and -0.73 for pts switching from UPA to ADA and ADA to UPA, respectively. The safety profiles of all pts who switched treatments appeared consistent with those observed for ADA and UPA during comparable periods. During 3m post-switch, the proportions (n%) of pts with serious AEs were 2.4% and 3.8% in the UPA-ADA and ADA-UPA groups, respectively; while serious infections were reported in 0.8% in the UPA-ADA group and in 2.5% in the ADA-UPA group. Safety at 6m overall was comparable to 3m post-switch (Table 2).

Conclusion: Data from this blinded, controlled study indicate that pts with initial insufficient response, either non-response or partial response, to either UPA or ADA may benefit from switching to the other therapy. No additional safety concerns were observed. These data suggest that a patient failing either UPA or ADA may respond to the alternate therapy.

References:

  1. Singh, et al. Arthritis Rheumatol, 2016;68:1-26.


Table 1


Table 2


Disclosure: R. Fleischmann, AbbVie, 2, 5, Acea, 2, 5, Akros, 5, Amgen, 2, 5, AstraZeneca, 2, 5, BMS, 2, 5, Bristol‐Myers Squibb, 2, 5, Bristol-Myers Squibb, 2, 5, Celgene, 2, 5, Celltrion, 5, Celtrion, 2, 5, Centrexion, 2, Eli Lilly, 2, 5, Eli Lilly and Company, 2, 5, EMD Merck-Serono, 2, 5, EMD Serono, 2, EMD-Serano, 2, EMD-Serono, 2, Genentech, 2, 5, Genetech, 2, GlaxoSmithKline, 2, 5, GSK, 2, 5, Janssen, 2, 5, Lilly, 2, 5, Merck, 2, Nektar, 2, Novartis, 2, 5, Pfizer, 2, 5, Pfizer Inc, 2, 5, Regeneron, 2, Resolve, 2, Roche, 2, Samsung, 5, Sandoz, 5, Sanofi Genzyme, 2, Sanofi‐Aventis, 2, 5, Sanofi-Aventis, 2, 5, Sanofi-Genzyme, 2, Selecta, 2, Tahio, 5, Taiho, 5, UCB, 2, 5; M. Genovese, AbbVie, 2, 5, Abbvie, 2, 5, AbbVie, Inc., 9, Astellas, 2, 5, Eli Lilly, 2, 5, Eli Lilly and Company, 2, 5, EMD Merck Serono, 2, 5, Galapagos, 2, 5, Galapagos NV, 2, 5, 9, Genentech/Roche, 2, 5, Gilead, 2, 5, Gilead Science, 9, Gilead Sciences, Inc., 2, 5, 9, GSK, 5, Lilly, 2, 5, 9, Novartis, 2, 5, Pfizer, 2, 5, 9, Pfizer Inc, 2, 5, Pfizer, Inc., 9, Pzier, 9, RPharm, 5, Sanofi Genzyme, 2, 5, Vertex, 2, 5; R. Blanco, AbbVie, 2, 5, 8, AbbVie, MSD, Roche, Pfizer, Bristol-Myers, Janssen., 2, 8, Bristol-Myers Squibb, 5, 8, Janssen, 5, 8, MSD, 2, 5, 8, Pfizer, 5, 8, Roche, 2, 5, 8; S. Hall, AbbVie, 2, 5, BMS, 2, 5, Eli Lilly, 2, 5, Janssen, 2, 5, Lilly, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5, UCB Pharma, 2, 5; G. Thomson, AbbVie, 2, Amgen, 5; F. Van den Bosch, AbbVie, 5, 8, Abbvie, 5, 8, AbbVie, Bristol-Myers Squibb, Celgene, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sanofi and UCB, 5, 8, ABBVIE, CELGENE, ELI LILLY, GALAPAGOS, MERCK, NOVARTIS, PFIZER, VCB, 5, 8, Bristol-Myers Squibb, 2, 5, 8, Celgene, 5, 8, Eli Lilly, 5, 8, Galapagos, 5, 8, Janssen, 5, 8, Merck, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Sanofi, 5, 8, UCB, 5, 8; C. Zerbini, Amgen, 2, Amgen, GSK, Lilly, Merck, Novartis, Pfizer, Sanofi-Aventis, Servier and Roche, 2, Lilly, 2, Merck, Pfizer, Sanofi-Aventis, 5, 8, Pfizer, 2, Sanofi, 2; J. Enejosa, AbbVie, 3, 4, Abbvie Inc, 1, 4; Y. Li, AbbVie, 3, 4; R. DeMasi, AbbVie Inc., 1, 3, 4; I. Song, AbbVie, 3, 4.

To cite this abstract in AMA style:

Fleischmann R, Genovese M, Blanco R, Hall S, Thomson G, Van den Bosch F, Zerbini C, Enejosa J, Li Y, DeMasi R, Song I. Clinical and Functional Outcomes Among Rheumatoid Arthritis Patients Switching Between JAK1-Selective Inhibitor Upadacitinib and Adalimumab Following Insufficient Response [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/clinical-and-functional-outcomes-among-rheumatoid-arthritis-patients-switching-between-jak1-selective-inhibitor-upadacitinib-and-adalimumab-following-insufficient-response/. Accessed August 9, 2022.
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