Patient-Reported Outcomes of Upadacitinib versus Adalimumab Use in Patients with Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate: 26-Week Analysis of a Phase 3 Study

Roy Fleischmann¹, Martin Bergman ², Namita Tundia ³, In-Ho Song ⁴, Jessica Suboticki ⁴, Yan Song ⁵ and Vibeke Strand ⁶, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Drexel University College of Medicine, Stockholm, Sweden, ³AbbVie Inc., North Chicago, IL, ⁴AbbVie Inc., North Chicago, IL, USA, North Chicago, IL, ⁵Analysis Group, Inc., Boston, MA, ⁶Division of Immunology/Rheumatology, Stanford University, Stanford, CA

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Janus kinase (JAK), patient-reported outcome measures, physical function, quality of life and rheumatoid arthritis, treatment

Session Information

Date: Monday, November 11, 2019

Title: RA – Diagnosis, Manifestations, & Outcomes Poster II: Treatments, Outcomes, & Measures

Session Type: Poster Session (Monday)

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

Background/Purpose: In patients with active rheumatoid arthritis (RA), 12-week treatment with upadacitinib (UPA) while on background MTX therapy resulted in significant and clinically meaningful improvements in patient-reported outcomes (PROs) compared with placebo (PBO); these improvements with UPA treatment also met or were superior to adalimumab (ADA) treatment.¹ The current analysis evaluated the potential long-term benefits of UPA versus ADA with background MTX on PROs in patients with active RA.

Methods: SELECT-COMPARE (NCT02629159) is an ongoing Phase 3, randomized, double-blind study where patients with moderately to severely active RA and inadequate responses to MTX received UPA 15 mg once daily (QD), ADA 40 mg every other week (EOW), or PBO while on background MTX therapy. PROs included: Patient Global Assessment of Disease Activity (PtGA), pain by visual analog scale (VAS), HAQ-DI, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and duration and severity of morning (AM) stiffness. The data cutoff for this analysis was July 6, 2018. Mean changes from baseline and 95% confidence intervals (CIs) were calculated for each PRO at Week 26. The percentages of patients who continued to report improvements ≥ minimum clinically important differences (MCID) in PRO scores at Week 26 were calculated based on those with MCID improvements at Week 12.

Results: Patients treated with UPA or ADA reported clinically meaningful changes from baseline in all PtGA, pain VAS, HAQ, FACIT-F, and duration and severity of AM stiffness at Week 26 (Table). Higher proportions of patients receiving UPA (74% to 84% of patients) continued to have clinically meaningful responses from Weeks 12 to 26 than with ADA (66% to 70% of patients; all P values < 0.05 except FACIT-F).

Conclusion: Clinically meaningful improvements in physical function, pain, fatigue, and AM stiffness were reported by patients with inadequate response to methotrexate with active RA at Week 12 which continued over 26 weeks with UPA 15 mg QD or ADA 40 mg EOW, with higher proportions maintaining these responses with UPA 15mg QD than ADA 40 mg EOW.

References: 1. Strand V, et al. Poster FRI0137 presented at EULAR 2019; Madrid, Spain.

Medical writing services provided by Emily Mercadante of JK Associates, Inc. (a member of Fishawack Group of Companies; Conshohocken, PA) and funded by AbbVie.

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. Bergman, Abbvie, 5, 8, AbbVie, 5, 8, AbbVie, BMS, Celgene Corporation, Genentech, Janssen, Merck, Novartis, Pfizer, Sanofi, 5, AbbVie, Celgene Corporation, Novartis, Pfizer, Sanofi, 8, Amgen, 5, 8, BMS, 5, 8, Celgene, 5, 8, Genentech, 5, Genentech/Roche, 5, 8, Genentech-Roche, 5, Gilead, 5, GlaxoSmithKline, 8, GSK, 8, Horizon, 5, Janssen, 5, 8, JNJ (parent of Janssen), 1, JNJ stock, 1, Johnson & Johnson, 1, 4, Johnson and Johnson, 1, Merck, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Sandoz, 5, Sanofi, 5, 8, Sanofi/Regeneron, 5, 8, Sanofi-Regeneron, 5, 8; N. Tundia, AbbVie, 1, 3; I. Song, AbbVie, 3, 4; J. Suboticki, AbbVie, 1, 3, 4; Y. Song, Analysis Group, Inc., 3, 9; V. Strand, Abbvie, 5, AbbVie, 5, Amgen, 5, Amgen, Abbvie, Bayer, BMS, Boehringer Ingelheim, Celltrion, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, UCB, 5, AstraZeneca, 5, AURA, 8, Bayer, 5, BMS, 5, Boehringer Ingelheim, 5, Celgene, 5, Celltrion, 5, Cleveland Clinic, 8, CORRONA, 5, Crescendo, 5, Crescendo Bioscience, 5, Eli Lilly, 5, EMD Serono, 5, Genentech, 5, GlaxoSmithKline, 5, GSK, 5, Horizon, 5, Inmedix, 5, Janssen, 5, Kezar, 5, Lilly, 5, Merck, 5, NACCME, 8, Novartis, 5, Pfizer, 5, Purdue, 8, RA Forum, 8, RAN, 8, Regeneron, 5, Roche, 5, Samsung, 5, Sandoz, 5, Sanofi, 5, Servier, 5, Setpoint, 5, SLRA, 8, UCB, 5, Up to Date, 7, Washington University, 8, WIR, 8, WRA, 8.

To cite this abstract in AMA style:

Fleischmann R, Bergman M, Tundia N, Song I, Suboticki J, Song Y, Strand V. Patient-Reported Outcomes of Upadacitinib versus Adalimumab Use in Patients with Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate: 26-Week Analysis of a Phase 3 Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/patient-reported-outcomes-of-upadacitinib-versus-adalimumab-use-in-patients-with-moderately-to-severely-active-rheumatoid-arthritis-and-an-inadequate-response-to-methotrexate-26-week-analysis-of-a-ph/. Accessed .

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