Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double‐Blind, Randomized Controlled Trial

Objective To evaluate the efficacy, including capacity for inhibition of radiographic progression, and safety of upadacitinib, a JAK1‐selective inhibitor, as compared to placebo or adalimumab in patients with rheumatoid arthritis (RA) who have experienced an inadequate response to methotrexate (MTX)...

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Published in:Arthritis & rheumatology (Hoboken, N.J.) N.J.), 2019-11, Vol.71 (11), p.1788-1800
Main Authors: Fleischmann, Roy, Pangan, Aileen L., Song, In‐Ho, Mysler, Eduardo, Bessette, Louis, Peterfy, Charles, Durez, Patrick, Ostor, Andrew J., Li, Yihan, Zhou, Yijie, Othman, Ahmed A., Genovese, Mark C.
Format: Article
Language:English
Subjects:
Adalimumab - therapeutic use
Adult
Aged
Antirheumatic Agents - therapeutic use
Arthritis
Arthritis, Rheumatoid - diagnostic imaging
Arthritis, Rheumatoid - drug therapy
Arthritis, Rheumatoid - physiopathology
Creatine
Creatine kinase
Creatine Kinase - metabolism
Double-Blind Method
Double-blind studies
Drug Therapy, Combination
Evaluation
Female
Health risk assessment
Herpes zoster
Herpes Zoster - epidemiology
Heterocyclic Compounds, 3-Ring - therapeutic use
Humans
Immunotherapy
Infections - epidemiology
Janus kinase
Janus Kinase Inhibitors - therapeutic use
Joint diseases
Male
Methotrexate
Methotrexate - therapeutic use
Middle Aged
Monoclonal antibodies
Pain
Randomization
Remission
Rheumatoid arthritis
Safety
Severity of Illness Index
Signs and symptoms
Thromboembolism
TNF inhibitors
Venous Thromboembolism - epidemiology
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Summary:Objective To evaluate the efficacy, including capacity for inhibition of radiographic progression, and safety of upadacitinib, a JAK1‐selective inhibitor, as compared to placebo or adalimumab in patients with rheumatoid arthritis (RA) who have experienced an inadequate response to methotrexate (MTX). Methods In total, 1,629 RA patients with an inadequate response to MTX were randomized (2:2:1) to receive upadacitinib (15 mg once daily), placebo, or adalimumab (40 mg every other week) while continuing to take a stable background dose of MTX. The primary end points were achievement of an American College of Rheumatology 20% (ACR20) improvement response and a Disease Activity Score in 28 joints using C‐reactive protein level (DAS28‐CRP) of
ISSN:2326-5191
2326-5205
DOI:10.1002/art.41032