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

@article{Fleischmann2019UpadacitinibVP,
  title={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},
  author={Roy M. Fleischmann and Aileen L. Pangan and I. H. Song and Eduardo Mysler and Louis Bessette and Charles G. Peterfy and Patrick Durez and Andrew J. K. Ostor and Yihan Li and Yijie Zhou and Ahmed A. Othman and Mark C. Genovese},
  journal={Arthritis \& Rheumatology},
  year={2019},
  volume={71}
}
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). 
Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate‐Naive Patients With Moderately‐to‐Severely Active Rheumatoid Arthritis (SELECT‐EARLY): A Multicenter, Multi‐Country, Randomized, Double‐Blind, Active Comparator–Controlled Trial
The SELECT‐EARLY trial was undertaken to study the effect of upadacitinib, an oral, reversible Janus kinase 1–selective inhibitor, as monotherapy in patients with predominantly early rheumatoid
Upadacitinib versus placebo or adalimumab with background methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate: a subgroup analysis of a phase III randomized controlled trial in Central and Eastern European patients
TLDR
Consistent with the global population of patients with rheumatoid arthritis and an inadequate response to MTX, in CEE patients, upadacitinib 15 mg demonstrated clinical and functional improvements versus placebo and adalimumab, radiographic improvements versus Placebo, and reasonable safety, over 48 weeks.
Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial
TLDR
Filgotinib improved RA signs and symptoms, improved physical function, inhibited radiographic progression and was well tolerated in patients with RA with inadequate response to MTX, and was non-inferior to adalimumab.
Benefit–Risk Analysis of Upadacitinib Compared with Adalimumab in the Treatment of Patients with Moderate-to-Severe Rheumatoid Arthritis
TLDR
In patients with active RA despite MTX use, UPA demonstrated an incremental achievement of clinical outcomes compared to ADA together with a similar profile of AESIs with ADA (with the exception of herpes zoster).
Efficacy and Safety of PF‐06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor, in Patients With Moderate‐to‐Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate
To evaluate the efficacy and safety of PF‐06651600 (ritlecitinib), an irreversible inhibitor of JAK3 and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family, in comparison
A review of upadacitinib in rheumatoid arthritis
TLDR
The purpose of this article is to provide a comprehensive review of upadacitinib, including preclinical development and characterization, phase I and II studies, and the phase III SELECT program.
Clinical Pharmacokinetics of Upadacitinib: Review of Data Relevant to the Rheumatoid Arthritis Indication
TLDR
Clinical pharmacokinetic data available to date that supported the clinical development program in RA and ultimately regulatory applications for upadacitinib in treatment of patients with moderate to severe RA are reviewed.
Upadacitinib: First Approval
TLDR
This article summarizes the milestones in the development of upadacitinib leading to this first approval for the treatment of rheumatoid arthritis.
Upadacitinib in rheumatoid arthritis: a profile of its use
TLDR
Across phase 3 trials in patients with RA, once-daily upadacitinib treatment was generally well tolerated and associated with rapid and clinically relevant disease remission or low disease activity when administered as monotherapy or in combination conventional synthetic DMARDs (csDMARDs), including in patients who were intolerant to or had an inadequate response to prior csDMARDSs or biological DMARD (bDMARD) therapy.
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This study enrolled adults who fulfilled the 2010 American College of Rheumatology (ACR)-European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis and evaluated the safety and efficacy of upadacitinib monotherapy after switching from methotrexate versus continuing metotrexate in patients with inadequate response to methot Rexate.
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TLDR
In this 52-week trial, adalimumab was more effective than placebo at inhibiting the progression of structural joint damage, reducing the signs and symptoms, and improving physical function in patients with active RA who had demonstrated an incomplete response to MTX.
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