Pivotal safety and efficacy data for upadacitinib (Rinvoq) in patients with rheumatoid arthritis and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) was published on 2018-01-01. This publication makes detailed findings from the SELECT-NEXT study available to the broader scientific and clinical community.
Background
Upadacitinib, also known by its brand name Rinvoq and formerly designated as ABT-494, is a drug investigated for its role in treating rheumatoid arthritis. This condition is a chronic autoimmune inflammatory disorder primarily affecting joints, leading to pain, swelling, stiffness, and potential joint damage. The study specifically focused on patients who had an inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), highlighting a critical unmet need for alternative or more effective treatment options in this patient population.
Trial design
The published data pertains to the SELECT-NEXT study, which was a pivotal clinical trial. This study was designed to compare upadacitinib against a placebo. It enrolled adult participants diagnosed with rheumatoid arthritis who were already on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) but had shown an inadequate response to these prior treatments. The primary objective, as indicated by the publication, was to assess the safety and efficacy of upadacitinib in this specific patient population, providing crucial insights into its potential as a therapeutic option.
What this means
The publication of pivotal safety and efficacy data for upadacitinib represents a significant milestone in its development for rheumatoid arthritis. This event makes comprehensive study results accessible to clinicians, researchers, and patient advocates, allowing for thorough independent review and discussion. Such publications are essential for informing clinical practice, guiding future research, and supporting regulatory submissions, ultimately contributing to the evidence base for treatment decisions in patients with rheumatoid arthritis who have not adequately responded to conventional therapies.
Source
The information regarding the safety and efficacy of upadacitinib was published on 2018-01-01 in The Lancet, as referenced through PubMed. The article, titled "Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs," is available on pubmed.ncbi.nlm.nih.gov.