Drug successful in phase III clinical trial
An international research group led by Charité – Universitätsmedizin Berlin has completed testing a new drug to treat rheumatoid arthritis. The drug is effective in patients with moderate to severe forms of the disease who have shown an inadequate response to conventional disease modifying drugs. Results from this research have been published in The Lancet*.
Rheumatoid arthritis is a painful inflammatory condition affecting the joints and tendons, which is typically characterized by periods of increased disease activity. Prof. Dr. Gerd-Rüdiger Burmester, Head of Charité’s Medical Department, Division of Rheumatology and Clinical Immunology, conducted a study to assess the efficacy of upadacitinib in patients with an inadequate response to ‘conventional synthetic disease-modifying antirheumatic drugs’. Upadacitinib is a selective inhibitor of the enzyme Janus kinase 1 (JAK1) and has been shown to be efficacious in this patient group in earlier phase II clinical trials. By inhibiting JAK1, upadacitinib disrupts an important signaling pathway that is responsible for triggering inflammatory responses.
In the phase III study presented, patients treated with upadacitinib showed significant improvements in joint swelling when compared to patients receiving placebo. Patients also experienced less pain and showed improvements in joint function. Prof. Burmester is very pleased to see this new tablet-based treatment produce such significant improvements in clinical symptoms. “Our results prove that JAK inhibitors represent an effective treatment alternative in patients with long-term conditions who do not respond adequately to conventional drugs, and in those for whom biologics are not a good treatment option. JAK inhibitors could help these patients achieve a quick response to treatment, allowing them to gain control over their illness. The trial sponsor AbbVie is currently in the process of collating all trial results and submitting them to the European and US regulatory authorities for review.”
*Burmester GR, et al. Safety and efficacy of upadacitinib in patients
with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet. 2018 Jun 23;391(10139):2503-2512. DOI: 10.1016/S0140-6736(18)31115-2.
Original article in The Lancet (abstract)
Prof. Dr. Gerd-Rüdiger Burmester
Head of the Department of Rheumatology and Clinical Immunology
Charité – Universitätsmedizin Berlin
t: +49 30 450 513 061
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