AbbVie has announced the publication of positive results from its pivotal Phase III SELECT-MONOTHERAPY clinical trial for moderately to severely active rheumatoid arthritis in The Lancet.
The drug evaluated, upadacitinib, was found to have achieved both primary endpoints with significantly higher rates of ACR20 response and low disease activity at week 14, compared to methotrexate.
Patients receiving either 15 mg or 30 mg of oral investigational JAK1-selective inhibitor also achieved significantly higher rates of clinical remission.
In the study, the safety profile of the monotherapy was consistent with previously reported Phase III SELECT clinical trials.
The data provided supports the potential for upadacitinib as an important treatment option for patients with rheumatoid arthritis.
Abbvie are “encouraged by the positive results published in The Lancet," said Alice Butler, UK medical director, AbbVie.
She contined, "Data from this study, the third of six in the SELECT clinical trial programme evaluating the potential for upadacitinib in rheumatoid arthritis, helps to deepen our understanding of JAK1-selective inhibition and the potential for monotherapy in this complex disease”
The drug gained Priority Review from the US Food and Drug Administration (FDA) back in February, after clinical trial data suggested that it could be more effective at treating rheumatoid arthritis than Abbvie’s blockbuster Humira.
Rheumatoid arthritis, which affects an estimated 400,000 people in the UK, is a chronic and debilitating disease. Methotrexate is commonly used as a first-line therapy in rheumatoid arthritis, but many patients do not respond to or cannot tolerate methotrexate, which puts them at risk for disease progression.