Positive results from Phase 3 SELECT-MONOTHERAPY trial published

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AbbVie has announced the publication of positive results from the pivotal Phase 3 SELECT-MONOTHERAPY clinical trial in The Lancet.

The study in 648 patients evaluates upadacitinib as a monotherapy treatment versus continuing methotrexate in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate.

After 14 weeks of treatment, both once-daily doses of upadacitinib met the study’s primary endpoints with significantly higher rates of ACR20 and low disease activity versus continuing stable methotrexate therapy.

Both doses also achieved all key secondary endpoints, including the proportion of patients achieving remission and improvements in physical function (defined as change in HAQ-DI from baseline).

Upadacitinib, an oral investigational JAK1-selective inhibitor, is not approved by regulatory authorities and its safety and efficacy have not been established.

Rheumatoid arthritis is a chronic and debilitating disease which affects an estimated 400,000 people in the UK. 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.

After inadequate response to methotrexate alone, methotrexate is commonly used as a background therapy with biologic DMARDs to optimise their efficacy.

Dr Josef S. Smolen, Department of Medicine, Division of Rheumatology, Medical University of Vienna, Austria, and first author on the publication, said: “These results show that upadacitinib as a monotherapy can provide clinically meaningful responses, including low disease activity, remission and significant improvements in physical function.

“Data from this study support the potential for upadacitinib as an important treatment option for patients with rheumatoid arthritis.”

Alice Butler, UK Medical Director, AbbVie, said: “We are encouraged by the positive results published in The Lancet. 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.”