Upadacitinib Demonstrates Positive Outcomes as Monotherapy in Rheumatoid Arthritis

Rheumatoid arthritis patients who failed first-line methotrexate achieved better outcomes with upadacitinib monotherapy, shows a new clinical trials report. (©UnguryanuShutterstock.com)

Rheumatoid arthritis patients who failed first-line methotrexate achieved better outcomes with upadacitinib monotherapy, shows a new clinical trials report.

In a study published in a recent issue of The Lancet, investigators found patients can safety switch to upadacitinib alone from methotrexate. As a result, they can experience greater disease activity control.

“Upadacitinib monotherapy was associated with significant improvement in multiple measures of disease outcomes, while having a safety profile consistent with previously reported findings,” says study author Josef Smolen, M.D., chair of rheumatology for the Medical University of Vienna in Austria. “This favorable benefit-risk profile of upadacitinib monotherapy has the potential to provide a treatment option for patients who are intolerant to methotrexate or who prefer a treatment without the need for concomitant csDMARDs.”

To test the safety and efficacy of upadacitinib, researchers divided 648 patients with active rheumatoid arthritis, despite stable methotrexate use, into groups of patients assigned once-daily extended-release 15 mg or 30 mg upadacitinib or to continue the previous methotrexate dose as a blinded study drug followed by 15 mg or 30 mg upadacitinib doses. Patients received no csDMARDs other than methotrexate.

After 14 weeks, according to study results, patients receiving upadacitinib monotherapy saw better results than patients receiving methotrexate. Based on findings, 68 percent of patients receiving 15mg upadacitinib and 71 percent of those receiving 30 mg upadacitinib achieved greater improvement in disease activity. Only 41 percent of methotrexate patients did so.

Patients taking upadacitinib also reported better physical function and quality of life.

The incidence of adverse events was roughly the same among upadacitinib and methotrexate patients. Approximately 47-49 percent of patients experienced an event in all three groups with infections being the most common problem.

Ultimately, researchers said, because results were similar between the 15 mg and 30 mg upadacitinib doses, clinicians will need to review individuals patients cases to determine the best treatment route when methotrexate fails to provide improvement.

REFERENCE:

Smolen J, Pangan A, Emery P, et al. “Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomized, placebo-controlled, double-blind phase 3 study.”The Lancet(2019), doi: 10.1016/S0140-6736(19)30419-2