Phase III SELECT-MONOTHERAPY trial data of ABT 494 in rheumatoid arthritis published in The Lancet.

AbbVie announced the publication of positive results from the pivotal Phase III SELECT-MONOTHERAPY clinical trial of ABT 494 (upadacitinib) in patients with moderately to severely active rheumatoid arthritis 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 (15 mg n=217 and 30 mg n=215) met the study's primary endpoints with significantly higher rates of ACR20 and low disease activity (LDA) versus continuing stable methotrexate therapy (n=216). 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. Results showed that after 14 weeks, 68 percent and 71 percent of patients who switched to upadacitinib monotherapy 15 mg and 30 mg at baseline, respectively, achieved ACR20 versus 41 percent of patients who continued to receive methotrexate therapy (p?0.0001 for both doses). Low disease activity was achieved by 45 percent of patients receiving upadacitinib 15 mg and 53 percent receiving upadacitinib 30 mg versus 19 percent receiving methotrexate (p<0.0001 for both doses) at week 14. The study also showed a significantly higher proportion of upadacitinib patients in both dose groups achieved clinical remission, ACR50 and ACR70 at week 14 compared to patients continuing on methotrexate.

See: "A Phase III Randomised, Placebo-controlled, Double-Blind Study of Upadacitinib as Monotherapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: SELECT-MONOTHERAPY." Smolen, J.S., et al. The Lancet. May 23, 2019 DOI: https://doi.org/10.1016/S0140-6736(19)30419-2.