Phase III SELECT-COMPARE clinical trial of ABT 494 in rheumatoid arthritis published in Arthritis and Rheumatology journal

AbbVie announced the publication of positive results from the pivotal Phase III SELECT-COMPARE clinical trial of ABT 494 (upadacitinib) in Arthritis and Rheumatology. The study evaluates upadacitinib compared to placebo and adalimumab in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate (MTX), and remain on a stable background of MTX. Data show that at 12 weeks, patients receiving a once-daily dose of upadacitinib (15mg, n=651 met the primary endpoints with significantly higher rates of ACR20 response (71%) and clinical remission (29%) versus patients receiving placebo (36% and 6% respectively, n=651, p?0.001 for both endpoints).

All key secondary endpoints were also achieved, including significantly higher rates of ACR50 response, in patients receiving upadacitinib versus placebo or adalimumab [n=327] in combination with methotrexate at week 12. Upadacitinib-treated patients showed significant improvements from baseline compared to patients receiving adalimumab in reduction of pain [-32.1 versus -25.6], as measured by the Visual Analog Scale (VAS), and improvements in physical function [0.60 versus -0.49] , as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), at week 12. Primary and secondary endpoints met at week 12 were maintained through 26 weeks, including significantly higher rates of low disease activity and clinical remission achieved in patients receiving upadacitinib plus MTX than those receiving adalimumab plus MTX and placebo plus MTX, respectively.

At week 12, an additional efficacy endpoint also demonstrated a significantly higher proportion of patients receiving upadacitinib plus MTX achieved low disease activity (45%) and remission (29%) versus adalimumab plus MTX (29% and 18% respectively). This was maintained through week 26 when upadacitinib was also shown to significantly inhibit radiographic progression, as measured by a mean change from baseline in modified Sharp score (mTSS), versus placebo. The overall safety profile of upadacitinib was similar to adalimumab, except for higher rates of herpes zoster and CPK elevations with upadacitinib. No new safety signals were reported compared to previously reported Phase III studies.

See: "Upadacitinib versus Placebo or Adalimumab in Rheumatoid Arthritis: Results of a Phase 3, Double-Blind, Randomized Controlled Trial." Fleischmann, R, et al. Arthritis and Rheumatology. 2019.