Phase III SELECT-MONOTHERAPY trial of ABT 494 shows benefits at 14 weeks in rheumatoid arthritis.- AbbVie.

AbbVie announced new patient-reported outcomes data from the ongoing Phase III SELECT-MONOTHERAPY trial evaluating ABT 494 (upadacitinib) (15 mg and 30 mg, once-daily), an investigational JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate. Improvements in physical function, health-related quality of life, pain and morning joint stiffness were reported after 14 weeks of treatment with upadacitinib monotherapy compared to patients continuing methotrexate.

Results from a separate, exploratory analysis evaluating the association between patient-reported outcomes and clinical outcomes will be presented at ACR and show that achieving substantial improvements in pain, physical function and fatigue were associated both with individual physician-derived measures and with composite disease outcomes such as ACR20/50/70, clinical remission and low disease activity. The analysis demonstrated how the use of patient-reported outcomes in clinical trials provides critical insight into the impact of rheumatoid arthritis on patients. The analysis included a diverse patient population with difficult-to-treat disease, refractory to biologics and conventional synthetic DMARDs, such as methotrexate, who were enrolled in the Phase III SELECT-NEXT, SELECT-BEYOND (both studies with background csDMARDs) and SELECT-MONOTHERAPY clinical trials. These results will be presented at the 2018 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting.