Upadacitinib is an investigational oral selective JAK1 inhibitor currently in Phase 3 clinical trials to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA) and Crohn’s disease.1 It is also being investigated to treat ulcerative colitis, ankylosing spondylitis, atopic dermatitis and giant cell arteritis.
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Results from the first phase of the ongoing SELET-COMPARE study have been announced. This 12 week, Phase 3, multicenter, randomized, double-blind study evaluated the efficacy and safety of upadacitinib.1 During the trial, 15 mg once-daily upadacitinib was compared with placebo and adalimumab in adult patients with moderate to severe RA receiving stable background methotrexate with an inadequate response. Patients receiving methotrexate were randomized 2:2:1 to receive 15 mg once-daily upadacitinib (n=651), placebo (n=651) or 40 mg adalimumab given as a subcutaneous injection every other week (n=327).
During this first phase, the study’s primary endpoints were the percentage of patients who achieve ACR20 and clinical remission (based on DAS28[CRP]) at Week 12 compared with placebo-treated patients. Secondary endpoints were a change in the modified total Sharp score; the percentage of patients who achieved ACR50, low disease activity, changes in pain measured by the Patient’s Assessment of Pain (based on VAS); and changes in physical function measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) for upadacitinib-treated patients compared with both placebo- and adalimumab-treated patients.