Phase III SELECT-PsA 1 study of Rinvoq shows positive top-line results in psoriatic arthritis.- AbbVie

AbbVie announced positive top-line results from the Phase III SELECT-PsA 1 clinical trial. In this study, both doses of Rinvoq (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who have responded inadequately or are intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs). Rinvoq also demonstrated significant improvements in signs and symptoms of the disease across a variety of endpoints compared to placebo. Rinvoq, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily therapy in psoriatic arthritis and multiple immune-mediated inflammatory diseases. Results show that at week 12, 71 percent and 79 percent of patients receiving 15 mg and 30 mg of Rinvoq achieved ACR20, respectively, compared to 36 percent of patients receiving placebo. In terms of ACR20 response at week 12 versus adalimumab, both Rinvoq doses achieved non-inferiority and only the 30 mg dose showed superiority. ACR50 at week 12 was achieved by 38 percent and 52 percent of patients receiving 15 mg and 30 mg of Rinvoq, respectively, compared to 13 percent of patients receiving placebo. In addition, 16 percent and 25 percent of patients receiving 15 mg and 30 mg of Rinvoq achieved ACR70, respectively, at week 12 compared to 2 percent of the placebo group. Patients receiving Rinvoq also had greater improvements in physical function at week 12, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Patients in the 15 mg and 30 mg Rinvoq groups reported a -0.42 and -0.47 change from baseline in HAQ-DI score, respectively, compared to -0.14 on placebo. Rinvoq also showed improvement in skin symptoms at week 16, with 63 percent and 62 percent of patients receiving 15 mg and 30 mg of Rinvoq achieving a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75), respectively, compared to 21 percent on placebo. Minimal disease activity (MDA) at week 24 was achieved in 37 percent and 45 percent of 15 mg and 30 mg Rinvoq-treated patients, respectively, versus 12 percent of the placebo group.