AbbVie announces positive results from SELECT-PsA 1, a Phase 3 study of Rinvoq compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. The study met primary and key secondary endpoints.
SELECT-PsA 1 is a multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of Rinvoq compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. Patients were randomized to Rinvoq 15 mg, Rinvoq 30 mg, adalimumab (40 mg EOW) or placebo followed by either Rinvoq 15 mg or Rinvoq 30 mg at week 24. The primary endpoint was the percentage of subjects receiving Rinvoq 15 mg or 30 mg who achieved an ACR20 response after 12 weeks of treatment versus placebo. Ranked secondary endpoints included change from baseline in HAQ-DI at week 12, proportion of patients achieving PASI 75 at week 16 and proportion of patients achieving MDA at week 24.
Results show that at week 12, 71% and 79% of patients receiving 15 mg and 30 mg of Rinvoq achieved ACR20, respectively, compared to 36% of patients receiving placebo. 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% and 62% 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% on placebo. Minimal disease activity (MDA) at week 24 was achieved in 37% and 45% of 15 mg and 30 mg Rinvoq-treated patients, respectively, versus 12% of the placebo group.
Results from the SELECT-PsA 1 study will be presented at a future medical meeting and published in a peer-reviewed publication.
About Rinvoq (upadacitinib)
Rinvoq is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.
Rinvoq was approved by the U.S. FDA in 2019 for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Rinvoq was also approved by the European Commission in December 2019 for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
About Psoriatic arthritis
Psoriatic arthritis is a form of arthritis that affects some people who have psoriasis — a condition that features red patches of skin topped with silvery scales. Most people develop psoriasis first and are later diagnosed with psoriatic arthritis, but the joint problems can sometimes begin before skin patches appear. Joint pain, stiffness and swelling are the main signs and symptoms of psoriatic arthritis. They can affect any part of your body, including your fingertips and spine, and can range from relatively mild to severe. In both psoriasis and psoriatic arthritis, disease flares may alternate with periods of remission.Source: AbbVie