The Phase 3 study evaluated RINVOQ for active psoriatic arthritis in adult patients who are intolerant to one or more non-biologic DMARDs
AbbVie’s RINVOQ show positive results in Phase 3 clinical trial on psoriatic arthritis patients. (Credit: AbbVie Inc.)
Us-based biopharmaceutical firm AbbVie has unveiled positive results from the Phase 3 SELECT-PsA 1 clinical trial of RINVOQ (upadacitinib) in adult patients with active psoriatic arthritis.
RINVOQ is a selective and reversible JAK inhibitor discovered and developed by AbbVie. The drug has been evaluated as a treatment for active psoriatic arthritis in adult patients who are intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs), in the current study.
In addition, RINVOQ has been previously investigated in various clinical studies, as a therapy for psoriatic arthritis and multiple immune-mediated inflammatory diseases.
AbbVie vice chairman and president Michael Severino said: “Patients living with psoriatic arthritis often suffer from joint pain, stiffness and fatigue, impacting their ability to work and lead a physically active life. The results of this large Phase 3 study further support the potential of RINVOQ to help these patients.
“We look forward to sharing these data with regulatory bodies around the world to support our application for label expansion for RINVOQ to include adult patients with active psoriatic arthritis.”
The Phase 3 study of RINVOQ has met both primary and secondary end-points
SELECT-PsA 1 is a Phase 3, multicentre, randomised, double-blind, active and placebo-controlled clinical study, aimed at evaluating the safety and efficacy of RINVOQ, compared to placebo and adalimumab in adult patients with active psoriatic arthritis, and who are intolerant to at least one non-biologic DMARD.
AbbVie said that the Phase 3 study has reached the primary endpoint of ACR20 response at week 12, compared to placebo in adult patients with active psoriatic arthritis.
In addition, the drug has also demonstrated considerable improvements in signs and symptoms of the disease across a variety of endpoints in the study, compared to placebo.
University of Glasgow institute of infection, immunity and inflammation professor Iain McInnes said: “The results of SELECT-PsA 1 showed that both doses of upadacitinib demonstrated significantly greater efficacy in joint and skin symptoms, as well as inhibition of radiographic progression, compared to placebo.
“These data are encouraging and add to the growing body of evidence that upadacitinib has the potential to improve outcomes for people living with psoriatic arthritis.”