Positive Topline Results in Phase 3 Trial for Upadactinib for Psoriatic Arthritis
Upadactinib met the primary endpoint for patients with active psoriatic arthritis who had responded inadequately or were intolerant to 1 or more non-biologic disease modifying anti-rheumatic drugs.
Positive top-line results have been released from the phase 3 SELECT-PsA 1 clinical trial. Upadactinib 15 mg and 30 mg met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis (PsA) who have responded inadequately or are intolerant to 1 or more non-biologic disease modifying anti-rheumatic drugs.
Upadactinib also demonstrated significant improvements in the signs and symptoms of PsA across a variety of endpoints compared with placebo. It is currently being studied as a once-daily therapy for patients with PsA and multiple immune-mediated inflammatory diseases.
"Patients living with psoriatic arthritis often suffer from joint pain, stiffness and fatigue, impacting their ability to work and lead a physically active life," said Michael Severino, MD, vice chairman and president, AbbVie, in a press release. "The results of this large phase 3 study further support the potential of [upadactinib] 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 [upadactinib] to include adult patients with active psoriatic arthritis."
Results from the SELECT-PsA 1 clinical trial show that at week 12, 71% and 79% of participants receiving 15 mg and 30 mg of upadactinib, respectively, achieved ACR20, compared with 36% of patients receiving placebo. Additionally, both doses achieved non-inferiority and only the 30 mg dose showed superiority in terms of ACR20 response at week 12 versus adalimumab.
ACR50 at week 12 was achieved by 38% and 52% of participants receiving 15 mg and 30 mg of upadactinib, respectively, compared with 13% of patients receiving placebo. In addition, 16% and 25% of patients receiving 15 mg and 30 mg of upadactinib, respectively, achieved ACR70 at week 12 compared with 2% of the placebo group
Patients receiving upadactinib had greater improvements in physical function at week 12. Upadactinib showed improvement in skin symptoms at week 16, with 63% and 62% of patients receiving 15 mg and 30 mg of upadactinib, respectively, achieving a 75% improvement in the Psoriasis Area Severity Index.
"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 with 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,” said Iain McInnes, FRCP, PhD, professor at the University of Glasgow Institute of Infection, Immunity, and Inflammation, in a press release.
RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis [news release]. Biospace website. Published February 5, 2020. https://www.biospace.com/article/releases/rinvoq-upadacitinib-meets-primary-and-key-secondary-endpoints-in-phase-3-study-in-psoriatic-arthritis/. Accessed February 5, 2020.