Upadacitinib Yields Positive Phase 3 Study Results in Psoriatic Arthritis
The SELECT-PsA phase 3 study is the first to evaluate the efficacy and safety of upadacitinib in adult patients with active psoriatic arthritis.
Both doses of upadacitinib (Rinvoq, Abbvie) have met the primary endpoint of American College of Rheumatology 20 (ACR20) response at 12 weeks compared with a placebo in adult patients with active psoriatic arthritis (PsA) who have responded inadequately to 1 or more biologic disease modifying anti-rheumatic drugs.
Positive top-line data were taken from the SELECT-PsA phase 3 study, the first to evaluate the efficacy and safety of upadacitinib in adult patients with active PsA. Patients with active PsA on both doses of upadacitinib (15 mg and 30 mg, once daily) achieved significantly greater responses compared with a placebo for all ranked secondary endpoints.
The SELECT-PsA phase 3 study found that at week 12, approximately 57% and 64% of patients receiving either 15 mg or 30 mg of upadacitinib, respectively, achieved ACR20 compared with 24% of patients given a placebo. ACR20 is defined by an improvement of 20% in the number of tender and swollen joints, according to the company press release.
Additionally, ACR50 was achieved by 32.38% of patients receiving either 15 mg or 30 mg compared with 5% of patients on placebo. Finally, 9% and 17% of patients achieved ACR70 with 15 mg or 30 mg of upadacitinib, respectively, compared with 0.5% of patients in the placebo group.
Patients receiving upadacitinib also had greater improvements in physical function at week 12, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Approximately 52% and 57% of patients receiving 15 mg or 30 mg of upadacitinib, respectively, achieved a 75% improvement in the Psoriasis Area Severity Index (PASI 75) compared with 16% of patients with a placebo.
According to Mayo Clinic, PsA is a form of arthritis that affects certain patients with psoriasis. Joint pain, stiffness, and swelling are the main signs and symptoms of PsA. Upadacitinib is a selective and reversible JAK inhibitor being studied as a once-daily therapy in PsA and multiple immune-mediated diseases.
Through week 28, serious infections occurred in approximately 0.5% and 2.8% of patients receiving either 15 mg or 30 mg of upadacitinib, respectively, compared with 0.5% receiving a placebo. There was 1 pulmonary embolism reported in the group receiving 15 mg of upadacitinib and none in the patients receiving 30 mg or placebo.
- RINVOQ™ (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis [press release]. Abbvie News Center. Published October 31, 2019. https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-meets-primary-and-all-ranked-secondary-endpoints-in-phase-3-study-in-psoriatic-arthritis.htm. Accessed October 31, 2019.
- Psoriatic Arthritis. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed October 31, 2019.