FDA Approves Upadacitinib (RINVOQ) for Treatment of Active Psoriatic Arthritis

The US Food and Drug Administration (FDA) has granted approval to upadacitinib (15 mg daily) for the treatment of adults with active psoriatic arthritis with inadequate response to at least 1 tumor necrosis factor (TNF) blocker.

Psoriatic arthritis, a systemic inflammatory disease, affects up to 30% of patients with psoriasis.

Backed by data from 2 Phase 3 studies, SELECT-PsA 1 and SELECT-PsA 2, the drug was shown to significantly reduce fatigue and improve skin manifestations, physical function, dactylitis, and enthesitis. Upadacitinib 15 mg met the primary endpoint of ACR20 by Week 12 in both trials (71% and 57%, respectively) when compared with placebo (36% and 24%, respectively). The drug also achieved higher ACR50 and ACR70 response rates (38% and 32%, respectively; 16% and 9%, respectively) when compared with placebo (13% and 5%, respectively; 2% and 1%, respectively).

No new safety concerns were reported, and results were consistent with existing indications for rheumatoid arthritis. The most common adverse reactions blood creatine phosphokinase elevations and respiratory tract infections.

About SELECT-PsA 1

Patients in SELECT-PsA 1, a multicenter, randomized, double-blind study, were randomized to take upadacitinib 15 mg, upadacitinib 30 mg, adalimumab 40 mg every other week, or placebo followed by upadacitinib 15 mg or 30 mg at Week 24.

In addition to ACR20, investigators analyzed changes from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI), the percentage of patients achieving a static Investigator Global Assessment (sIGA) of psoriasis of 0 or 1, radiographic progression, and those achieving Psoriasis Area Severity Index (PASI) 75 response at Week 16. Minimal Disease Activity (MDA) and changes in enthesitis and dactylitis at Week 24 were also observed.

About SELECT-PsA 2

Similar to SELECT-PsA 1, this multicenter, randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of the drug for patients with moderate-to-severe psoriatic arthritis. Patients in this group had an intolerance or inadequate response to 1 or more biologic disease-modifying antirheumatic drugs (DMARDs). Patients received upadacitinib 15 mg, upadacitinib 30 mg, or placebo followed by upadacitinib 15 mg or 30 mg at Week 24.

Secondary endpoints included changes in HAQ-DI at Week 12, ACR50 and ACR70 response rates at Week 12, PASI 75 at Week 16, and MDA at Week 24. The study is ongoing.

About upadacitinib

Upadacitinib, a selective JAK inhibitor developed by AbbVie, has shown greater efficacy in inhibiting JAK-1 vs JAK-2, JAK-3, and TYK-2. It is currently FDA-approved for adults with moderate-to-severe rheumatoid arthritis who have inadequate response or intolerance to at least 1 TNF blocker. The European Commission granted approval for adults with moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The organization also approved the drug for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate-to-severe atopic dermatitis.

What the approval means

"Many adults still struggle to find a treatment option that helps them lower their disease activity," Iain McInnes, MD, PhD, lead investigator of the SELECT-PsA 1 trial, stated. "With this FDA approval, RINVOQ has the potential to help more people find meaningful relief from the signs and symptoms of psoriatic arthritis that they see and feel and to help reach their treatment goals."