December 15, 2021
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FDA approves Rinvoq for patients with active psoriatic arthritis

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The FDA has approved Rinvoq, a 15-mg, once-daily oral JAK inhibitor, for the treatment of adults with active psoriatic arthritis who have had an inadequate response, or intolerance to, TNF inhibitors, according to an AbbVie press release.

Rinvoq (upadacitinib) had received European Commission approval in January for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis. However, the FDA delayed its decision to provide further time to review safety data from ORAL Surveillance and potential risks associated with JAK inhibitors.

Image of arthritic hand
The FDA has approved upadacitinib 15 mg for the treatment of adults with active PsA who have had an inadequate response, or intolerance to, TNF inhibitors, according to an AbbVie press release. Source: Adobe Stock.

“The efficacy of Rinvoq in relieving the many manifestations of psoriatic arthritis is well-characterized in two large, long term clinical studies,” Michael Severino, MD, vice chairman and president of AbbVie, said in the release. “This new approval underscores our mission to deliver a portfolio of therapies that can help more people with rheumatic diseases achieve disease control.”

The FDA based its approval on data from two phase 3 trials — SELECT-PsA 1 and SELECT-PsA 2 — that assessed the efficacy, safety and tolerability of upadacitinib in patients with PsA. Upadacitinib met the primary endpoint — ACR20 response at week 12 compared with placebo — in adults with active PsA who demonstrated an inadequate response to non-biologic or biologic DMARDs. Additionally, the drug achieved noninferiority to adalimumab (Humira, AbbVie) — 40 mg administered every other week — regarding the ACR20 response at week 12.

Michael Severino

Patients who received upadacitinib demonstrated greater improvements in physical function — as measured by HAQ-DI at week 12 — and skin symptoms — as measured by PASI-75 at week 16. In addition, a greater proportion of patients treated with upadacitinib achieved minimal disease activity compared with those who received placebo at week 24.

“Many adults still struggle to find a treatment option that helps them lower their disease activity,” Iain B. McInnes, PhD, FRCP, professor of medicine and Versus Arthritis professor of rheumatology at the University of Glasgow, and lead investigator for the SELECT-PsA 1 trial, said in the release. “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.”

Iain B. McInnes

Integrated safety data from SELECT-PsA 1 and SELECT-PsA 2 confirmed a safety profile for patients with active PsA who received upadacitinib consistent with that established among patients with RA. The most common adverse events observed among patients receiving upadacitinib included upper respiratory tract infection, nasopharyngitis and increases in blood creatine phosphokinase, alanine aminotransferase and aspartate transaminase.

Earlier this month, the FDA updated the prescribing information for upadacitinib to include a new boxed warning for major adverse cardiovascular events, and updated previous boxed warnings regarding mortality, malignancies and thrombosis.