Upadacitinib Receives FDA Approval for Treatment of Active Psoriatic Arthritis

The safety profile observed in patients with active psoriatic arthritis administered upadacitinib was consistent with the safety profile observed in patients with rheumatoid arthritis.

The FDA has approved upadacitinib (Rinvoq; AbbVie) for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to 1 or more tumor necrosis factor blockers.

The approval is supported by data from 2 pivotal phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2. Both trials assessed the efficacy, safety, and tolerability of upadacitinib in patients with psoriatic arthritis and both found that the safety profile in patients treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis.

“The efficacy of Rinvoq in relieving the many manifestations of psoriatic arthritis is well-characterized in 2 large, long term clinical studies,” said Michael Severino, MD, vice chairman and president of AbbVie, in a press release.

Across both trials, upadacitinib met its primary endpoint of American College of Rheumatology (ACR) 20% improvement at week 12 and patients receiving upadacitinib 15 mg achieved significantly higher responses. In the SELECT-PsA 1 trial, 71% of patients achieved an ACR20 response compared to 57% in the SELECT-PsA 2 trial. Furthermore, 36% and 24% of patients receiving the placebo in both trials achieved an ACR20 response.

In addition to strong ACR20 responses, patients in both trials who were treated with upadacitinib 15 mg achieved higher ACR50 responses at week 12 compared to placebo, with 38% of patients in the SELECT-PsA 1 trial and 32% of patients in the SELECT-PsA 2 trial. ACR70 responses were achieved in 16% and 9% of patients in each trial, respectively.

Treatment with upadacitinib 15 mg also resulted in improvements in dactylitis and enthesitis in patients with pre-existing dactylitis or enthesitis. In the SELECT-PsA 1 trial, treatment with upadacitinib 15 mg significantly inhibited the progression of structural joint damage compared to placebo, as assessed by the change from baseline in modified Total Sharp Score at week 24.

In both trials, patients receiving upadacitinib 15 mg experienced significantly greater improvement from baseline in fatigue. Treatment with upadacitinib also resulted in improved skin manifestations in patients with psoriatic arthritis, although it has not been studied and is not indicated for the treatment of plaque psoriasis.

Overall, the safety profile observed in patients with active psoriatic arthritis was consistent with the safety profile observed in patients with rheumatoid arthritis. During the 24-week placebo-controlled period, the most common adverse events reported with upadacitinib were upper respiratory tract infection and blood creatine phosphokinase elevations.

The frequencies of herpes zoster and herpes simplex were 1.1% and 1.4%, respectively. A higher incidence of acne and bronchitis were also observed in patients treated with upadacitinib.

“Many adults still struggle to find a treatment option that helps them lower their disease activity,” said Iain McInnes, MD, PhD, lead investigator of the SELECT-PsA 1 trial, in the press 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.”

REFERENCE

Rinvoq (upadacitinib) Receives US FDA Approval for Active Psoriatic Arthritis. News Release. AbbVie; December 14, 2021. Accessed December 15, 2021. https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-receives-us-fda-approval-for-active-psoriatic-arthritis.htm