For patients with psoriatic arthritis, upadacitinib at a dose of 15 mg or 30 mg once daily is more effective than placebo, according to a study published in the April 1 issue of the New England Journal of Medicine.
Iain B. McInnes, M.D., Ph.D., from the University of Glasgow in the United Kingdom, and colleagues conducted a 24-week, phase 3 trial involving 1,704 patients with psoriatic arthritis who were randomly assigned in a 1:1:1:1 ratio to receive oral upadacitinib at a dose of 15 mg or 30 mg once daily, placebo, or subcutaneous adalimumab.
The researchers found that the percentage of patients with an American College of Rheumatology 20 (ACR20) response (≥20 percent decrease in the number of tender and swollen joints and ≥20 percent improvement in at least three of five other domains) at week 12 was 70.6, 78.5, 36.2, and 65.0 percent with 15-mg upadacitinib, 30-mg upadacitinib, placebo, and adalimumab, respectively. For the ACR20 response at week 12, both upadacitinib doses were noninferior to adalimumab; the 30-mg dose was superior to adalimumab. The incidence of adverse events through week 24 was 66.9, 72.3, 59.6, and 64.8 percent with 15-mg upadacitinib, 30-mg upadacitinib, placebo, and adalimumab, respectively.
"Longer and larger trials are required to determine the effect and risks of upadacitinib and its effects as compared with other drugs used to treat psoriatic arthritis," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including AbbVie, which manufactures upadacitinib and funded the study.