Trial of Upadacitinib outperforms Adalimumab for Psoriatic A
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The Janus kinase inhibitor upadacitinib is a potential treatment for psoriatic arthritis. A Study was conducted to know the efficacy and safety of upadacitinib as compared with adalimumab, in patients who have an inadequate response to nonbiologic disease-modifying antirheumatic drugs.

In a 24-week, phase 3 trial, researchers randomly assigned patients 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 (40 mg every other week). The primary end point was an American College of Rheumatology 20 (ACR20) response (more than 20% decrease in the number of tender and swollen joints and more than 20% improvement in at least 3 of 5 other domains) at week 12 with upadacitinib as compared with placebo. Secondary end points included comparisons of upadacitinib with adalimumab. A total of 1704 patients received an active drug or placebo.

--The percentage of patients who had an ACR20 response at week 12 was 70.6% with 15-mg upadacitinib, 78.5% with 30-mg upadacitinib, 36.2% with placebo, and 65.0% with adalimumab.

--The difference between groups for 15-mg upadacitinib as compared with adalimumab was 5.6 % points and for 30-mg upadacitinib 13.5 percentage points.

--Both upadacitinib doses were noninferior to adalimumab for the ACR20 response at week 12; the 30-mg dose but not the 15-mg dose was superior to adalimumab.

--The incidence of adverse events through week 24 was 66.9% with 15-mg upadacitinib, 72.3% with 30-mg upadacitinib, 59.6% with placebo, and 64.8% with adalimumab.

--There were serious infections in 1.2%, 2.6%, 0.9%, and 0.7% of the patients, respectively.

--Hepatic disorders occurred in 9.1% of patients in the 15-mg upadacitinib group and 12.3% in the 30-mg upadacitinib group, but grade 3 increases in aminotransferase levels occurred in 2% of patients or fewer in all groups.

In particular, the percentage of patients with psoriatic arthritis who had an ACR20 response at week 12 was significantly higher with 15-mg or 30-mg upadacitinib than with placebo. The 30-mg dose was superior to adalimumab. Adverse events were more frequent with upadacitinib than with placebo.