Upadacitinib Demonstrates Consistent Long-Term Safety Profile in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

Upadacitinib demonstrated a consistent long-term safety profile among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), according to study results presented at the American College of Rheumatology (ACR) Convergence 2021, held virtually from November 5 to 9, 2021.

The objective of the current study was to assess the long-term safety of upadacitinib among patients with PsA, RA, and AS.

Safety data from the SELECT clinical program were collected for RA (6 trials), PsA (2 trials), and AS (1 trial). Treatment-emergent adverse events, defined as adverse events on or after the first dose and 30 days or fewer after the last dose for upadacitinib and methotrexate, or 70 days or fewer for adalimumab, were reported as exposure-adjusted adverse event rates.

A total of 4278 patients – 3209 with RA, 907 with PsA, and 182 with AS – who received at least 1 dose of upadacitinib 15 mg were included in the study. Discontinuation due to adverse events were similar across the upadacitinib, adalimumab, and methotrexate groups and patient populations.

Pneumonia was the most common serious infection and serious adverse event among patients with RA and PsA and it was the main adverse event leading to discontinuation of upadacitinib among patients with RA. Psoriatic arthropathy and headache was the most common adverse event leading to discontinuation of treatment among those with PsA and AS, respectively.

Although there was no difference in the risk for serious infection and opportunistic infection between treatment groups and across RA, PsA, and AS populations, herpes zoster was more common with upadacitinib compared with adalimumab or methotrexate, showing similar rates of the viral infection among patients with RA, PsA, and AS.

Rates of nonmelanoma skin cancer was numerically higher with upadacitinib than methotrexate or adalimumab in patients with RA and PsA; however, rates of other malignancies, major adverse cardiovascular events, and venous thromboembolic events were similar across all treatment groups. Mortality was not higher than expected in the general populations.

“No new safety risks were identified with long-term treatment in RA, PsA, or AS. [Upadacitinib] 15 mg demonstrated a consistent safety profile across RA, PsA, and AS populations in the SELECT clinical program,” the researchers concluded.

Reference

Burmester G, Cohen S, Winthrop K, et al. Long-term safety profile of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. Presented at: ACR Convergence 2021; November 3-10, 2021. Abstract 1691.