Gerd R. Burmester, Stanley B. Cohen, Atul Deodhar, Eduardo Mysler, Andrea Rubbert-Roth, Yoshiya Tanaka, Kevin L. Winthrop, Andrew Gara, Derek Coombs, Ivan Lagunes, Leila Larbi, Sebastian Meerwein, Tim Shaw, and Jeffrey R. Curtis

This poster reports the long-term safety of upadacitinib* (UPA) 15 mg across 11 Phase 3 trials from the SELECT clinical program in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA). This analysis included 4,998 patients (RA, n=3,209; PsA, n=907; AS, n=596; nr-axSpA, n=286), totaling 16,683.5 patient-years of exposure, with the majority of exposure from RA studies. Across RA, PsA, AS, and nr-axSpA, UPA 15 mg demonstrated a generally consistent safety profile, with no new safety risks identified with long-term treatment, as shown in previous reports.

*Upadacitinib is indicated for adult patients with RA, PsA, AS, and nr-axSpA who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Refer to the BOXED WARNING for upadacitinib on Serious Infections, Mortality, Malignancies, Major Adverse Cardiovascular Events, and Thrombosis.

Adverse reaction rates observed in clinical trials and long-term extension studies may not predict rates observed in clinical practice. Certain adverse events (AEs) may require longer observation periods and larger patient exposure to ascertain risk.

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