AB0522 SAFETY PROFILE OF UPADACITINIB UP TO 3 YEARS IN PATIENTS WITH PSORIATIC ARTHRITIS: AN INTEGRATED ANALYSIS FROM THE PHASE 3 PROGRAM

Abstract

Background: The efficacy & safety of upadacitinib (UPA) in patients (pts) with active psoriatic arthritis (PsA) were demonstrated through 24 weeks in the phase 3 SELECT‐PsA 1 & ‐PsA 2 placebo‐controlled clinical trials. Objective: To describe the long‐term integrated safety profile of UPA relative to adalimumab (ADA) in pts with PsA treated in the SELECT program. Methods: The SELECT‐PsA program enrolled pts with prior inadequate response or intolerance to ≥1 non‐biologic DMARD (SELECT‐PsA 1) or ≥1 bDMARD (SELECT‐PsA 2). Both trials include UPA 15mg & 30mg, only SELECT‐PsA 1 includes long‐term comparison with ADA 40mg EOW. Treatment‐emergent adverse events (TEAEs) were summarized for: pooled UPA15; pooled UPA30; & ADA. TEAEs are reported as exposure‐ adjusted event rates (EAERs; events/100 pts years [E/100 PY]) up to a cut‐off date of 06/2020. Results: 2257 pts received ≥1 dose of UPA15 (N = 907; 1247.2 PYs), UPA 30 (N = 921; 1257.4 PYs), or ADA (N = 429; 549.7 PYs), with median (max) exposures of 69 (155), 69 (154), and 68 (152) weeks, respectively. EAERs of TEAEs & serious AEs were generally similar between UPA15 & ADA & higher with UPA30; rates of AEs leading to study drug discontinuation were similar across all groups. Similarly, rates of serious infection were comparable between UPA15 & ADA & higher with UPA30. The most common serious infection was pneumonia. Rates of herpes zoster were lower with UPA15 than UPA30 but higher than ADA. Lower rates of opportunistic infections (OI) excluding tuberculosis were observed with UPA15 vs UPA30; the most common OI was mucosal candida infection. Malignancies were reported at similar rates across all treatment groups. Rates of adjudicated MACE & VTEs were ≤0.3 E/100 PY for both UPA arms; all pts had ≥1 risk factor. One adjudicated GI perforation was reported with UPA15. Hepatic disorders were mostly transient, non‐serious transaminase increases. CPK elevations were reported more frequently with UPA30 vs UPA15; most were asymptomatic; no rhabdomyolysis reported. Study drug discontinuation due to lab‐related TEAEs was uncommon. Conclusion: Safety profiles of UPA15 & ADA were generally similar; the rates of most AEs were higher with UPA30 vs ADA. Through the cut‐off date, the safety profile of UPA15 & UPA30 in PsA pts demonstrated consistent results compared to what has been observed with UPA in rheumatoid arthritis.