The safety assessment of ustekinumab on psoriasis and psoriatic arthritis: A real-world analysis based on the FDA adverse event reporting system database

OBJECTIVE: To assess safety of ustekinumab (UST) on treatment of patients with psoriasis and psoriatic arthritis (PsA) by analyze UST related adverse drug events (ADEs). METHODS: Data on ADEs associated with UST on psoriasis and PsA were collected from the fourth quarter of 2009 through the third quarter of 2024 in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FEARS) database. A variety of signal quantization techniques such as reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS) are used for analysis. RESULTS: A total of 67,765 ADE reports with UST on psoriasis and PsA as the primary suspected agent covered 25 system organ classes (SOCs). The three most common ADEs are infections and infestations (n = 9698), general disorders and administration site conditions (n = 6336), and injury, poisoning, and procedural complications (n = 6091). Specifically, reproductive system diseases (n = 262) was identified as unique adverse reactions not mentioned in official drug labels. At the preferred term (PT) level, the most common ADEs were psoriasis exacerbation (n = 3486), lower respiratory tract infection (n = 1302) and latent tuberculosis (n = 121). Strong yet rare signals, including notalgia paraesthetica (n = 3, empirical bayesian geometric mean [EBGM] 154.7) and chronic actinic dermatitis (n = 3, EBGM 101.15), were also detected. Compared to patients with PsA, patients with psoriasis treated with UST exhibit significantly stronger associations with hepatobiliary disorders (n = 955, ROR 2.44, PRR 2.4, information component [IC] 1.26, EBGM 2.4) and neoplasms (n = 3150, ROR 2.61, PRR 2.49, IC 1.31, EBGM 2.49). Spontaneous reports consistently demonstrated higher signal strength for infections and skin disorders compared to healthcare professional (HCP) reports. In contrast, at the PT level, HCP reports tended to emphasize stronger signals for rare or specific conditions. CONCLUSION: This study highlights a spectrum of UST-associated ADEs covering 25 SOCs in the treatment of patients with psoriasis and PsA, which emphasizes the need for vigilant clinical monitoring, particularly for infections, hepatobiliary disorders, and rare but high-signal events such as notalgia paraesthetica, chronic actinic dermatitis and pure testicular seminoma stage I. Clinicians should combine insights from both spontaneous and HCP reports and pay special attention to infections and reproductive system disorders.