A Long-Term Real-Life Safety Study of Guselkumab in Psoriasis Patients with Infectious Comorbidities, Malignancies or Heart Disease: The EARLY Study

Background: Guselkumab is proven effective and safe for moderate-to-severe plaque psoriasis, but its safety in patients with comorbid infectious diseases and malignancies has been less studied. Objective: This real-life longitudinal study assessed the clinical outcomes and long-term safety of guselkumab in psoriasis patients with chronic infections, malignancies, or heart disease. Methods: A cohort of 1,024 patients with moderate-to-severe psoriasis treated with guselkumab was evaluated for the presence of chronic infection (hepatitis B and C, tuberculosis, and HIV), and cancer. Sub-group analysis was also performed in patients with heart disease. Patients with cancer were categorized into the Precedent Cancer Group (PCG), with diagnoses made before the study, and the Intercurrent Cancer Group (ICG); occurring during the study. Stratification was also performed based on oncological risk (high-risk and low-risk groups), according to 2022 Italian guidelines. Results: Among 1,024 patients, 7.5% (n=77) had HBV, 7.4% (n=76) had LTBI, 2.7% (n=28) had HCV, and 0.7% (n=8) were HIV-positive. No reactivation of infectious diseases was observed during a follow-up period of 188±44 weeks. In the 65 cancer patients (6.3% of the cohort), 78.5% (n=51) were in the PCG and 21.5% (n=14) in the ICG. Time from cancer diagnosis to guselkumab initiation averaged 11.8±15.5 months in high-risk and 113.3±58.5 months in low-risk patients. In patients with heart disease, mean follow-up was 122±76 weeks. Conclusions: This longitudinal real-life study demonstrates the long-term safety of guselkumab in psoriasis patients with chronic infection, cancer or heart disease. Stratification by oncological risk provided valuable insights for therapeutic management.