A long-term real-world safety study of guselkumab in patients with psoriasis who have 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. Objectives: The EARLY study was a real-world longitudinal study designed to assess clinical outcomes and long-term safety of guselkumab in patients with psoriasis who also had chronic infections, malignancies or heart disease. Methods: A cohort of 1024 patients with moderate-to-severe psoriasis treated with guselkumab was evaluated for the presence of chronic infection [hepatitis B virus (HBV) and hepatitis C virus (HCV), tuberculosis and HIV] and cancer. Subgroup analysis was also performed in patients with heart disease. Patients with cancer were categorized into the precedent cancer (PC) group, with diagnoses made before the study, and the intercurrent cancer (IC) group, with diagnosis 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 1024 patients, 7.5% (n = 77) had HBV, 7.4% (n = 76) had latent tuberculosis infection, 2.7% (n = 28) had HCV, and 0.8% (n = 8) were HIV-positive. In these patients (n = 189), no reactivation of infectious diseases was observed during a mean follow-up period of 128.5 (SD 81.2) weeks. In the 65 patients with cancer (6.3% of the cohort), 78% (n = 51) were in the PC group and 22% (n = 14) were in the IC group. Time from cancer diagnosis to guselkumab initiation averaged 11.8 (SD 15.5) months in patients at high risk and 113.3 (SD 58.5) months in patients at low risk. In patients with heart disease, mean follow-up was 121.0 (SD 76.9) weeks. Conclusions: This longitudinal real-world study demonstrates the long-term safety of guselkumab in patients with psoriasis who had chronic infections, cancer or heart disease. Stratification by oncological risk provided valuable insights for therapeutic management.