Guselkumab long-term real-world safety: Results from the EARLY study

Guselkumab, an IL-23 inhibitor, has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis. However, data in patients with serious comorbidities, such as malignancies and infections, are limited.

A real-world, longitudinal study aimed to assess clinical outcomes and long-term safety of guselkumab in 1,024 patients with plaque psoriasis and cancer, chronic infection (hepatitis B and C, tuberculosis, and HIV), or heart disease. Patients with cancer were categorized into diagnoses made before or during the study, with stratification based on oncological risk (high risk and low risk), according to 2022 Italian guidelines. Results from the study were published in Clinical and Experimental Dermatology by Mortato et al.

Key learnings

No reactivation of HBV, HCV, LTBI, or HIV was observed over the extended follow-up period of 122–180 weeks, despite a significant proportion of participants (7.5% HBV, 7.4% LTBI, 2.7% HCV, 0.7% HIV-positive) presenting with these conditions.

Stratification by oncological risk confirmed that guselkumab can be safely administered even in patients with high-risk cancer, when managed carefully with oncology collaboration. Guselkumab was generally administered earlier in high-risk vs low-risk patients (median 11.8 ± 15.5 months vs 113.3 ± 58.5 months from cancer diagnosis).

Patients with heart disease tolerated guselkumab well, with no major cardiovascular events reported during an average follow-up of 122 weeks, in accordance with findings from a previous retrospective study in patients with a moderate risk of cardiovascular disease.

These findings support the expanded use of guselkumab in psoriasis patients with complex comorbidities, promoting personalized treatment strategies and risk stratification rather than categorical exclusion.