EARLY: Guselkumab Use Supported in PsO Patients With HBV, Cancer, or Heart Disease
Key Takeaways:
Guselkumab did not cause reactivation of HBV, HCV, LTBI, or HIV during long-term follow-up.
Patients with active or historical cancer safely received guselkumab regardless of cancer risk classification.
Cardiovascular comorbidities did not impact guselkumab’s safety profile.
Guselkumab, an IL-23 inhibitor approved for moderate-to-severe psoriasis, showed long-term safety in patients with complex comorbidities—including chronic infections, prior malignancies, and cardiovascular disease—according to findings from the EARLY Study.
The longitudinal, multicenter cohort study evaluated 1,024 patients across 10 Italian dermatology centers. Researchers sought to fill a critical evidence gap: the safety of biologic therapy in psoriasis patients who are typically excluded from randomized trials due to comorbid conditions. Over an average follow-up of 3.5 years, the study observed no reactivation of chronic infections, low risk of malignancy recurrence consistent with , and a favorable safety profile in patients with cardiovascular disease.
Among the cohort, 7.5% had hepatitis B virus (HBV), 7.4% had latent tuberculosis infection (LTBI), 2.7% had hepatitis C (HCV), and 0.7% were HIV-positive.
Despite extended exposure to guselkumab (mean follow-up ranging from 122 to 188 weeks), no cases of infection reactivation occurred. All infectious disease patients were monitored by specialists throughout the study period.
Of the 65 patients with cancer, 78.5% were classified as having precedent cancers and 21.5% developed malignancy during treatment. Stratification by oncologic risk, based on 2022 Italian guidelines, showed no significant difference in safety outcomes. Cardiovascular disease was present in 18.6% of the population, with ischemic heart disease, myocardial infarction, and hypertensive heart disease most common. Average follow-up of 122 weeks, no cardiovascular-specific safety concerns emerged.
“This longitudinal real-life study demonstrates the long-term safety of guselkumab in psoriasis patients with chronic infection, cancer or heart disease,” the authors wrote. “Stratification by oncological risk provided valuable insights for therapeutic management.”
Source: Mortato E, et al. Clin Exp Dermatol. 2025. doi:10.1093/ced/llaf172