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. 2025 Aug 22;50(9):1786-1794.
doi: 10.1093/ced/llaf172.

A long-term real-world safety study of guselkumab in patients with psoriasis who have infectious comorbidities, malignancies or heart disease: the EARLY study

Edoardo Mortato  1   2 , Marina Talamonti  3 , Lorenzo Marcelli  1 , Matteo Megna  4 , Annunziata Raimondo  5 , Giacomo Caldarola  6   7 , Nicoletta Bernardini  8 , Anna Balato  9 , Anna Campanati  10 , Maria Esposito  11 , Claudio Bonifati  12 , Viviana Lora  12 , Luca Potestio  4 , Serena Lembo  5 , Francesco Loconsole  2 , Eleonora De Luca  6   7 , Nevena Skroza  8 , Dario Buononato  9 , Tommaso Bianchelli  13 , Maria Concetta Fargnoli  14 , Nello Tommasino  4 , Felice Primavera  2 , Clara De Simone  6   7 , Luca Bianchi  1   3 , Marco Galluzzo  1   3
Affiliations

A long-term real-world safety study of guselkumab in patients with psoriasis who have infectious comorbidities, malignancies or heart disease: the EARLY study

Edoardo Mortato et al. Clin Exp Dermatol. .

Abstract

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.

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Conflict of interest statement

Conflicts of interest: M.G. and M.T. declare to have acted as speakers and/or consultants for AbbVie, Almirall, Eli Lilly, Johnson & Johnson, LEO Pharma, Novartis and Sanofi, outside the submitted work. L.B. declares to have acted as a speaker and/or consultant for AbbVie, Almirall, Eli Lilly, Johnson & Johnson, LEO Pharma, Novartis, Pfizer, Sanofi and UCB outside the submitted work. A.B. has served as consultant and/or has received fees from: AbbVie, Almirall, Amgen, Boehringer Ingelheim, BMS, LEO Pharma, Eli Lilly, Johnson & Johnson, Novartis, Sanofi and UCB, outside the submitted work. N.B. and N.S. declare to have acted as speakers and/or consultants for AbbVie, Almirall, Eli Lilly, Johnson & Johnson, LEO Pharma, Novartis and UCB, outside the submitted work. G.C. has received consulting fees, honoraria and support for attending meetings from AbbVie, Eli Lilly, Johnson & Johnson, UCB, Novartis and LEO Pharma. C.D.S. has received support for consulting fees, honoraria and support for attending meetings from AbbVie, Eli Lilly, Johnson & Johnson, UCB, LEO Pharma, Sanofi, Almirall, Boehringer Ingelheim and Bristol Myer Squibb. M.M. declare to have acted as speakers and/or consultants for AbbVie, Amgen, Almirall, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, Eli Lilly, UCB, outside the submitted work. S.L. declares to have acted as speakers and/or consultants for AbbVie, Eli Lilly, Sanofi, Novartis, Janssen, LEO Pharma outside the submitted work. A.R. declares to have acted as a speaker and/or consultant for Almirall, Janssen, Pfizer, AbbVie and Novartis outside the submitted work. M.E. has served as speaker/consultant for AbbVie, Amgen, Almirall, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi and UCB. M.C.F. has served as consultant/advisor, received speaker honoraria and/or grants, and/or is investigator for Amgen, Almirall, AbbVie, Boehringer Ingelheim, BMS, Galderma, Kyowa Kyrin, Incyte, LEO Pharma, Pierre Fabre, UCB, Lilly, Pfizer, Janssen, MSD, Novartis, Sanofi, Regeneron, Sun Pharma, Takeda. A.C. has served as speaker/consultant for AbbVie, Almirall, Amgen, BMS, Difa-Cooper, Eli Lilly, Janssen, LEO Pharma, Mertz, Novartis, Pfizer, Sanofi and UCB. T.B. has served as speaker/consultant for AbbVie, Almirall, Amgen, Janssen, Novartis, Pfizer, Sanofi and UCB. The other authors declare no conflict of interests.

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