Integrated Safety Analysis on Skin Cancers among Patients with Psoriasis Receiving Ixekizumab in Clinical Trials
Smith, Saxon (The Australian National University)
Stratigos, Alexandros (Andreas Syggros Hospital)
Augustin, Matthias (Universitätsklinikum Hamburg-Eppendorf (UKE))
Carrascosa, José Manuel (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Grond, Susanne (Eli Lilly and Company)
Riedl, Elisabeth (Medical University of Vienna. Department of Dermatology)
Xu, Wen (Eli Lilly (Indianalopis, Estats Units d'Amèrica))
Patel, Himanshu (Eli Lilly (Indianalopis, Estats Units d'Amèrica))
Lebwohl, Mark (Mount Sinai Hospital (New York, Estats Units d'Amèrica))
Universitat Autònoma de Barcelona

Data:	2023
Resum:	Limited data exist on skin cancer risk in patients with psoriasis using biologics. Here, we report treatment-emergent adverse events (TEAEs) of skin cancer in patients treated with ixekizumab from psoriasis clinical trials. Integrated safety databases from 17 clinical trials of adults with moderate-to-severe psoriasis treated with ≥ 1 dose of ixekizumab for ≤ 5 years were used to analyze exposure-adjusted incidence rates (IRs) per 100 patient-years of exposure (PYE) and clinically characterize dermatologist-adjudicated skin cancer TEAEs. Of 6892 patients, 58 presented with ≥ 1 skin cancer TEAE (IR 0. 3) with IRs remaining stable with longer ixekizumab exposure. Non-melanoma skin cancer (NMSC) was the most common event (IR 0. 3) affecting 55 patients; of those, 44 had basal cell carcinoma (IR 0. 2) and 16 had squamous cell carcinoma (IR 0. 1). Two treatment-emergent melanoma events were identified; neither were classified as serious AEs. Incidence of skin neoplasms in patients with psoriasis treated with ixekizumab for ≤ 5 years was low, and among those events, NMSC was most common. Limitations included that longer exposure may be required to confirm risk of skin cancer and that the study exclusion criteria of several studies, which excluded patients with skin cancer events within 5 years prior to baseline, might limit interpretation of skin cancer risk in this cohort. These findings support the safety profile of ixekizumab for patients requiring long-term psoriasis control. The online version contains supplementary material available at 10. 1007/s13555-023-00966-4.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Ixekizumab ; Long-term ; Malignancy ; Melanoma ; Non-melanoma skin cancer ; Psoriasis ; Safety ; Skin cancer ; Skin neoplasm
Publicat a:	Dermatology and Therapy, Vol. 13 (june 2023) , p. 1773-1787, ISSN 2190-9172

DOI: 10.1007/s13555-023-00966-4
PMID: 37351831

15 p, 322.2 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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