Journal of drugs in dermatology : JDD · 2012
Two cases of hepatitis B in patients with moderate to severe psoriasis with ustekinumab.
Клинический случайСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Opel Daniel, Economidi Afrodite, Chan Daphne, Wasfi Yasmine, Mistry Sameer, Vergou Theognosia, Antoniou Christina, Sofen Howard
Аннотация
BACKGROUND: Patients with psoriasis who are treated with systemic and biologic therapies may have an increased risk of infections, including hepatitis B virus (HBV). Cytokines that modulate CD4+ T cell subsets, including interleukin (IL)-12 and IL-23, have been suggested to play a role in the pathogenesis of HBV infection.
OBJECTIVE: To report the first known cases of acute HBV infection in 2 ustekinumab-treated patients with psoriasis from a phase 3 (PHOENIX 1) and a phase 4 (TRANSIT) study.
RESULTS: Both ustekinumab-treated patients generated an immune response toward HBV and experienced typical courses of infection, without progression to chronic HBV infection.
CONCLUSION: Continued monitoring of liver-related adverse events in clinical trials, registries, and spontaneous reporting from the postmarketing setting will further contribute to understanding the role of ustekinumab in viral hepatitis.
OBJECTIVE: To report the first known cases of acute HBV infection in 2 ustekinumab-treated patients with psoriasis from a phase 3 (PHOENIX 1) and a phase 4 (TRANSIT) study.
RESULTS: Both ustekinumab-treated patients generated an immune response toward HBV and experienced typical courses of infection, without progression to chronic HBV infection.
CONCLUSION: Continued monitoring of liver-related adverse events in clinical trials, registries, and spontaneous reporting from the postmarketing setting will further contribute to understanding the role of ustekinumab in viral hepatitis.
Предметные рубрики MeSH
AdultAlanine TransaminaseAntibodies, Monoclonal, HumanizedAspartate AminotransferasesBlood Chemical AnalysisClinical Trials, Phase III as TopicClinical Trials, Phase IV as TopicDNA, ViralHepatitis BHepatitis B AntibodiesHepatitis B Surface AntigensHumansLiver Function TestsMalePsoriasisRiskSkinUstekinumab