Liver Injury in Psoriasis Patients Receiving Ustekinumab: A Retrospective Study of 44 Patients Treated in the Clinical Practice Setting.
BACKGROUND
The therapy of patients with psoriasis and liver disease can be a challenge due to the increased risk of adverse effects from traditional systemic treatments; in addition, although the anti-tumor necrosis factor agents are considered safer, they have also been associated with drug-induced liver injury and reactivation of viral hepatitis. Ustekinumab has a different mechanism of action and the little that is known of its effects on the liver comes from pivotal studies. The objectives of this study were to estimate the incidence of drug-induced liver injury in patients treated with ustekinumab in daily clinical practice and to analyze liver alterations in those patients with pre-existing liver disease.


METHODS
All patients treated with the standard regimen of ustekinumab were included in the study. Variables gathered included age, sex, type of psoriasis, nail involvement, arthritis, previous treatments, history of liver disease, viral serology, Psoriasis Area Severity Index (at baseline and at 12, 16, and 52 weeks), transaminase levels, manifestations of liver disease, liver ultrasound, and factors such as body mass index, alcohol consumption, and ferritin levels.


RESULTS
Grade 1 elevation of the transaminases was only observed in 6 patients; no cases of severe hypertransaminasemia were observed. None of the patients with elevation of the transaminases at baseline developed problems during treatment.


CONCLUSIONS
Ustekinumab-related liver injury is uncommon and mild. From a hepatic point of view, the drug appears safe, even in patients with pre-existing liver disease and those who have developed altered liver function previously with other drugs.
Instituto de Investigación Sanitaria Princesa (IP), Madrid, España; Departamento de Dermatología, Hospital Universitario de la Princesa, Madrid, España. Electronic address: mar.llamasvelasco@gmail.com.
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Llamas-Velasco
Departamento de Dermatología, Hospital Universitario de la Princesa, Madrid, España.
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MJ
Concha-Garzón
Instituto de Investigación Sanitaria Princesa (IP), Madrid, España; Departamento de Dermatología, Hospital Universitario de la Princesa, Madrid, España.
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A
García-Diez
Instituto de Investigación Sanitaria Princesa (IP), Madrid, España; Departamento de Dermatología, Hospital Universitario de la Princesa, Madrid, España.
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Daudén
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D015897:Comorbidity; D003879:Dermatologic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D053762:Interleukin-12 Subunit p40 / Q000037:antagonists & inhibitors; D008107:Liver Diseases / Q000097:blood / Q000150:complications; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy*; D012189:Retrospective Studies; D013030:Spain / Q000453:epidemiology; D000069549:Ustekinumab / Q000009:adverse effects* / Q000627:therapeutic use; D055815:Young Adult
D003879:Dermatologic Agents; D053762:Interleukin-12 Subunit p40; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000069549:Ustekinumab
Drug toxicity; Hepatopatía; Liver disease; Toxicidad farmacológica; Ustekinumab