Monitorización farmacocinética de adalimumab como marcador precoz de fallo secundario en los pacientes con psoriasis en placa moderada-grave

Abstract

Objectiveto analyze the relationship between infra-therapeutic serum concentrations (SC) of adalimumab (ADA) and secondary failure to treatment in patients with moderate-severe plaque psoriasis. Patients and methodretrospective observational study. Inclusion criteria: adult patients diagnosed with moderate–severe plaque psoriasis under treatment with ADA in whom a pharmacokinetic monitoring had been performed. Variables: demographic, related to the pathology (psoriasis area severity index (PASI) ≥ 5 non-responder), related to treatment (time under treatment and dosage schedule) and related to monitoring (ADA SC (μg/ml) and anti-adalimumab antibodies (AAA; UA/ml)).The association between the results of the pharmacokinetic monitoring and the effectiveness of treatment was evaluated through the relationship between the infra-therapeutic SC (< 3.5 μg/ml) and the appearance of secondary failure, as well as the time elapsed. Results25 patients (7 women) were included, with 49 (95%CI 44,54) years, being 36% (9/25) non-responders. The patients were treated with ADA during 3.6 (95%CI 26, 4.7) years, 32% (8/25) with the dosage schedule reflected in the summary of product characteristics, 40% (10/25) with optimizations and 28% (7 / 25) with intensification. 34 monitoring of ADA Sc were performed (1.4 monitoring/patient), with a median of 3.8 (IQR 9.2) μg/ml; and 12 AAA monitoring (1.1 monitoring/patient), 6 of them being positive. In 57% (4/7) of patients with infra-therapeutic ADA SC, secondary treatment failures were evidenced 3.4 (IQR 1.5) months after the pharmacokinetic monitoring was performed. ConclusionsADA pharmacokinetic monitoring is a tool to support clinical decisions that allows knowing and predicting the clinical response in patients with moderate-severe plaque psoriasis.