Abstract

ALANON PARDO, MM; PROY VEGA, B; RONCERO GARCIA-ESCRIBANO, O  and  VALENZUELA GAMEZ, JC. Pharmacokinetic monitoring of supratherapeutic adalimumab levels in patient with Crohn's disease. Rev. OFIL·ILAPHAR [online]. 2020, vol.30, n.4, pp.347-350.  Epub May 25, 2021. ISSN 1699-714X.  https://dx.doi.org/10.4321/s1699-714x2020000400016.

The pharmacokinetic monitoring of biological therapies against tumor necrosis-a (TNF-a) was recently introduced at our hospital thanks to the initiative of our inflammatory bowel disease team, composed of specialists in pharmacology, digestive system disease, and clinical analysis. The aim of the program was to optimize the therapy delivered to patients in clinical remission (pro-active monitoring) or clinical failure (reactive monitoring).

We report the case of a patient diagnosed with Crohn’s disease and under combined treatment with methotrexate and adalimumab. In September 2018, the dose of adalimumab was empirically increased to 40 mg/week due to the onset of extraintestinal manifestations (arthralgias and paraesthesias in lower limbs). In February 2019, the patient was in clinical remission with respect to the intestinal symptoms, but the extraintestinal manifestations persisted and the patient also reported anal aphthae. Consequently, serum adalimumab concentrations were monitored and found to widely exceed the recommended therapeutic interval (5-12 µg/ml). We report the multidisciplinary follow-up of the clinical case and the dosage adjustment based on Bayesian predictions, pharmacokinetic and pharmacodynamic principles, and the patient’s clinical situation. Pharmacokinetic monitoring of supratherapeutic adalimumab levels proved to be a useful tool to achieve the optimal dosage of this drug and to objectively evaluate the patient’s adverse reactions. The Spanish Pharmacosurveillance System has been notified of this case.

Keywords : Therapeutic drug monitoring; adalimumab; chronic inflammatory diseases.

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