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IMPLEMENTATION OF A SERUM MONITORING PROTOCOL FOR INFLIXIMAB IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

European Statement

Clinical Pharmacy Services

Author(s)

Mafalda Cavalheiro 1
Maria José Rei 1
Ana Rita Silva 1
Patrícia Batalha Silva 1
Carolina Marques 1
Miriam Capoulas 1
1- Pharmacy Department, Hospital da Luz Lisboa, Portugal

Why was it done?

Low serum Infliximab are associated with lost of response and development of immunogenicity. Moreover, therapeutic levels without the control of the inflammatory activity may inform about the necessity of changing the therapeutic class. While monitoring serum levels in the absence of response is already well established, the proactive monitoring of serum levels at defined timings during the induction and maintenance phases of therapy is beginning to be recommended by several leading organizations.

What was done?

Establishment of a protocol for proactive serum monitoring of Infliximab in inflammatory bowel disease, to guide the interpretation of serum levels, optimize dosage and therapeutic response.

How was it done?

Implementation took place in several stages. 1) Theoretical and practical training culminating in the discussion and drafting of a technical guideline including a monitoring protocol with the Gastroenterology team. 2) Organization of the sample collection and analysis circuit. The analytical technique is a rapid test that allows the detection of infliximab levels and anti-infliximab antibodies. 3) Finally, dosage optimization (maintenance of the reference dosage or intensification – shortening the administration interval or increasing the dose) is carried out with the support of population pharmacokinetic models using the DoseMeRx software, interpreted in the context of the overall response assessment in conjunction with the clinical team. The main limitation identified had to do with awareness of the medical team to rational dosage adjustments based on the population model.

What has been achieved?

15 patients were included with a median age of 33 years; 11 of these were diagnosed with Ulcerative Colitis and 4 with Crohn’s Disease. A total of 24 tests were carried out (21 with a proactive strategy and three with a reactive strategy). Of the doses taken at week 6, 60% were below the reference range considered. The dosage regimen was intensified in 64% of the recommendations. Of the patients analyzed, 76% maintained their response, although the duration of treatment was less than a year in most cases.

What next?

The strategy of proactive monitoring and dose intensification may have contributed to achieving and maintaining the response to treatment with Infliximab, but the small number of patients and the duration of the analysis call for further analysis.

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