Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients

Study Overview
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Brief Summary
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The main goal of this study is to determine optimal cut-off values of adalimumab trough levels corresponding to good clinical response. Determination of these values is necessary to compose a therapeutic algorithm, in which the dosing schedule can be adjusted according to serum trough levels of adalimumab and AAA (anti-adalimumab antibodies). A secondary objective of this study is to further detect and quantify AAA and to correlate them with adalimumab and clinical response in a real life setting cohort of psoriatic patients.

Detailed Description
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In a multicenter cross-sectional study, 73 adult patients treated with adalimumab (40 mg) every other week for at least 24 weeks are assessed for psoriasis disease severity through measurement of the Psoriasis Area and Severity Index (PASI) before adalimumab treatment start, and prior to sampling. Patients who interrupted their treatment schedule during the 24 weeks prior to blood sampling are excluded. Samples of patients who were treated with adalimumab for any other inflammatory disease and later developed psoriasis are also excluded. Percentage of PASI improvement compared to baseline (∆PASI) represents clinical response. Patients are classified as nonresponders (∆PASI<50), moderate responders (∆PASI 50-75) or good responders (∆PASI 75-100).Serum is collected for adalimumab trough level and anti-drug antibody determination (Sanquin, The Netherlands). By receiver-operator characteristics (ROC) analysis, a cut-off value of adalimumab trough level can be determined to distinguish insufficient from adequate responders.

Official Title
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Therapeutic Drug Monitoring of Adalimumab in Psoriasis Patients

Conditions
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Psoriasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: minimum age 18 years old chronic plaque psoriasis adalimumab (40mg) subcutaneously every other week at least 24 weeks of adalimumab treatment Exclusion Criteria: interruption of treatment schedule during 24 weeks prior to sampling adalimumab for other inflammatory disease and later developed psoriasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic plaque psoriasis<br>Patients suffering from chronic plaque psoriasis, treated with adalimumab (40mg) subcutaneously every other week after an initial dose of 80 mg. Treatment duration of at least 24 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 75% improvement in clinical response | Minimum of 75 % PASI improvement compared to baseline (∆PASI 75) represents 75% improvement in clinical response. | at least 24 weeks of treatment duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-adalimumab antibody formation |  | at least 24 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adalimumab, biologicals, immunogenicity