A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated

Recently, the optimal therapeutic serum trough level range of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab serum through level above this therapeutic range did not add to clinical response. Based on this therapeutic window, the introduction of dose adjustments based on serum trough levels (therapeutic drug monitoring) will be further validated in a prospective controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab STLs, dose reduction based on therapeutic drug monitoring (TDM) is able to maintain the initial clinical outcome.

Inclusion Criteria:Participants must be >18 years of age.Participants must have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without PsA), prior to the first administration of study intervention.Participant must remain on a highly effective method of birth control during the study or during the entire treatment with adalimumab (whether with is longer)Participants are considered eligible according to the following TB screening criteria:Have no history of latent or active TB before screeningHave no signs or symptoms suggestive for active TB upon medical history and/or physical examinationHave had no recent close contact with a person with active TBParticipants must agree not to receive a live virus or live bacterial vaccination at least 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention (except for varicella and MMR vaccines), during the study, or within 3 months after the last administration of study intervention.Participants must avoid prolonged sun exposure and use of tanning booths or other ultraviolet light sources during study.Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.Exclusion Criteria:Participants who have currently a predominant nonplaque forms of psoriasis (eg. Erythrodermic, guttate, pustular)Participants who are pregnant, nursing or planning a pregnancy or fathering a child while enrolled in the study or within 12 weeks after receiving the last administration of study interventionParticipants who have received, or are expected to receive, any live virus or bacterial vaccination (with the exception of varicella or MMR vaccines) within 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention, during the study, or within 12 weeks after the last administration of study interventionParticipants who have known allergies, hypersensitivity or intolerance to adalimumab or its excipientsParticipants who have any malignancy or have a history of malignancyParticipants who are unable or unwilling to undergo multiple venapunctures