Adjusting Biologic Dosing by Blood Drug Levels in Psoriasis

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with psoriasis who have been treated with secukinumab, ixekizumab or guselkumab for at least 6 months at the standard dose.

Age

18 years or older

Sex

Men and women can join.

Disease stage

Documented psoriasis, mainly plaque (vulgaris) type, diagnosed by a dermatologist.

Earlier treatment

Must be treated now with secukinumab, ixekizumab or guselkumab for 6 months or more, at the standard dosing scheme.

Main reasons for not taking part

• The biologic is mainly used for another illness, such as rheumatoid arthritis
• Taking systemic immunosuppressants other than methotrexate or acitretin
• Severe illness with short life expectancy, or uncontrolled psoriatic arthritis
• Likely unable to follow the study plan
• Currently wishing to become pregnant

The registry criteria, word for word

What the trial wants to find out

Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.

The 2 groups in the trial

• Standard dosing of biologicsNo study treatment, for comparison

  Patients will receive biological therapy according to standard clinical practice. Secukinumab, ixekizumab and guselkumab will be administered according to standard dosing regimen. Adjustments in doses and intervals, or biological switch according to clinical parameters or at the physicians' discretion are considered as standard clinical practice. Investigators will not have access to information on levels of the drug or antidrug antibodies and no decision tree will be provided to guide treatment adjustments.

• Proactive TDM based dosingTreatment being tested

  Stepwise treatment modifications based on drug levels: if the drug level is below/above the target the dose of the biologic will be increased/decreased by stepwise interval shortening/lengthening - first modified by 33% and then 50% increase or decrease. If the target is still not reached at the next study visit, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached. In case the dosing regimen shifts from dose increase to dose decrease or vice versa, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached.

  Treatment: Proactive TDM-based dosing of secukinumab, Proactive TDM-based dosing of ixekizumab, and Proactive TDM-based dosing of guselkumab