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Proactive TDM Versus Standard Use of Biologics in Psoriasis

ConditionPsoriasis Vulgaris
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults; aged 18 years or older

Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist

Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme.

The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures

Disqualifiers

Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication)

Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc)

Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline

Presumed inability to follow the study protocol

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proactive TDM-based dosing of secukinumab

    Drug

    Maintenance/normal dose is 300 mg/4 weeks or 300 mg/ month First dose reduction step: 300 mg/6 weeks. Second dose reduction step: 300 mg/8 weeks. Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 300 mg/3 weeks Second dose escalation step: 300 mg/2 weeks Further dose escalation step: shortening with 1 additional week

  • Proactive TDM-based dosing of ixekizumab

    Drug

    Maintenance/normal dose is 80 mg/4 weeks. First dose reduction step: 80 mg/6 weeks. Second dose reduction step: 80 mg/8 weeks Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 80 mg/3 weeks Second dose escalation step: 80 mg/2 weeks Further dose escalation step: shortening with 1 additional week

  • Proactive TDM-based dosing of guselkumab

    Drug

    Maintenance/normal dose is 100 mg/8 weeks. First dose reduction step: 100 mg/12 weeks. Second dose reduction step: 100 mg/16 weeks. Further dose reduction steps: prolongation with 1 additional week First dose escalation step: 100 mg/6 weeks Second dose escalation step: 100 mg/4 weeks Further dose escalation step: shortening with 1 additional week

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Standard dosing of biologicsNo intervention 0 interventions
Group B: Proactive TDM based dosingExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Non-inferiority of sustained disease control

Sustained disease control, defined as an absolute PASI ≤ 2 OR a delta PASI from baseline ≥ 50% during at least 80% of all 12-weekly study visits over a period of 76 weeks.

Time frame
76 weeks

Secondary outcomes

1

Psoriasis disease activity, measured with the Psoriasis Area and Severity Index (PASI) at each 12-weekly study visit.

Change from baseline at week 76 in PASI score. The PASI measures disease activity. The scores ranges from 0 (skin lesion free) to 72 with higher scores indicating higher disease activity.

Time frame
76 weeks
2

Dermatology-related quality of life as measured with the Dermatology Life Quality Index (DLQI-R) at each 12-weekly study visit.

Change from baseline at week 76 in DLQI\_R score. The DLQI\_R measures QoL. The score ranges from 0 (no impact) to 30 (greatest impact) with higher scores indicating higher impact on quality of life.

Time frame
76 weeks
3

Health status of participants, assessed by using the Short Form 36 (SF-36) version 2 questionnaire at every 12-weekly time point.

Change from baseline at week 76 in SF-36 score. The SF-36 measures QoL. The score ranges from 0 (maximum disability) to 100 (no disability). In the field of dermatology, the SF36 has been proposed as the instrument of choice for evaluating QoL in a generic way by Both et al.. Although we acknowledge that the SF36 can be perceived as more difficult to fill in by the patients, comparison of QoL measures by Fernandez-Penas et al, showed that SF-36 was more sensitive than other instruments in detecting worse QoL in male patients. The minimal clinical important difference (MCID) for SF-36 is considered 10 units.

Time frame
76 weeks
4

Whether participants will have serious adverse events (SAE) and adverse events of special interest (AEoSI) during the study period.

AEoSI include, but are not limited to, * Occurrence of infusion reactions * Drug (biologic) Immunogenicity * Moderate-to severe infections * Newly diagnosis of cancer * New-onset of psoriatic arthritis * Joint complains

Time frame
week 76

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Belgium Health Care Knowledge Centre

Collaborator

Source ClinicalTrials.gov
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