Psoriasis Vulgaris Clinical Trial
— HELIOSOfficial title:
Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study
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.
Status | Not yet recruiting |
Enrollment | 210 |
Est. completion date | March 1, 2028 |
Est. primary completion date | March 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults; aged 18 years or older 2. Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist 3. Patients must be currently treated with secukinumab, ixekizumab or guselkumab = 6 months according to the standard dosing scheme. 4. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures Exclusion Criteria: 1. Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication) 2. Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc) 3. Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline 4. Presumed inability to follow the study protocol 5. Active pregnancy wish |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Antwerpen | Antwerpen | |
Belgium | AZ Sint-Jan | Brugge | |
Belgium | UCL Saint-Luc | Brussel | |
Belgium | ULB Erasme | Brussel | |
Belgium | UZ Brussel | Brussel | |
Belgium | Grand Hôpital de Charleroi | Charleroi | |
Belgium | Dermatologiepraktijk huidziekten Geel | Geel | |
Belgium | AZ Maria Middelares | Gent | |
Belgium | UZ Gent | Gent | |
Belgium | Clinique André Renard | Herstal | |
Belgium | Dermatologie Handelskaai | Kortrijk | |
Belgium | UZ Leuven | Leuven | |
Belgium | Dermatologie Maldegem | Maldegem |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | Belgium Health Care Knowledge Centre |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 3-monthly study visits over a period of 18 months. | 18 months | |
Secondary | Psoriasis disease activity, measured with the Psoriasis Area and Severity Index (PASI) at each 3-monthly study visit. | Change from baseline at 18 months 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. | 18 months | |
Secondary | Dermatology-related quality of life as measured with the Dermatology Life Quality Index (DLQI-R) at each 3-monthly study visit. | Change from baseline at 18 months 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. | 18 months | |
Secondary | Health status of participants, assessed by using the Short Form 36 (SF-36) version 2 questionnaire at every 3-monthly time point. | Change from baseline at 18 months 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. | 18 months | |
Secondary | 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 |
18 months | |
Secondary | Pharmacokinetics of the drugs of interest | Drug concentrations of each included drug, measured in blood serum samples which will be collected from participants at each 3-monthly time point.
The drug concentrations will be evaluated with an enzyme-linked immunosorbent assay (ELISA) and compared to the target/reference concentration. In the intervention group, these drug concentrations will guide the modification of the dosing interval (according to a predefined decision tree). |
18 months | |
Secondary | Immunogenicity of the drugs of interest | Anti-drug antibody levels of each included drug, measured in blood serum samples which will be collected from participants at each 3-monthly time point. | 18 months | |
Secondary | Utilities, derived from EuroQoL 5 Dimensions (EQ-5D-5L) questionnaires, which will be measured at each 3-monthly time point. | Utility scores will be used to calculate quality adjusted life years (QALYs) which are used to determine cost-effectiveness of the intervention. | 18 months | |
Secondary | Volumes of care, as measured with the iMTA Medical Consumption Questionnaire (MCQ) at each 3-monthly time point. | The iMTA Medical Consumption Questionnaire (iMCQ) is an instrument for measuring medical consumption. The iMCQ includes questions related to frequently occurring contacts with health care providers. The iMCQ is a generic questionnaire and will be used to calculate direct medicals costs and non-medical costs. | 18 months |
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