Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients (BIOLOPTIM-GUS)

Evaluation of the Preditive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Guselkumab and the Development of the Concentration-response Curve of Guselkumab for Psoriasis Patients.

Biologic such as guselkumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of guselkumab and determine the therapeutic window of guselkumab in psoriasis patients.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Procedure: Venapuncture; Other: Patient questionnaires

Detailed Description

Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of guselkumab (i.e. one loading dose (100 mg) at week 0 and week 4 and followed by subcutaenously injections every 8 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards guselkumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jo Lambert, Prof; Phone Number: +32 09 332 22 87; Email: jo.lambert@uzgent.be
• Study Contact Backup: Name: Lynda Grine, Dr; Phone Number: +32 09 332 22 87; Email: lynda.grine@uzgent.be

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • University Hospital Ghent
    • Ghent, East-Flanders, Belgium, 9000
      • AZ Maria Middelares
    • Ghent, East-Flanders, Belgium, 9000
      • AZ Sint-Lucas
    • Maldegem, East-Flanders, Belgium, 9990
      • Private practice Dermatology
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • University Hospital
  • West-Flanders
    • Brugge, West-Flanders, Belgium, 8000
      • AZ Sint-Jan
    • Torhout, West-Flanders, Belgium, 8820
      • AZ Delta Rembert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
2. 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:

1. Participants who have currently a predominant nonplaque form of psoriasis
2. Participants who are pregnant, nursing or planning a pregnancy
3. Participants who are unable or unwilling to undergo multiple venapunctures
4. Participants who are treated according to a different dosing schedule than standard dosing of guselkumab

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of case - guselkumab; Patients will continue to receive guselkumab according to the standard dosing schedule; subcutaneous injection of 100 mg at weeks 0 and 4 and then every 8 weeks	Procedure: Venapuncture; Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of guselkumab.; Other: Patient questionnaires; The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of early serum trough concentrations of guselkumab	Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.	Week 0 until week 24 of treatment
Predictive value of early anti-drug antibodies of guselkumab	Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.	Week 0 until week 24 of treatment
Development of the therapeutic window of guselkumab in psoriasis	Defining a therapeutic window for guselkumab based on serum trough concentrations corresponding with adequate clinical response	Week 0 until week 52 of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLQI	The DLQI (Dermatology Life Quality Index) (range 0-30) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the disease on participant's QoL. It is a ten item questionnaire that, in addition to evaluated overall QoL, can be used to assess six different aspects that may affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leasure, 4) work or school performances, 5) personal relationships, and 6) treatment. The scoring of each question is as follows: Very much - scored 3; A lot - scored 2; A little - scored 1; Not at all - scored 0; Not relevant - scored 0; Question 7, 'prevented work or studying' - scored 3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.	Week 0 until week 52 of treatment
EQ VAS	The EQ VAS (Visual Analogue Scale) (range 0-10) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	Week 0 until week 52 of treatment
EQ-5D-5L	The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Week 0 until week 52 of treatment

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: KU Leuven; University Ghent
• Investigators: Principal Investigator: Jo Lambert, Prof., University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; Therapeutic drug monitoring; Guselkumab
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: BIOLOPTIM-GUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No