Evaluation of the Sensitivity and Specificity of a Novel Quality of Life Tool to Assess the Treatment Satisfaction in Psoriasis Patients (PSO-TARGET)

Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients

The severity of psoriasis can be influenced by a great variety of factors including extent of the disease, lesions location and impact on quality of life. The current standard of care for psoriasis is focusing on the reduction of the skin symptoms as defined by the PASI, somewhat setting asides the patient's feelings in terms of which aspects of his/her life are affected by the disease. Despite the fact that multiple patient reported outcomes (PRO) questionnaires are available to evaluate the impact of the disease on patients' quality of life, only few items address the subjective impact of skin disease. Among the available PROs the Dermatology Life Quality Index (DLQI) is the most frequently used. It is a standardized tool designed to cover a broad range of dermatologic afflictions but lacks specificity towards the effect of psoriasis on quality of life. The DLQI is composed of ten questions grouped in 6 domains "symptoms and feelings", "daily activities", "leisure", "work/school", "personal relationships" and "treatment". Each answer is graded from 0 to 3. The DLQI score is calculated by adding the score of each question, resulting in a maximum score of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

Because of its limitations, some patients cannot seem to completely restore a normal quality of life (e.g. DLQI 0-1) even though their reached a perfect PASI score (100). This phenomenon may be explained by the fact that the patient's own perception can be different from the physician's perspective and may have changed in time, between follow-ups. These are as many reasons as why it is highly difficult to accurately fathom the therapeutic expectations of the psoriasis patients. The standard tools currently in use are not able to assess the perception of the disease by the patient its evolution over time. In addition, it is widely recognized that alexithymia is more prevalent in the psoriasis patients than in the general population and patients with alexithymia appear to suffer higher psoriasis burden as they have more difficulties to express their expectations. Since patients struggle to recognize and verbalize their emotions, it can be useful and informative to offer patients a variety of verbatim in which they can identify. PSO-TARGET is an exploratory observational, non-interventional study aiming to evaluate a novel approach of assessing psoriasis patients' satisfaction towards their biologic treatment from a quality of life standpoint by using a psoriasis-specific Quality of Life assessment grid.

The aim of this exploratory study is to evaluate the sensitivity and specificity of the PSO-TARGET QoL Component grid as part of a new approach for assessing the level of achievement of the psoriasis patient's therapeutic goal, identified by himself, after a treatment with Kyntheum®.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: DLQI and PSO-TARGET QoL grid

• Study Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Cliniques Universitaires Saint Luc - UCLouvain
  • Geel, Belgium
    • Private Practice
  • Genk, Belgium
    • Private Practice
  • Kalken, Belgium
    • Private Practice
  • Lasne, Belgium
    • Centre Dermatologique du Roy
  • Maldegem, Belgium
    • Dermatology Maldegem
  • Mons, Belgium
    • CHU Ambroise Pare
  • Namur, Belgium
    • CHU UCL Namur - Sainte Elisabeth
  • Namur, Belgium
    • Private Practice
  • Waregem, Belgium
    • Private Practice
• France
  • Auray, France
    • CHU de Rennes
  • Besançon, France
    • CHRU de Besancon - Hopital Jean Minjoz
  • Bezannes, France
    • Polyclinique de Courlancy-Bezanes
  • Boulogne-sur-Mer, France
    • Centre Hospitalier de Boulogne-sur-mer
  • Caen, France
    • CHU de Caen
  • Chalon-sur-Saône, France
    • CH William Morey
  • Corbeil-Essonnes, France
    • Nouvel Hôpital Sud Francilien
  • Montivilliers, France
    • Hopital Jacques Monod
  • Nice, France
    • Cide Azur
  • Olonne-sur-Mer, France
    • Ch Cote de Lumiere
  • Paris, France
    • Hopital Paris Saint-Joseph
  • Perpignan, France
    • CH de Perpignan
  • Poitiers, France
    • Chu de Poitiers
  • Toulon, France
    • Hôpital d'Instruction des Armées Sainte Anne
  • Toulouse, France
    • Hôpital Larrey
  • Vandœuvre-lès-Nancy, France
    • CHRU de NANCY - BSM BRABOIS
  • Épagny, France
    • Ch Annecy Genevois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The safety population will comprise all included patients having received at least one dose of treatment.

The efficacy population will comprise all included patients who fulfill all inclusion and exclusion criteria.

The total number of patients included in the study, in each analysis population and related reasons of exclusion will be described.

The total number of patients attended each visit, number and reasons of study discontinuation will also be described.

Description

Inclusion Criteria:

• Age > 18 years
• Patient for whom the dermatologist decided to initiate a treatment by Kyntheum® according to SmPC.
• Patient who signed an informed consent

Exclusion Criteria:

• Vulnerable subjects according to the law;

  • pregnant, parturient or breast feeding women;
  • deprived of their freedom by administrative, medical or legal decision or who is under trusteeship/guardianship;
  • legally protected, or unable to express their consent to participate;
  • With no affiliation to a social security system;
• Psychologically/linguistically unable to express their consent to participate
• With an hypersensitivity to at least one of the excipients of Kyntheum®
• Participating at the same time in another clinical trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Included patients; Fill patient questionnaires at inclusion visit, around 3 months and 12 months	Other: DLQI and PSO-TARGET QoL grid; At inclusion visit, and after 3 and 12 months, the patient will fill a patient questionnaire containing DLQI and PSO-TARGET QoL grid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI in assessing the impact of the treatment on the patients' quality of life.	At first follow-up visit (around 12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients who achieved the main treatment goal identified by the patient himself in the QoL component grid at baseline.	The therapeutic objective achievement is defined as "satisfied" or "very satisfied" response on 4 points Likert scale.	At first follow-up visit (around 12 weeks)
Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI		At last follow up (around 52 weeks)
Research of predictive factors (among baseline characteristics) of the achievement of the main treatment goal.		At first follow-up visit (around 12 weeks)
Percentage of agreement between the physician-reported and the patient-reported dimensions		At first follow-up visit (around 12 weeks)
Rate of patients having changed objective at the 1st follow-up visit		At first follow-up visit (around 12 weeks)
Percentage of patients who have maintained at 52 ± 4 weeks the level of satisfaction achieved at the 1st follow-up visit.		At last follow up (around 52 weeks)
Psoriasis Area and Severity Index (PASI)	Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface	at baseline
Psoriasis Area and Severity Index (PASI)	Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface	at the 1st follow-up visit ), at the 2nd follow-up visit (52 ± 4 weeks.).
Psoriasis Area and Severity Index (PASI)	Calculation of the percentage of skin surface area affected. Estimation of how many hands surface (palm + fingers) of the patient correspond to psoriatic lesions. one hand surface is considered as 1% of total body skin surface	at the 2nd follow-up visit (around 52 weeks.).
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.		at baseline, at the 1st follow-up visit (12/ 16 weeks), at the 2nd follow-up visit 52 ± 4 weeks.
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.		at the 1st follow-up visit (around 12 weeks)
Level of accordance between PASI 90/100 and the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid.		at the 2nd follow-up visit (around 52 weeks)
Dermatology Life Quality Index (DLQI Scores)	Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)	at baseline
Dermatology Life Quality Index (DLQI Scores)	Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)	at the 1st follow-up visit (around 12 weeks)
Dermatology Life Quality Index (DLQI Scores)	Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible)	at the 2nd follow-up visit (around 52 weeks)

Collaborators and Investigators

• Sponsor: Clinact
• Collaborators: LEO Pharma
• Investigators: Principal Investigator: Ziad Reguiai, Dr. MED, Polyclinique de Courlancy-Bezanes

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): March 13, 2023

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: PSO-TARGET

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