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

NCT04765332 | Completed

• 1 other identifier: PSO-TARGET
• Study Type: observational
• Target: 143
• Locations: 2 countries
• Sites: 27

Brief Summary

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®.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• The percentage of patients who achieved the main treatment goal identified by the patient himself in the QoL component grid at baseline.

  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)

Study Arms (1)

Included patients

Fill patient questionnaires at inclusion visit, around 3 months and 12 months

Other: DLQI and PSO-TARGET QoL grid

Interventions

DLQI and PSO-TARGET QoL grid OTHER

At inclusion visit, and after 3 and 12 months, the patient will fill a patient questionnaire containing DLQI and PSO-TARGET QoL grid

Included patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinact: lead
• LEO Pharma: collaborator

Study Sites (27)

Cliniques Universitaires Saint Luc - UCLouvain

Brussels, Belgium

Location

Private practice

Geel, Belgium

Location

Private practice

Genk, Belgium

Location

Private practice

Kalken, Belgium

Location

Centre Dermatologique du Roy

Lasne, Belgium

Location

Dermatology Maldegem

Maldegem, Belgium

Location

CHU Ambroise Paré

Mons, Belgium

Location

CHU UCL Namur - Sainte Elisabeth

Namur, Belgium

Location

Private practice

Namur, Belgium

Location

Private practice

Waregem, Belgium

Location

Chu de Rennes

Auray, France

Location

Chru de Besancon - Hopital Jean Minjoz

Besançon, France

Location

Polyclinique de Courlancy-Bezanes

Bezannes, France

Location

Centre Hospitalier de Boulogne-sur-mer

Boulogne-sur-Mer, France

Location

CHU de CAEN

Caen, France

Location

Ch William Morey

Chalon-sur-Saône, France

Location

Nouvel Hôpital Sud Francilien

Corbeil-Essonnes, France

Location

Ch Annecy Genevois

Épagny, France

Location

Hopital Jacques Monod

Montivilliers, France

Location

Cide Azur

Nice, France

Location

Ch Cote de Lumiere

Olonne-sur-Mer, France

Location

Hopital Paris Saint-Joseph

Paris, France

Location

Ch de Perpignan

Perpignan, France

Location

CHU de Poitiers

Poitiers, France

Location

Hôpital d'Instruction des armées SAINTE ANNE

Toulon, France

Location

Hopital Larrey

Toulouse, France

Location

CHRU de NANCY - BSM BRABOIS

Vandœuvre-lès-Nancy, France

Location

Related Publications (2)

• Reguiai Z, Ghislain PD, Baudier E, Zraik A, Boye T. Real-World Effectiveness of Brodalumab in Challenging Psoriasis Subgroups: Insights from the PSO-TARGET Cohort. Dermatol Ther (Heidelb). 2025 Dec 23. doi: 10.1007/s13555-025-01629-2. Online ahead of print.

  PMID: 41432882 DERIVED

• Reguiai Z, Ghislain PD, Moulin P, Baudier E, Schepkens C, Sintes M, Boye T. PSO-TARGET: a New Tool to Identify the Therapeutic Expectations of Psoriasis Patients Treated with Biologics. Dermatol Ther (Heidelb). 2025 Mar;15(3):707-719. doi: 10.1007/s13555-025-01356-8. Epub 2025 Feb 21.

  PMID: 39979765 DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ziad Reguiai, Dr. MED

  POLYCLINIQUE DE COURLANCY-BEZANES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 21, 2021
• Study Start: December 4, 2020
• Primary Completion: May 10, 2022
• Study Completion: March 13, 2023
• Last Updated: March 19, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (10); FR (17)