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

NCT ID: NCT04765332

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2023-03-13

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Included patients

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

DLQI and PSO-TARGET QoL grid

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

Clinact

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ziad Reguiai, Dr. MED

Role: PRINCIPAL_INVESTIGATOR

POLYCLINIQUE DE COURLANCY-BEZANES

Locations

Cliniques Universitaires Saint Luc - UCLouvain

Brussels, , Belgium

Private practice

Geel, , Belgium

Private practice

Genk, , Belgium

Private practice

Kalken, , Belgium

Centre Dermatologique du Roy

Lasne, , Belgium

Dermatology Maldegem

Maldegem, , Belgium

CHU Ambroise Paré

Mons, , Belgium

CHU UCL Namur - Sainte Elisabeth

Namur, , Belgium

Private practice

Namur, , Belgium

Private practice

Waregem, , Belgium

Chu de Rennes

Auray, , France

Chru de Besancon - Hopital Jean Minjoz

Besançon, , France

Polyclinique de Courlancy-Bezanes

Bezannes, , France

Centre Hospitalier de Boulogne-sur-mer

Boulogne-sur-Mer, , France

CHU de CAEN

Caen, , France

Ch William Morey

Chalon-sur-Saône, , France

Nouvel Hôpital Sud Francilien

Corbeil-Essonnes, , France

Ch Annecy Genevois

Épagny, , France

Hopital Jacques Monod

Montivilliers, , France

Cide Azur

Nice, , France

Ch Cote de Lumiere

Olonne-sur-Mer, , France

Hopital Paris Saint-Joseph

Paris, , France

Ch de Perpignan

Perpignan, , France

CHU de Poitiers

Poitiers, , France

Hôpital d'Instruction des armées SAINTE ANNE

Toulon, , France

Hopital Larrey

Toulouse, , France

CHRU de NANCY - BSM BRABOIS

Vandœuvre-lès-Nancy, , France

Countries

Belgium; France

References

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.

Reference Type: DERIVED

PMID: 39979765 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PSO-TARGET

Identifier Type: -

Identifier Source: org_study_id