Clinical trial NCT04765332: Evaluation of the Sensitivity and Specificity of a Novel Quality of Life Tool to Assess the Treatment Satisfaction in Psoriasis Patients
Official title: Evaluation of the Sensitivity and Specificity of a Novel Quality of Life (QoL) Tool to Assess the Treatment Satisfaction in Psoriasis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Clinact
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2021-02-21
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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®.


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

Primary outcomes:
measure: 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.
timeFrame: At first follow-up visit (around 12 weeks)
Secondary outcomes:
measure: The percentage of patients who achieved the main treatment goal identified by the patient himself in the QoL component grid at baseline.
timeFrame: At first follow-up visit (around 12 weeks)
measure: Level of concordance between the satisfaction level in regard to the therapeutic objective set by the PSO-TARGET QoL Component grid and the DLQI
timeFrame: At last follow up (around 52 weeks)
measure: Research of predictive factors (among baseline characteristics) of the achievement of the main treatment goal.
timeFrame: At first follow-up visit (around 12 weeks)
measure: Percentage of agreement between the physician-reported and the patient-reported dimensions
timeFrame: At first follow-up visit (around 12 weeks)
measure: Rate of patients having changed objective at the 1st follow-up visit
timeFrame: At first follow-up visit (around 12 weeks)
measure: Percentage of patients who have maintained at 52 ± 4 weeks the level of satisfaction achieved at the 1st follow-up visit.
timeFrame: At last follow up (around 52 weeks)
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: at baseline
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: at the 1st follow-up visit ), at the 2nd follow-up visit (52 ± 4 weeks.).
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: at the 2nd follow-up visit (around 52 weeks.).
measure: 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.
timeFrame: at baseline, at the 1st follow-up visit (12/ 16 weeks), at the 2nd follow-up visit 52 ± 4 weeks.
measure: 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.
timeFrame: at the 1st follow-up visit (around 12 weeks)
measure: 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.
timeFrame: at the 2nd follow-up visit (around 52 weeks)
measure: Dermatology Life Quality Index (DLQI Scores)
timeFrame: at baseline
measure: Dermatology Life Quality Index (DLQI Scores)
timeFrame: at the 1st follow-up visit (around 12 weeks)
measure: Dermatology Life Quality Index (DLQI Scores)
timeFrame: at the 2nd follow-up visit (around 52 weeks)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc - UCLouvain
city: Geel
country: Belgium
facility: Private practice
city: Genk
country: Belgium
facility: Private practice
city: Kalken
country: Belgium
facility: Private practice
city: Lasne
country: Belgium
facility: Centre Dermatologique du Roy
city: Maldegem
country: Belgium
facility: Dermatology Maldegem
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Namur
country: Belgium
facility: CHU UCL Namur - Sainte Elisabeth
city: Namur
country: Belgium
facility: Private practice
city: Waregem
country: Belgium
facility: Private practice
city: Auray
country: France
facility: Chu de Rennes
city: Besançon
country: France
facility: Chru de Besancon - Hopital Jean Minjoz
city: Bezannes
country: France
facility: Polyclinique de Courlancy-Bezanes
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne-sur-mer
city: Caen
country: France
facility: CHU de CAEN
city: Chalon-sur-Saône
country: France
facility: Ch William Morey
city: Corbeil-Essonnes
country: France
facility: Nouvel Hôpital Sud Francilien
city: Montivilliers
country: France
facility: Hopital Jacques Monod
city: Nice
country: France
facility: Cide Azur
city: Olonne-sur-Mer
country: France
facility: Ch Cote de Lumiere
city: Paris
country: France
facility: Hopital Paris Saint-Joseph
city: Perpignan
country: France
facility: Ch de Perpignan
city: Poitiers
country: France
facility: CHU de Poitiers
city: Toulon
country: France
facility: Hôpital d'Instruction des armées SAINTE ANNE
city: Toulouse
country: France
facility: Hopital Larrey
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de NANCY - BSM BRABOIS
city: Épagny
country: France
facility: Ch Annecy Genevois
Study officials:
affiliation: POLYCLINIQUE DE COURLANCY-BEZANES
name: Ziad Reguiai, Dr. MED
role: PRINCIPAL_INVESTIGATOR
References: