Impact of Clinical and Psychological Factors on Treatment Satisfaction in Psoriatic Patients in Biological Therapy (PsoSAT)

This study aims to identify, through the use of questionnaires, demographic, clinical and psychological factors that could better correlate with the satisfaction of psoriatic patients in systemic therapy with biological drugs for more than a year belonging to the Dermatology Clinics of the A. Gemelli-IRCCS University Hospital

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Other: Questionnaire

Detailed Description

Psoriasis is a chronic inflammatory disease with a significant impact on the quality of life of those affected. The introduction of monoclonal antibodies directed against key cytokines in the pathogenesis of the disease has so far allowed to obtain excellent results not only in terms of objective clinical response (PASI90, PASI100), but also in terms of quality of life (DLQI) thanks to the speed of action, the long-term response and the better safety profile compared to so-called "traditional" drugs, such as cyclosporine, methotrexate and acitretin.

Patient satisfaction is one of the main elements to ensure the success of a systemic therapy for a chronic disease such as psoriasis, as it is closely related to adherence to treatment Although the literature suggests that treatment satisfaction derives mainly from objective data such as the extent of residual disease, there are no unequivocal data on which values of the disease severity index (PASI) are associated with greater patient satisfaction. Recent studies have also shown that a certain percentage of patients who achieve optimal responses with biological therapies (PASI90, PASI100, absolute PASI <2), still report an impact of the disease on their quality of life (assessed by DLQI) (2021 Life Basel Kirsten et al Which PASI OutcomeIs Most Relevant to the Patients in Real-World Care?) This paradox has been partly explained by the localization of residual disease in so-called sensitive sites and by the presence of a possible associated symptomatology, but it is still partially unexplored how the psychological profile of the patient can influence this aspect. (DermatolTher 2022 Lebwol M. et al "Evolution of Patient Perceptions of Psoriatic Disease: Results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) Survey"). In particular, it remains to be clarified the weight of some psychopathological characteristics of patients and how these can negatively affect the quality of life and consequently satisfaction with treatment. On the other hand, it is known that there is an increased prevalence of numerous psychiatric pathologies in psoriatic patients: depression, bipolar disorder, anxiety, psychosis, cognitive impairment, sexual disorders, sleep disorders, eating behavior and personality disorders. (Rev. Neurosci 2018 Amanat M. et al "Neurological and psychiatricdisorders in psoriasis").

With regard to personality alterations, several studies have shown an increased prevalence (37.4%) of a particular personality profile, Type D, in patients with psoriasis: this is a personality profile characterized by negative emotionality, often associated with a higher incidence of psychiatric diseases (such as anxiety and depression) and which could affect satisfaction with therapies.

• Study Type: Observational
• Enrollment (Estimated): 104

Contacts and Locations

• Study Contact: Name: Gennaro Marco Falco, MD; Phone Number: +393402379939; Email: gianmarcofalco@gmail.com

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli
      • Contact: Gennaro Marco Falco; Email: gianmarcofalco@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with psoriasis belonging to the Dermatology and Venereology clinics of FPG already treated with a systemic biological drug for at least one year will be included

Description

Inclusion Criteria:

• Patients with age>18 years, of both sexes;
• Diagnosis of plaque psoriasis, with or without concomitant arthritis
• Patients who have been receiving systemic biologics for at least one year and have disease severity (PASI) and quality of life (DLQI) data available at baseline (prior to initiation of treatment);
• Signature of the written informed consent;

Exclusion Criteria:

• Presence of a psychiatric pathology already diagnosed
• Patients with psoriasis variants (pustular, guttate, palmoplantar)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Patients diagnosed with Psoriasis referred to the outpatient clinics of Dermatology and Venereology of FPG already treated with a systemic biologic drug for at least one year.	Other: Questionnaire; DLQI TSQM v.II PHQ-9 DS14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between PASI and satisfaction	PASI (Psoriasis Activity and Severity Index) (0-72)	1 year
Correlation between DLQI and satisfacion	DLQI (Dermatology Life Quality Index) (0-30)	1 year
Correlation between clinical variables and satisfaction	Satisfaction is measured via TSQM v.II. TSQM v.II has 11 questions in four subscales including effectiveness, side effects, convenience of use and overall satisfaction. The sum of the scores of each subscale is displayed as a number from zero to 100.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between satisfaction and Type D Personality	"Type D Personality" will be identified through a special validated questionnaire (DS14) that identifies this type of personality in those who obtain scores of "Negative Affectivity" or "Social Inhibition" higher than 10	1 year
Correlatione between satisfaction and PHQ-9	PHQ-9 investigates the presence "in the last two weeks" of the 9 symptoms of depression according to the DSM-IV also taken up in the DSM-5. Only this question determines the score of the PHQ-9. Each symptom is assessed on a 4-point scale. The second question assesses the functional impairment that depression causes on the normal course of the patient's life. This question does not count towards the PHQ-9 score. The PHQ-9 score ranges from 0 to 27. Scores between 5 and 9indicate the presence of a subthreshold depression. The score of 10 is the optimal cut-off to highlight clinically relevant depressions	1 year

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: October 21, 2023
• First Submitted That Met QC Criteria: October 21, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 5601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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