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

NCT ID: NCT06102356

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2024-06-15

Brief Summary

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

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 Outcomes 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 Lebwohl 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. Neuroscience, Amanat M. et al "Neurological and psychiatric disorders 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.

Conditions

Psoriasis

Study Design

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

Study Groups

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.

Questionnaire

Intervention Type: OTHER

DLQI TSQM v.II PHQ-9 DS14

Interventions

Questionnaire

DLQI TSQM v.II PHQ-9 DS14

Intervention Type: OTHER

Eligibility Criteria

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)

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Caldarola Giacomo

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5601

Identifier Type: -

Identifier Source: org_study_id