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

Psoriasis is a chronic-recurrent inflammatory disease with a significant impact on patients' physical and psychological well-being. Fortunately, in recent years, the introduction of increasingly selective biologic therapies on the market has resulted in an excellent control of the disease, with high rates of complete (PASI100) or nearly complete (PASI90) in treated patients. At the same time, however, various studies have shown that these patients' quality of life and satisfaction with these therapies do not always correlate with the high levels of efficacy of these drugs, and this is often a limitation, as it has negative feedbacks on treatment adherence. This study aims to identify, through the use of questionnaires, demographic, clinical and psychological factors that might best correlate with the satisfaction of psoriatic patients on therapy systemic with biologic drugs for more than one year afferent to the Dermatology Outpatient Clinics of the Policlinico Universitario A. Gemelli-IRCCS.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Patients with age of more than18 years, of either sex;
• Diagnosis of Plaque Psoriasis, with or without concomitant arthritis;
• Patients who have been treated with systemic biologic drugs for at least one year whose available data on disease severity (PASI) and quality of life (DLQI) at baseline (before initiation treatment);
• Signature of written informed consent;

Exclusion Criteria:

• Presence of an already diagnosed psychiatric condition.
• Patients with variants of psoriasis (pustular, guttate, palmoplantar)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed with psoriasis; Psoriasis already treated with a systemic biologic drug for at least one year.	Other: Questionnaire; DLQI, PHQ 9, TSQM 2, DS14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9) - towards treatment, in a sample of psoriatic patients on therapy for more than one year with a biologic drug	The primary objective of the study is to evaluate satisfaction with treatment of psoriatic patients who have been on therapy for at least one year with a biologic drug. Satisfaction will be expressed in terms of a score derived from the Treatment Satisfaction Questionnaire for Medication (TSQM-9).(0-100) higher scores mean a better outcome.	1 year
DLQI	Evaluate after 1 year of treatment with biologic drug: the DLQI (0-30). Lower scores mean a better outcome.; the DLQI improvement from baseline	1 year
Effect of clinical variables on satisfaction of treatment	Evaluate the effect of objectively measurable clinical variables such as: the age of onset and duration of disease; the presence of comorbidities; the possible combination with other treatments; the residual location of disease; the presence/absence of psoriatic arthritis; the residual PASI; the PASI improvement from baseline; The achievement of an optimal response in terms of:Absolute PASI90% and 100% reduction in PASI score from baselineDLQI between 0-5	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Type D personality with satisfaction with treatment.	As a secondary objective, the relationship of specific characteristics will also be assessed. psychopathology (Type D personality, Depression) with satisfaction with treatment.	1 year

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Investigators: Principal Investigator: Giacomo Caldarola, Università Cattolica del Sacro Cuore, Roma

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 5601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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