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

NCT07498543 | Completed

• 1 other identifier: 5601
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• 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 PASI * 90% and 100% reduction in PASI score from baseline * DLQI between 0-5

  1 year

Secondary Outcomes (1)

• Correlation of Type D personality with satisfaction with treatment.

  1 year

Study Arms (1)

Patients diagnosed with psoriasis

Psoriasis already treated with a systemic biologic drug for at least one year.

Other: Questionnaire

Interventions

Questionnaire OTHER

DLQI, PHQ 9, TSQM 2, DS14

Patients diagnosed with psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Giacomo Caldarola

  Università Cattolica del Sacro Cuore, Roma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: March 27, 2026
• Study Start: October 12, 2023
• Primary Completion: October 12, 2023
• Study Completion: June 1, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)