Psoriasis
Conditions
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.
Interventions
OTHERQuestionnaire
DLQI, PHQ 9, TSQM 2, DS14
Sponsors
Catholic University of the Sacred Heart
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | 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. |
| DLQI | 1 year | Evaluate after 1 year of treatment with biologic drug: * the DLQI (0-30). Lower scores mean a better outcome. * the DLQI improvement from baseline |
| Effect of clinical variables on satisfaction of treatment | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Type D personality with satisfaction with treatment. | 1 year | As a secondary objective, the relationship of specific characteristics will also be assessed. psychopathology (Type D personality, Depression) with satisfaction with treatment. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORGiacomo Caldarola
Università Cattolica del Sacro Cuore, Roma
Outcome results
None listed