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临床试验/NCT06102356
NCT06102356已完成不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Correlation between PASI and satisfaction

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

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

结局指标

主要结局

Correlation between PASI and satisfaction

时间窗: 1 year

PASI (Psoriasis Activity and Severity Index) (0-72)

Correlation between DLQI and satisfaction

时间窗: 1 year

DLQI (Dermatology Life Quality Index) (0-30)

Correlation between clinical variables and satisfaction

时间窗: 1 year

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.

次要结局

  • Correlation between satisfaction and Type D Personality(1 year)
  • Correlation between satisfaction and PHQ-9(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caldarola Giacomo

Clinical professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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