Assessment of illness burden and patient needs

Background: A central topic in people-centered healthcare is to identify patient needs at an early stage and to avoid cumulating disease burden and irreversible damage to the patients’ life trajectories. Such damage can arise from quality of life impairments, decreased personal and professional chance (“missed opportunities”) and a high level of stigmatization. In spite of the dramatic increases in effective drugs available for the treatment of moderate to severe psoriasis, there remain unmet needs in marked numbers of patients even in the absence of current skin lesions.

Study Objectives:

• Investigate the potential unmet needs of persons with psoriasis.

• Analyze the current degree of disease burden and cumulative life course impairment (CLCI).

• Assess the retrospective (lifetime) CLCI as well as the risk factors for future CLCI.

• Identify the target group and health care needs for additional biological components such as Bimekizumab in the German health care for psoriasis, and address safety considerations.

Study Design:

• Systematic literature review

• Routine data analysis

• Prospective study

Target Group: patients with psoriasis

Sponsor: UCB 

Period: December 2021 – February 2023

Background: Patients with atopic dermatitis frequently report physical impairments such as itch, pain, dry skin and the need to scratch oneself, but also sleep disturbances, anxiety, feelings of depression, perceived stigmatization, and a lack of hope. Thus, atopic dermatitis places an emotional, social and physical burden on patients. The impact of topical basic therapy on the social wellbeing of people with atopic dermatitis and the feeling of stigmatization has hardly been studied.

Study Objectives:

• Characterize the psychosocial impact of different disease severities of atopic dermatitis with a special focus on social wellbeing and stigma.

• Analyze the effects of skin care with AtopiControl Lotion on these health outcomes.

Study Design: observational study

Target Group: patients with atopic dermatitis receiving topical treatment with AtopiControl Lotion and a control group not receiving topical treatment (n = 79)

Sponsor: Beiersdorf AG

Completed: 2021

Background: Dry skin (xerosis cutis) is a very common symptom in the general population and especially in persons with skin diseases. In more severe cases, it poses a substantial burden due to the feeling of dryness, itch, or burning but also due to its effects on interpersonal relationships (rejection, stigmatization, social isolation) and psychological wellbeing (sleep alterations, body image, anxiety).

Study Objectives:

• Characterize the disease burden experienced by persons with and without xerosis cutis, and its association with a broad range of psychosocial variables from the patient’s perspective (quality of life, perceived stigma, dysmorphic body concerns and anxiety). 

• Evaluate the effect of a short physician education/instruction related to the use of skin care products on the abovementioned outcomes.

Study Design: cross-sectional study

Target Group:

• Persons with atopic dermatitis and xerosis cutis

• Persons with xerosis cutis only

• Persons without xerosis cutis (n = 127)

Sponsor: Beiersdorf AG

Completed: 2020 

Associated Publications:

Exploring the burden of xerosis cutis and the impact of dermatological skin care from patient's perspective

Background: Chronic pruritus (itch) is common in patients with psoriasis, and often leads to high levels of stress and a loss of quality of life. It affects behavior such as scratching, irritability, or social withdrawal, and can cause or exacerbate visible skin lesions. Consequently, pruritus is likely to have a negative impact on social interactions and even be a starting point for social fears and stigmatization.

Study Objectives:

• Characterize the psychosocial impact of chronic pruritus with a special focus on social interaction and stigma.

• Compare the psychosocial impact between patients with psoriasis affected and those unaffected by pruritus.

Study Design: cross-sectional study

Target Group: psoriatic patients with (n = 50) and without (n = 50) pruritus

Sponsor: Leo Pharma GmbH

Completed: 2021

Associated Publications:

Significance of chronic pruritus for intrapersonal burden and interpersonal experiences of stigmatization and sexuality in patients with psoriasis

Background: Considering the large number of systemic drugs for psoriasis, clinical decision is often based on the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA) and Dermatology Life Quality Index (DLQI) scores. However, in line with the people-centered health care approach and the holistic definition of health by the World Health Organization (WHO), treatment choices should be based not only on hard clinical measures such as PASI but also on patient preferences and values. Therefore, a shared decision making process between clinician and patient is essential. In shared decision making, the clinician informs the patient on the options available based on the best medical evidence and the patient participates in informing about his/her needs and preferences, allowing an optimal evidenced-based and patient-oriented decision and patient care. Such process is particularly important in case of vulnerable patient groups such as women at childbearing age and in case of multiple treatment options.

Study Objectives:

• Characterize the specific patient needs of WoCBA related to psoriasis treatment.

• Assess the impact of psoriasis on psychosocial determinants of patient burden, in particular self-perception, perceived stigma and social impairment in WoCBA.

• Determine the interaction of childbearing age with the patient’s perceived stigma, sexual dysfunction, self-perception, disfigurement/body image and social impairment. 

• Examine how patient strain and needs interfere with the need for drug treatment specifically in childbearing age.

Study Design:

• Cross-sectional

• Non-interventional

• Focus groups

• Quantitative and qualitative analyses

Target Group: women at childbearing age (18-45 years) with moderate to severe psoriasis

Sponsor: UCB 

Period: September 2021 – December 2022

Background: Patients with genital psoriasis frequently experience significant impairments in quality of life, higher rates of depression, sexual dysfunction, decreased frequency of sexual activity, reduced sexual desire, avoidance of sexual relationships, and worsening of symptoms after sexual activity. The impaired sexual experience can be explained by both physical effects, such as cracking or pain, and psychosocial effects, such as embarrassment and feelings of stigmatization.

Study Objectives:

• Characterize the disease burden experienced by patients with psoriasis with and without lesions in the anogenital area, and to describe their sociodemographic and clinical profiles.

• Assess its association with a broad range of psychosocial variables from the patient’s perspective, namely patient needs and benefits, perceived stigma, coping and sexual functioning.

Study Design:

• Cross-sectional

• Non-interventional

Target Group: patients with plaque-type or intertriginous psoriasis who present for the first time and seek treatment in routine care (n = 500)

Sponsor: Eli Lilly

Period: June 2020 -  December 2022