Psoriasis

National Taiwan University Dermatology department

The Impact of Targeted Therapy on Microorganism in Patients With Psoriasis

Study 1:The sampling of eyebrow hairs and skin scales before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. Study 2: The same above mentioned microorganisms exams were done at enrollment and repeated again 12 weeks after the discontinuation of therapies. Comparison of the prevalence of latent virus and changes from baseline in viral load of human papillomaviruses virus between psoriasis patients who are treating with and without target therapies is performed.

Study 1:The sampling of blood before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. Study 2: The same above mentioned microorganisms exams were done at enrollment and repeated again 12 weeks after the discontinuation of therapies. Comparison of the prevalence of latent virus, and changes from baseline in viral load of cytomegalovirus between psoriasis patients who are treating with and without target therapies is performed.

Study 1:The sampling of blood before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. Study 2: The same above mentioned microorganisms exams were done at enrollment and repeated again 12 weeks after the discontinuation of therapies. Comparison of the prevalence of latent virus, and changes from baseline in viral load of Epstein-Barr virus between psoriasis patients who are treating with and without target therapies is performed.

Study 1:The sampling of skin scales before the initiation of biologics therapy, 12 and 24 weeks after initiation of the target therapies, 12 weeks after discontinuation of target therapies. Study 2: The same above mentioned microorganisms exams were done at enrollment and repeated again 12 weeks after the discontinuation of therapies. Comparison of the prevalence of bacteria and fungi skin colonization between psoriasis patients who are treating with and without target therapies is performed.

National Taiwan University Hospital

Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.

Anti-TNF

Gender

Region of Enrollment

Weight

Height

Body Mass Index (BMI)

Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Psoriasis Area and Severity Index (PASI) Score

DLQI is a questionnaire to evaluate dermatology patients for their quality of life for the following subsets of parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Questions related with these parameters are summed up and the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on patient's life whereas 0-1 means that the disease has no effect at all.

Dermatology Life Quality Index (DLQI) Score

Duration of Psoriasis

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from -5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement).

Dynamic Physician Global Assessment (PGA) of Change in Psoriasis

In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement).

Dynamic Patient Global Assessment (PGA) of Change in Psoriasis

In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale:
Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis.

Baseline Static Physician Global Assessment of Psoriasis, prior to initiation of anti-TNF therapy.

Baseline

Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.

Week 24

Static Physician Global Assessment (PGA) of Psoriasis

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.

Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score

The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Percentage of Participants With 75% Reduction in PASI Score

The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):
Percent work time missed in the last 7 days due to problems associated with psoriasis;
Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;
Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;
Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.
Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.

Percent Change From Baseline in Work Productivity and Activity Impairment

The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above.
Please see the Adverse Event module below for additional details.

psoralen/נקרוזה

The Impact of Targeted Therapy on Microorganism in Patients With Psoriasis

A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis

המאגר השלם ביותר של צמחי מרפא המגובה על ידי המדע