The objective of this non-interventional, observational study is to assess the effect of adalimumab on health-related quality of life in participants with Psoriasis in Korea.
Study Type
OBSERVATIONAL
Enrollment
97
Hallym University Sacred Heart Hospital /ID# 161697
Anyang-si, Gyeonggi-do, Gyeonggido, South Korea
CHA Bundang Medical center, CHA University /ID# 161696
Seongnam-si, Gyeonggido, South Korea
Ajou University Hospital /ID# 161698
Suwon, Gyeonggido, South Korea
Change in EuroQol 5 dimension (EQ-5D) score up to week 24
The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. The EQ-5D results can be converted to health utility scores. Completion time for the EQ-5D is approximately 2-3 minutes.
Time frame: From Week 0 (baseline) to 24
Change in EuroQol 5 dimension (EQ-5D) score up to week 16
The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. The EQ-5D results can be converted to health utility scores. Completion time for the EQ-5D is approximately 2-3 minutes.
Time frame: From Week 0 (baseline) to 16
Change in PASI score
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
Time frame: Week 0 (baseline), Week 16, and Week 24
Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 90
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-90 responders are the participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24.
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Yonsei University Health System, Severance Hospital /ID# 166300
Seodaemun-gu, Seoul Teugbyeolsi, South Korea
Hanyang University Seoul Hospi /ID# 169553
Seongdong-gu, Seoul Teugbyeolsi, South Korea
Busan National University Hosp /ID# 166299
Busan, South Korea
Inje University Ilsan Paik Hos /ID# 166302
Goyang, South Korea
Korea University Ansan Hosp /ID# 161695
Gyeonggi-do, South Korea
Korea University Ansan Hosp /ID# 161699
Gyeonggi-do, South Korea
Kyunghee University Hospital /ID# 161694
Seoul, South Korea
...and 2 more locations
Time frame: Up to Week 24
Change in EQ-5D Visual Analogue Scale (VAS)
The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. In addition, a VAS rates current health state between 0-100. The EQ-5D results can be converted to health utility scores. Completion time for the EQ-5D is approximately 2-3 minutes.
Time frame: Week 0 (baseline), Week 16, Week 24
Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24.
Time frame: Up to Week 24
Change in Nail Psoriasis Severity Index (NAPSI) score in participants with nail psoriasis
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants).
Time frame: Week 0 (baseline), Week 16, Week 24
Change in Short Form (36) Health Survey (SF-36) domain scales
The SF-36 is a subject-reported questionnaire of subject health-related QoL. It measures generic health concepts relevant across age, disease, and treatment groups. There are 36 items in total and the recall period is the last 4 weeks. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. Completion time for the SF-36 is approximately 10 minutes.
Time frame: Week 0 (baseline), Week 16, Week 24
Change in Dermatology Life Quality Index (DLQI)
The DLQI is developed as a simple, concise, practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains 10 items dealing with subjects' self-assessments of how their Psoriasis has affected their everyday lives during the latest 7-day period. The DLQI score ranges from 0-30, with 0 corresponding to the best quality of life and 30 the worst. The DLQI has well established properties of reliability and validity when used in a dermatology clinical practice setting.
Time frame: Week 0 (baseline), Week 16, Week 24
Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 100
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-100 responders are the participants who achieved at least a 100% reduction (improvement) from baseline in PASI score at Week 24.
Time frame: Up to Week 24
Change in subject satisfaction questions
The Treatment Satisfaction Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction with their medication. This is a 100-point scale with higher scores indicating greater satisfaction with medication and provides scores on four scales - side effects, effectiveness, convenience and global satisfaction.
Time frame: Week 0 (baseline), Week 16, and Week 24