Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Completed

Conditions: Moderate to Severe Plaque Psoriasis

Registration Number: NCT01202565

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary: There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice.

The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.

Detailed Description: This is post-marketing observational study (PMOS) in which HUMIRA® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication, and following the local prescription and/or reimbursement guidance.

Follow-up visits are not strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each participant. Five visits are indicated within the 12-month observational period: Baseline and follow-up at 3 months, 6 months, 9 months and at 12 months (Study End).

As nails are not included in the general measures of disease severity (such as Psoriasis Area and Severity Index \[PASI\]), the Nail Psoriasis Severity Index (NAPSI) will be used to assign a score of nail psoriasis. The scalp, though being involved in the general measures of disease severity (e.g. PASI), represents only 4-5% of the body surface and is therefore poorly represented. Psoriasis Scalp Severity Index (PSSI) will be used to quantify the intensity of scalp psoriasis and its changes during the study. The association between general skin and localized nail and scalp, and changes in quality of life in response to adalimumab therapy will also be examined.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 506

Inclusion Criteria

Patients will be enrolled in this PMOS if they fulfill all of the below criteria:

Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines
Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI score of hands and feet ≥ 10) and/or significant psoriatic scalp affection (Psoriasis Scalp Severity Index PSSI score ≥ 10)
Adult (≥18 years of age)
Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines
Willing to provide informed consent if requested by the local law regulations

Exclusion Criteria

Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS:

Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
Participate in another clinical/observational study

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12	Baseline and Month 12	NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. 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 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12	Baseline and Month 12	The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)	Baseline and Months 3, 6, 9, and 12	NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. 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 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). A negative change from Baseline indicates improvement.
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis	Baseline and Months 3, 6, 9, and 12	Good clinical response on nails is defined as ≥ 50% improvement from Baseline in total NAPSI score. The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. 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 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
Percentage of Participants Achieving Complete Clearing of Nails	Months 3, 6, 9, and 12	Complete clearing of nails is defined as a total NAPSI score of zero. The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. 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 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)	Baseline and Months 3, 6, 9, and 12	The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. A negative change from Baseline indicates improvement.
Percentage of Participants Achieving Good Clinical Response on Scalp	Baseline and Months 3, 6, 9, and 12	Good clinical response on scalp is defined as a ≥ 50% improvement from Baseline in PSSI score. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.
Percentage of Participants Achieving Complete Clearing of Scalp	Months 3, 6, 9, and 12	Complete clearing on scalp is defined as a PSSI score of zero. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	Baseline and Month 12	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: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Change From Baseline in PASI Score	Baseline and Months 3, 6, 9, and 12	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. A negative change from Baseline indicates improvement.
Percentage of Participants Achieving a PASI 90 Response	Baseline and Months 3, 6, 9, and 12	The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI 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.
Percentage of Participants Achieving a PASI 75 Response	Baseline and Months 3, 6, 9, and 12	The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI 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.
Percentage of Participants Achieving a PASI 50 Response	Baseline and Months 3, 6, 9, and 12	The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI 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.
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score	Baseline and Month 12	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: Month 12 value - Baseline value / Baseline value \* 100. A negative change from Baseline indicates improvement.
Change From Baseline in DLQI Score	Baseline and Months 3, 6, 9, and 12	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. A negative change from Baseline indicates improvement.
Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis	Baseline and Month 12	Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis	Baseline and Month 12	Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis	Baseline and Month 12	Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis	Baseline and Month 12	Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Associations Between General Improvement in Psoriasis With Improvement in Quality of Life	Baseline and Month 12	Associations between general improvement in quality of life, measured by percentage change of DLQI, and general improvement in psoriasis at the same time, measured by percentage improvement of the PASI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.

Trial Locations

Locations (73): Site Reference ID/Investigator# 56763
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Klimkovice, Czech Republic
Site Reference ID/Investigator# 63776
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Chotoviny, Czech Republic
Site Reference ID/Investigator# 58083
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Jihlava, Czech Republic
Site Reference ID/Investigator# 42514
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Kaposvar, Hungary
Site Reference ID/Investigator# 42513
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Pecs, Hungary
Site Reference ID/Investigator# 42502
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Szeged, Hungary
Site Reference ID/Investigator# 56542
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Prague 2, Czech Republic
Site Reference ID/Investigator# 30743
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Budapest, Hungary
Site Reference ID/Investigator# 42507
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Debrecen, Hungary
Site Reference ID/Investigator# 42512
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Pecs, Hungary
Site Reference ID/Investigator# 30744
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Afula, Israel
Site Reference ID/Investigator# 49888
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Jerusalem, Israel
Site Reference ID/Investigator# 49886
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Petach Tiqwa, Israel
Site Reference ID/Investigator# 49887
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Ramat Gan, Israel
Site Reference ID/Investigator# 51783
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Tel Aviv, Israel
Site Reference ID/Investigator# 46184
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Alexandria, Romania
Site Reference ID/Investigator# 44580
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Bucharest, Romania
Site Reference ID/Investigator# 44572
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Bucharest, Romania
Site Reference ID/Investigator# 44575
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Bucharest, Romania
Site Reference ID/Investigator# 44576
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Bucharest, Romania
Site Reference ID/Investigator# 44562
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Constanta, Romania
Site Reference ID/Investigator# 46185
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Bucharest, Romania
Site Reference ID/Investigator# 44563
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Bucharest, Romania
Site Reference ID/Investigator# 44566
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Bucharest, Romania
Site Reference ID/Investigator# 44567
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Bucharest, Romania
Site Reference ID/Investigator# 44569
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Bucharest, Romania
Site Reference ID/Investigator# 44571
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Bucharest, Romania
Site Reference ID/Investigator# 44557
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Craiova, Romania
Site Reference ID/Investigator# 44549
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Iasi, Romania
Site Reference ID/Investigator# 44554
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Reghin, Romania
Site Reference ID/Investigator# 42517
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Szombathely, Hungary
Site Reference ID/Investigator# 44564
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Bucharest, Romania
Site Reference ID/Investigator# 44561
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Constanta, Romania
Site Reference ID/Investigator# 44550
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Targu Mures, Romania
Site Reference ID/Investigator# 30746
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Banska Bystrica, Slovakia
Site Reference ID/Investigator# 42521
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Bratislava, Slovakia
Site Reference ID/Investigator# 42518
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Presov, Slovakia
Site Reference ID/Investigator# 64524
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Donetsk, Ukraine
Site Reference ID/Investigator# 66642
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Donetsk, Ukraine
Site Reference ID/Investigator# 56699
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Kiev, Ukraine
Site Reference ID/Investigator# 55443
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Lviv, Ukraine
Site Reference ID/Investigator# 56762
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Klimkovice, Czech Republic
Site Reference ID/Investigator# 42506
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Debrecen, Hungary
Site Reference ID/Investigator# 42510
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Debrecen, Hungary
Site Reference ID/Investigator# 30742
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Kostelec nad Ohri, Czech Republic
Site Reference ID/Investigator# 57563
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Tallinn, Estonia
Site Reference ID/Investigator# 57564
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Tallinn, Estonia
Site Reference ID/Investigator# 57567
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Tartu, Estonia
Site Reference ID/Investigator# 54503
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Prague 10, Czech Republic
Site Reference ID/Investigator# 58084
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Prague 8, Czech Republic
Site Reference ID/Investigator# 57562
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Tallinn, Estonia
Site Reference ID/Investigator# 42508
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Debrecen, Hungary
Site Reference ID/Investigator# 42509
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Debrecen, Hungary
Site Reference ID/Investigator# 42515
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Kecskemet, Hungary
Site Reference ID/Investigator# 42516
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Miskolc, Hungary
Site Reference ID/Investigator# 42511
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Pecs, Hungary
Site Reference ID/Investigator# 44854
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Pecs, Hungary
Site Reference ID/Investigator# 30745
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Cluj-Napoca, Romania
Site Reference ID/Investigator# 44558
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Craiova, Romania
Site Reference ID/Investigator# 44559
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Craiova, Romania
Site Reference ID/Investigator# 44547
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Iasi, Romania
Site Reference ID/Investigator# 42522
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Martin, Slovakia
Site Reference ID/Investigator# 44544
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Ljubljana, Slovenia
Site Reference ID/Investigator# 44560
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Craiova, Romania
Site Reference ID/Investigator# 44548
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Iasi, Romania
Site Reference ID/Investigator# 46183
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Oradea, Romania
Site Reference ID/Investigator# 44555
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Ploiesti, Romania
Site Reference ID/Investigator# 42519
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Kosice, Slovakia
Site Reference ID/Investigator# 47702
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Sezana, Slovenia
Site Reference ID/Investigator# 62304
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Kharkiv, Ukraine
Site Reference ID/Investigator# 70493
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Lviv, Ukraine
Site Reference ID/Investigator# 30747
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Ljubljana, Slovenia
Site Reference ID/Investigator# 44542
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Maribor, Slovenia