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

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.

Time frame: Baseline and Month 12

Population: Nail Psoriasis set, which includes participants with a Baseline NAPSI score ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.

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.

Time frame: Baseline and Month 12

Population: Scalp Psoriasis Set (SPS), which includes participants with a Baseline PSSI ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.

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.

Time frame: Baseline and Month 12

Population: Nail Psoriasis Set; participants with both NAPSI and PASI data available. LOCF was used.

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.

Time frame: Baseline and Month 12

Population: Full Analysis Set; participants with both PASI and DLQI data available. LOCF was used.

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.

Time frame: Baseline and Month 12

Population: Scalp Psoriasis Set; participants with both PSSI and PASI data available. LOCF was used.

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.

Time frame: Baseline and Month 12

Population: Nail Psoriasis Set; participants with both NAPSI and DLQI data available. LOCF was used.

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.

Time frame: Baseline and Month 12

Population: Scalp Psoriasis Set; participants with both PSSI and DLQI data available. LOCF was used.

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Full Analysis Set with Baseline DLQI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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).

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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).

Time frame: Months 3, 6, 9, and 12

Population: Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Months 3, 6, 9, and 12

Population: Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Baseline and Months 3, 6, 9, and 12

Population: Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N.

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.

Time frame: Baseline and Month 12

Population: Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.

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.

Time frame: Baseline and Month 12

Population: Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.