An observational study in Moderate to Severe Plaque Psoriasis, sponsored by AbbVie (prior sponsor, Abbott). Completed at 73 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-07.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
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.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 506 is above the median of 200 across 396 observational studies indexed under Psoriasis.
Browse Psoriasis studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Per this PMOS protocol, the study population will consists of adult patients with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate or PUVA (photochemotherapy combining psoralen with ultraviolet A treatment), and exhibit a significant psoriatic affection of the scalp and/or nails.
Patients will be enrolled in this PMOS if they fulfill all of the below criteria:
Exclusion Criteria:
Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS:
Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to 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.
Time frame: Baseline and Month 12
Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to 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.
Time frame: Baseline and Month 12
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
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
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
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
Percentage of Participants Achieving Complete Clearing of Nails
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
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
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
Percentage of Participants Achieving Good Clinical Response on Scalp
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
Percentage of Participants Achieving Complete Clearing of Scalp
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
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
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
Change From Baseline in PASI Score
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
Percentage of Participants Achieving a PASI 90 Response
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
Percentage of Participants Achieving a PASI 75 Response
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
Percentage of Participants Achieving a PASI 50 Response
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
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
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
Change From Baseline in DLQI Score
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
Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis
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
Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis
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
Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis
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
Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis
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
Associations Between General Improvement in Psoriasis With Improvement in Quality of Life
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
The study was conducted in Slovenia, Hungary, Slovakia, Romania, Israel, Czech Republic, Ukraine and Estonia.
| Milestone | Adalimumab |
|---|---|
| Started | 506 |
| Full analysis set | 501 |
| Completed | 439 |
| Not completed | 67 |
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 | Adalimumab |
|---|---|
| Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12 | -74.6 ± 26.9 |
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.
| percent change | Adalimumab |
|---|---|
| Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12 | -89.7 ± 30.0 |
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.
| units on a scale | Adalimumab |
|---|---|
| Month 3 (N=154) | -4.6 ± 3.0 |
| Month 6 (N=144) | -7.6 ± 3.2 |
| Month 9 (N=136) | -9.1 ± 3.5 |
| Month 12 (N=125) | -10.5 ± 3.1 |
| Month 12-LOCF (N=156) | -9.6 ± 3.7 |
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 | Adalimumab |
|---|---|
| Month 3 (N=154) | 33.1 |
| Month 6 (N=144) | 68.1 |
| Month 9 (N=136) | 85.3 |
| Month 12 (N=125) | 90.4 |
| Month 12-LOCF (N=156) | 84.0 |
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).
| percentage of participants | Adalimumab |
|---|---|
| Month 3 (N=154) | 1.9 |
| Month 6 (N=144) | 11.8 |
| Month 9 (N=136) | 22.1 |
| Month 12 (N=125) | 40.0 |
| Month 12-LOCF (N=156) | 33.3 |
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.
| units on a scale | Adalimumab |
|---|---|
| Month 3 (N=400) | -17.2 ± 11.6 |
| Month 6 (N=377) | -22.2 ± 12.7 |
| Month 9 (N=365) | -24.2 ± 14.0 |
| Month 12 (N=346) | -25.8 ± 14.5 |
| Month 12-LOCF (N=402) | -24.3 ± 15.1 |
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 | Adalimumab |
|---|---|
| Month 3 (N=400) | 67.0 |
| Month 6 (N=377) | 92.8 |
| Month 9 (N=365) | 97.5 |
| Month 12 (N=346) | 98.3 |
| Month 12-LOCF (N=402) | 93.8 |
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.
| percentage of participants | Adalimumab |
|---|---|
| Month 3 (N=400) | 27.0 |
| Month 6 (N=377) | 39.5 |
| Month 9 (N=365) | 47.9 |
| Month 12 (N=346) | 71.7 |
| Month 12-LOCF (N=402) | 66.7 |
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.
| percent change | Adalimumab |
|---|---|
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | -83.3 ± 36.0 |
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.
| units on a scale | Adalimumab |
|---|---|
| Month 3 (N=490) | -14.5 ± 10.1 |
| Month 6 (N=468) | -17.9 ± 10.2 |
| Month 9 (N=449) | -19.6 ± 10.1 |
| Month 12 (N=429) | -20.6 ± 9.9 |
| Month 12-LOCF (N=495) | -19.1 ± 11.0 |
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 | Adalimumab |
|---|---|
| Month 3 (N=490) | 25.1 |
| Month 6 (N=468) | 38.0 |
| Month 9 (N=449) | 51.4 |
| Month 12 (N=429) | 72.0 |
| Month 12-LOCF (N=495) | 65.3 |
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 | Adalimumab |
|---|---|
| Month 3 (N=490) | 43.5 |
| Month 6 (N=468) | 66.7 |
| Month 9 (N=449) | 84.6 |
| Month 12 (N=429) | 91.8 |
| Month 12-LOCF (N=495) | 84.0 |
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.
| percentage of participants | Adalimumab |
|---|---|
| Month 3 (N=490) | 69.2 |
| Month 6 (N= 468) | 92.5 |
| Month 9 (N=449) | 95.5 |
| Month 12 (N= 429) | 97.2 |
| Month 12-LOCF (N=495) | 91.1 |
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.
| percent change | Adalimumab |
|---|---|
| Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score | -83.6 ± 41.8 |
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.
| units on a scale | Adalimumab |
|---|---|
| Month 3 (N=448) | -12.6 ± 7.1 |
| Month 6 (N=426) | -16.1 ± 7.2 |
| Month 9 (N=415) | -17.9 ± 7.0 |
| Month 12 (N=396) | -18.9 ± 6.9 |
| Month 12-LOCF (N=453) | -17.4 ± 8.4 |
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.
| correlation coefficient | Adalimumab |
|---|---|
| Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis | 0.61 |
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.
| correlation coefficient | Adalimumab |
|---|---|
| Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis | 0.65 |
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.
| correlation coefficient | Adalimumab |
|---|---|
| Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis | 0.60 |
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.
| correlation coefficient | Adalimumab |
|---|---|
| Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis | 0.59 |
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.
| correlation coefficient | Adalimumab |
|---|---|
| Associations Between General Improvement in Psoriasis With Improvement in Quality of Life | 0.78 |
Collected over 12 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adalimumab | — | 5/501 (1%) | 19/501 (3.8%) |
| Event | Adalimumab |
|---|---|
| PsoriasisSkin and subcutaneous tissue disorders | 3/501 |
| DeathGeneral disorders | 1/501 |
| Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/501 |
| Polyneuropathy alcoholicNervous system disorders | 1/501 |
| Event | Adalimumab |
|---|---|
| PsoriasisSkin and subcutaneous tissue disorders | 19/501 |
Full analysis set, which included participants with a signed informed consent and with any available data regarding treatment with adalimumab.
| Age, Continuous(years) | Adalimumab |
|---|---|
| Mean | 47.0 ± 12.6 |
| Sex: Female, Male(Participants) | Adalimumab |
|---|---|
| Female | 187 |
| Male | 314 |
| Nail Psoriasis Severity Index (NAPSI) Score(units on a scale) | Adalimumab |
|---|---|
| Mean | 13.0 ± 2.1 |
| Psoriasis Scalp Severity Index (PSSI) Score(units on a scale) | Adalimumab |
|---|---|
| Mean | 26.8 ± 14.1 |
| Psoriasis Area and Severity Index (PASI) Score(units on a scale) | Adalimumab |
|---|---|
| Mean | 22.0 ± 9.7 |
| Dermatology Life Quality Index (DLQI) Score(units on a scale) | Adalimumab |
|---|---|
| Mean | 20.0 ± 6.5 |
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AbbVie (prior sponsor, Abbott)