Psoriasis Vulgaris
Conditions
Brief summary
An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.
Interventions
DRUGLEO 90100
Sponsors
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
(all subjects) * Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA. * Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area. * A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA. * PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1. * PGA score of at least mild on scalp at SV1, SV2 and V1. * A serum albumin-corrected calcium below the upper reference limit at SV2. Inclusion Criteria (for subjects performing HPA axis assessment) * Psoriasis vulgaris on trunk and/or limbs affecting at least 10% BSA. * Psoriasis vulgaris on the scalp affecting at least 20% of total scalp area. * PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1. * PGA score of at least moderate on scalp at SV1, SV2 and V1. * Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge).
Exclusion criteria
(all subjects): * A history of hypersensitivity to any component of LEO 90100. * Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial: 1. etanercept - within 4 weeks prior to V1 2. adalimumab, infliximab - within 2 months prior to V1 3. ustekinumab - within 4 months prior to V1 4. experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to V1 * Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial. * PUVA therapy within 4 weeks prior to V1. * UVB therapy within 2 weeks prior to V1 or during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) | From Week -1 to Week 8 | Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. |
| Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 | 30 minutes after ACTH-challenge at Week 4 | Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline. |
| Change in Albumin-corrected Serum Calcium From Baseline to Week 4 | From baseline to Week 4 | Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. |
| Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4 | From baseline to Week 4 | Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. |
| Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4 | From baseline to Week 4 | Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4 | Week 4 | Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity. |
| Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4 | 30 and 60 minutes after ACTH-challenge at Week 4 | Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline. |
| Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4 | From baseline to Week 4 | Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome. |
| Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4 | Week 4 | Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity. |
| Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4 | From baseline to Week 4 | Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing. |
| Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body | Week 4 | Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA. |
| Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp | Week 4 | Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA. |
| Percentage Change in PASI From Baseline to Week 4 | From baseline to Week 4 | Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease. |
Countries
Netherlands, Poland, Romania, United States
Participant flow
Pre-assignment details
117 subjects were enrolled, this number includes all subjects who provided consent for participation in the trial and were screened. Out of the 117 subjects who were screened, 106 subjects met all inclusion criteria and none of the exclusion criteria, and were started on treatment in the LEO 90100 arm.
Participants by arm
| Arm | Count |
|---|---|
| LEO 90100 LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set. | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | LEO 90100 |
|---|---|
| Age, Continuous | 14.2 years STANDARD_DEVIATION 1.4 |
| Duration of plaque psoriasis | 4.3 years STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Type I | 5 Participants |
| Fitzpatrick Skin Type Type II | 44 Participants |
| Fitzpatrick Skin Type Type III | 46 Participants |
| Fitzpatrick Skin Type Type IV | 10 Participants |
| Fitzpatrick Skin Type Type V | 1 Participants |
| Height | 165.79 cm STANDARD_DEVIATION 9.77 |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 102 Participants |
| Region of Enrollment Netherlands | 9 Participants |
| Region of Enrollment Poland | 63 Participants |
| Region of Enrollment Romania | 32 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 45 Participants |
| Weight | 60.01 kg STANDARD_DEVIATION 14.41 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 22 / 106 |
| serious Total, serious adverse events | 0 / 106 |
Outcome results
Primary
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Time frame: From baseline to Week 4
Population: Safety analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 90100 | Change in Albumin-corrected Serum Calcium From Baseline to Week 4 | -0.016 mmol/L | Standard Deviation 0.119 |
Primary
Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
Time frame: From baseline to Week 4
Population: 24-hour urine in HPA set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 90100 | Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4 | -0.2892 mmol/g | Standard Deviation 2.1185 |
Primary
Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Time frame: From baseline to Week 4
Population: 24-hour urine HPA set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 90100 | Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4 | -0.335 mmol/24hr | Standard Deviation 2.076 |
Primary
Number of Subjects With Adverse Events (AEs)
Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Time frame: From Week -1 to Week 8
Population: Safety analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Upper respiratory tract infection | 8 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Nasopharyngitis | 4 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Folliculitis | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Impetigo | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Oral herpes | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Pharyngitis | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Pulpitis dental | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Rhinitis | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Acne | 2 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Erythema | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Pruritus generalised | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Psoriasis | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Skin reaction | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Application site pain | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Product physical consistency issue | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Arthralgia | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Myalgia | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Myopia | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Arthropod bite | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Haemangioma of liver | 1 Participants |
| LEO 90100 | Number of Subjects With Adverse Events (AEs) | Skin neoplasm excision | 1 Participants |
Primary
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Time frame: 30 minutes after ACTH-challenge at Week 4
Population: Per protocol analysis set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 90100 | Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 | Serum cortisol equal to or below 18 mcg/dl | 3 Participants |
| LEO 90100 | Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 | Serum cortisol above 18 mcg/dl | 30 Participants |
Secondary
Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4
Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing.
Time frame: From baseline to Week 4
Population: Spot urine non-HPA set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 90100 | Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4 | 0.4620 mmol/g | Standard Deviation 1.8892 |
Secondary
Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4
Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome.
Time frame: From baseline to Week 4
Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 90100 | Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4 | -32.5 mm on VAS scale | Standard Deviation 27.3 |
Secondary
Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4
Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Time frame: 30 and 60 minutes after ACTH-challenge at Week 4
Population: Per protocol analysis set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 90100 | Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4 | Serum cortisol equal to or below 18 mcg/dL | 1 Participants |
| LEO 90100 | Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4 | Serum cortisol above 18 mcg/dl | 32 Participants |
Secondary
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body
Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
Time frame: Week 4
Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 90100 | Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body | Yes | 74 Participants |
| LEO 90100 | Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body | No | 29 Participants |
Secondary
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp
Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
Time frame: Week 4
Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 90100 | Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp | No | 25 Participants |
| LEO 90100 | Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp | Yes | 78 Participants |
Secondary
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4
Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
Time frame: Week 4
Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 90100 | Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4 | Yes | 86 Participants |
| LEO 90100 | Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4 | No | 17 Participants |
Secondary
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4
Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
Time frame: Week 4
Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 90100 | Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4 | Yes | 84 Participants |
| LEO 90100 | Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4 | No | 19 Participants |
Secondary
Percentage Change in PASI From Baseline to Week 4
Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.
Time frame: From baseline to Week 4
Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 90100 | Percentage Change in PASI From Baseline to Week 4 | -82.05 Percentage change in PASI | Standard Deviation 17.87 |