The study was conducted to describe the demographics, disease characteristics, disease severity, comorbidities and patient reported outcomes at baseline and follow-up periods among adult patients diagnosed with PsO in CorEvitas' PsO Registry under routine medical care initiating secukinumab (SEC).
This is a retrospective analysis of a prospective observational cohort using CorEvitas' PsO registry of adult PsO patients. This study describes clinical and patient reported outcomes among adult patients initiating Secukinumab (SEC). Biologic experienced and naïve patients are examined separately. This study also describes changes in clinical and patient reported outcomes over time. CorEvitas' Psoriasis Registry is a prospective, observational cohort of adult PsO patients starting systemic therapy, launched in April 2015 with sites in the US and Canada. Data collection occurs every \~6 months at routine dermatology visits. This study included US PsO patients who initiated secukinumab at or after enrollment and had a subsequent 6- and/or 12-month follow-up visit (Apr 2015 to Dec 2020).The index date is defined as the date of the first SEC initiation at or after enrollment.
Study Type
OBSERVATIONAL
Enrollment
1,518
Patients with Psoriasis who initiated Secukinumab
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Age
Age was reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Gender
Gender was reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Race
Race was reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Ethnicity
Ethnicity was reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Body weight
Body weight was reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Number of patients: Weight category
Number of patients with Weight category were reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Number of patients: CDC BMI categories
Number of patients with CDC BMI categories were reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Number of patients: Smoking history
Number of patients with Smoking history were reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Number of patients: Alcohol use history
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Number of patients with Alcohol use history were reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Number of patients: Insurance type
Number of patients with Insurance type were reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Number of patients: Provider region (US Census Bureau)
Number of patients with Provider region (US Census Bureau) were reported to describe the sociodemographic characteristics of the patients.
Time frame: Baseline
Psoriasis duration
Psoriasis duration was reported to describe the Disease characteristics of the patients.
Time frame: Baseline
Age at onset of PsO symptoms
Age at onset of PsO symptoms was reported to describe the Disease characteristics of the patients.
Time frame: Baseline
Number of patients: Morphology
Number of patients with Morphology were reported to describe the disease characteristics of the patients.
Time frame: Baseline
Number of patients: Comorbid psoriatic arthritis (PsA)
Number of patients with Comorbid psoriatic arthritis (PsA) were reported to describe the disease characteristics of the patients.
Time frame: Baseline
Psoriatic arthritis duration
Psoriatic arthritis duration was reported to describe the Disease characteristics of the patients.
Time frame: Baseline
Number of patients: History of comorbidities/toxicities
Number of patients with History of comorbidities/toxicities were reported to describe the disease characteristics of the patients.
Time frame: Baseline
Number of patients: History of IBD
Number of patients with History of IBD were reported to describe the disease characteristics of the patients.
Time frame: Baseline
Number of patients: Any infection
Number of patients with any infection were reported to describe the disease characteristics of the patients.
Time frame: Baseline
Dermatology Life Quality Index (DLQI) (Score: 0-30)
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: Baseline
Number of patients: DLQI: Effect on life
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: Baseline
Patient global assessment (PGA)
The PGA scoring system is based on response to treatment as measured by lesion erythema, induration, and scale, with score assignments that range from clear, almost clear, mild, moderate, to severe.
Time frame: Baseline
Patient itch assessment (VAS: 0-100)
Patient itch assessment was reported to evaluate overall, how severe was the itch from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Time frame: Baseline
Patient fatigue assessment (VAS: 0-100)
Patient fatigue assessment was reported to evaluate overall, how severe was the fatigue from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Time frame: Baseline
Patient skin pain assessment (VAS: 0-100)
Patient skin pain assessment was reported to evaluate overall, how severe was the skin pain from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Time frame: Baseline
Patient health state today (EQ-5D VAS: 0-100)
Questions: Given questions in the following 5 dimensions: (a) mobility, (b) self-care, (c) usual activities, (d) pain/discomfort and (e) anxiety/depression. With each dimension scored in 3 levels: 1 = {(a)-(c) =No problems, (d)=No pain, (e)=Not anxious or depressed}; 2 = {(a)-(c) = Some problems, (d) = Moderate pain or discomfort, (e ) = Moderately anxious or depressed}; 3={(a) = Confined to bed, (b)-(c)= Unable to do, (d) = Extreme pain or discomfort, (e) = Extremely anxious or depressed} With each dimension scored in 5 levels: 1 = No problems, 2 = Slight problems, 3 = Moderate problems, 4 = Severe problems, 5 = Extreme problems.
Time frame: Baseline
Number of patients: Mobility problems
Included the following: No problems, some problems, confined to bed
Time frame: Baseline
Number of patients: Self-care problems
Included the following: No problems, some problems, unable
Time frame: Baseline
Number of patients: Usual activities problems
Included the following: No problems
Time frame: Baseline
Number of patients: Some problems
Included the following: Unable
Time frame: Baseline
Number of patients: Pain or discomfort
Included the following: None, moderate and extreme
Time frame: Baseline
Number of patients: Work Productivity and Activity Impairment Questionnaire (WPAI) (0 to 100%)
Questions:1 = Currently employed? 2 = Hours missed due to psoriasis? 3 = Hours missed other reasons? 4 = Hours actually worked? 5 = Degree problem affected productivity while working (VAS (0 to 100) measurement)? 6 = Degree problem affected regular activities (VAS (0 to 100) measurement)? Scores: Multiply scores by 100 to express in percentages for reported categories: Percent work time missed due to problem: Q2/(Q2+Q4) Percent impairment while working due to problem: Q5/10 Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\] Percent activity impairment due to problem: Q6/10
Time frame: Baseline
PASI (Score: 0-72)
PASI (Score: 0-72) was reported to describe the PsO Specific Measures of the patients.
Time frame: Baseline
BSA (% involvement)
BSA (% involvement) was reported to describe the PsO Specific Measures of the patients.
Time frame: Baseline
Number of patients: BSA categorical
Number of patients with BSA categorical were reported to describe the PsO Specific Measures of the patients.
Time frame: Baseline
Number of patients: Investigator Global Assessment
Number of patients with Investigator Global Assessment were reported to describe the PsO Specific Measures of the patients.
Time frame: Baseline
Number of patients: PEST Score
Number of patients with PEST Score were reported to describe the PsO Specific Measures of the patients.
Time frame: Baseline
Number of patients: Therapies - Prior and Concomitant Drugs
Included the following: Unique prior biologic count Prior biologic exposures Unique prior non-biologic count Prior non-biologic exposures Nonbiologic naïve Current or prior topical use Concomitant non-biologic systemics
Time frame: Baseline
Number of patients: Primary reason for SEC initiation
Number of patients with Primary reason for SEC initiation
Time frame: Baseline
Change from baseline in Investigator Global Assessment (IGA)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in PASI (Score: 0-72)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in BSA (% involvement)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient health state today (EQ-5D VAS: 0-100)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in WPAI summary scores
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in DLQI (Score: 0-30)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient global assessment
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use. The PGA scoring system is based on response to treatment as measured by lesion erythema, induration, and scale, with score assignments that range from clear, almost clear, mild, moderate, to severe.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient itch assessment (VAS: 0-100)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use. Patient itch assessment was reported to evaluate overall, how severe was the itch from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient fatigue assessment (VAS: 0-100)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use. Patient fatigue assessment was reported to evaluate overall, how severe was the fatigue from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)
Change from baseline in Patient skin pain assessment (VAS: 0-100)
Changes in continuous outcomes between baseline, 6 and 12 month follow-up visit among patients remaining on SEC at 6 and 12 months, by prior biologic use. Patient skin pain assessment was reported to evaluate overall, how severe was the skin pain from psoriasis in the past week. The score ranged from 0 to 100, where negative change indicated that the score declined over time.
Time frame: Baseline, 6 and 12 months follow-up visits post index ( The index date is defined as the date of the first SEC initiation at or after enrollment i.e. Apr 2015 to Dec 2020)