Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis in a Real World Setting in the US (Bionaive Secukinumab Users NVS 521)

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Secukinumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must: Have been diagnosed with PsO by a dermatologist. Be at least 18 years of age. Be willing and able to provide written informed consent for participation in the registry. Have started on or switched to an eligible systemic PsO treatment at enrollment1 or within the previous 12 months of the date of enrollment. Exclusion Criteria: Patient is participating in or planning to participate in an interventional clinical trial with a nonmarketed or marketed investigational drug (i.e. phase I-IV drug trial).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Secukinumab: Overall Cohort<br>Patients with Psoriasis who initiated Secukinumab | Drug: Secukinumab<br>* Patients with Psoriasis who initiated Secukinumab<br>|
| Biologic Experienced<br>Patients who had the history of use of ≥1 biologic medication for the treatment of PsO at the time of SEC initiation | |
| Biologic Naive<br>Patients who had no history of use of biologic medication for the treatment of PsO at the time of SEC initiation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age was reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Gender | Gender was reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Race | Race was reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Ethnicity | Ethnicity was reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Body weight | Body weight was reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Number of patients: Weight category | Number of patients with Weight category were reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Number of patients: CDC BMI categories | Number of patients with CDC BMI categories were reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Number of patients: Smoking history | Number of patients with Smoking history were reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Number of patients: Alcohol use history | Number of patients with Alcohol use history were reported to describe the sociodemographic characteristics of the patients. | Baseline | 
| Number of patients: Insurance type | Number of patients with Insurance type were reported to describe the sociodemographic characteristics of the patients. | 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. | Baseline | 
| Psoriasis duration | Psoriasis duration was reported to describe the Disease characteristics of the patients. | Baseline | 
| Age at onset of PsO symptoms | Age at onset of PsO symptoms was reported to describe the Disease characteristics of the patients. | Baseline | 
| Number of patients: Morphology | Number of patients with Morphology were reported to describe the disease characteristics of the patients. | 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. | Baseline | 
| Psoriatic arthritis duration | Psoriatic arthritis duration was reported to describe the Disease characteristics of the patients. | 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. | Baseline | 
| Number of patients: History of IBD | Number of patients with History of IBD were reported to describe the disease characteristics of the patients. | Baseline | 
| Number of patients: Any infection | Number of patients with any infection were reported to describe the disease characteristics of the patients. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline | 
| Number of patients: Mobility problems | Included the following: No problems, some problems, confined to bed | Baseline | 
| Number of patients: Self-care problems | Included the following: No problems, some problems, unable | Baseline | 
| Number of patients: Usual activities problems | Included the following: No problems | Baseline | 
| Number of patients: Some problems | Included the following: Unable | Baseline | 
| Number of patients: Pain or discomfort | Included the following: None, moderate and extreme | 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 | Baseline | 
| PASI (Score: 0-72) | PASI (Score: 0-72) was reported to describe the PsO Specific Measures of the patients. | Baseline | 
| BSA (% involvement) | BSA (% involvement) was reported to describe the PsO Specific Measures of the patients. | Baseline | 
| Number of patients: BSA categorical | Number of patients with BSA categorical were reported to describe the PsO Specific Measures of the patients. | 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. | Baseline | 
| Number of patients: PEST Score | Number of patients with PEST Score were reported to describe the PsO Specific Measures of the patients. | 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 | Baseline | 
| Number of patients: Primary reason for SEC initiation | Number of patients with Primary reason for SEC initiation | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) |