Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis
- Registration Number
- NCT05513014
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1518
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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Secukinumab: Overall Cohort Secukinumab Patients with Psoriasis who initiated Secukinumab
- Primary Outcome Measures
Name Time Method Gender Baseline Gender was reported to describe the sociodemographic characteristics of the patients.
Number of patients: Smoking history Baseline Number of patients with Smoking history were reported to describe the sociodemographic characteristics of the patients.
Number of patients: Alcohol use history Baseline Number of patients with Alcohol use history were reported to describe the sociodemographic characteristics of the patients.
Race Baseline Race was reported to describe the sociodemographic characteristics of the patients.
Number of patients: CDC BMI categories Baseline Number of patients with CDC BMI categories were reported to describe the sociodemographic characteristics of the patients.
Psoriatic arthritis duration Baseline Psoriatic arthritis duration was reported to describe the Disease characteristics of the patients.
Age Baseline Age was reported to describe the sociodemographic characteristics of the patients.
Ethnicity Baseline Ethnicity was reported to describe the sociodemographic characteristics of the patients.
Number of patients: Comorbid psoriatic arthritis (PsA) Baseline Number of patients with Comorbid psoriatic arthritis (PsA) were reported to describe the disease characteristics of the patients.
Patient itch assessment (VAS: 0-100) Baseline 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.
Patient fatigue assessment (VAS: 0-100) Baseline 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.
Number of patients: Weight category Baseline Number of patients with Weight category were reported to describe the sociodemographic characteristics of the patients.
Psoriasis duration Baseline Psoriasis duration was reported to describe the Disease characteristics of the patients.
Number of patients: Morphology Baseline Number of patients with Morphology were reported to describe the disease characteristics of the patients.
Number of patients: History of IBD Baseline Number of patients with History of IBD were reported to describe the disease characteristics of the patients.
Number of patients: Any infection Baseline Number of patients with any infection were reported to describe the disease characteristics of the patients.
Body weight Baseline Body weight was reported to describe the sociodemographic characteristics of the patients.
Number of patients: Insurance type Baseline Number of patients with Insurance type were reported to describe the sociodemographic characteristics of the patients.
Number of patients: DLQI: Effect on life Baseline 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.
Patient global assessment (PGA) Baseline 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.
Patient health state today (EQ-5D VAS: 0-100) Baseline 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.BSA (% involvement) Baseline BSA (% involvement) was reported to describe the PsO Specific Measures of the patients.
Number of patients: Investigator Global Assessment Baseline Number of patients with Investigator Global Assessment were reported to describe the PsO Specific Measures of the patients.
Number of patients: PEST Score Baseline Number of patients with PEST Score were reported to describe the PsO Specific Measures of the patients.
Number of patients: Primary reason for SEC initiation Baseline Number of patients with Primary reason for SEC initiation
Number of patients: Provider region (US Census Bureau) Baseline Number of patients with Provider region (US Census Bureau) were reported to describe the sociodemographic characteristics of the patients.
Age at onset of PsO symptoms Baseline Age at onset of PsO symptoms was reported to describe the Disease characteristics of the patients.
Number of patients: History of comorbidities/toxicities Baseline Number of patients with History of comorbidities/toxicities were reported to describe the disease characteristics of the patients.
Number of patients: Self-care problems Baseline Included the following: No problems, some problems, unable
PASI (Score: 0-72) Baseline PASI (Score: 0-72) was reported to describe the PsO Specific Measures of the patients.
Number of patients: Mobility problems Baseline Included the following: No problems, some problems, confined to bed
Number of patients: Usual activities problems Baseline Included the following: No problems
Number of patients: Work Productivity and Activity Impairment Questionnaire (WPAI) (0 to 100%) Baseline 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
Number of patients: Therapies - Prior and Concomitant Drugs Baseline 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 systemicsDermatology Life Quality Index (DLQI) (Score: 0-30) Baseline 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.
Number of patients: Some problems Baseline Included the following: Unable
Number of patients: BSA categorical Baseline Number of patients with BSA categorical were reported to describe the PsO Specific Measures of the patients.
Patient skin pain assessment (VAS: 0-100) Baseline 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.
Number of patients: Pain or discomfort Baseline Included the following: None, moderate and extreme
- Secondary Outcome Measures
Name Time Method Change from baseline in DLQI (Score: 0-30) 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) 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.Change from baseline in WPAI summary scores 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) 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.
Change from baseline in Patient global assessment 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) 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.Change from baseline in Patient skin pain assessment (VAS: 0-100) 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) 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.Change from baseline in PASI (Score: 0-72) 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) 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.
Change from baseline in Investigator Global Assessment (IGA) 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) 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.
Change from baseline in BSA (% involvement) 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) 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.
Change from baseline in Patient health state today (EQ-5D VAS: 0-100) 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) 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.
Change from baseline in Patient itch assessment (VAS: 0-100) 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) 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.Change from baseline in Patient fatigue assessment (VAS: 0-100) 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) 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.
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States