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

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)

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Secukinumab

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.

• Study Type: Observational
• Enrollment (Actual): 1518

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with psoriasis who initiated Secukinumab

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Secukinumab: Overall Cohort; Patients with Psoriasis who initiated Secukinumab	Drug: Secukinumab; Patients with Psoriasis who initiated Secukinumab
Biologic Experienced; Patients who had the history of use of ≥1 biologic medication for the treatment of PsO at the time of SEC initiation
Biologic Naive; 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?

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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CAIN457AUS31 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2021
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (ACTUAL): August 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457AUS31