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

NCT05513014 | Completed

• 1 other identifier: CAIN457AUS31
• Study Type: observational
• Target: 1,518
• Locations: 1 country
• Sites: 1

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).

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (39)

• 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 Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (3)

Secukinumab: Overall Cohort

Patients with Psoriasis who initiated Secukinumab

Drug: 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

Interventions

Secukinumab DRUG

Patients with Psoriasis who initiated Secukinumab

Secukinumab: Overall Cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with psoriasis who initiated Secukinumab

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CAIN457AUS31 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: March 21, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

US (1)