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

Psoriasis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05513014
• Other study ID #: CAIN457AUS31
• Status: Completed
• Start date: March 21, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 1518
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Secukinumab
Patients with Psoriasis who initiated Secukinumab

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Results for CAIN457AUS31 from the Novartis Clinical Trials Website