Clinical trial NCT05513014: Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 1518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with psoriasis who initiated Secukinumab

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Race
timeFrame: Baseline
measure: Ethnicity
timeFrame: Baseline
measure: Body weight
timeFrame: Baseline
measure: Number of patients: Weight category
timeFrame: Baseline
measure: Number of patients: CDC BMI categories
timeFrame: Baseline
measure: Number of patients: Smoking history
timeFrame: Baseline
measure: Number of patients: Alcohol use history
timeFrame: Baseline
measure: Number of patients: Insurance type
timeFrame: Baseline
measure: Number of patients: Provider region (US Census Bureau)
timeFrame: Baseline
measure: Psoriasis duration
timeFrame: Baseline
measure: Age at onset of PsO symptoms
timeFrame: Baseline
measure: Number of patients: Morphology
timeFrame: Baseline
measure: Number of patients: Comorbid psoriatic arthritis (PsA)
timeFrame: Baseline
measure: Psoriatic arthritis duration
timeFrame: Baseline
measure: Number of patients: History of comorbidities/toxicities
timeFrame: Baseline
measure: Number of patients: History of IBD
timeFrame: Baseline
measure: Number of patients: Any infection
timeFrame: Baseline
measure: Dermatology Life Quality Index (DLQI) (Score: 0-30)
timeFrame: Baseline
measure: Number of patients: DLQI: Effect on life
timeFrame: Baseline
measure: Patient global assessment (PGA)
timeFrame: Baseline
measure: Patient itch assessment (VAS: 0-100)
timeFrame: Baseline
measure: Patient fatigue assessment (VAS: 0-100)
timeFrame: Baseline
measure: Patient skin pain assessment (VAS: 0-100)
timeFrame: Baseline
measure: Patient health state today (EQ-5D VAS: 0-100)
timeFrame: Baseline
measure: Number of patients: Mobility problems
timeFrame: Baseline
measure: Number of patients: Self-care problems
timeFrame: Baseline
measure: Number of patients: Usual activities problems
timeFrame: Baseline
measure: Number of patients: Some problems
timeFrame: Baseline
measure: Number of patients: Pain or discomfort
timeFrame: Baseline
measure: Number of patients: Work Productivity and Activity Impairment Questionnaire (WPAI) (0 to 100%)
timeFrame: Baseline
measure: PASI (Score: 0-72)
timeFrame: Baseline
measure: BSA (% involvement)
timeFrame: Baseline
measure: Number of patients: BSA categorical
timeFrame: Baseline
measure: Number of patients: Investigator Global Assessment
timeFrame: Baseline
measure: Number of patients: PEST Score
timeFrame: Baseline
measure: Number of patients: Therapies - Prior and Concomitant Drugs
timeFrame: Baseline
measure: Number of patients: Primary reason for SEC initiation
timeFrame: Baseline
Secondary outcomes:
measure: Change from baseline in Investigator Global Assessment (IGA)
timeFrame: 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)
measure: Change from baseline in PASI (Score: 0-72)
timeFrame: 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)
measure: Change from baseline in BSA (% involvement)
timeFrame: 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)
measure: Change from baseline in Patient health state today (EQ-5D VAS: 0-100)
timeFrame: 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)
measure: Change from baseline in WPAI summary scores
timeFrame: 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)
measure: Change from baseline in DLQI (Score: 0-30)
timeFrame: 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)
measure: Change from baseline in Patient global assessment
timeFrame: 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)
measure: Change from baseline in Patient itch assessment (VAS: 0-100)
timeFrame: 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)
measure: Change from baseline in Patient fatigue assessment (VAS: 0-100)
timeFrame: 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)
measure: Change from baseline in Patient skin pain assessment (VAS: 0-100)
timeFrame: 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)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: