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OpenTrials
Completed

NCT Number: NCT05513014

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

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).

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

secukinumab

Drug

Patients with Psoriasis who initiated Secukinumab

Primary outcomes

  1. Age

    Time frame: Baseline

    Age was reported to describe the sociodemographic characteristics of the patients.

  2. Gender

    Time frame: Baseline

    Gender was reported to describe the sociodemographic characteristics of the patients.

  3. Race

    Time frame: Baseline

    Race was reported to describe the sociodemographic characteristics of the patients.

  4. Ethnicity

    Time frame: Baseline

    Ethnicity was reported to describe the sociodemographic characteristics of the patients.

  5. Body weight

    Time frame: Baseline

    Body weight was reported to describe the sociodemographic characteristics of the patients.

  6. Number of patients: Weight category

    Time frame: Baseline

    Number of patients with Weight category were reported to describe the sociodemographic characteristics of the patients.

  7. Number of patients: CDC BMI categories

    Time frame: Baseline

    Number of patients with CDC BMI categories were reported to describe the sociodemographic characteristics of the patients.

  8. Number of patients: Smoking history

    Time frame: Baseline

    Number of patients with Smoking history were reported to describe the sociodemographic characteristics of the patients.

  9. Number of patients: Alcohol use history

    Time frame: Baseline

    Number of patients with Alcohol use history were reported to describe the sociodemographic characteristics of the patients.

  10. Number of patients: Insurance type

    Time frame: Baseline

    Number of patients with Insurance type were reported to describe the sociodemographic characteristics of the patients.

  11. Number of patients: Provider region (US Census Bureau)

    Time frame: Baseline

    Number of patients with Provider region (US Census Bureau) were reported to describe the sociodemographic characteristics of the patients.

  12. Psoriasis duration

    Time frame: Baseline

    Psoriasis duration was reported to describe the Disease characteristics of the patients.

  13. Age at onset of PsO symptoms

    Time frame: Baseline

    Age at onset of PsO symptoms was reported to describe the Disease characteristics of the patients.

  14. Number of patients: Morphology

    Time frame: Baseline

    Number of patients with Morphology were reported to describe the disease characteristics of the patients.

  15. Number of patients: Comorbid psoriatic arthritis (PsA)

    Time frame: Baseline

    Number of patients with Comorbid psoriatic arthritis (PsA) were reported to describe the disease characteristics of the patients.

  16. Psoriatic arthritis duration

    Time frame: Baseline

    Psoriatic arthritis duration was reported to describe the Disease characteristics of the patients.

  17. Number of patients: History of comorbidities/toxicities

    Time frame: Baseline

    Number of patients with History of comorbidities/toxicities were reported to describe the disease characteristics of the patients.

  18. Number of patients: History of IBD

    Time frame: Baseline

    Number of patients with History of IBD were reported to describe the disease characteristics of the patients.

  19. Number of patients: Any infection

    Time frame: Baseline

    Number of patients with any infection were reported to describe the disease characteristics of the patients.

  20. Dermatology Life Quality Index (DLQI) (Score: 0-30)

    Time frame: 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.

  21. Number of patients: DLQI: Effect on life

    Time frame: 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.

  22. Patient global assessment (PGA)

    Time frame: 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.

  23. Patient itch assessment (VAS: 0-100)

    Time frame: 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.

  24. Patient fatigue assessment (VAS: 0-100)

    Time frame: 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.

  25. Patient skin pain assessment (VAS: 0-100)

    Time frame: 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.

  26. Patient health state today (EQ-5D VAS: 0-100)

    Time frame: 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.

  27. Number of patients: Mobility problems

    Time frame: Baseline

    Included the following: No problems, some problems, confined to bed

  28. Number of patients: Self-care problems

    Time frame: Baseline

    Included the following: No problems, some problems, unable

  29. Number of patients: Usual activities problems

    Time frame: Baseline

    Included the following: No problems

  30. Number of patients: Some problems

    Time frame: Baseline

    Included the following: Unable

  31. Number of patients: Pain or discomfort

    Time frame: Baseline

    Included the following: None, moderate and extreme

  32. Number of patients: Work Productivity and Activity Impairment Questionnaire (WPAI) (0 to 100%)

    Time frame: 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

  33. PASI (Score: 0-72)

    Time frame: Baseline

    PASI (Score: 0-72) was reported to describe the PsO Specific Measures of the patients.

  34. BSA (% involvement)

    Time frame: Baseline

    BSA (% involvement) was reported to describe the PsO Specific Measures of the patients.

  35. Number of patients: BSA categorical

    Time frame: Baseline

    Number of patients with BSA categorical were reported to describe the PsO Specific Measures of the patients.

  36. Number of patients: Investigator Global Assessment

    Time frame: Baseline

    Number of patients with Investigator Global Assessment were reported to describe the PsO Specific Measures of the patients.

  37. Number of patients: PEST Score

    Time frame: Baseline

    Number of patients with PEST Score were reported to describe the PsO Specific Measures of the patients.

  38. Number of patients: Therapies - Prior and Concomitant Drugs

    Time frame: 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 systemics

  39. Number of patients: Primary reason for SEC initiation

    Time frame: Baseline

    Number of patients with Primary reason for SEC initiation

Secondary outcomes

  1. Change from baseline in Investigator Global Assessment (IGA)

    Time frame: 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.

  2. Change from baseline in PASI (Score: 0-72)

    Time frame: 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.

  3. Change from baseline in BSA (% involvement)

    Time frame: 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.

  4. Change from baseline in Patient health state today (EQ-5D VAS: 0-100)

    Time frame: 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.

  5. Change from baseline in WPAI summary scores

    Time frame: 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.

  6. Change from baseline in DLQI (Score: 0-30)

    Time frame: 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.

  7. Change from baseline in Patient global assessment

    Time frame: 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.

  8. Change from baseline in Patient itch assessment (VAS: 0-100)

    Time frame: 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.

  9. Change from baseline in Patient fatigue assessment (VAS: 0-100)

    Time frame: 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.

  10. Change from baseline in Patient skin pain assessment (VAS: 0-100)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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