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Completed

NCT Number: NCT05320159

Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)

This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services' (MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes.

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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 Investigative Site

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

About this study

This was a retrospective cohort study utilizing data from Modernizing Medicine Data Services' (MMDS) electronic medical records (EMR)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes. Psoriasis (PsO) patients initiating secukinumab were identified and indexed to the first secukinumab use using the most recent data at study initiation (data period: March 1, 2018 to August 31, 2019) and with a subsequent data refresh (data period: March 1, 2017 - July 31, 2020).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥1 orders/administrations for secukinumab within the index window (March 1, 2018 to August 31,2019 for the base analysis; March 1, 2018 to January 31, 2020 for the refresh analysis). The date of the first order or administration was be the index date
  • Patients in the MMDS database with a diagnosis of PsO on or prior to the 1st secukinumab order/administration
  • ≥18 years of age as of the index date
  • To ensure capturing continuous patient activities in the EMR dataset, patients must have at least one more visit (any visit regardless of diagnosis) in addition to the index visit within the first 6 months after secukinumab initiation
  • Patients must have at least one visit (any visit regardless of diagnosis) within the 12 months pre-index period

Exclusion criteria

  • Evidence of secukinumab use in the 12-month pre-index period
  • Data quality issues (missing age, gender, prescription order information)

Treatment and study plan

secukinumab

Drug

Included all the patients treated with secukinumab

Other names: Cosentyx

Primary outcomes

  1. Treatment satisfaction level at Baseline

    Time frame: Baseline

    Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system.

    For this analysis, the responses were classified into three groups:

    • Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree)
    • Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree)
    • Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)

  2. Treatment satisfaction level at 6 months post-index

    Time frame: 6 months after initiating treatment with secukinumab (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)

    Patient reported satisfaction with treatment effectiveness was captured on a 5-point scale - "I believe this treatment is effective in clearing my skin of psoriasis." (1 = strongly agree, 2 = somewhat agree, 3 = Neither agree nor disagree, 4 = Somewhat disagree, 5 = Strongly disagree; n, %) in the EMR data system.

    For this analysis, the responses were classified into three groups:

    • Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree)
    • Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree)
    • Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)

Secondary outcomes

  1. Age

    Time frame: Baseline (March 1, 2017 - March 1, 2018)

    Age information was reported

  2. Gender

    Time frame: Baseline (March 1, 2017 - March 1, 2018)

    Gender information was reported

  3. Number of patients at various regions

    Time frame: Baseline (March 1, 2017 - March 1, 2018)

    Patient regions: Northeast, Midwest, South, West, Unknown

  4. Number of patients with different race

    Time frame: Baseline (March 1, 2017 - March 1, 2018)

    Race: White, Hispanic, African American, Asian, other/unknown

  5. Weight

    Time frame: Baseline (March 1, 2017 - March 1, 2018)

    Weight of patients was reported

  6. Number of patients at Index year

    Time frame: Study Period: March 1, 2017 - July 31, 2020

    Number of patients at each index year were reported

  7. Number of patients with plaque psoriasis subtype

    Time frame: Baseline (March 1, 2017 - March 1, 2018)

    Plaque psoriasis subtype was categorized as: generalized plaque psoriasis, localized plaque psoriasis, localized scalp psoriasis, inverse psoriasis, palmoplantar psoriasis, guttate psoriasis, nail psoriasis, psoriasis vulgaris, ostraceous psoriasis, or plaque psoriasis with unknown subtype during the 12 month pre-index period (including index date)

  8. Number of patients with Plaque location

    Time frame: Baseline (March 1, 2017 - March 1, 2018)

    Plaque location was categorized as recorded in EMR, including hand, arm, leg, trunk, scalp, head and neck, other/unknown

  9. Comorbidities of interest

    Time frame: Baseline (March 1, 2017 - March 1, 2018)

    Comorbidities of interest during the 12 months pre-index were reported

  10. Physician global assessment (PGA)

    Time frame: Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)

    PGA is scored on a 6-point scale from 0-5: 0 = clear, 1 = minimal, 2 = mild, 3 =moderate, 4 = marked, and 5 = severe

  11. Total body surface area (TBSA)

    Time frame: Baseline and 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)

    Total body surface area (BSA) was expressed as the percentage of body surface involved; BSA values of <3%, 3-10%, and >10% (reported as n, %) will be considered as mild, moderate, or severe, respectively.

  12. Psoriasis-related therapy

    Time frame: 6 months post index including index date (The date of the first order or administration was the index date; index period: March 1, 2018 - January 31, 2020)

    The following categories were included:

    • Biologics
    • Methotrexate
    • Corticosteroids (oral/injection)
    • Topical therapy
    • Phototherapy and Psoralen plus ultraviolet A photochemotherapy (PUVA)
    • NSAID/salicylates
    • Other systemic plaque psoriasis therapy (Acitretin)
    • Apremilast (PDE4 inhibitor)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Characteristics, Treatment Patterns, and Treatment Satisfaction Among Psoriasis Patients Treated With Cosentyx (Secukinumab)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2022
Registry last updated
Jul 1, 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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