Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320159
• Other study ID #: CAIN457AUS28
• Status: Completed
• Start date: February 3, 2021
• Est. completion date: March 31, 2021

Study information

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

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17743
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Secukinumab
Included all the patients treated with secukinumab

Locations

Country	Name	City	State
United States	Novartis Investigative Site	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	Treatment satisfaction level at 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)	Baseline
Primary	Treatment satisfaction level at 6 months post-index	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)	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)
Secondary	Age	Age information was reported	Baseline (March 1, 2017 - March 1, 2018)
Secondary	Gender	Gender information was reported	Baseline (March 1, 2017 - March 1, 2018)
Secondary	Number of patients at various regions	Patient regions: Northeast, Midwest, South, West, Unknown	Baseline (March 1, 2017 - March 1, 2018)
Secondary	Number of patients with different race	Race: White, Hispanic, African American, Asian, other/unknown	Baseline (March 1, 2017 - March 1, 2018)
Secondary	Weight	Weight of patients was reported	Baseline (March 1, 2017 - March 1, 2018)
Secondary	Number of patients at Index year	Number of patients at each index year were reported	Study Period: March 1, 2017 - July 31, 2020
Secondary	Number of patients with plaque psoriasis subtype	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)	Baseline (March 1, 2017 - March 1, 2018)
Secondary	Number of patients with Plaque location	Plaque location was categorized as recorded in EMR, including hand, arm, leg, trunk, scalp, head and neck, other/unknown	Baseline (March 1, 2017 - March 1, 2018)
Secondary	Comorbidities of interest	Comorbidities of interest during the 12 months pre-index were reported	Baseline (March 1, 2017 - March 1, 2018)
Secondary	Physician global assessment (PGA)	PGA is scored on a 6-point scale from 0-5: 0 = clear, 1 = minimal, 2 = mild, 3 =moderate, 4 = marked, and 5 = severe	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)
Secondary	Total body surface area (TBSA)	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.	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)
Secondary	Psoriasis-related therapy	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)	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)

External Links

•   Results for CAIN457AUS28 from the Novartis Clinical Trials Results Database