Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)

Characteristics, Treatment Patterns, and Treatment Satisfaction 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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Secukinumab

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 17743

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Psoriasis patients treated with Cosentyx (secukinumab)

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Overall cohort: Secukinumab; Included all the patients treated with secukinumab	Drug: Secukinumab; Included all the patients treated with secukinumab; Other Names: Cosentyx
Bio-naive; Included PsO patients initiating treatment with secukinumab. Bio-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the following biologic drugs of interest anytime pre-index: secukinumab, certolizumab, etanercept, adalimumab, infliximab, golimumab, ustekinumab, ixekizumab, brodalumab, abatacept, and guselkumab and risankizumab during all available history	Drug: Secukinumab; Included all the patients treated with secukinumab; Other Names: Cosentyx
Bio-experienced; Included PsO patients initiating treatment with secukinumab. Patients had pre-index use of one or more of the biologic drugs of interest during all available history	Drug: Secukinumab; Included all the patients treated with secukinumab; Other Names: Cosentyx
Systemic-naive; Included PsO patients initiating treatment with secukinumab. Systemic-naïve was defined as no observed treatment (i.e., injection, prescription or patient reported history) with any of the biologic treatments or with any of the following systemic (i.e., oral or injectable - no topical forms) drugs of interest pre-index: methotrexate, corticosteroids, acitretin or apremilast.	Drug: Secukinumab; Included all the patients treated with secukinumab; Other Names: Cosentyx
Systemic-experienced; Included PsO patients initiating treatment with secukinumab. Systemic-experienced patients had pre-index use of one or more of the systemic drugs of interest.	Drug: Secukinumab; Included all the patients treated with secukinumab; Other Names: Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age information was reported	Baseline (March 1, 2017 - March 1, 2018)
Gender	Gender information was reported	Baseline (March 1, 2017 - March 1, 2018)
Number of patients at various regions	Patient regions: Northeast, Midwest, South, West, Unknown	Baseline (March 1, 2017 - March 1, 2018)
Number of patients with different race	Race: White, Hispanic, African American, Asian, other/unknown	Baseline (March 1, 2017 - March 1, 2018)
Weight	Weight of patients was reported	Baseline (March 1, 2017 - March 1, 2018)
Number of patients at Index year	Number of patients at each index year were reported	Study Period: March 1, 2017 - July 31, 2020
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)
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)
Comorbidities of interest	Comorbidities of interest during the 12 months pre-index were reported	Baseline (March 1, 2017 - March 1, 2018)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CAIN457AUS28 from the Novartis Clinical Trials Results Database

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457AUS28