Clinical trial NCT05320159: Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)
Official title: Characteristics, Treatment Patterns, and Treatment Satisfaction Among Psoriasis Patients Treated With Cosentyx (Secukinumab)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 17743
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: Psoriasis patients treated with Cosentyx (secukinumab)

Brief 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Treatment satisfaction level at Baseline
timeFrame: Baseline
measure: Treatment satisfaction level at 6 months post-index
timeFrame: 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 outcomes:
measure: Age
timeFrame: Baseline (March 1, 2017 - March 1, 2018)
measure: Gender
timeFrame: Baseline (March 1, 2017 - March 1, 2018)
measure: Number of patients at various regions
timeFrame: Baseline (March 1, 2017 - March 1, 2018)
measure: Number of patients with different race
timeFrame: Baseline (March 1, 2017 - March 1, 2018)
measure: Weight
timeFrame: Baseline (March 1, 2017 - March 1, 2018)
measure: Number of patients at Index year
timeFrame: Study Period: March 1, 2017 - July 31, 2020
measure: Number of patients with plaque psoriasis subtype
timeFrame: Baseline (March 1, 2017 - March 1, 2018)
measure: Number of patients with Plaque location
timeFrame: Baseline (March 1, 2017 - March 1, 2018)
measure: Comorbidities of interest
timeFrame: Baseline (March 1, 2017 - March 1, 2018)
measure: Physician global assessment (PGA)
timeFrame: 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)
measure: Total body surface area (TBSA)
timeFrame: 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)
measure: Psoriasis-related therapy
timeFrame: 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)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: