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Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05320159
Enrollment
17743
Registered
2022-04-11
Start date
2021-02-03
Completion date
2021-03-31
Last updated
2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

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).

Interventions

DRUGSecukinumab

Included all the patients treated with secukinumab

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Treatment satisfaction level at BaselineBaselinePatient 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: 1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree) 2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree) 3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)
Treatment satisfaction level at 6 months post-index6 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: 1. Satisfied with treatment effectiveness (1 = strongly agree, 2 = somewhat agree) 2. Dissatisfied with treatment effectiveness ( 4 = Somewhat disagree, 5 = Strongly disagree) 3. Neither satisfied nor dissatisfied with treatment effectiveness (3 = Neither agree nor disagree)

Secondary

MeasureTime frameDescription
Number of patients at various regionsBaseline (March 1, 2017 - March 1, 2018)Patient regions: Northeast, Midwest, South, West, Unknown
Number of patients with different raceBaseline (March 1, 2017 - March 1, 2018)Race: White, Hispanic, African American, Asian, other/unknown
WeightBaseline (March 1, 2017 - March 1, 2018)Weight of patients was reported
Number of patients at Index yearStudy Period: March 1, 2017 - July 31, 2020Number of patients at each index year were reported
Number of patients with plaque psoriasis subtypeBaseline (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)
AgeBaseline (March 1, 2017 - March 1, 2018)Age information was reported
Comorbidities of interestBaseline (March 1, 2017 - March 1, 2018)Comorbidities of interest during the 12 months pre-index were reported
Physician global assessment (PGA)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
Total body surface area (TBSA)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.
Psoriasis-related therapy6 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: 1. Biologics 2. Methotrexate 3. Corticosteroids (oral/injection) 4. Topical therapy 5. Phototherapy and Psoralen plus ultraviolet A photochemotherapy (PUVA) 6. NSAID/salicylates 7. Other systemic plaque psoriasis therapy (Acitretin) 8. Apremilast (PDE4 inhibitor)
Number of patients with Plaque locationBaseline (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
GenderBaseline (March 1, 2017 - March 1, 2018)Gender information was reported

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026