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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall cohort: Secukinumab | Included all the patients treated with secukinumab |
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| 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 |
| |
| 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 |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | Included all the patients treated with secukinumab |
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| 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:
| 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:
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Psoriasis patients treated with Cosentyx (secukinumab)
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | East Hanover | New Jersey | 07936-1080 | United States |
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| Label | URL |
|---|---|
| Results for CAIN457AUS28 from the Novartis Clinical Trials Results Database | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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| 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:
| 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) |