Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry

NCT ID: NCT06172426

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-17

Study Completion Date

2022-12-07

Brief Summary

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This was a retrospective cohort study to assess the incidence rate of psoriatic arthritis (PsA) among psoriasis (PsO) patients newly initiated on secukinumab or any biologics/apremilast (small molecule). The analysis was performed in two databases, IBM® MarketScan® database: Commercial Claims and Encounters (CCAE) and Medicare Supplemental Beneficiaries (MDCR) from 01 January 2010 to 30 June 2021 and BADBIR from 01 January 2016 to 01 September 2021.

Detailed Description

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Conditions

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Psoriatic Arthritis Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MarketScan® secukinumab, other biologics/apremilast, and any biologics/apremilast cohort

No interventions assigned to this group

BADBIR secukinumab cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Included patients with at least 1 secukinumab claim between 01 January 2015 and 30 June 2020 (index date is the first secukinumab claim)
* Included patients age ≥18 years as of the year of index date
* Included patients with at least 1 non-ruleout psoriasis diagnosis during 2 years of pre-index period
* Included patients with continuous medical/pharmacy coverage in the 2-year pre-index period
* Included patients with continuous medical/pharmacy coverage in the 1-year post-index period


* Included non-switched patients with secukinumab treatment on or after the enrollment between 01 January 2017 to 01 September 2020

* Non-switched patients are those who did not use other biologics/apremilast treatments on the enrollment date
* Index date will be the date of the first secukinumab treatment date
* Included patients with age ≥ 18 on the index date
* Included patients with psoriasis diagnosis in the pre-index period and index date
* Included patients with ≥ 1 year follow-up period

* Follow-up period is the gap between patient's last visit date and index date

Exclusion Criteria

* Excluded patients with any psoriatic arthritis diagnosis during 2 years to 5 years pre-index period, as well as on the index date
* Excluded patients with any biologics/apremilast including secukinumab claim during the 2-year pre-index (excluding index date)
* Excluded patients received other non-secukinumab biologics/apremilast during 6 months post index date period (including index date) (This criterion is only applicable for the secukinumab cohort)

BADBIR cohort:


* Excluded patients with psoriatic arthritis (PsA) prior to and on index date
* Excluded patients with any biologics/apremilast including secukinumab in the baseline period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CAIN457A2026

Identifier Type: -

Identifier Source: org_study_id