Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

Study Overview
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Brief Summary
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The patients included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan. The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in psoriasis patients treated with ustekinumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.

Detailed Description
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The participants included in this study will be drawn from the Ingenix Normative Health Informatics Database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse US health plan. This study will include cohorts of participants who have claims consistent with a diagnosis of psoriasis and who initiate ustekinumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments. Participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of ustekinumab for up to 8 years. A sample of enrolled health plan members without claims evidence of diagnosis or treatment of psoriasis will also be selected. The claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected outcomes. Potential cases of the study outcome identified through claims may be confirmed through medical record review. No study agents will be administered in this study. All patients will receive standard-of-care treatment as prescribed by their physician.

Official Title
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A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Psoriasis Treated With Ustekinumab and Other Types of Biological and Systemic Non-biological Treatments

Conditions
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Psoriasis

Intervention / Treatment
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* Biological: anti-TNF biologics
* Other: general population
* Biological: non-anti-TNF biologics
* Biological: ustekinumab
* Drug: systemic non-biological treatments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete medical coverage and pharmacy benefits Six months of continuous enrollment prior to the date of cohort entry Exclusion Criteria: Participants will be excluded if they do not have information on age, gender or enrollment

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 001<br>ustekinumab as prescribed | Biological: ustekinumab<br>* as prescribed<br>|
| 002<br>anti-TNF biologics as prescribed | Biological: anti-TNF biologics<br>* as prescribed<br>|
| 003<br>non-anti-TNF biologics as prescribed | Biological: non-anti-TNF biologics<br>* as prescribed<br>|
| 004<br>systemic non-biological treatments as prescribed | Drug: systemic non-biological treatments<br>* as prescribed<br>|
| 005<br>general population non-treated cohort | Other: general population<br>* non-treated cohort<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the incidence of serious infections, tuberculosis and non-TB mycobacterial infections, malignancies, and other selected outcomes in patients with psoriasis initiating ustekinumab and other biological and systemic non-biological treatments |  | The study will be approximately 8 years in duration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, ustekinumab, anti-TNF biologics, non-anti-TNF biologics, systemic non-biological treatments