Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting

Study Overview
=================
Brief Summary
-----------------
Study is not recruiting and using secondary data sources only

Detailed Description
-----------------
Study is not recruiting and using secondary data sources only

Official Title
-----------------
Post-Marketing Real World Safety Study of Risankizumab in the United States

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Risankizumab
* Biological: Comparator 1
* Drug: Comparator 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Study is not recruiting and using secondary data sources only

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Risankizumab<br>Participants will receive risankizumab as prescribed by their physician. | Drug: Risankizumab<br>* Subcutaneous Injection<br>* Other names: Skyrizi;|
| Comparator Group 1<br>Participants will receive biologics other than interleukin (IL)-23 antagonists as prescribed by their physician. | Biological: Comparator 1<br>* Subcutaneous or Intravenous Injection<br>|
| Comparator Group 2<br>Participants will receive non-biologic systemic small molecules as prescribed by their physician. | Drug: Comparator 2<br>* Oral, Opthalmic, Subcutaneous or Intravenous Injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Participants With Major Adverse Cardiovascular Events (MACE) | MACE is defined as any fatal or nonfatal myocardial infarction (MI) or stroke (including cerebral infarction, nontraumatic intracerebral hemorrhage, and nontraumatic subarachnoid hemorrhage). | Up to approximately 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Participants With Serious Infections | Serious infections is defined as inpatient encounter for infections or receiving treatment with intravenous antibiotics, anti-viral or anti-fungal medications. | Up to approximately 10 years | 
| Incidence Rate of Participants With Tuberculosis | Tuberculosis is defined as inpatient encounter for active tuberculosis, or outpatient encounter with a dispensing of at least two classes of first-line anti-tuberculosis medications (e.g., isoniazid, rifampin, pyrazinamide, or ethambutol) for a sufficient duration to differentiate prophylaxis and treatment use. | Up to approximately 10 years | 
| Incidence Rate of Participants With Opportunistic Infections Excluding Tuberculosis and Herpes Zoster | Opportunistic infections are defined as outpatient or inpatient encounter for opportunistic infections excluding tuberculosis and herpes zoster. | Up to approximately 10 years | 
| Incidence Rate of Participants With Serious Hypersensitivity Reactions | Serious hypersensitivity reactions are defined as emergency department (ED) or inpatient encounter for serious hypersensitivity reactions including anaphylaxis. | Up to approximately 10 years | 
| Incidence Rate of Participants With Autoimmune Disease | Autoimmune disease is defined as outpatient or inpatient encounter for systemic lupus erythematosus (SLE). | Up to approximately 10 years | 
| Incidence Rate of Participants With Neurologic or Demyelinating Disease | Neurologic or demyelinating disease is defined as outpatient or inpatient encounter for multiple sclerosis (MS), optic neuritis, and the peripheral demyelinating disease Guillain-Barré syndrome. | Up to approximately 10 years | 
| Incidence Rate of Participants With Gastrointestinal Adverse Events | Gastrointestinal adverse events are defined as inpatient encounter for gastrointestinal perforation. Gastrointestinal (GI) perforation is defined as perforation of the esophagus, stomach, small intestine, large intestine, and unspecified lower GI. | Up to approximately 10 years | 
| Incidence Rate of Participants With Nonmalignant-Hematologic Adverse Events | Nonmalignant-hematologic adverse events are defined as outpatient or inpatient encounter for a non-malignant hematological adverse events (pancytopenia, agranulocytosis and aplastic anemia). | Up to approximately 10 years |