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Study is not recruiting and using secondary data sources only
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Study is not recruiting and using secondary data sources only
Study is not recruiting and using secondary data sources only
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Participants will receive risankizumab as prescribed by their physician. |
| |
| Comparator Group 1 | Participants will receive biologics other than interleukin (IL)-23 antagonists as prescribed by their physician. |
| |
| Comparator Group 2 | Participants will receive non-biologic systemic small molecules as prescribed by their physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous Injection |
|
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| 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 |
| 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 |
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Study is not recruiting and using secondary data sources only
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Study is not recruiting and using secondary data sources only
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
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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 |
|---|---|
| C000601773 | risankizumab |
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| Comparator 1 | Biological | Subcutaneous or Intravenous Injection |
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| Comparator 2 | Drug | Oral, Opthalmic, Subcutaneous or Intravenous Injection |
|
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 |