Psoriasis
Conditions
Brief summary
Study is not recruiting and using secondary data sources only
Detailed description
Study is not recruiting and using secondary data sources only
Interventions
DRUGRisankizumab
Subcutaneous Injection
BIOLOGICALComparator 1
Subcutaneous or Intravenous Injection
DRUGComparator 2
Oral, Opthalmic, Subcutaneous or Intravenous Injection
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study is not recruiting and using secondary data sources only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Participants With Major Adverse Cardiovascular Events (MACE) | Up to approximately 10 years | MACE is defined as any fatal or nonfatal myocardial infarction (MI) or stroke (including cerebral infarction, nontraumatic intracerebral hemorrhage, and nontraumatic subarachnoid hemorrhage). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Participants With Tuberculosis | Up to approximately 10 years | 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. |
| Incidence Rate of Participants With Opportunistic Infections Excluding Tuberculosis and Herpes Zoster | Up to approximately 10 years | Opportunistic infections are defined as outpatient or inpatient encounter for opportunistic infections excluding tuberculosis and herpes zoster. |
| Incidence Rate of Participants With Serious Hypersensitivity Reactions | Up to approximately 10 years | Serious hypersensitivity reactions are defined as emergency department (ED) or inpatient encounter for serious hypersensitivity reactions including anaphylaxis. |
| Incidence Rate of Participants With Serious Infections | Up to approximately 10 years | Serious infections is defined as inpatient encounter for infections or receiving treatment with intravenous antibiotics, anti-viral or anti-fungal medications. |
| Incidence Rate of Participants With Neurologic or Demyelinating Disease | Up to approximately 10 years | 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. |
| Incidence Rate of Participants With Gastrointestinal Adverse Events | Up to approximately 10 years | 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. |
| Incidence Rate of Participants With Nonmalignant-Hematologic Adverse Events | Up to approximately 10 years | Nonmalignant-hematologic adverse events are defined as outpatient or inpatient encounter for a non-malignant hematological adverse events (pancytopenia, agranulocytosis and aplastic anemia). |
| Incidence Rate of Participants With Autoimmune Disease | Up to approximately 10 years | Autoimmune disease is defined as outpatient or inpatient encounter for systemic lupus erythematosus (SLE). |
Outcome results
None listed