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

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

Study is not recruiting and using secondary data sources only

Study Overview

• Status: Withdrawn
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Risankizumab; Biological: Comparator 1; Drug: Comparator 2

Detailed Description

Study is not recruiting and using secondary data sources only

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study is not recruiting and using secondary data sources only

Description

Study is not recruiting and using secondary data sources only

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

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

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

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: P16-772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes