Statements (103)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:pharmaceuticals
|
| gptkbp:approves |
gptkb:Crohn's_disease
gptkb:2019 gptkb:FDA gptkb:psoriatic_arthritis psoriasis |
| gptkbp:brand |
gptkb:risankizumab-rzaa
|
| gptkbp:class |
gptkb:monoclonal_antibody
|
| gptkbp:clinical_trial |
gptkb:Ult_IMMa-1
gptkb:Ult_IMMa-2 gptkb:FUTURE_3 gptkb:Crohn's_disease gptkb:psoriatic_arthritis over 4000 Phase 3 FUTURE 1 FUTURE 2 FUTURE 4 significant improvement in skin clearance CRO-001 CRO-002 CRO-003 CRO-004 CRO-005 completed Phase 1 and Phase 2 trials multiple international sites |
| gptkbp:contraindication |
active infections
live vaccines history of hypersensitivity hypersensitivity to risankizumab |
| gptkbp:developed_by |
gptkb:Abb_Vie
|
| gptkbp:dosage_form |
solution for injection
|
| gptkbp:drug_interactions |
limited interactions reported
|
| gptkbp:duration |
every 12 weeks after initial doses
|
| gptkbp:effective_date |
April 2019
|
| gptkbp:feedback |
generally positive
|
| gptkbp:financial_support |
available through Abb Vie
|
| gptkbp:formulation |
auto-injector
pre-filled syringe sterile solution biologic therapy |
| gptkbp:funding |
funded by Abb Vie
|
| https://www.w3.org/2000/01/rdf-schema#label |
Skyrizi
|
| gptkbp:indication |
active psoriatic arthritis
moderate to severe plaque psoriasis Crohn's disease in adults |
| gptkbp:ingredients |
gptkb:risankizumab
|
| gptkbp:invention |
2029
patented |
| gptkbp:is_monitored_by |
allergic reactions
infections liver function regular follow-up appointments blood cell counts |
| gptkbp:manufacturer |
gptkb:Abb_Vie_Inc.
|
| gptkbp:marketed_as |
gptkb:Skyrizi
multiple countries |
| gptkbp:mechanism_of_action |
IL-23 inhibitor
|
| gptkbp:patient_education |
provided by healthcare professionals
|
| gptkbp:patient_population |
adults
pediatric patients over 18 years old |
| gptkbp:pharmacokinetics |
long half-life
inhibits IL-23 pathway |
| gptkbp:price |
varies by region
|
| gptkbp:provides_guidance_on |
recommended for moderate to severe cases
|
| gptkbp:recruitment |
based on severity of psoriasis
|
| gptkbp:regulatory_compliance |
gptkb:FDA
gptkb:Health_Canada gptkb:EMA TGA approved for use in multiple countries |
| gptkbp:research |
ongoing studies for other indications
|
| gptkbp:research_focus |
long-term safety and efficacy
|
| gptkbp:route_of_administration |
subcutaneous injection
|
| gptkbp:safety_measures |
risk of serious infections
|
| gptkbp:service_frequency |
every 12 weeks after initial doses
once every 12 weeks after loading doses |
| gptkbp:side_effect |
fatigue
headache nausea thrombosis injection site reactions upper respiratory infections serious infections hypersensitivity reactions gastrointestinal perforations malignancies |
| gptkbp:storage |
refrigerated
|
| gptkbp:support |
granted in Australia
granted in Canada granted in Europe |
| gptkbp:target_audience |
adults with moderate to severe plaque psoriasis
|
| gptkbp:treatment |
clear or almost clear skin
assessed through PASI score monitored by healthcare providers other biologics available |
| gptkbp:type_of_care |
important for treatment success
|
| gptkbp:type_of_insurance |
may vary by plan
|
| gptkbp:used_for |
treatment of plaque psoriasis
|
| gptkbp:website |
thigh or abdomen
|
| gptkbp:bfsParent |
gptkb:Abb_Vie
|
| gptkbp:bfsLayer |
4
|