Risankizumab

Identification

Summary

Risankizumab is an interleukin-23 antagonist used to treat plaque psoriasis, psoriatic arthritis, and Crohn's disease in adults.

Brand Names

Skyrizi 150 Mg Dose Pack

Generic Name

Risankizumab

DrugBank Accession Number

DB14762

Background

Risankizumab is a fully humanized IgG1 monoclonal antibody (mAb) directed against interleukin 23 (IL-23).⁷ It gained its first global approval in Japan in March 2019, followed by approval in Canada, the US, and Europe in April 2019.⁵ Risankizumab is used to treat plaque psoriasis, psoriatic arthritis, and Crohn's disease.^7,9,10 Risankizumab is being investigated for atopic dermatitis.⁵

Type

Biotech

Groups

Approved, Investigational

Biologic Classification

Protein Based Therapies
Monoclonal antibody (mAb)

Protein Chemical Formula

C₆₄₇₆H₉₉₉₂N₁₇₂₀O₂₀₁₆S₄₄

Protein Average Weight

149000.0 Da (approximate)

Sequences

>Risankizumab A Chain Sequence
QVQLVQSGAEVKKPGSSVKVSCKASGYTFTDQTIHWMRQAPGQGLEWIGYIYPRDDSPKY
NENFKGKVTITADKSTSTAYMELSSLRSEDTAVYYCAIPDRSGYAWFIYWGQGTLVTVSS
ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSS
GLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEAAGG
PSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYN
STYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREE
MTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRW
QQGNVFSCSVMHEALHNHYTQKSLSLSPG

>Risankizumab B Chain Sequence
QVQLQSGAEVKKPGSSVKVSCKASGYTFTDQTIHWMRQAPGQGLEWIGYIYPRDDSPKYN
ENFKGKVTITADKSTSTAYMELSSLRSEDTAVYYCAIPDRSGYAWFIYWGQGTLVTVSSA
STKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSG
LYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEAAGGP
SVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNS
TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEM
TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQ
QGNVFSCSVMHEALHNHYTQKSLSLSPG

>Risankizumab C Chain Sequence
DIQMTQSPSSLSASVGDRVTITCKASRDVAIAVAWYQQKPGKVPKLLIYWASTRHTGVPS
RFSGSGSRTDFTLTISSLQPEDVADYFCHQYSSYPFTFGSGTKLEIKRTVAAPSVFIFPP
SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT
LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

>Risankizumab D Chain Sequence
DIQMTQSPSSLSASVGDRVTITCKASRDVAIAVAWYQQKPGKVPKLLIYWASTRHTGVPS
RFSGSGSRTDFTLTISSLQPEDVADYFCHQYSSYPFTFGSGTKLEIKRTVAAPSVFIFPP
SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT
LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

References:

KEGG DRUG: Risankizumab [Link]

Download FASTA Format

Synonyms

Risankizumab
risankizumab-rzaa

External IDs

655066-01
ABBV-066
BI 655066

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Pharmacology

Indication

Risankizumab is indicated to treat:

moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.^7,9,10
active psoriatic arthritis in adults.^7,9,10 In Canada and Europe, it may be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).^9,10
moderately to severely active Crohn's disease in adults.^7,9,10 In Canada, it is used in patients who have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids; or an inadequate response, intolerance, or loss of response to immunomodulators or biologic therapies.⁹

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Associated Conditions

Indication Type	Indication	Combined Product Details	Approval Level	Age Group	Patient Characteristics	Dose Form
Management of	Moderate plaque-type psoriasis		••••••••••••	•••••	•••••••••• ••• ••••••••••••	•••••••••
Management of	Moderate plaque-type psoriasis		••••••••••••	•••••	••••••••• ••• •••••••• •••••••	•••••••••
Treatment of	Psoriasis		••••••••••••		•••••••••• ••• •••••••• ••••••• ••• •••••••••	•••••••••• •••••••••• ••••••••
Management of	Psoriatic arthritis		••••••••••••	•••••	•••••••••• •••••••• •• ••••••••••• •• ••••••
Used in combination to manage	Psoriatic arthritis	Regimen in combination with: Methotrexate (DB00563)	••••••••••••	•••••	•••••••••• •••••••• •• ••••••••••• •• ••••••

Contraindications & Blackbox Warnings

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Pharmacodynamics

Risankizumab works to suppress the inflammatory effects of interleukin (IL)-23. It inhibits the release of pro-inflammatory cytokines and chemokines.⁷ In vitro, risankizumab blocked IL-17 production;⁵ however, risankizumab does not actually bind to IL-17.¹

Mechanism of action

Interleukin (IL)-23 is a pro-inflammatory cytokine implicated in various chronic inflammatory disorders, such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. IL-23 binds to the IL-23 receptor to activate the IL-23/Th17 axis, which is responsible for mediating T cell-mediated immune responses and inflammation.^2,5 The IL-23/Th17 axis triggers the differentiation of Th-17 and Th-22 cells and induces the release of inflammatory cytokines and chemokines such as IL-17.^1,2 While the IL-23/Th17 axis serves a critical role in protection against pathogens, it is also involved in chronic, autoimmune, inflammatory disorders.³

IL-23 is made up of two subunits, p19 and p40: p19 is specific to IL-23 and p40 is present on both IL-12 and IL-23.² Risankizumab binds to the p19 subunit of IL-23 with high affinity ² and neutralizes it, thereby preventing its interaction with the IL-23 receptor and activation of IL-23 signalling cascades.⁵

Target	Actions	Organism
AInterleukin-23	inhibitor	Humans

Absorption

Drug plasma concentrations increased dose-proportionally after subcutaneous administration of a single dose over the dose range from 18 mg to 360 mg and intravenous administration over a dose range from 200 mg to 1800 mg via a 3-hour infusion. In patients with plaque psoriasis who received a subcutaneous dose of 150 mg risankizumab, steady-state peak concentration (C_max) and trough concentration (C_trough) were 12 mcg/mL and 2 mcg/mL, respectively.⁷

In subjects with Crohn’s disease treated with 600 mg intravenous induction dose at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneous maintenance dose at Week 12 and every 8 weeks thereafter, the median Cmax and Ctrough are estimated to be 156 mcg/mL and 38.8 mcg/mL, respectively, during Weeks 8-12; and the steady state median Cmax and Ctrough are estimated to be 14.0 mcg/mL and 4.1 mcg/mL, respectively for 180 mg or 28.0 mcg/mL and 8.1 mcg/mL, respectively, for 360 mg, during Weeks 40-48.⁷

The absolute bioavailability of risankizumab was approximately 74 to 89% following subcutaneous injection. In healthy subjects, following administration of a single subcutaneous dose, C_max was reached by 3 to 14 days.⁷

Volume of distribution

The estimated steady-state volume of distribution (inter-subject CV%) was 11.2 L (34%) in subjects with plaque psoriasis, and 7.68 L (64%) in subjects with Crohn’s disease.⁷

Protein binding

No information is available.

Metabolism

The metabolic pathway of risankizumab has not been fully characterized. As a humanized IgG1 monoclonal antibody, it is likely to be catabolized into small peptides and amino acids in the same way as endogenous IgG.^7,4

Route of elimination

As an IgG1 monoclonal antibody, risankizumab is not expected to be filtered by glomerular filtration in the kidneys or to be excreted as an intact molecule in the urine.¹⁰

Half-life

The terminal elimination half-life was approximately 28 days in patients with plaque psoriasis and 21 days in patients with Crohn’s disease.⁷

Clearance

The estimated systemic clearance (inter-subject CV%) was 0.31 L/day (24%) in patients with plaque psoriasis and 0.30 L/day (34%) in patients with Crohn’s disease.⁷

Adverse Effects

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Toxicity

The NOAEL was 50 mg/kg in monkeys following intravenous or subcutaneous administration.⁸ There is no information available regarding the overdose of risankizumab.

Pathways

Not Available

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Not Available

Interactions

Drug Interactions Learn More" title="About Drug Interactions" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

Drug	Interaction
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Abatacept	The risk or severity of adverse effects can be increased when Abatacept is combined with Risankizumab.
Abciximab	The risk or severity of adverse effects can be increased when Abciximab is combined with Risankizumab.
Adalimumab	The risk or severity of adverse effects can be increased when Adalimumab is combined with Risankizumab.
Adenovirus type 7 vaccine live	The therapeutic efficacy of Adenovirus type 7 vaccine live can be decreased when used in combination with Risankizumab.
Aducanumab	The risk or severity of adverse effects can be increased when Aducanumab is combined with Risankizumab.

Food Interactions

No interactions found.

Products

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Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
Skyrizi	Injection, solution, concentrate	600 mg	Intravenous	Abb Vie Deutschland Gmb H & Co. Kg	2023-02-08	Not applicable
Skyrizi	Injection, solution	75 mg/0.83ml	Subcutaneous	Abb Vie Deutschland Gmb H & Co. Kg	2021-02-11	Not applicable
Skyrizi	Kit	180 mg/1.2mL	Intravenous	AbbVie Inc.	2022-09-23	Not applicable
Skyrizi	Solution	360 mg / 2.4 mL	Subcutaneous	Abbvie	2023-03-14	Not applicable
Skyrizi	Solution	150 mg / 1 mL	Subcutaneous	Abbvie	2022-06-01	Not applicable

Mixture Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
Skyrizi	Risankizumab (75 mg/0.83mL) + Isopropyl alcohol (0.70 mL/1mL)	Injection, solution; Kit	Subcutaneous; Topical	AbbVie Inc.	2019-04-23	2023-01-31

Chemical Identifiers

UNII: 90ZX3Q3FR7
CAS number: 1612838-76-2

References

General References

Machado A, Torres T: Spotlight on risankizumab and its potential in the treatment of plaque psoriasis: evidence to date. Psoriasis (Auckl). 2018 Nov 13;8:83-92. doi: 10.2147/PTT.S165943. eCollection 2018. [Article]
Haugh IM, Preston AK, Kivelevitch DN, Menter AM: Risankizumab: an anti-IL-23 antibody for the treatment of psoriasis. Drug Des Devel Ther. 2018 Nov 12;12:3879-3883. doi: 10.2147/DDDT.S167149. eCollection 2018. [Article]
Suleiman AA, Khatri A, Minocha M, Othman AA: Population Pharmacokinetics of the Interleukin-23 Inhibitor Risankizumab in Subjects with Psoriasis and Crohn's Disease: Analyses of Phase I and II Trials. Clin Pharmacokinet. 2019 Mar;58(3):375-387. doi: 10.1007/s40262-018-0704-z. [Article]
Ryman JT, Meibohm B: Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576-588. doi: 10.1002/psp4.12224. Epub 2017 Jul 29. [Article]
McKeage K, Duggan S: Risankizumab: First Global Approval. Drugs. 2019 Jun;79(8):893-900. doi: 10.1007/s40265-019-01136-7. [Article]
European Medicines Agency Summaries Opinion: Skyrizi [Link]
FDA Approved Drug Products: Skyrizi (risankizumab-rzaa) for subcutaneous injection [Link]
Abbvie: Skyrizi (Risankizumab-rzaa) MSDS [Link]
Health Canada Approved Drug Products: SKYRIZI (risankizumab) subcutaneous injection [Link]
EMA Approved Drug Products: Skyrizi (Risankizumab) Subcutaneous Injection [Link]

External Links

RxNav: 2166040
Wikipedia: Risankizumab

Clinical Trials

Clinical Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">

Phase	Status	Purpose	Conditions	Count
4	Active Not Recruiting	Treatment	Psoriasis / Psoriasis Vulgaris (Plaque Psoriasis)	1
4	Not Yet Recruiting	Treatment	Psoriasis	1
4	Recruiting	Prevention	Crohn's Disease (CD)	1
4	Recruiting	Treatment	Crohn's Disease (CD)	1
4	Recruiting	Treatment	Psoriasis	2

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Form	Route	Strength
Injection	Intravenous	60 mg/1mL
Injection	Subcutaneous	150 mg/1mL
Injection, solution	Parenteral; Subcutaneous	150 MG
Injection, solution	Parenteral; Subcutaneous	360 mg
Injection, solution	Parenteral; Subcutaneous	75 MG
Injection, solution	Subcutaneous	360 mg
Injection, solution, concentrate	Intravenous	600 mg
Injection, solution; kit	Subcutaneous	90 mg/1mL
Injection, solution; kit	Subcutaneous; Topical
Kit	Intravenous	180 mg/1.2mL
Kit	Intravenous	360 mg/2.4mL
Solution	Intravenous	60 mg / mL
Solution	Subcutaneous	150 mg / 1 mL
Solution	Subcutaneous	360 mg / 2.4 mL
Solution	Subcutaneous	75.000 mg
Solution	Subcutaneous	90 mg / 1 mL
Injection, solution		150 mg/ml
Injection, solution	Subcutaneous
Injection, solution	Subcutaneous	150 mg
Injection, solution	Subcutaneous	150 mg/mL
Injection, solution	Subcutaneous	75 mg/0.83mL

Prices

Not Available

Patents

Not Available

Properties

State: Liquid
Experimental Properties: Not Available

Targets

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Details1. Interleukin-23 (Protein Group)

Kind: Protein group
Organism: Humans
Pharmacological action: Yes
Actions: Inhibitor

General Function: Protein heterodimerization activity
Specific Function: Cytokine that can act as a growth factor for activated T and NK cells, enhance the lytic activity of NK/lymphokine-activated killer cells, and stimulate the production of IFN-gamma by resting PBMC....

Components:

Name	UniProt ID
Interleukin-12 subunit beta	P29460
Interleukin-23 subunit alpha	Q9NPF7

References

Haugh IM, Preston AK, Kivelevitch DN, Menter AM: Risankizumab: an anti-IL-23 antibody for the treatment of psoriasis. Drug Des Devel Ther. 2018 Nov 12;12:3879-3883. doi: 10.2147/DDDT.S167149. eCollection 2018. [Article]
Machado A, Torres T: Spotlight on risankizumab and its potential in the treatment of plaque psoriasis: evidence to date. Psoriasis (Auckl). 2018 Nov 13;8:83-92. doi: 10.2147/PTT.S165943. eCollection 2018. [Article]
FDA Approved Drug Products: Skyrizi (risankizumab-rzaa) for subcutaneous injection [Link]

Drug created at April 23, 2019 22:37 / Updated at December 23, 2022 00:49

Risankizumab

Identification

References:

Pharmacology

Interactions

Products

Categories

Chemical Identifiers

References

Clinical Trials

Pharmacoeconomics

Properties

Targets

Components:

References