Chemical: Drug
ustekinumab

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1. Annotation of FDA Label for ustekinumab and IL12A,IL12B,IL23A

Informative PGx

Summary

The FDA-approved drug label for ustekinumab (STELARA) states that serious infections from mycobacteria, salmonella and BCG vaccinations have been reported in patients who are genetically deficient in IL-12/IL-23, and that diagnostic tests for these infections should be considered as dictated by clinical circumstances.

Annotation

Ustekinumab (STELARA) is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients with plaque psoriasis, psoriatic arthritis or Crohn's disease.

Excerpt from the ustekinumab (STELARA) drug label:

Theoretical Risk for Vulnerability to Particular Infections...Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA may be susceptible to these types of infections. Appropriate diagnostic testing should be considered, e.g., tissue culture, stool culture, as dictated by clinical circumstances.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the ustekinumab drug label.

*Disclaimer: The contents of this page have not been endorsed by the FDA and are the sole responsibility of PharmGKB.

Full label available at DailyMed

Genes and/or phenotypes found in this label

  • IL12A
    • other, Warnings and precautions section
    • source: U.S. Food and Drug Administration
  • IL12B
    • other, Warnings and precautions section
    • source: U.S. Food and Drug Administration
  • IL23A
    • other, Warnings and precautions section
    • source: U.S. Food and Drug Administration

PharmGKB contains no Clinical Variants that meet the highest level of criteria.

To see more Clinical Variants with lower levels of criteria, click the button at the bottom of the page.

Disclaimer: The PharmGKB's clinical annotations reflect expert consensus based on clinical evidence and peer-reviewed literature available at the time they are written and are intended only to assist clinicians in decision-making and to identify questions for further research. New evidence may have emerged since the time an annotation was submitted to the PharmGKB. The annotations are limited in scope and are not applicable to interventions or diseases that are not specifically identified.

The annotations do not account for individual variations among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made solely by the clinician and the patient. PharmGKB assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the PharmGKB clinical annotations, or for any errors or omissions.

? = Mouse-over for quick help

The table below contains information about pharmacogenomic variants on PharmGKB. Please follow the link in the "Variant" column for more information about a particular variant. Each link in the "Variant" column leads to the corresponding PharmGKB Variant Page. The Variant Page contains summary data, including PharmGKB manually curated information about variant-drug pairs based on individual PubMed publications. The PMIDs for these PubMed publications can be found on the Variant Page.

The tags in the first column of the table indicate what type of information can be found on the corresponding Variant Page.

Links in the "Gene" column lead to PharmGKB Gene Pages.

List of all variant annotations for ustekinumab

Gene ? Variant?
(147)
Alternate Names ? Chemicals ? Alleles ?
(+ chr strand)
Function ? Amino Acid?
Translation
No VIP available CA VA HLA-C *06:02:01:01 N/A N/A N/A
No VIP available No Clinical Annotations available VA
rs1050152 NC_000005.10:g.132340627C>T, NC_000005.9:g.131676320C>T, NG_012129.1:g.51176C>T, NM_003059.2:c.1507C>T, NP_003050.2:p.Leu503Phe, NR_037898.1:n.560-5701G>A, NR_110997.1:n.561-5701G>A, XM_006714675.2:c.979C>T, XM_011543589.1:c.1231C>T, XP_006714738.1:p.Leu327Phe, XP_011541891.1:p.Leu411Phe, rs17680807, rs52829495, rs57045625
C > T
SNP
L503F
No VIP available No Clinical Annotations available VA
rs1061622 NC_000001.10:g.12252955T>G, NC_000001.11:g.12192898T>G, NG_029791.1:g.30896T>G, NM_001066.2:c.587T>G, NP_001057.1:p.Met196Arg, XM_011542060.1:c.587T>G, XM_011542061.1:c.587T>G, XM_011542062.1:c.566T>G, XM_011542063.1:c.587T>G, XP_011540362.1:p.Met196Arg, XP_011540363.1:p.Met196Arg, XP_011540364.1:p.Met189Arg, XP_011540365.1:p.Met196Arg, XR_244793.1:n.692T>G, rs13306722, rs1681698, rs17037789, rs17883437, rs2228492, rs52797629, rs60195947
T > G
SNP
M196R
No VIP available No Clinical Annotations available VA
rs11209026
G > A
SNP
R381Q
No VIP available No Clinical Annotations available VA
rs11591741
G > C
SNP
No VIP available No Clinical Annotations available VA
rs17716942
T > C
SNP
No VIP available No Clinical Annotations available VA
rs191190
C > T
SNP
No VIP available No Clinical Annotations available VA
rs1975974
A > G
SNP
No VIP available No Clinical Annotations available VA
rs2145623
G > C
SNP
No VIP available No Clinical Annotations available VA
rs240993
T > C
SNP
No VIP available No Clinical Annotations available VA
rs27524
A > G
SNP
No VIP available No Clinical Annotations available VA
rs2787094
C > G
SNP
No VIP available CA VA
rs3213094
C > T
SNP
No VIP available No Clinical Annotations available VA
rs4406273
G > A
SNP
No VIP available CA VA
rs610604 NC_000006.11:g.138199417G>T, NC_000006.12:g.137878280G>T, NG_032761.1:g.15837G>T, NM_001270507.1:c.987-152G>T, NM_001270508.1:c.987-152G>T, NM_006290.3:c.987-152G>T, XM_005267119.1:c.987-152G>T, XM_006715555.1:c.348-152G>T, XM_011536095.1:c.987-152G>T, XM_011536096.1:c.987-152G>T, rs17780315, rs60223250
G > T
SNP
No VIP available No Clinical Annotations available VA
rs6311 NC_000013.10:g.47471478C>T, NC_000013.11:g.46897343C>T, NG_013011.1:g.4692G>A, NM_000621.4:c.-998G>A, NM_001165947.2:c.-510G>A, rs36213154, rs61203218
C > T
SNP
No VIP available No Clinical Annotations available VA
rs6427528 NC_000001.10:g.160516308A>G, NC_000001.11:g.160546518A>G, NM_001184879.1:c.*1738T>C, NM_001184881.1:c.*1808T>C, NM_001184882.1:c.*1738T>C, NM_003874.3:c.*1738T>C, XM_005245568.1:c.*1738T>C, XM_011510094.1:c.*1738T>C, XM_011510095.1:c.*1738T>C, XR_922203.1:n.611+9331A>G, rs57622592
A > G
SNP
No VIP available No Clinical Annotations available VA
rs7574865 NC_000002.11:g.191964633T=, NC_000002.11:g.191964633T>G, NC_000002.12:g.191099907T=, NC_000002.12:g.191099907T>G, NG_012852.1:g.56293A=, NG_012852.1:g.56293A>C, NM_001243835.1:c.274-23582A=, NM_001243835.1:c.274-23582A>C, NM_003151.3:c.274-23582A=, NM_003151.3:c.274-23582A>C, XM_005246817.1:c.301-23582A=, XM_005246817.1:c.301-23582A>C, XM_005246817.3:c.301-23582A=, XM_005246817.3:c.301-23582A>C, XM_006712719.2:c.274-23582A=, XM_006712719.2:c.274-23582A>C, XM_011511704.1:c.301-23582A=, XM_011511704.1:c.301-23582A>C, XM_011511705.1:c.274-23582A=, XM_011511705.1:c.274-23582A>C, XM_011511706.1:c.301-23582A=, XM_011511706.1:c.301-23582A>C, rs52795984, rs57433953
T > G
SNP
No VIP available No Clinical Annotations available VA
rs763780 NC_000006.11:g.52101739T>C, NC_000006.12:g.52236941T>C, NG_031869.1:g.12560A>G, NM_052872.3:c.482A>G, NP_443104.1:p.His161Arg, XM_011514276.1:c.482A>G, XP_011512578.1:p.His161Arg, XR_926873.1:n.-173T>C, rs56499381, rs57501176
T > C
SNP
H161R
No VIP available No Clinical Annotations available VA
rs774359 NC_000009.11:g.27561049T>C, NC_000009.12:g.27561051T>C, NG_031977.1:g.17816A>G, NM_001256054.1:c.665+534A>G, NM_001256054.2:c.665+534A>G, NM_018325.4:c.665+534A>G, NM_145005.6:c.*530A>G, rs386612890, rs59596579
T > C
SNP
No VIP available No Clinical Annotations available VA
rs848
A > C
SNP
No VIP available No Clinical Annotations available VA
rs9304742
T > C
SNP
Alleles, Functions, and Amino Acid Translations are all sourced from dbSNP 147

Overview

Generic Names
Trade Names
Brand Mixture Names

PharmGKB Accession Id

PA166048654

Type(s):

Drug

Other Vocabularies

Genes that are associated with this drug in PharmGKB's database based on (1) variant annotations, (2) literature review, (3) pathways or (4) information automatically retrieved from DrugBank, depending on the "evidence" and "source" listed below.

Curated Information ?

No related drugs are available.

Curated Information ?

EvidenceDisease
No Dosing Guideline available No Drug Label available CA VA No VIP available No VIP available
Psoriasis

Publications related to ustekinumab: 6

No Dosing Guideline available No Drug Label available No Clinical Annotation available VA No VIP available No VIP available
Pharmacogenetics of ustekinumab in patients with moderate-to-severe plaque psoriasis. Pharmacogenomics. 2017. Prieto-Pérez Rocío, et al. PubMed
No Dosing Guideline available No Drug Label available CA VA No VIP available No VIP available
Polymorphisms in CD84, IL12B and TNFAIP3 are associated with response to biologics in patients with psoriasis. The British journal of dermatology. 2016. van den Reek J M P A, et al. PubMed
No Dosing Guideline available No Drug Label available No Clinical Annotation available VA No VIP available No VIP available
The polymorphism rs763780 in the IL-17F gene is associated with response to biological drugs in patients with psoriasis. Pharmacogenomics. 2015. Prieto-Pérez Rocío, et al. PubMed
No Dosing Guideline available No Drug Label available No Clinical Annotation available VA No VIP available No VIP available
The TNFRSF1B rs1061622 polymorphism (p.M196R) is associated with biological drug outcome in Psoriasis patients. Archives of dermatological research. 2015. González-Lara Leire, et al. PubMed
No Dosing Guideline available No Drug Label available No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
Biologic therapies in the treatment of psoriasis: a comprehensive evidence-based basic science and clinical review and a practical guide to tuberculosis monitoring. Clinical reviews in allergy & immunology. 2013. Sivamani Raja K, et al. PubMed
No Dosing Guideline available No Drug Label available CA VA No VIP available No VIP available
Pharmacogenetics of Psoriasis: HLACw6 but not LCE3B/3C deletion nor TNFAIP3 polymorphism predisposes to clinical response to IL12/23 blocker ustekinumab. The British journal of dermatology. 2013. Talamonti M, et al. PubMed

Clinical Trials

These are trials that mention ustekinumab and are related to either pharmacogenetics or pharmacogenomics.

No trials loaded.

NURSA Datasets

provided by nursa.org

No NURSA datasets available.

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Sources for PharmGKB drug information: DrugBank, PubChem.