Risankizumab

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Risankizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
Targetinterleukin 23A
Names
PronunciationRIS an KIZ ue mab
Trade namesSkyrizi
Other namesBI-655066, ABBV-066, risankizumab-rzaa
Clinical data
Drug classMonoclonal antibody[1]
Main usesplaque psoriasis[1]
Side effectsUpper respiratory tract infection, headache, tiredness, pain at the site of injection[2][3]
Pregnancy
category
  • AU: B1[4]
  • US: N (Not classified yet)[4]
Routes of
use
Subcutaneous injection
External links
AHFS/Drugs.comMonograph
US NLMRisankizumab
MedlinePlusa619035
Legal
License data
Legal status
Chemical and physical data
FormulaC6476H9992N1720O2016S44
Molar mass145611.84 g·mol−1

Risankizumab, sold under the brand name Skyrizi, is a medication used to treat moderate to severe plaque psoriasis.[1] Other uses may include generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis.[6]

Common side effects include upper respiratory tract infection, headache, tiredness, and pain at the site of injection.[2][3] It also increases the risk of other infections.[3] While there is no evidence of harm in pregnancy, such use has not been well studied.[7] It is a monoclonal antibody that attaches to and blocks interleukin 23A (IL-23A).[2][8]

Risankizumab was approved for medical use in the United States in 2019.[3][2] In the United States it costs about 17,800 USD per dose as of 2021.[9] In the United Kingdom this amount costs the NHS about £3,300.[10]

Medical uses

The efficacy, safety and tolerability was further investigated in a phase III program comprising four clinical trials which compared risankizumab to ustekinumab, adalimumab and placebo in the indication of plaque psoriasis. The results of these trials confirmed the efficacy and tolerability of risankizumab.[11]

Dosage

It is used as a 150 mg dose.[3] This is given at time zero, after 4 weeks, and than every 12 weeks.[3]

History

Risankizumab was approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate-to-severe plaque psoriasis in April 2019.[12][13][14]

It was part of a collaboration between Boehringer Ingelheim and AbbVie.

The FDA approved risankizumab based on evidence primarily from five clinical trials (Trial 1/NCT0202684370, Trial 2/NCT02684357, Trial 3/NCT02672852, Trial 4/ NCT02694523 and Trial 5/NCT02054481) of 1606 patients with moderate to severe plaque psoriasis.[12] The trials were conducted in Asia, Canada, Europe, Mexico, South America, and the United States.[12]

Society and culture

Brand names

The brand name Skyrizi is pronounced Sky-RIZZ-ee; /skaɪrɪzzi/.

References

  1. 1.0 1.1 1.2 1.3 "Skyrizi- risankizumab-rzaa kit". DailyMed. 12 June 2020. Retrieved 23 September 2020.
  2. 2.0 2.1 2.2 2.3 2.4 "Skyrizi". Retrieved 18 October 2021.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 "Risankizumab-rzaa Monograph for Professionals". Drugs.com. Retrieved 18 October 2021.
  4. 4.0 4.1 "Risankizumab (Skyrizi) Use During Pregnancy". Drugs.com. 15 July 2019. Retrieved 23 September 2020.
  5. "Skyrizi 75 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). Retrieved 23 September 2020.
  6. "Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis". The Rheumatologist. 15 April 2019.
  7. "Risankizumab (Skyrizi) Use During Pregnancy". Drugs.com. Retrieved 18 October 2021.
  8. Singh S, Kroe-Barrett RR, Canada KA, Zhu X, Sepulveda E, Wu H, et al. (July–August 2015). "Selective targeting of the IL23 pathway: Generation and characterization of a novel high-affinity humanized anti-IL23A antibody". mAbs. 7 (4): 778–91. doi:10.1080/19420862.2015.1032491. PMC 4622456. PMID 25905918.
  9. "Skyrizi Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 18 October 2021.
  10. BNF (80 ed.). BMJ Group and the Pharmaceutical Press. September 2021 – March 2021. p. 1326. ISBN 978-0-85711-369-6.
  11. Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, et al. (August 2018). "Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials". Lancet. 392 (10148): 650–661. doi:10.1016/S0140-6736(18)31713-6. PMID 30097359. S2CID 51957517.
  12. 12.0 12.1 12.2 "Drug Trials Snapshots: Skyrizi". U.S. Food and Drug Administration (FDA). 14 May 2019. Archived from the original on 28 September 2019. Retrieved 24 November 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  13. "Drug Approval Package: Skyrizi". U.S. Food and Drug Administration (FDA). 30 May 2019. Retrieved 24 November 2019.
  14. "Skyrizi (risankizumab-rzaa) FDA Approval History". Drugs.com. 23 April 2019. Retrieved 24 November 2019.

External links

External sites:
Identifiers: