Risankizumab Explained

Type:mab
Mab Type:mab
Source:zu
Target:interleukin 23A
Pronounce:
Tradename:Skyrizi
Dailymedid:Risankizumab
Pregnancy Au:B1
Pregnancy Au Comment:[1]
Routes Of Administration:Subcutaneous injection
Atc Prefix:L04
Atc Suffix:AC18
Legal Au:S4
Legal Au Comment:[2]
Legal Ca:Rx-only
Legal Ca Comment:/ Schedule D[3] [4]
Legal Uk:POM
Legal Uk Comment:[5]
Legal Us:Rx-only
Legal Us Comment:[6]
Legal Eu:Rx-only
Legal Status:Rx-only
Cas Number:1612838-76-2
Pubchemsubstance:363669765
Iuphar Ligand:8922
Drugbank:DB14762
Chemspiderid:none
Unii:90ZX3Q3FR7
Kegg:D11052
Chembl:3990029
Synonyms:BI-655066, ABBV-066, risankizumab-rzaa
C:6476
H:9992
N:1720
O:2016
S:44

Risankizumab, sold under the brand name Skyrizi, is a humanized monoclonal antibody used for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease. It is designed to target interleukin 23A (IL-23A).[7] It is given by subcutaneous injection.

The most common side effects include upper respiratory infections (nose and throat infection).

Risankizumab is approved for medical use in the European Union,[8] the United States, Canada, and Japan.[9] [10]

Medical uses

Risankizumab is indicated for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease. In Japan, it is also indicated for the treatment of generalized pustular psoriasis and erythrodermic psoriasis.

Adverse effects

Injection site reactions such as redness and pain have been reported but are uncommon, being reported in approximately 0.8% of cases.[11]

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]

The FDA approved risankizumab based on evidence primarily from five clinical trials (Trial 1/NCT02684370, Trial 2/NCT02684357, Trial 3/NCT02672852, Trial 4/ NCT02694523, and Trial 5/NCT02054481) of 1606 participants with moderate to severe plaque psoriasis. The trials were conducted in Asia, Canada, Europe, Mexico, South America, and the United States.

In June 2024, the FDA approved risankizumab for adults with moderate to severe forms of ulcerative colitis.[15]

Clinical trials

Psoriasis

In a phase I clinical trial, thirty-nine patients received single-dose risankizumab, eighteen of which received the drug intravenously, thirteen subcutaneously, and eight received the placebo drug. There were several instances that adverse effects occurred but in the same frequency for the placebo and the experimental groups. Four serious adverse events occurred in the risankizumab treated patients, all of which were judged not treatment related. Risankizumab was associated with clinical improvement in individuals treated with the drug, from week 2 and maintained for up to 66 weeks after treatment. At week 12 of treatment, 75%, 90%, and 100% decreases in the Psoriasis Area and Severity Index (PASI) were achieved by 87%, 58%, and 16% of risankizumab treated patients, regardless of dose, respectively, versus individuals receiving placebo. Significant correlation between treatment-associated molecular changes and PASI improvement was observed in the risankizumab treated patients.[16]

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.[17]

Notes and References

  1. Web site: Risankizumab (Skyrizi) Use During Pregnancy . Drugs.com . 15 July 2019 . 23 September 2020.
  2. Web site: Skyrizi (Abbvie Pty Ltd) . Therapeutic Goods Administration (TGA) . 11 November 2022 . 9 April 2023.
  3. Web site: Skyrizi Product information . Health Canada . 25 April 2012 . 29 May 2022.
  4. Web site: Summary Basis of Decision (SBD) for Skyrizi . . 23 October 2014 . 29 May 2022.
  5. Web site: Skyrizi 75 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC) . (emc) . 23 September 2020.
  6. Web site: Skyrizi- risankizumab-rzaa kit . DailyMed . 12 June 2020 . 23 September 2020.
  7. Singh S, Kroe-Barrett RR, Canada KA, Zhu X, Sepulveda E, Wu H, He Y, Raymond EL, Ahlberg J, Frego LE, Amodeo LM, Catron KM, Presky DH, Hanke JH . 6 . Selective targeting of the IL23 pathway: Generation and characterization of a novel high-affinity humanized anti-IL23A antibody . mAbs . 7 . 4 . 778–791 . July–August 2015 . 25905918 . 4622456 . 10.1080/19420862.2015.1032491 .
  8. Web site: Skyrizi EPAR . European Medicines Agency (EMA) . 27 February 2019 . 23 September 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis . AbbVie . 23 April 2019 . 9 August 2023.
  10. Web site: 15 April 2019 . Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis . The Rheumatologist.
  11. Kim PJ, Lansang RP, Vender R . A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections . Journal of Cutaneous Medicine and Surgery . 27 . 4 . 358–367 . July 2023 . 37533141 . 10.1177/12034754231188444 . 10486173 .
  12. Web site: Drug Trials Snapshots: Skyrizi . U.S. Food and Drug Administration (FDA) . 14 May 2019 . https://web.archive.org/web/20190928024055/https://www.fda.gov/drugs/drug-trials-snapshots-skyrizi . 28 September 2019 . live . 24 November 2019.
  13. Web site: Drug Approval Package: Skyrizi . U.S. Food and Drug Administration (FDA) . 30 May 2019 . 24 November 2019.
  14. Web site: Skyrizi (risankizumab-rzaa) FDA Approval History . Drugs.com . 23 April 2019 . 24 November 2019.
  15. Web site: 18 June 2024 . AbbVie says FDA approves Skyrizi for ulcerative colitis .
  16. Krueger JG, Ferris LK, Menter A, Wagner F, White A, Visvanathan S, Lalovic B, Aslanyan S, Wang EE, Hall D, Solinger A, Padula S, Scholl P . 6 . Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: Safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial . The Journal of Allergy and Clinical Immunology . 136 . 1 . 116–124.e7 . July 2015 . 25769911 . 10.1016/j.jaci.2015.01.018 .
  17. Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp KA, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes JM, Thompson EH, Bachelez H . 6 . 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 . August 2018 . 30097359 . 10.1016/S0140-6736(18)31713-6 . 51957517 .

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