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Risankizumab

Risankizumab, sold under the brand name Skyrizi , is a humanized monoclonal antibody used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.[6] It is designed to target interleukin 23A (IL-23A).[6][7] It is given by subcutaneous injection.[6]

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,[6] Canada,[3] and Japan.[9][10]

Medical uses

Risankizumab is indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.[3][6][8] In Japan, it is also indicated for the treatment of generalized pustular psoriasis and erythrodermic psoriasis.[9]

Adverse effects

Side effects may include and are not necessarily limited to injection site reactions, such as redness and pain, which have been reported but are uncommon, occurring in approximately0.8% of cases.[11]

History

Risankizumab was approved by the US 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 (NCT02684370, NCT02684357, NCT02672852, NCT02694523, and NCT02054481) of 1,606participants with moderate to severe plaque psoriasis.[12] The trials were conducted in Asia, Canada, Europe, Mexico, South America, and the United States.[12]

In June 2024, the FDA approved risankizumab for adults with moderate to severe forms of ulcerative colitis.[15][16]

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.[17]

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.[18]

External lists

References

  1. Risankizumab (Skyrizi) Use During Pregnancy Drugs.com, 15 July 2019, retrieved 23 September 2020^
  2. Skyrizi (Abbvie Pty Ltd) Therapeutic Goods Administration (TGA), 11 November 2022, retrieved 9 April 2023^
  3. Skyrizi Product information Health Canada, 25 April 2012, retrieved 29 May 2022^
  4. Summary Basis of Decision (SBD) for Skyrizi Health Canada, 23 October 2014, retrieved 29 May 2022^
  5. Skyrizi 75 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC) (emc), retrieved 23 September 2020^
  6. Skyrizi- risankizumab-rzaa kit DailyMed, 18 June 2024, retrieved 2 November 2024^
  7. Selective targeting of the IL23 pathway: Generation and characterization of a novel high-affinity humanized anti-IL23A antibody mAbs, July–August 2015^
  8. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Skyrizi EPAR European Medicines Agency (EMA), 27 February 2019, retrieved 23 September 2020^
  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, retrieved 9 August 2023^
  10. Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis The Rheumatologist, 15 April 2019^
  11. A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections Journal of Cutaneous Medicine and Surgery, July 2023^
  12. Drug Trials Snapshots: Skyrizi U.S. Food and Drug Administration (FDA), 14 May 2019, retrieved 24 November 2019^
  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^
  15. AbbVie says FDA approves Skyrizi for ulcerative colitis 18 June 2024^
  16. Abigail Brooks. FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis HCP Live, 18 June 2024, retrieved 2 November 2024^
  17. 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, July 2015^
  18. 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, August 2018^