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Risankizumab, sold under the brand name Skyrizi (/skaɪˈrɪzi/ sky-RIZZ-ee), is a humanized monoclonal antibody used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is designed to target interleukin 23A (IL-23A). 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, the United States, Canada, and Japan.

Medical uses

Risankizumab is indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. 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.

History

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

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.

Clinical trials

This section needs more reliable medical references for verification or relies too heavily on primary sources. Please review the contents of the section and add the appropriate references if you can. Unsourced or poorly sourced material may be challenged and removed. Find sources: "Risankizumab" – news · newspapers · books · scholar · JSTOR (January 2017)

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.

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.

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. ^ "Skyrizi EPAR". European Medicines Agency (EMA). 27 February 2019. Retrieved 23 September 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
8. ^ "AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis". AbbVie (Press release). 23 April 2019. Retrieved 9 August 2023.
9. 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): 778–791. doi:10.1080/19420862.2015.1032491. PMC 4622456. PMID 25905918.{{cite journal}}: CS1 maint: overridden setting (link)
10. ^ "Drug Approval Package: Skyrizi". U.S. Food and Drug Administration (FDA). 30 May 2019. Retrieved 24 November 2019.
11. "Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis". The Rheumatologist. 15 April 2019.
12. Kim PJ, Lansang RP, Vender R (July 2023). "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. doi:10.1177/12034754231188444. PMC 10486173. PMID 37533141.
13. ^ "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. This article incorporates text from this source, which is in the public domain.
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. Brooks A (18 June 2024). "FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis". HCP Live. Retrieved 2 November 2024.
17. Krueger JG, Ferris LK, Menter A, Wagner F, White A, Visvanathan S, et al. (July 2015). "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. doi:10.1016/j.jaci.2015.01.018. PMID 25769911.{{cite journal}}: CS1 maint: overridden setting (link)
18. 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.{{cite journal}}: CS1 maint: overridden setting (link)

External lists

• Clinical trial number NCT02684370 for "BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis" at ClinicalTrials.gov
• Clinical trial number NCT02684357 for "BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis" at ClinicalTrials.gov
• Clinical trial number NCT02672852 for "BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment" at ClinicalTrials.gov
• Clinical trial number NCT02694523 for "BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis" at ClinicalTrials.gov
• Clinical trial number NCT02054481 for "BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab" at ClinicalTrials.gov

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