Risankizumab
 | This article needs more reliable medical references for verification or relies too heavily on primary sources. (January 2017) |  |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | interleukin 23A |
| Clinical data | |
| Trade names | Skyrizi |
| Other names | BI-655066, ABBV-066, risankizumab-rzaa |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619035 |
| License data |
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| Routes of administration | Subcutaneous injection |
| ATC code | |
| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number | |
| PubChem SID | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6476H9992N1720O2016S44 |
| Molar mass | 145611.84 g·mol−1 |
Risankizumab (trade name Skyrizi) is a humanized monoclonal antibody targeting interleukin 23A (IL-23A).[1] Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie. Risankizumab has been approved in Europe, USA, Canada and Japan for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Clinical trials
Psoriasis
In a phase I clinical trial, thirty-nine patients received single-dose risankizumab, 18 of which received the drug intravenously, 13 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.[2]
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.[3] A marketing authorization application for risankizumab has been submitted to the US regulatory authority (Food and Drug Administration), the European Medicines Agency (EMA), and other regulatory agencies.[needs update]
History
Risankizumab was approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate-to-severe plaque psoriasis on 23 April 2019.[4][5][6]
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.[4] The trials were conducted in Asia, Canada, Europe, Mexico, South America, and the United States.[4]
References
- ^ 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.
- ^ 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.
- ^ 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.
- ^ a b c "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.
- ^ "Drug Approval Package: Skyrizi". U.S. Food and Drug Administration (FDA). 30 May 2019. Retrieved 24 November 2019. This article incorporates text from this source, which is in the public domain.
- ^ "Skyrizi (risankizumab-rzaa) FDA Approval History". Drugs.com. 23 April 2019. Retrieved 24 November 2019.
External links
- "Risankizumab". Drug Information Portal. U.S. National Library of Medicine.
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