Risankizumab
Humanized | |
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| Target | interleukin 23A |
| Clinical data | |
| Pronunciation | /ˌrɪsənˈkɪzʊmæb/ RIS-ən-KIZ-uu-mab |
| Trade names | Skyrizi |
| Other names | BI-655066, ABBV-066, risankizumab-rzaa |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619035 |
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Subcutaneous injection | |
| ATC code | |
| Legal status | |
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| Formula | C6476H9992N1720O2016S44 |
| Molar mass | 145611.84 g·mol−1 |
Risankizumab, sold under the brand name Skyrizi, is a humanized
The most common side effects include
Risankizumab is approved for medical use in the European Union,[7] the United States,[6][10] Canada,[3] and Japan.[8][11]
Medical uses
Risankizumab is
Adverse effects
Injection site reactions such as redness and pain have been reported but are uncommon, being reported in approximately 0.8% of cases.[12]
History
Risankizumab was approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate-to-severe plaque psoriasis in April 2019.[13][10][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.[13] The trials were conducted in Asia, Canada, Europe, Mexico, South America, and the United States.[13]
Clinical trials
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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.[15]
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.[16]
References
- ^ "Risankizumab (Skyrizi) Use During Pregnancy". Drugs.com. 15 July 2019. Retrieved 23 September 2020.
- ^ "Skyrizi (Abbvie Pty Ltd)". Therapeutic Goods Administration (TGA). 11 November 2022. Retrieved 9 April 2023.
- ^ a b c "Skyrizi Product information". Health Canada. 25 April 2012. Retrieved 29 May 2022.
- ^ "Summary Basis of Decision (SBD) for Skyrizi". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ "Skyrizi 75 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). Retrieved 23 September 2020.
- ^ a b c d e f "Skyrizi- risankizumab-rzaa kit". DailyMed. 12 June 2020. Retrieved 23 September 2020.
- ^ a b c d e f g "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.
- ^ a b c "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.
- PMID 25905918.
- ^ a b "Drug Approval Package: Skyrizi". U.S. Food and Drug Administration (FDA). 30 May 2019. Retrieved 24 November 2019.
- ^ "Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis". The Rheumatologist. 15 April 2019.
- PMID 37533141.
- ^ 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.
- ^ "Skyrizi (risankizumab-rzaa) FDA Approval History". Drugs.com. 23 April 2019. Retrieved 24 November 2019.
- PMID 25769911.
- S2CID 51957517.
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
