Risankizumab
{{Short description|Humanized monoclonal antibody}}
{{Use dmy dates|date=June 2024}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Infobox drug
| type = mab
| image =
| alt =
| caption =
| mab_type = mab
| source = zu
| target = interleukin 23A
| pronounce = {{IPAc-en|ˌ|r|ɪ|s|ə|n|ˈ|k|ɪ|z|ʊ|m|æ|b}}
{{respell|RIS|ən|KIZ|uu|mab}}
| tradename = Skyrizi
| Drugs.com = {{drugs.com|monograph|risankizumab-rzaa}}
| MedlinePlus = a619035
| DailyMedID = Risankizumab
| pregnancy_AU = B1
| pregnancy_AU_comment = {{cite web | title=Risankizumab (Skyrizi) Use During Pregnancy | website=Drugs.com | date=15 July 2019 | url=https://www.drugs.com/pregnancy/risankizumab.html | access-date=23 September 2020}}
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| routes_of_administration = Subcutaneous injection
| class =
| ATC_prefix = L04
| ATC_suffix = AC18
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| legal_AU = S4
| legal_BR =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = / Schedule D{{cite web | title=Skyrizi Product information | website=Health Canada | date=25 April 2012 | url=https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=97761 | access-date=29 May 2022}}{{cite web | title=Summary Basis of Decision (SBD) for Skyrizi | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00444&lang=en | access-date=29 May 2022}}
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| legal_UK = POM
| legal_US = Rx-only
| legal_EU = Rx-only
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| CAS_number = 1612838-76-2
| CAS_supplemental =
| PubChem =
| PubChemSubstance = 363669765
| IUPHAR_ligand = 8922
| DrugBank = DB14762
| ChemSpiderID = none
| UNII = 90ZX3Q3FR7
| KEGG = D11052
| ChEBI =
| ChEMBL = 3990029
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = BI-655066, ABBV-066, risankizumab-rzaa
| IUPAC_name =
| C = 6476 | H = 9992 | N = 1720 | O = 2016 | S = 44
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Risankizumab, sold under the brand name Skyrizi ({{IPAc-en|s|k|aɪ|'|r|ɪ|z|i}} {{respell|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).{{cite journal | vauthors = 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 | display-authors = 6 | title = Selective targeting of the IL23 pathway: Generation and characterization of a novel high-affinity humanized anti-IL23A antibody | journal = mAbs | volume = 7 | issue = 4 | pages = 778–791 | date = July–August 2015 | pmid = 25905918 | pmc = 4622456 | doi = 10.1080/19420862.2015.1032491 }} 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,{{cite web | title=Skyrizi EPAR | website=European Medicines Agency (EMA) | date=27 February 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/skyrizi | access-date=23 September 2020}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. the United States, Canada, and Japan.{{cite press release | title=AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis | website=AbbVie | date=23 April 2019 | url=https://news.abbvie.com/news/press-releases/abbvie-expands-immunology-portfolio-in-us-with-fda-approval-skyrizi-risankizumab-rzaa-for-moderate-to-severe-plaque-psoriasis.htm | access-date=9 August 2023}}{{cite web |date=15 April 2019 |title=Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis |url=https://www.the-rheumatologist.org/article/japan-approves-risankizumab-for-psoriasis-psoriatic-arthritis/ |publisher=The Rheumatologist}}
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.{{cite journal | vauthors = Kim PJ, Lansang RP, Vender R | title = A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections | journal = Journal of Cutaneous Medicine and Surgery | volume = 27 | issue = 4 | pages = 358–367 | date = July 2023 | pmid = 37533141 | doi = 10.1177/12034754231188444 | pmc = 10486173 }}
History
Risankizumab was approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate-to-severe plaque psoriasis in April 2019.{{cite web | title=Drug Trials Snapshots: Skyrizi | website=U.S. Food and Drug Administration (FDA) | date=14 May 2019 | url=https://www.fda.gov/drugs/drug-trials-snapshots-skyrizi | archive-url=https://web.archive.org/web/20190928024055/https://www.fda.gov/drugs/drug-trials-snapshots-skyrizi | archive-date=28 September 2019 | url-status=live | access-date=24 November 2019}} {{PD-notice}}{{cite web | title=Drug Approval Package: Skyrizi | website=U.S. Food and Drug Administration (FDA) | date=30 May 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761105Orig1s000TOC.cfm | access-date=24 November 2019}}{{cite web | title=Skyrizi (risankizumab-rzaa) FDA Approval History | website=Drugs.com | date=23 April 2019 | url=https://www.drugs.com/history/skyrizi.html | access-date=24 November 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.{{Cite web |date=18 June 2024 |title=AbbVie says FDA approves Skyrizi for ulcerative colitis |url=https://marketwatch.com/story/abbvie-says-fda-approves-skyrizi-for-ulcerative-colitis-3815324b}}{{cite web |last=Brooks |first=Abigail |title=FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis |website=HCP Live |date=18 June 2024 |url=https://www.hcplive.com/view/fda-approves-risankizumab-skyrizi-for-ulcerative-colitis |access-date=2 November 2024}}
Clinical trials
{{more medical citations needed|section|date=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.{{cite journal | vauthors = 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 | display-authors = 6 | title = 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 | journal = The Journal of Allergy and Clinical Immunology | volume = 136 | issue = 1 | pages = 116–124.e7 | date = July 2015 | pmid = 25769911 | doi = 10.1016/j.jaci.2015.01.018 }}
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.{{cite journal | vauthors = 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 | display-authors = 6 | title = 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 | journal = Lancet | volume = 392 | issue = 10148 | pages = 650–661 | date = August 2018 | pmid = 30097359 | doi = 10.1016/S0140-6736(18)31713-6 | s2cid = 51957517 }}
References
{{Reflist}}
External lists
- {{ClinicalTrialsGov|NCT02684370|BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis}}
- {{ClinicalTrialsGov|NCT02684357|BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis}}
- {{ClinicalTrialsGov|NCT02672852|BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment}}
- {{ClinicalTrialsGov|NCT02694523|BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis}}
- {{ClinicalTrialsGov|NCT02054481|BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab}}
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{{Monoclonals for immune system}}
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