瑞沙珠单抗

瑞沙珠单抗
单克隆抗体
种类	完整抗体
目标	interleukin 23A
临床资料
读音	/ˌrɪsənˈkɪzʊmæb/; RIS-ən-KIZ-uu-mab
商品名（英语：Drug nomenclature）	Skyrizi
其他名称	BI-655066, ABBV-066, risankizumab-rzaa
AHFS/Drugs.com	Monograph
MedlinePlus	a619035
核准状况	美 DailyMed: Risankizumab;
怀孕分级	澳: B1 ; ;
给药途径	皮下注射
ATC码	L04AC18 (WHO) ;
法律规范状态
法律规范	澳：限医生处方（S4）; 加：处方药（℞-only）/ Schedule D; 欧：Rx-only; 英：处方药（℞-only） (POM); 美：处方药（℞-only）; Rx-only;
识别信息
CAS号	1612838-76-2
PubChem SID	363669765;
IUPHAR/BPS	8922;
DrugBank	DB14762;
ChemSpider	none;
UNII	90ZX3Q3FR7;
KEGG	D11052;
ChEMBL	ChEMBL3990029;
化学信息
化学式	C6476H9992N1720O2016S44
摩尔质量	145,611.84 g·mol−1

瑞沙珠单抗（英语：Risankizumab），商品名为喜开悦（英语：Skyrizi）是一种皮下注射的人源单克隆抗体，用于治疗斑块状银屑病、干癣性关节炎、克隆氏症和溃疡性结肠炎^[9]。它可以结合并阻断介白素23A（英语：Interleukin 23 subunit alpha）（IL-23A）^[9] ^[10]。

最常见的副作用包括上呼吸道感染（鼻咽感染）^[9]。

瑞沙珠单抗于2019年在美国取得医疗使用许可^[11] ^[12]，此外全球包括欧盟^[9]、加拿大^[3]、日本^[8] ^[13]和台湾皆可获得医疗使用许可。

参考文献

^ Risankizumab (Skyrizi) Use During Pregnancy. Drugs.com. 15 July 2019 [23 September 2020].
^ Skyrizi (Abbvie Pty Ltd). Therapeutic Goods Administration (TGA). 11 November 2022 [9 April 2023].
^ ^3.0 ^3.1 Skyrizi Product information. Health Canada. 25 April 2012 [29 May 2022].
^ Summary Basis of Decision (SBD) for Skyrizi. Health Canada. 23 October 2014 [29 May 2022].
^ Skyrizi 75 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC). (emc). [23 September 2020].
^ Skyrizi- risankizumab-rzaa kit. DailyMed. 18 June 2024 [2 November 2024].
^ Skyrizi EPAR. European Medicines Agency (EMA). 27 February 2019 [23 September 2020]. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ ^8.0 ^8.1 AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis. AbbVie (新闻稿). 23 April 2019 [9 August 2023].
^ ^9.0 ^9.1 ^9.2 ^9.3 Skyrizi EPAR. European Medicines Agency (EMA). 27 February 2019 [23 September 2020].
^ Singh S, Kroe-Barrett RR, Canada KA, Zhu X, Sepulveda E, Wu H, et al. Selective targeting of the IL23 pathway: Generation and characterization of a novel high-affinity humanized anti-IL23A antibody. mAbs. July–August 2015, 7 (4): 778–791. PMC 4622456 . PMID 25905918. doi:10.1080/19420862.2015.1032491.
^ Risankizumab-rzaa Monograph for Professionals. Drugs.com. [18 October 2021]. （原始内容存档于28 September 2021）（英语）.
^ Skyrizi. [18 October 2021]. （原始内容存档于25 October 2020）.
^ Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis. The Rheumatologist. 15 April 2019.

外部连节

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

[Drugs.com_pregnancy-1] Risankizumab (Skyrizi) Use During Pregnancy. Drugs.com. 15 July 2019 [23 September 2020].

[2] Skyrizi (Abbvie Pty Ltd). Therapeutic Goods Administration (TGA). 11 November 2022 [9 April 2023].

[Skyrizi_Product_information_CA-3] 3.0 ^3.1 Skyrizi Product information. Health Canada. 25 April 2012 [29 May 2022].

[4] Summary Basis of Decision (SBD) for Skyrizi. Health Canada. 23 October 2014 [29 May 2022].

[Skyrizi_SmPC-5] Skyrizi 75 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC). (emc). [23 September 2020].

[Skyrizi_FDA_label-6] Skyrizi- risankizumab-rzaa kit. DailyMed. 18 June 2024 [2 November 2024].

[Skyrizi_EPAR-7] Skyrizi EPAR. European Medicines Agency (EMA). 27 February 2019 [23 September 2020]. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[AbbVie_PR_20190423-8] 8.0 ^8.1 AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis. AbbVie (新闻稿). 23 April 2019 [9 August 2023].

[Skyrizi_EPAR3-9] 9.0 ^9.1 ^9.2 ^9.3 Skyrizi EPAR. European Medicines Agency (EMA). 27 February 2019 [23 September 2020].

[10] Singh S, Kroe-Barrett RR, Canada KA, Zhu X, Sepulveda E, Wu H, et al. Selective targeting of the IL23 pathway: Generation and characterization of a novel high-affinity humanized anti-IL23A antibody. mAbs. July–August 2015, 7 (4): 778–791. PMC 4622456 . PMID 25905918. doi:10.1080/19420862.2015.1032491.

[AHFS2021-11] Risankizumab-rzaa Monograph for Professionals. Drugs.com. [18 October 2021]. （原始内容存档于28 September 2021）（英语）.

[EPAR2021-12] Skyrizi. [18 October 2021]. （原始内容存档于25 October 2020）.

[13] Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis. The Rheumatologist. 15 April 2019.

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