瑞沙珠單抗

瑞沙珠單抗
單克隆抗體
種類	完整抗體
目標	interleukin 23A
臨床資料
讀音	/ˌrɪsənˈkɪzʊmæb/; RIS-ən-KIZ-uu-mab
商品名（英語：Drug nomenclature）	Skyrizi
其他名稱	BI-655066, ABBV-066, risankizumab-rzaa
AHFS/Drugs.com	Monograph
MedlinePlus	a619035
核准狀況	美 DailyMed: Risankizumab;
懷孕分級	澳: B1 ; ;
給藥途徑	皮下注射
ATC碼	L04AC18 (WHO) ;
法律規範狀態
法律規範	澳：限醫生處方（S4）; 加：處方藥（℞-only）/ Schedule D; 歐：Rx-only; 英：處方藥（℞-only） (POM); 美：處方藥（℞-only）; Rx-only;
識別資訊
CAS號	1612838-76-2
PubChem SID	363669765;
IUPHAR/BPS	8922;
DrugBank	DB14762;
ChemSpider	none;
UNII	90ZX3Q3FR7;
KEGG	D11052;
ChEMBL	ChEMBL3990029;
化學資訊
化學式	C6476H9992N1720O2016S44
摩爾質量	145,611.84 g·mol−1

瑞沙珠單抗（英語：Risankizumab），商品名為喜開悅（英語：Skyrizi）是一種皮下注射的人源單克隆抗體，用於治療斑塊狀銀屑病、乾癬性關節炎、克隆氏症和潰瘍性結腸炎^[9]。它可以結合併阻斷介白素23A（英語：Interleukin 23 subunit alpha）（IL-23A）^[9] ^[10]。

最常見的副作用包括上呼吸道感染（鼻咽感染）^[9]。

瑞沙珠單抗於2019年在美國取得醫療使用許可^[11] ^[12]，此外全球包括歐盟^[9]、加拿大^[3]、日本^[8] ^[13]和台灣皆可獲得醫療使用許可。

參考文獻

^ 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 (新聞稿). 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]. （原始內容存檔於28 September 2021）（英語）.
^ Skyrizi. [18 October 2021]. （原始內容存檔於25 October 2020）.
^ Japan Approves Risankizumab for Psoriasis & Psoriatic Arthritis. The Rheumatologist. 15 April 2019.

外部連節

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 (新聞稿). 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]. （原始內容存檔於28 September 2021）（英語）.

[EPAR2021-12] Skyrizi. [18 October 2021]. （原始內容存檔於25 October 2020）.

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

[1]

[2]

[3]

[4]

[7]

[5]

[6]

[8]

[9]

[10]

[11]

[12]

[13]