賽妥珠單抗
賽妥珠單抗(英語:certolizumab pegol)以商品名Cimzia於市面上銷售,是一種生物製藥,用於治療克隆氏症、[1][2]類風濕性關節炎、乾癬性關節炎和強直性脊柱炎。此藥物為單株抗體片段,具有精準靶向並抑制腫瘤壞死因子的特異性。藥物生產者為總部位於比利時的全球性製藥公司優時比。[3][4][5]
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![]() 含200毫克賽妥珠單抗的注射器 | |
單克隆抗體 | |
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種類 | Fab'片段 |
目標 | 腫瘤壞死因子 |
臨床資料 | |
商品名 | Cimzia |
其他名稱 | CDP870 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a608041 |
核准狀況 |
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懷孕分級 |
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給藥途徑 | 皮下注射 |
ATC碼 | |
法律規範狀態 | |
法律規範 |
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藥物動力學數據 | |
生物半衰期 | 約11日 |
排泄途徑 | 腎臟 (僅為聚乙二醇) |
識別資訊 | |
CAS號 | 428863-50-7 ![]() |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
ChEMBL | |
化學資訊 | |
化學式 | C2115H3252N556O673S16 |
摩爾質量 | 47,749.46 g·mol−1 |
賽妥珠單抗已被列入世界衛生組織基本藥物標準清單之中。[7]
醫療用途
編輯特定群體
編輯妊娠
編輯個體懷孕期間可使用賽妥珠單抗於治療發炎性疾病。在懷孕後期接觸該藥物的嬰兒,可能需要延後接種部分疫苗。[12]
在英國,使用藥物的孕婦會在懷孕約20週時接受一次非常詳細的掃描以檢查胎兒的發育狀況。雖然可能會提供額外的生長掃描,但無需針對出生缺陷進行檢查。[12]曾有一項針對2,000名懷孕者使用此藥物的研究,並無因此而有較高出生缺陷比例的報導。[13]
母乳哺育
編輯賽妥珠單抗是一種非常大的蛋白質,估計只有很少量會進入母乳。就是有少許會進入母乳,也不易為嬰兒吸收。[13]
副作用
編輯使用賽妥珠單抗的副作用通常輕微,包括上呼吸道感染、泌尿道感染和皮疹。頭痛和注射部位反應。在罕見情況下,曾有嚴重的副作用報告,包括嚴重感染和癌症。[14]
禁忌症
編輯與其他藥物交互作用
編輯使用此藥物的患者可能會增加須住院或死亡的嚴重感染風險。大多數發生這些感染的患者正同時使用免疫抑制劑,如胺甲蝶呤或類固醇。[16][15]
作用方法
編輯賽妥珠單抗是一種針對腫瘤壞死因子的單株抗體片段。更準確地說,它是人源化TNF抑制劑單株抗體的聚乙二醇化Fab'片段。[18]
臨床試驗
編輯近期發展
編輯優時比公司於2019年3月28日宣佈FDA已批准CIMZIA® (賽妥珠單抗) 新增一項適應症 - 適用於具有客觀活動性發炎徵兆,而無放射影像確認之中軸性脊椎關節炎(non-radiographic axial spondyloarthritis,簡稱nr-axSpA)成人患者的治療。此項批准是FDA首個,也是目前唯一的nr-axSpA治療藥物。[23]
參考文獻
編輯- ^ 1.0 1.1 Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, et al. Certolizumab pegol for the treatment of Crohn's disease. The New England Journal of Medicine. July 2007, 357 (3): 228–238. PMID 17634458. doi:10.1056/NEJMoa067594 .
- ^ Goel N, Stephens S. Certolizumab pegol. mAbs. 2010, 2 (2): 137–147. PMC 2840232 . PMID 20190560. doi:10.4161/mabs.2.2.11271.
- ^ Kaushik VV, Moots RJ. CDP-870 (certolizumab) in rheumatoid arthritis. Expert Opinion on Biological Therapy. April 2005, 5 (4): 601–606. PMID 15934837. S2CID 21974683. doi:10.1517/14712598.5.4.601.
- ^ 4.0 4.1 Drug Approval Package: Cimzia (Certolizumab Pegol) NDA #125160. U.S. Food and Drug Administration (FDA). 1999-12-24 [2020-07-18].
- ^ Cimzia- certolizumab pegol kit Cimzia- certolizumab pegol injection, solution. DailyMed. 2020-04-24 [2020-07-18].
- ^ HIGHLIGHTS OF PRESCRIBING INFORMATION(CIMZIA) (PDF). UCB. April 2016 [2024-08-02].
CIMZIA is administered by subcutaneous injection.
- ^ World Health Organization. World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. 2021. hdl:10665/345533 . WHO/MHP/HPS/EML/2021.02.
- ^ Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease. UCB press release. [2008-04-22]. (原始內容存檔於2012-02-18).
- ^ Waknine Y. FDA Approvals: Patanase, Actonel, Cimzia. Medscape. 2008-05-01 [2008-05-01].
- ^ Cimzia European Public Assessment Report. European Medicines Agency. [2009-11-15]. (原始內容存檔於2009-11-09).
- ^ Cimzia (certolizumab pegol) approved by the U.S. FDA for treatment of adult patients with active psoriatic arthritis. [2013-10-01]. (原始內容存檔於2013-10-01).
- ^ 12.0 12.1 Certolizumab. Bumps. [2024-08-02].
- ^ 13.0 13.1 Certolizumab Pegol (Cimzia®). Mother To Baby. Feburary 2024 [2024-08-02].
- ^ Cimzia Side Effects and How to Manage Them. GoodRx Health. [2024-08-02].
- ^ 15.0 15.1 Cimzia - IMPORTANT SAFETY INFORMATION & INDICATIONS. UCBCares®. [2024-08-02].
- ^ Certolizumab Pegol Kit - Uses, Side Effects, and More. WebMD. [2024-08-02].
- ^ Lee JU, Shin W, Son JY, Yoo KY, Heo YS. Molecular Basis for the Neutralization of Tumor Necrosis Factor α by Certolizumab Pegol in the Treatment of Inflammatory Autoimmune Diseases. International Journal of Molecular Sciences. January 2017, 18 (1): 228. PMC 5297857 . PMID 28124979. doi:10.3390/ijms18010228 .
- ^ 18.0 18.1 Schreiber S, Khaliq-Kareemi M, Lawrance I, Hanauer S, McColm J, Bloomfield R, Sandborn W. Certolizumab pegol, a humanised anti-TNF pegylated FAb' fragment, is safe and effective in the maintenance of response and remission following induction in active Crohn's disease: a phase 3 study (precise). Gut. 2005, 54 (suppl 7): A82.
- ^ Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, McColm JA, Innes A, Schreiber S. Certolizumab pegol administered subcutaneously is effective and well tolerated in patients with active Crohn's disease: results from a 26-week, placebo-controlled Phase 3 study (PRECiSE 1). Gastroenterology. 2006, 130 (4): A107.
- ^ New Analysis Shows Cimzia (Certolizumab Pegol) Maintained Remission and Response in Recent Onset Crohn's Disease (新聞稿). UCB. 2006-10-23 [2009-11-15]. (原始內容存檔於2020-03-29).
- ^ Sieper J, Tubergen A, Coteur G, Woltering F, Landewe R. PMS50 – Rapid Improvements In Patient-Reported Outcomes With Certolizumab Pegol In Patients With Axial Spondyloarthritis, Including Ankylosing Spondylitis And Non-Radiographic Axial Spondyloarthritis: 24-Week Results Of A Phase 3 Double Blind Randomized Placebo-Controlled Study. Value in Health. May 2013, 16 (3): A227. doi:10.1016/j.jval.2013.03.1150 .
- ^ Ruiz Garcia V, Burls A, Cabello JB, Vela Casasempere P, Bort-Marti S, Bernal JA. Certolizumab pegol (CDP870) for rheumatoid arthritis in adults. The Cochrane Database of Systematic Reviews. September 2017, 2017 (9): CD007649. PMC 6483724 . PMID 28884785. doi:10.1002/14651858.CD007649.pub4.
- ^ CIMZIA® (certolizumab pegol) is Now the First and Only U.S. FDA-Approved Treatment for Non-Radiographic Axial Spondyloarthritis. UCB USA. 2019-03-28 [2024-08-03].