【前期回顧】：Immundiagnostik常見單抗類藥物與抗藥物抗體(ADA)檢測(cè)工具匯總

英夫利昔單抗(Infliximab)與抗Infliximab抗體: 

英夫利昔單抗(Infliximab)是一類抑制TNFα的藥物，主要用于克羅恩病, 類風(fēng)濕關(guān)節(jié)炎, 強(qiáng)直性脊柱炎，牛皮癬關(guān)節(jié)炎，潰瘍性結(jié)腸炎的緩解和治療。抗TNFα治療的臨床療效通常與治療性抗體的谷濃度相關(guān)，即下一次應(yīng)用抗TNFα抗體之前的藥物濃度。有幾個(gè)因素影響谷濃度，其中包括抗TNFα拮抗劑輸注的劑量和頻率、疾病活動(dòng)度、個(gè)體藥代動(dòng)力學(xué)和免疫反應(yīng)（形成抗藥物抗體，ADA）。人們認(rèn)為，ADA在功能性上中和了治療性抗體或誘導(dǎo)其快速消除。ADA形成的后果可能是治療失敗和抗TNFα抗體應(yīng)用期間的過敏反應(yīng)。  

檢測(cè)的意義：檢測(cè)抗英夫利昔單抗(Infliximab)藥物水平可幫助監(jiān)測(cè)藥物水平（尤其是谷濃度），以確保藥物在循環(huán)中有足夠的濃度，并在必要時(shí)調(diào)整其劑量。此外，在治療過程中，谷濃度降低表明存在藥物抗體。   如果患者體內(nèi)產(chǎn)生抗英夫利昔單抗(Infliximab)抗體，則使用抗體藥的療法會(huì)導(dǎo)致無用的免疫反應(yīng)。這可能導(dǎo)致過敏反應(yīng)，導(dǎo)致療效降低以及治療失敗。對(duì)抗英夫利昔單抗(Infliximab)抗體水平的監(jiān)測(cè)有利于早期干預(yù)（例如，增加藥物劑量或頻率，增加給藥免疫抑制藥物，切換另一種藥物），從而實(shí)現(xiàn)有效治療，降低副作用。   

在這里艾美捷為大家提供知名的診斷試劑和服務(wù)供應(yīng)商Immundiagnostik（IDK）公司研發(fā)的爆款產(chǎn)品——抗英夫利昔單抗(Infliximab)藥物水平檢測(cè)試劑盒和抗英夫利昔單抗(Infliximab)ADA水平檢測(cè)試劑盒：

相關(guān)產(chǎn)品推薦：

*以上產(chǎn)品僅用于科研，不得做醫(yī)療及診斷用途  

儲(chǔ)存條件及有效期：本產(chǎn)品在2-8℃下保存可穩(wěn)定至所標(biāo)示的有效期。 工作洗液配制后須儲(chǔ)存于密封容器中，在2-8℃下可保存1個(gè)月。 結(jié)合物稀釋后不穩(wěn)定，無法保存，須現(xiàn)配現(xiàn)用。 生產(chǎn)日期及失效日期見試劑盒標(biāo)簽。  

適用儀器：適用于具有450nm、620nm波長(zhǎng)的所有全自動(dòng)、半自動(dòng)酶標(biāo)儀。  

樣本類型：EDTA血漿和血清

樣本保存：新鮮采集的EDTA血漿或血清在室溫（15-30℃）或2-8℃下可保存7天，若須長(zhǎng)期保存，請(qǐng)置于-20℃下保存。 已稀釋的EDTA血漿或血清樣本在室溫下可保存7天，在2-8℃可保存15天，在-20℃至少可保存7周。應(yīng)盡量避免反復(fù)凍融，凍融次數(shù)不超過3次  

K 9655部分引文：

1. Afif W, Loftus E V, Faubion WA, Kane S V, Bruining DH, Hanson KA, et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. The American journal of gastroenterology. 2010/02/11. 2010 May;105(5):1133–9.

2. Beglinger C, Binek J, Braegger C, Michetti P, Rogler G, Sauter B, et al. InfliximabMonotherapie versus Kombinationstherapie mit Immunmodulatoren. The medical journal. 2008;1:32–4.

3. Bender NK, Heilig CE, Dr?ll B, Wohlgemuth J, Armbruster F-P, Heilig B. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatology international. 2006/09/29. 2007 Jan 11;27(3):269–74.

4. Bendtzen K, Geborek P, Svenson M, Larsson L, Kapetanovic MC, Saxne T. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis and rheumatism. 2006 Dec;54(12):3782–9.

5. Bradley JR. TNF-mediated inflammatory disease. The Journal of pathology. 2008 Jan;214(2):149–60.

6. St Clair EW, Wagner CL, Fasanmade A a, Wang B, Schaible T, Kavanaugh A, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, doubleblind, placebo-controlled trial. Arthritis and rheumatism. 2002 Jun;46(6):1451–9.

7. Chang JT, Lichtenstein GR. Drug insight: antagonists of tumor-necrosis factor-alpha in the treatment of inflammatory bowel disease. Nature clinical practice Gastroenterology & hepatology. 2006 Apr;3(4):220–8.

8. Colombel J-F, Loftus E V, Tremaine WJ, Egan LJ, Harmsen WS, Schleck CD, et al. The safety profile of infliximab in patients with Crohn’s disease: the Mayo clinic experience in 500 patients. Gastroenterology. 2004 Jan;126(1):19–31.

9. Cominelli F. Cytokine-based therapies for Crohn’s disease--new paradigms. The New England journal of medicine. 2004 Nov 11;351(20):2045–8.

10. Cornillie F, Shealy D, D’Haens G, Geboes K, Van Assche G, C

K 9654部分引文：

1. Afif W, Loftus EV, Jr., Faubion WA, Kane SV, Bruining DH, Hanson KA, Sandborn WJ (2010). Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol 105(5): 1133-1139.

2. Kopylov U, Mazor Y, Yavzori M, Fudim E, Katz L, Coscas D, Picard O, Chowers Y, Eliakim R, Ben-Horin S (2012). Clinical utility of antihuman lambda chain-based enzyme-linked immunosorbent assay (ELISA) versus double antigen ELISA for the detection of anti-infliximab antibodies. Inflamm Bowel Dis 18(9): 1628-1633.

3. Tak PP (2012). A personalized medicine approach to biological treatment of rheumatoid arthritis: a preliminary treatment algorithm. Rheumatology 51(4): 600-609.

4. Ordas I, Mould DR, Feagan BG, Sandborn WJ (2012) Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther 91(4): 635-646.

5. Bender NK, Heilig CE, Droll B, Wohlgemuth J, Armbruster FP, Heilig B (2007). Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatol Int 27(3): 269-274.

K 9650部分引文：

1. Afif, W. et al., 2010. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. The American journal of gastroenterology, 105(5), pp.1133–9.

2. Kopylov, U. et al., 2012. Clinical utility of antihuman lambda chain-based enzymelinked immunosorbent assay (ELISA) versus double antigen ELISA for the detection of anti-infliximab antibodies. Inflammatory bowel diseases, 18(9), pp.1628–33.

3. Tak, P.P., 2012. A personalized medicine approach to biologic treatment of rheumatoid arthritis: a preliminary treatment algorithm. Rheumatology (Oxford, England), 51(4), pp.600–9.

4. Ordás, I. et al., 2012. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clinical pharmacology and therapeutics, 91(4), pp.635–46.

5. Bender, N.K. et al., 2007. Immunogenicity, efficacy and adverse events of adalimumab in RA patients. Rheumatology international, 27(3), pp.269–74.

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