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在银屑病患者中检测抗 TNF 制剂的抗体:一项初步研究。

Detection of antibodies to anti-TNF agents in psoriatic patients: a preliminary study.

机构信息

IRCCS Azienda Ospedaliera Universitaria, San Martino - IST, Genoa, Italy.

出版信息

G Ital Dermatol Venereol. 2013 Apr;148(2):171-4.

Abstract

AIM

The efficacy of anti-TNFα agents in psoriasis (Pso) has been established in different clinical trials and in every day practice. However, a portion of patients (non-responder patients) persists with active disease or relapses even during current biological therapy. In addition to this, the use of biologic agents can give adverse drug reactions. All these factors may be due to the immunogenicity of these new biological drugs. All the biological proteins, including fully human proteins, have the potential to induce immunogenicity which leads to the development of specific antidrug antibodies (ADAs).

METHODS

In a retrospective way, we studied ADAs, using ELISA test, in a group of 51 patients with moderate to severe Pso treated with anti TNF α drugs: 18 Etanercept (ETN), 15 infliximab (IFX) and 18 adalimumab (AdA).

RESULTS

Anti-IFX antibodies were positive in 13.3%, anti AdA in 16.6% while all the patients treated with ETN did not present ADAs. Our opinion is that it is important to verify non-responder patients due to neutralizing ADAs so that we can change the drug before patients get worse. Moreover, it is important to detect ADAs since positive patients are more likely to develop acute hypersensitivity reactions. The development of antimonoclonal specific IgGs may also lead to an effector mechanism involving complement activation and production of anaphylotoxins which determine side effects that can be, in some cases, very severe. ADAs can be responsible of the poor response to the drugs and can impact the safety profile of the drugs.

CONCLUSION

We think that the detection of ADAs will be useful for the management of the drugs and the disease in all patients with psoriasis in treatment with anti biological drugs as a routine clinical practice.

摘要

目的

抗 TNFα 制剂在银屑病(Pso)中的疗效已在不同的临床试验和日常实践中得到证实。然而,一部分患者(无应答患者)即使在接受当前的生物治疗时,疾病仍持续活跃或复发。此外,生物制剂的使用会引起药物不良反应。所有这些因素可能是由于这些新型生物药物的免疫原性。所有的生物蛋白,包括完全人蛋白,都有潜在的免疫原性,导致特异性抗药物抗体(ADAs)的产生。

方法

我们以回顾性的方式,使用 ELISA 试验,研究了 51 名中重度 Pso 患者使用抗 TNFα 药物(18 名依那西普(ETN)、15 名英夫利昔单抗(IFX)和 18 名阿达木单抗(AdA))治疗后的 ADA。

结果

抗 IFX 抗体阳性率为 13.3%,抗 AdA 抗体阳性率为 16.6%,而所有接受 ETN 治疗的患者均未出现 ADA。我们认为,检测无应答患者是否存在中和性 ADA 非常重要,以便在患者病情恶化之前更换药物。此外,检测 ADA 也很重要,因为阳性患者更有可能发生急性过敏反应。抗单克隆特异性 IgG 的产生也可能导致涉及补体激活和产生过敏毒素的效应机制,从而决定可能在某些情况下非常严重的副作用。ADA 可能是药物反应不佳的原因,并可能影响药物的安全性。

结论

我们认为,在所有接受抗生物药物治疗的银屑病患者中,作为常规临床实践,检测 ADA 将有助于药物和疾病的管理。

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