Immunogenicity, efficacy and adverse events of adalimumab in RA patients
Immunogenicity, efficacy and adverse events of adalimumab in RA patients
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DOI：
10.1007/s00296-006-0183-7
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发表时间：
2007-01-01
影响因子：
4
通讯作者：
Heilig, Bernhard
中科院分区：
文献类型：
--
作者：
Bender, Niko K.;Heilig, Christoph E.;Heilig, Bernhard
为了评估阿达木单抗（一种人源抗TNF-α mAb）的免疫原性，我们在15例高度活动性类风湿关节炎患者中评价了阿达木单抗抗体的形成、疗效和不良事件。4例患者接受阿达木单抗单药治疗，11例患者合并使用DMARD。通过DAS 28测量疾病活性。ELISA法检测抗体。13例（87%）患者在45周内退出治疗，共有13例（87%）患者显示阿达木单抗抗体，包括11例退出治疗的患者。在4例未合并DMARD的患者和9例合并DMARD的患者中，我们检测到抗阿达木单抗抗体。总体而言，7例药物不良反应患者中有5例和所有9例缺乏疗效的患者均与抗体形成有关。两名抗体阳性患者出现了症状。结果表明，尽管阿达木单抗具有完全的人源序列，但阿达木单抗具有免疫原性，并在高比例的阿达木单抗治疗患者中诱导抗体。
To assess the immunogenicity of adalimumab, a human anti-TNF-alpha mAb, we evaluated the formation of antibodies to adalimumab, efficacy and adverse events among 15 patients with highly active rheumatoid arthritis. Four patients were treated with adalimumab as monotherapy, and 11 patients with concomitant DMARDs. Disease activity was measured by DAS28. The antibodies were detected by ELISA. Thirteen (87%) patients withdrew from therapy within 45 weeks and overall 13 (87%) patients showed antibodies to adalimumab including 11 patients who withdrew from therapy. In four patients without concomitant DMARDs and in nine patients with concomitant DMARDs, we detected anti-adalimumab antibodies. Overall, five of seven patients with adverse drug reactions and all nine patients with lack of efficacy were associated with the formation of antibodies. Two antibody-positive patients developed an exantheme. The results indicate that adalimumab is, in spite of its fully human sequences, immunogenic and induces antibodies in a high rate of adalimumab-treated patients.