BACKGROUND Antidrug antibodies (ADAs) may change pharmacokinetic or pharmacodynamic profiles of biologic therapies, potentially decreasing efficacy. OBJECTIVE To evaluate the potential effects of brodalumab immunogenicity on safety, efficacy, and retreatment. METHODS Data from 1 phase 2 and 3 phase 3 studies of brodalumab in psoriasis were analyzed. RESULTS Overall, 2.7% of patients had positive test results for binding ADAs after receiving brodalumab; ADAs were transient in 1.4% of patients, and there were no neutralizing ADAs. Among ADA-positive patients, 60.0% (3/5) achieved a static physician's global assessment score of 0 or 1 at week 12 in the group receiving the brodalumab 210 mg every 2 weeks, compared with 79.1% (1131/1429) of ADA-negative patients. All patients (100%) who experienced return of disease and were retreated with brodalumab 210 mg every 2 weeks (none were ADA positive) achieved at least a 75% improvement in Psoriasis Area And Severity Index, ≥90% of whom regained response by week 8 of retreatment. Hypersensitivity reactions were less frequent with brodalumab than with placebo. Injection site reactions occurred in 1.8% of patients treated with brodalumab versus 2% of patients treated with ustekinumab. LIMITATIONS Retreatment could be assessed in only 1 phase 3 brodalumab study. CONCLUSION Brodalumab compares favorably with other biologics in terms of immunogenicity and high rates of efficacy recapture upon retreatment.

中文翻译：

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Brodalumab临床研究中的免疫原性和皮肤清除率重新获得。

背景技术抗药物抗体（ADAs）可能会改变生物疗法的药代动力学或药效动力学特征，从而可能降低疗效。目的评估布罗达单抗的免疫原性对安全性，疗效和再治疗的潜在影响。方法分析1阶段2和3阶段3阶段的溴代单抗治疗牛皮癣的数据。结果总体上，接受布达单抗治疗的患者中有2.7％的患者结合ADA的检测结果为阳性。ADA在1.4％的患者中是短暂的，并且没有中和的ADA。在ADA阳性患者中，每2周接受Brodalumab 210 mg的组在第12周时有60.0％（3/5）的静态医师总体评估得分为0或1，而ADA的患者为79.1％（1131/1429） -阴性患者。所有经历疾病复发并每两周接受210 mg溴达单抗治疗的患者（100％）（无ADA阳性）牛皮癣面积和严重程度指数至少改善了75％，≥90％的患者本周恢复了反应8进行复治。Brodalumab的超敏反应发生率低于安慰剂。注射部位反应发生在1.8％的Brodalumab治疗患者中，而2％的患者使用ustekinumab治疗。局限性仅在1个3期brodalumab研究中可以评估再治疗。结论就免疫原性和重新治疗后高的药效回收率而言，Brodalumab与其他生物制剂相比具有优势。≥90％的患者在再治疗的第8周恢复了反应。Brodalumab的超敏反应发生率低于安慰剂。注射部位反应发生在1.8％的Brodalumab治疗患者中，而2％的患者使用ustekinumab治疗。局限性仅在1个3期brodalumab研究中可以评估再治疗。结论就免疫原性和重新治疗后高的药效回收率而言，Brodalumab与其他生物制剂相比具有优势。≥90％的患者在再治疗的第8周恢复了反应。Brodalumab的超敏反应发生率低于安慰剂。注射部位反应发生在1.8％的Brodalumab治疗患者中，而2％的患者使用ustekinumab治疗。局限性仅在1个3期brodalumab研究中可以评估再治疗。结论就免疫原性和重新治疗后高的药效回收率而言，Brodalumab与其他生物制剂相比具有优势。