The Safety Profiles of Adalimumab, Infliximab, Etanercept, Secukinumab and Ustekinumab in Psoriasis - A 30-month Observational Cohort Prospective Study of Adverse Events in Biologic Therapy.

Zoltán Paluch, Emanuel Marques, Petr Boháč, Kateřina Zemková, Jana Hercogová
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Abstract

Background: Although biologic agents are very effective, long-term comparative studies demonstrating their safety relative to one another are still lacking.

Methods: A total of 124 patients with psoriasis were followed up for 30 months; 74 received anti-TNF-alpha inhibitors (adalimumab, etanercept, infliximab), 33 were on ustekinumab, and 17 were treated with secukinumab. The rates of adverse events in these groups were recorded and statistically analyzed.

Results: Infliximab-treated patients showed a high occurrence of asymptomatic, but increased liver enzymes, fatigue, and respiratory as well as dermatologic infections. Adalimumab-treated patients were more often affected by musculoskeletal disorders and infections of all types. Patients treated with secukinumab presented with higher rates of cardiovascular disorders as well as respiratory and dermatologic infections. The group receiving etanercept was more often diagnosed with musculoskeletal and reproductive disorders, specifically menstrual disorders. The rates of therapy discontinuation and serious adverse events did not reach statistically significant values.

Conclusion: A higher incidence of adverse events was observed among adalimumab-, and infliximab-treated patients, with ustekinumab found to have the safest profile. Our results demonstrate that a personalized approach, including evaluation of a patient's risk profile, is necessary before commencing a biologic. Further research is warranted to confirm the findings of our study.

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阿达木单抗(Adalimumab)、英夫利昔单抗(Infliximab)、依那西普(Etanercept)、塞库单抗(Secukinumab)和优思库单抗(Ustekinumab)治疗银屑病的安全性概况--一项为期 30 个月的生物疗法不良事件观察性队列前瞻性研究。
背景:尽管生物制剂非常有效,但仍缺乏证明其安全性的长期比较研究:尽管生物制剂非常有效,但目前仍缺乏证明其安全性的长期比较研究:对124名银屑病患者进行了为期30个月的随访,其中74人接受了抗肿瘤坏死因子α抑制剂(阿达木单抗、依那西普、英夫利昔单抗)治疗,33人接受了乌斯特库单抗治疗,17人接受了赛库单抗治疗。对这些组别的不良反应发生率进行了记录和统计分析:结果:接受英夫利西单抗治疗的患者出现无症状但肝酶升高、疲劳、呼吸道感染和皮肤感染的比例较高。接受阿达木单抗治疗的患者更常见肌肉骨骼疾病和各类感染。接受secukinumab治疗的患者出现心血管疾病以及呼吸道和皮肤感染的比例较高。接受依那西普治疗的患者更常被诊断出患有肌肉骨骼和生殖系统疾病,尤其是月经失调。治疗中断率和严重不良事件发生率未达到统计学意义上的显著值:阿达木单抗和英夫利昔单抗治疗患者的不良反应发生率较高,而乌司替尼的安全性最高。我们的研究结果表明,在开始使用生物制剂之前,有必要采取个性化的方法,包括评估患者的风险状况。为了证实我们的研究结果,有必要开展进一步的研究。
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