Background

Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.

Objective

To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.

Methods

The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.

Results

Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5).

Limitations

Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.

Conclusion

Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.

中文翻译：

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九种牛皮癣全身药物的长期安全性：一项队列研究，使用西班牙皮肤病生物治疗不良事件注册中心（BIOBADADERM）进行注册。

背景

注册表研究需要广泛描述全身性药物治疗牛皮癣的安全性。

目的

描述用于治疗中度至重度银屑病的全身用药物阿维A，阿达木单抗，阿米司特，环孢菌素，依那西普，英夫利昔单抗，甲氨蝶呤，苏金单抗和乌斯他单抗的全身性安全性研究结果皮肤病（BIOBADADERM）注册表。

方法

以甲氨蝶呤为参照，通过前瞻性队列研究确定每种药物的不良反应的发生率比（IRR）和调整后的IRR（包括倾向评分）。

结果

我们的研究包括2845名患者（8954个治疗周期； 9642个患者-年）。在几种系统器官类别中，乌斯妥单抗和苏金单抗的不良事件发生率最低，具有统计学上显着的比率下降（IRR <1），而环孢素和英夫利昔单抗最高，比率上升（IRR≥5） ）。

局限性

观察性研究，药物分配未随机分配，易感人群耗竭，未指定处方剂量。

结论

我们的数据提供了现实生活中的比较安全性信息，可以帮助临床医生在可用产品之间进行选择。