Boston Collaborative Drug Surveillance Program, 11 Muzzey Street, Lexington, MA, 02421, USA.
Amgen Inc., Thousand Oaks, CA, USA.
Drug Saf. 2022 Nov;45(11):1403-1411. doi: 10.1007/s40264-022-01235-7. Epub 2022 Sep 23.
This real-world safety analysis was requested by the European Medicines Agency following approval of apremilast, an oral treatment for psoriasis or psoriatic arthritis.
We aimed to compare incidence rates of adverse events of special interest identified a priori, in patients receiving apremilast with those receiving other systemic treatments for psoriasis or psoriatic arthritis.
This 5-year cohort study was conducted in Clinical Practice Research Datalink GOLD between January 2015 and June 2020. Incidence rates of adverse events of special interest were estimated for four matched cohorts: apremilast-exposed and three matched non-apremilast cohorts (oral only, injectable only, and oral and injectable psoriasis or psoriatic arthritis treatments).
The apremilast-exposed cohort included 341 patients and the three non-apremilast cohorts included 4981 patients. There were no incident cases of vasculitis, hematologic malignancy, non-melanoma skin malignancy, treated depression, treated anxiety, or suicidal behaviors in the apremilast-exposed cohort during the follow-up. Similar incidence rates of all-cause mortality, major adverse cardiac events, tachyarrhythmias, and solid malignancies were recorded in the apremilast and non-apremilast cohorts. The incidence rate (95% confidence interval) per 1000 person-years of opportunistic and serious infections in the apremilast-exposed cohort (64 [40-102])) was similar to incidence rates in the oral (50 [42-60]) and oral and injectable non-apremilast cohorts (57 [47-69]), while the incidence rates were lower in the injectable treatment-only cohort (20 [10-41]). Limitations include small numbers of apremilast-exposed patients and potential exposure misclassification partly owing to missing information on biologic and other specialty treatment use.
No new apremilast safety signals were identified in this study. These results provide evidence that the long-term safety of apremilast in psoriasis and psoriatic arthritis in a real-world setting is comparable to that reported in clinical trials.
在批准阿普米司特（一种用于治疗银屑病或银屑病关节炎的口服药物）后，应欧洲药品管理局的要求进行了这项真实世界安全性分析。
我们旨在比较接受阿普米司特治疗与接受其他用于治疗银屑病或银屑病关节炎的全身治疗的患者中预先确定的特殊关注不良事件的发生率。
这项为期 5 年的队列研究于 2015 年 1 月至 2020 年 6 月在临床实践研究数据链接 GOLD 中进行。对于四个匹配队列，估计了特殊关注不良事件的发生率：阿普米司特暴露队列和三个非阿普米司特队列（仅口服、仅注射和口服和注射用于治疗银屑病或银屑病关节炎的药物）。
阿普米司特暴露队列包括 341 名患者，而三个非阿普米司特队列包括 4981 名患者。在随访期间，阿普米司特暴露队列中没有发生血管炎、血液恶性肿瘤、非黑色素瘤皮肤恶性肿瘤、治疗抑郁症、治疗焦虑症或自杀行为的病例。阿普米司特和非阿普米司特队列中记录了全因死亡率、主要不良心脏事件、心动过速和实体恶性肿瘤的相似发生率。阿普米司特暴露队列中机会性和严重感染的发生率（95%置信区间）为每 1000 人年 64 [40-102]）与口服（50 [42-60]）和口服和注射非阿普米司特队列（57 [47-69]）的发生率相似，而注射用单药治疗队列的发生率较低（20 [10-41]）。局限性包括阿普米司特暴露患者人数较少，并且由于缺乏关于生物制剂和其他专科治疗使用的信息，可能存在暴露分类错误。
本研究未发现阿普米司特的新安全性信号。这些结果提供了证据，表明在真实环境中使用阿普米司特治疗银屑病和银屑病关节炎的长期安全性与临床试验报告的安全性相当。
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