Background

Long-term safety of topical calcineurin inhibitors is not well understood. APPLES (A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis; NCT00475605) examined incidence of lymphoma and other cancers in a pediatric population with atopic dermatitis.

Objective

To quantify incident malignancies during 10 years in children with atopic dermatitis who used topical tacrolimus for ≥6 weeks.

Methods

Standardized incidence ratios for cancer events were analyzed relative to sex-, age-, and race-matched control data from national cancer registries.

Results

There were 7954 eligible patients enrolled at 314 sites in 9 countries. During 44,629 person-years, 6 confirmed incident cancers occurred (standardized incidence ratio, 1.01; 95% confidence interval, 0.37-2.20). No lymphomas occurred.

Limitations

Observational prospective cohort study.

Conclusion

The cancer incidence was as expected, given matched background data. This finding provides no support for the hypothesis that topical tacrolimus increases long-term cancer risk in children with atopic dermatitis.

中文翻译：

---

使用局部他克莫司治疗特应性皮炎的儿童中没有增加癌症发生率的证据。

背景

局部钙调神经磷酸酶抑制剂的长期安全性尚不清楚。APPLES（评估他克莫司软膏治疗特应性皮炎的长期安全性的前瞻性儿科纵向评估； NCT00475605）检查了特应性皮炎儿科人群中淋巴瘤和其他癌症的发生率。

目的

定量使用局部他克莫司≥6周的特应性皮炎患儿在10年内发生的恶性肿瘤。

方法

相对于来自国家癌症登记机构的性别，年龄和种族匹配的对照数据，分析了癌症事件的标准发生率。

结果

在9个国家/地区的314个地点招募了7954名合格患者。在44,629人年期间，发生了6例确诊的癌症事件（标准发生率，1.01； 95％置信区间，0.37-2.20）。无淋巴瘤发生。

局限性

观察性前瞻性队列研究。

结论

给定匹配的背景数据，癌症发生率符合预期。这一发现不支持以下观点，即他克莫司局部使用会增加特应性皮炎患儿的长期癌症风险。