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生物制剂初治儿童银屑病患者的恶性肿瘤风险:美国索赔数据库中的回顾性队列研究。

The risk of malignancy among biologic-naïve pediatric psoriasis patients: A retrospective cohort study in a US claims database.

机构信息

Pfizer Inc, Collegeville, Pennsylvania; Evidera, Waltham, Massachusetts.

Pfizer Inc, Collegeville, Pennsylvania; Evidera, Waltham, Massachusetts.

出版信息

J Am Acad Dermatol. 2017 Aug;77(2):293-301.e1. doi: 10.1016/j.jaad.2017.03.044. Epub 2017 Jun 13.

DOI:10.1016/j.jaad.2017.03.044
PMID:28623045
Abstract

BACKGROUND

Little published literature exists regarding malignancy risk in pediatric psoriasis patients.

OBJECTIVE

To compare malignancy risk in biologic-naïve pediatric psoriasis patients with a matched pediatric population without psoriasis.

METHODS

This retrospective cohort study used IMS LifeLink Health Plan Claims data covering 1998-2008. Cancer incidence was compared with the US Surveillance, Epidemiology, and End Results (SEER) data using standardized incidence ratios (SIR), and between cohorts using Cox models.

RESULTS

Among 9045 pediatric psoriasis patients and 77,206 comparators, 18 probable or highly probable cancers were identified. Pediatric psoriasis patients had a nonsignificantly lower incidence than comparators (hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.05-3.54). The HR increased to 1.67 (95% CI 0.54-5.18) when cancer diagnosed during the first 90 days of follow-up was included. The pediatric psoriasis cohort had a significantly increased lymphoma rate compared with SEER (SIR 5.42, 95% CI 1.62-12.94), but no significant increase relative to the comparator cohort.

LIMITATIONS

Misclassification of disease and outcome might have occurred with patients in the claims database.

CONCLUSION

Patients with pediatric psoriasis showed no significant increase in overall cancer risk compared with those without psoriasis. A potential increased risk for lymphoma was observed when compared with the general population.

摘要

背景

关于儿童银屑病患者的恶性肿瘤风险,发表的文献很少。

目的

比较生物治疗初治的儿童银屑病患者与无银屑病的匹配儿科人群的恶性肿瘤风险。

方法

这项回顾性队列研究使用 IMS LifeLink 健康计划索赔数据,涵盖了 1998-2008 年。使用标准化发病率比(SIR)将癌症发病率与美国监测、流行病学和最终结果(SEER)数据进行比较,并使用 Cox 模型在队列之间进行比较。

结果

在 9045 名儿科银屑病患者和 77206 名对照者中,发现了 18 例可能或高度可能的癌症。与对照者相比,儿科银屑病患者的发病率显著降低(风险比 [HR] 0.43,95%置信区间 [CI] 0.05-3.54)。当包括随访前 90 天内诊断的癌症时,HR 增加至 1.67(95%CI 0.54-5.18)。与 SEER 相比,儿科银屑病队列的淋巴瘤发生率显著增加(SIR 5.42,95%CI 1.62-12.94),但与对照队列相比无显著增加。

局限性

在索赔数据库中的患者中可能发生了疾病和结局的错误分类。

结论

与无银屑病的患者相比,儿童银屑病患者的总体癌症风险无显著增加。与一般人群相比,观察到淋巴瘤的风险可能增加。

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