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经典和生物系统性疗法治疗老年银屑病的安全性:一项来自国家BIOBADADERM注册研究的观察性研究

Safety of classic and biologic systemic therapies for the treatment of psoriasis in elderly: an observational study from national BIOBADADERM registry.

作者信息

Medina C, Carretero G, Ferrandiz C, Dauden E, Vanaclocha F, Gómez-García F J, Herrera-Ceballos E, De la Cueva-Dobao P, Belinchón I, Sánchez-Carazo J L, Alsina M, López-Estebaranz J L, Ferrán M, Carrascosa J M, Torrado R, Argila D, Rivera R, Jiménez-Puya R, García-Doval I

机构信息

Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain.

出版信息

J Eur Acad Dermatol Venereol. 2015 May;29(5):858-64. doi: 10.1111/jdv.12688. Epub 2014 Sep 3.

Abstract

BACKGROUND

Psoriasis patients over 65 years-old (elderly) constitute a growing group, underrepresented in clinical trials, and likely to be more prone to adverse events.

OBJECTIVE

To describe safety of systemic psoriasis therapy in patients over 65 years-old compared to younger patients.

METHODS

Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were grouped in elderly (≥ 65 years old) and younger patients. Rates of adverse events were described by severity and type, and the risks compared in both groups, taking into account exposure to classic or biologic drugs, using Cox regression.

RESULTS

175 (9.8%) of 1793 patients were elderly. Overall risk of adverse events was not higher in elderly (drug group adjusted HR 1.09 (95%CI: 0.93-1.3)). Serious adverse events were more common in elderly (drug group adjusted HR 3.2 (95%CI: 2.0-5.1)). Age adjusted HR of all adverse events was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR 0.7 (95%CI: 0.6-0.7)). Age did not seem to modify the effect of therapy (biologic vs. classic) in the risk of adverse events (likelihood ratio test for interaction, p = 0.12 for all adverse events, p = 0-09 for serious adverse events).

CONCLUSIONS

Serious adverse events are more common in elderly patients, although they may be related to other variants that are associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk of adverse events in the whole group. We found no differences in this association between young and elderly. These results are reassuring, although uncontrolled confounding could not be excluded as an explanation for these findings, and the power of the study to detect differences was low.

摘要

背景

65岁以上的银屑病患者(老年人)群体日益壮大,但在临床试验中代表性不足,且可能更易发生不良事件。

目的

描述65岁以上患者与年轻患者相比,系统性银屑病治疗的安全性。

方法

纳入西班牙全国性系统性治疗银屑病患者登记数据库Biobadaderm中的患者,分为老年组(≥65岁)和年轻组。按严重程度和类型描述不良事件发生率,并使用Cox回归比较两组风险,同时考虑经典药物或生物制剂的使用情况。

结果

1793例患者中有175例(9.8%)为老年人。老年人不良事件的总体风险并不更高(药物组校正后风险比为1.09(95%置信区间:0.93 - 1.3))。严重不良事件在老年人中更为常见(药物组校正后风险比为3.2(95%置信区间:2.0 - 5.1))。在整个样本中,与经典药物相比,使用生物制剂的患者所有不良事件的年龄校正后风险比更低(风险比为0.7(95%置信区间:0.6 - 0.7))。年龄似乎并未改变治疗方式(生物制剂与经典药物)对不良事件风险的影响(交互作用似然比检验,所有不良事件p = 0.12,严重不良事件p = 0.09)。

结论

严重不良事件在老年患者中更为常见,尽管这可能与该年龄组相关的其他因素有关,而非治疗本身所致。在整个群体中,使用生物制剂与较低的不良事件风险相关。我们未发现年轻组和老年组在这方面存在差异。尽管不能排除未控制的混杂因素作为这些结果的解释,且研究检测差异的效能较低,但这些结果令人安心。

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