美国中重度银屑病生物制剂的真实世界剂量升级。

Real-world dose escalation of biologics for moderate-to-severe psoriasis in the United States.

机构信息

Department of Dermatology, University of Miami Miller School of Medicine, Miami, FL, USA.

AbbVie Inc, North Chicago, IL, USA.

出版信息

J Dermatolog Treat. 2023 Dec;34(1):2200869. doi: 10.1080/09546634.2023.2200869.

DOI:10.1080/09546634.2023.2200869

PMID:37025014

Abstract

AIM

To compare real-world dose escalation of risankizumab with other US Food and Drug Administration (FDA)-approved biologic treatments for management of moderate-to-severe psoriasis (PsO) in the United States.

METHODS

The Merative® MarketScan® Research Database was used to identify adults with ≥2 medical claims for PsO, ≥3 claims of the index biologic medication in the maintenance period, and ≥6 months continuous enrollment pre-induction and ≥6 months after initiation of the maintenance period. Dose escalation was defined as ≥2 dosing intervals where the average daily dose was ≥30% higher than the expected daily dose (per FDA-approved dosing). Comparisons between risankizumab and other cohorts were made using chi-square tests and logistic regression models.

RESULTS

At the 30% threshold, the percentage of patients with dose escalation in the full maintenance period was significantly lower with risankizumab (2.0%) compared with other drug classes (tumor necrosis factor, interleukin (IL)-12/23, IL-17, or other IL-23 inhibitors: 17.6%, 10.0%, 18.3%, or 7.1%, respectively; < 0.0001 for each) and individual biologics (adalimumab, ustekinumab, secukinumab, ixekizumab, and guselkumab; 17.9%, 10.0%, 15.7%, 18.0%, and 7.2%, respectively; < 0.0001).

CONCLUSION

A significantly lower proportion of risankizumab-treated patients with PsO had dose escalations compared with patients treated with other biologics.

摘要

目的

比较里莎鲁单抗与美国食品和药物管理局 (FDA) 批准的其他生物制剂治疗中重度银屑病 (PsO) 的真实世界剂量升级情况。

方法

使用 Merative® MarketScan® Research Database 确定≥2 次 PsO 医疗索赔、≥3 次维持期索引生物药物索赔且≥6 个月连续入组预诱导期和维持期开始后≥6 个月的≥2 次≥30%剂量高于预期日剂量（按 FDA 批准的剂量）的成年人。剂量升级定义为≥2 个剂量间隔，其中平均日剂量比预期日剂量（按 FDA 批准的剂量）高出≥30%。使用卡方检验和逻辑回归模型比较里莎鲁单抗与其他队列。

结果

在 30%的阈值下，里莎鲁单抗在整个维持期剂量升级的患者比例明显低于其他药物类别（肿瘤坏死因子、白细胞介素（IL）-12/23、IL-17 或其他 IL-23 抑制剂：17.6%、10.0%、18.3%或 7.1%； < 0.0001）和个别生物制剂（阿达木单抗、乌司奴单抗、司库奇尤单抗、依奇珠单抗和古塞库单抗：17.9%、10.0%、15.7%、18.0%和 7.2%； < 0.0001）。