溃疡性结肠炎患者使用优特克单抗和阿达木单抗的真实世界维持期持续性研究

Real-World Maintenance Phase Persistence on Ustekinumab and Adalimumab in Ulcerative Colitis.

作者信息

Zhdanava Maryia, Kachroo Sumesh, Shah Aditi, Ding Zhijie, Lefebvre Patrick, Zhao Ruizhi, Kerner Caroline, Pilon Dominic

机构信息

Analysis Group, Inc, Montréal, QC, Canada.

Janssen Scientific Affairs, LLC, Horsham, PA, USA.

出版信息

Patient Prefer Adherence. 2024 Apr 10;18:809-820. doi: 10.2147/PPA.S446861. eCollection 2024.

PURPOSE

To describe real-world persistence in bio-naïve and bio-experienced adults with ulcerative colitis (UC) treated with ustekinumab, a recently approved anti-interleukin 12/23 antibody, or adalimumab, an anti-TNF biologic.

METHODS

This is a descriptive, retrospective cohort study. Patients initiating ustekinumab or adalimumab (index date, between 10/21/2019 and 08/13/2021) were selected from the Komodo Health comprehensive dataset and stratified into bio-naïve and bio-experienced subgroups based on biologic use 12 months pre-index date. Endpoints evaluated at 12-months after maintenance phase start using Kaplan-Meier analysis included 1) persistence; 2) persistence while being corticosteroid-free (<14 consecutive days of corticosteroid supply after day 90 post-index); and, 3) persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies).

RESULTS

Ustekinumab cohort included 778 patients (236 bio-naïve, 542 bio-experienced) and adalimumab cohort included 1693 patients (1517 bio-naive, 176 bio-experienced). At 12 months after maintenance phase start, 75.5% and 50.5% of bio-naïve patients persisted on ustekinumab and adalimumab and 72.3% and 56.9% of bio-experienced patients persisted on ustekinumab and adalimumab, respectively. Further, 55.1% and 38.2% of bio-naïve patients were persistent and corticosteroid-free with ustekinumab and adalimumab; 43.7% and 33.4% of bio-experienced patients were persistent and corticosteroid-free with ustekinumab and adalimumab, respectively. Moreover, 68.1% and 44.5% of bio-naïve patients were persistent and on monotherapy with ustekinumab and adalimumab; 61.6% and 47.9% of bio-experienced patients were persistent and on monotherapy with ustekinumab and adalimumab, respectively.

CONCLUSION

At 12 months after maintenance phase start, patients with UC treated with ustekinumab had numerically higher persistence, including persistence while corticosteroid-free and persistence while on monotherapy, than patients treated with adalimumab.

目的

描述初治生物制剂和曾接受生物制剂治疗的成年溃疡性结肠炎（UC）患者使用乌司奴单抗（一种最近获批的抗白细胞介素12/23抗体）或阿达木单抗（一种抗TNF生物制剂）治疗后的真实世界持续治疗情况。

方法

这是一项描述性回顾性队列研究。从Komodo Health综合数据集中选取在2019年10月21日至2021年8月13日期间开始使用乌司奴单抗或阿达木单抗的患者（索引日期），并根据索引日期前12个月的生物制剂使用情况分为初治生物制剂组和曾接受生物制剂治疗组。使用Kaplan-Meier分析在维持期开始后12个月评估的终点包括：1）持续治疗；2）在无糖皮质激素情况下的持续治疗（索引日期后90天起连续使用糖皮质激素少于14天）；3）单药治疗时的持续治疗（未使用免疫调节剂/非索引生物制剂/高级疗法）。

结果

乌司奴单抗队列包括778例患者（236例初治生物制剂患者，542例曾接受生物制剂治疗患者），阿达木单抗队列包括1693例患者（1517例初治生物制剂患者，176例曾接受生物制剂治疗患者）。在维持期开始后12个月，初治生物制剂组中分别有75.5%和50.5%的患者持续使用乌司奴单抗和阿达木单抗，曾接受生物制剂治疗组中分别有72.3%和56.9%的患者持续使用乌司奴单抗和阿达木单抗。此外，初治生物制剂组中分别有55.1%和38.2%的患者持续治疗且无糖皮质激素使用，曾接受生物制剂治疗组中分别有43.7%和33.4%的患者持续治疗且无糖皮质激素使用。此外（此处原文有误，应为而且）初治生物制剂组中分别有68.1%和44.5%的患者持续治疗且单药使用乌司奴单抗和阿达木单抗，曾接受生物制剂治疗组中分别有61.6%和47.9%的患者持续治疗且单药使用乌司奴单抗和阿达木单抗。