乌司奴单抗治疗克罗恩病的长期疗效与抗肿瘤坏死因子药物相当。

Long-term effectiveness of ustekinumab comparable to antitumor necrosis factor agents in patients with Crohn's disease.

机构信息

Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.

Department of Health Administration and Policy, Tohoku University Graduate School of Medicine, Sendai, Japan.

出版信息

J Gastroenterol Hepatol. 2022 Nov;37(11):2105-2112. doi: 10.1111/jgh.15992. Epub 2022 Sep 16.

BACKGROUND

Ustekinumab (UST), an antibody against the p40 subunit of interleukin-12/23, has been proven to be effective in patients with Crohn's disease (CD). However, large, long-term comparative studies of UST against anti--tumor necrosis factor (TNF) agents are lacking. We compared the effectiveness of anti-TNF agents and UST in CD patients without prior use of biologics.

METHODS

We used a large nationwide anonymized Japanese database containing administrative medical claims data and various related patient data. In a propensity score-matched cohort with similar clinical characteristics, 2-year effectiveness was compared between patients treated with infliximab or adalimumab (anti-TNF group) and those treated with UST (UST group). Primary outcomes were cumulative rates of hospitalization, surgery, and persistence.

RESULTS

Among 53 540 CD patients, 7047 were extracted for eligibility, of which 5665 were treated with an anti-TNF agent and 1382 with UST. After propensity score matching, the cumulative hospitalization rates were comparable between anti-TNF and UST groups (P = 0.85; 25.3% vs 26.5% at 1 year, 33.8% vs 39.8% at 2 years). The cumulative surgery rates were also comparable between these groups (P = 0.46; 5.5% vs 5.1% at 1 year, 8.3% vs 8.4% at 2 years). The persistence rate at 1 year was higher in UST group (90.8% vs 92.5%), and that at 2 years was higher in anti-TNF group (81.2% and 74.6%); however, there was no significant difference in the cumulative persistence rate (P = 0.55).

CONCLUSIONS

Anti-TNF agents and UST appear to have comparable effectiveness for CD patients without prior use of biologics.

背景

乌司奴单抗（UST）是一种针对白细胞介素-12/23 的 p40 亚单位的抗体，已被证明对克罗恩病（CD）患者有效。然而，缺乏针对 CD 患者在使用生物制剂前使用 UST 与抗肿瘤坏死因子（TNF）药物的大型长期对比研究。我们比较了无生物制剂使用史的 CD 患者中抗 TNF 药物和 UST 的有效性。

方法

我们使用了一个包含管理医疗索赔数据和各种相关患者数据的大型全国性匿名日本数据库。在具有相似临床特征的倾向评分匹配队列中，比较了接受英夫利昔单抗或阿达木单抗（抗 TNF 组）和 UST（UST 组）治疗的患者的 2 年疗效。主要结局是住院、手术和持续治疗的累积率。

结果

在 53540 例 CD 患者中，有 7047 例符合入选条件，其中 5665 例接受抗 TNF 药物治疗，1382 例接受 UST 治疗。经过倾向评分匹配后，抗 TNF 组和 UST 组的累积住院率无差异（P=0.85；1 年时为 25.3%比 26.5%，2 年时为 33.8%比 39.8%）。两组的累积手术率也无差异（P=0.46；1 年时为 5.5%比 5.1%，2 年时为 8.3%比 8.4%）。1 年时 UST 组的持续治疗率较高（90.8%比 92.5%），2 年时抗 TNF 组的持续治疗率较高（81.2%和 74.6%）；然而，累积持续治疗率无显著差异（P=0.55）。