Abstract：
BACKGROUND: This study investigated the safety and effectiveness of ustekinumab (UST) in Korean patients with Crohn\'s disease (CD).
METHODS: Adult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn\'s Disease patients treated with STelARa) study between April 2018 and April 2022. Both the clinical effectiveness and adverse effects of UST therapy were analyzed. Missing data were handled using nonresponder imputation (ClinicalTrials.gov Identifier: NCT03942120).
RESULTS: Of the 464 patients enrolled from 44 hospitals across Korea, 457 and 428 patients (Crohn\'s disease activity index ≥150) were included in the safety analysis and effectiveness analysis sets, respectively. At weeks 16 to 20 after initiating UST, clinical response, clinical remission, and corticosteroid-free remission rates were 75.0% (321 of 428), 64.0% (274 of 428), and 61.9% (265 of 428), respectively. At week 52 to 66, clinical response, clinical remission, and corticosteroid-free remission rates were 62.4% (267 of 428), 52.6% (225 of 428), and 50.0% (214 of 428), respectively. Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171 of 428) and 41.6% (178 of 428) at week 16 to 20 and week 52 to 66, respectively. Biologic-naïve patients exhibited significantly higher rates of combined effectiveness than biologic-experienced patients (50.3% vs 30.7% at week 16-20, P < .001; 47.7% vs 36.0% at week 52-66, P = .014). No additional benefits were observed with the concomitant use of immunomodulators. Ileal location was independently associated with a higher probability of clinical remission compared with colonic or ileocolonic location at week 52 to 66. Adverse and serious adverse events were observed in 28.2% (129 of 457) and 12.7% (58 of 457), respectively, with no new safety signal associated with UST treatment.
CONCLUSIONS: Ustekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea.
Ustekinumab was well-tolerated and safe for Koran patients with Crohn’s disease with no new safety signal as induction and maintenance therapy. Biologic-naïve patients exhibited better effectiveness outcomes, whereas combination therapy with immunomodulators was not superior to ustekinumab monotherapy.
METHODS: Adult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn\'s Disease patients treated with STelARa) study between April 2018 and April 2022. Both the clinical effectiveness and adverse effects of UST therapy were analyzed. Missing data were handled using nonresponder imputation (ClinicalTrials.gov Identifier: NCT03942120).
RESULTS: Of the 464 patients enrolled from 44 hospitals across Korea, 457 and 428 patients (Crohn\'s disease activity index ≥150) were included in the safety analysis and effectiveness analysis sets, respectively. At weeks 16 to 20 after initiating UST, clinical response, clinical remission, and corticosteroid-free remission rates were 75.0% (321 of 428), 64.0% (274 of 428), and 61.9% (265 of 428), respectively. At week 52 to 66, clinical response, clinical remission, and corticosteroid-free remission rates were 62.4% (267 of 428), 52.6% (225 of 428), and 50.0% (214 of 428), respectively. Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171 of 428) and 41.6% (178 of 428) at week 16 to 20 and week 52 to 66, respectively. Biologic-naïve patients exhibited significantly higher rates of combined effectiveness than biologic-experienced patients (50.3% vs 30.7% at week 16-20, P < .001; 47.7% vs 36.0% at week 52-66, P = .014). No additional benefits were observed with the concomitant use of immunomodulators. Ileal location was independently associated with a higher probability of clinical remission compared with colonic or ileocolonic location at week 52 to 66. Adverse and serious adverse events were observed in 28.2% (129 of 457) and 12.7% (58 of 457), respectively, with no new safety signal associated with UST treatment.
CONCLUSIONS: Ustekinumab was well-tolerated, effective, and safe as induction and maintenance therapy for CD in Korea.
Ustekinumab was well-tolerated and safe for Koran patients with Crohn’s disease with no new safety signal as induction and maintenance therapy. Biologic-naïve patients exhibited better effectiveness outcomes, whereas combination therapy with immunomodulators was not superior to ustekinumab monotherapy.
摘要：
背景：这项研究调查了ustekinumab（UST）在韩国克罗恩病（CD）患者中的安全性和有效性。
方法：2018年4月至2022年4月，前瞻性纳入接受UST治疗的成人CD患者（接受STelARa治疗的克罗恩病患者的标记后监测）研究。分析UST治疗的临床疗效和不良反应。缺失的数据使用无应答者插补处理(ClinicalTrials.gov标识符:NCT03942120)。
结果：在来自韩国44家医院的464名患者中，457和428名患者（克罗恩病活动指数≥150）被纳入安全性分析和有效性分析集，分别。在启动UST后第16至20周，临床反应，临床缓解，无皮质类固醇缓解率为75.0%(321/428)，64.0%（428人中的274人），和61.9%(428人中的265人)，分别。在第52到66周，临床反应，临床缓解，无皮质类固醇的缓解率为62.4%(428例中的267例)，52.6%（428个中的225个），和50.0%（428个中的214个），分别。在第16周至第20周和第52周至第66周，综合有效性（临床反应+生化反应）分别为40.0％（428中的171）和41.6％（428中的178）。未接受生物治疗的患者的综合有效率明显高于接受生物治疗的患者（16-20周为50.3%vs30.7%，P<.001；52-66周为47.7%vs36.0%，P=.014）。伴随使用免疫调节剂没有观察到额外的益处。与第52至66周的结肠或回肠结肠位置相比，回肠位置与更高的临床缓解概率独立相关。不良和严重不良事件分别为28.2%(457个中的129个)和12.7%(457个中的58个)。分别,没有与UST治疗相关的新安全信号。
结论：Ustekinumab耐受性良好，有效,在韩国作为CD的诱导和维持治疗是安全的。
Ustekinumab对患有克罗恩病的可兰经患者具有良好的耐受性和安全性，没有新的安全信号作为诱导和维持治疗。未接受生物治疗的患者表现出更好的疗效，而免疫调节剂联合治疗并不优于ustekinumab单药治疗.
方法：2018年4月至2022年4月，前瞻性纳入接受UST治疗的成人CD患者（接受STelARa治疗的克罗恩病患者的标记后监测）研究。分析UST治疗的临床疗效和不良反应。缺失的数据使用无应答者插补处理(ClinicalTrials.gov标识符:NCT03942120)。
结果：在来自韩国44家医院的464名患者中，457和428名患者（克罗恩病活动指数≥150）被纳入安全性分析和有效性分析集，分别。在启动UST后第16至20周，临床反应，临床缓解，无皮质类固醇缓解率为75.0%(321/428)，64.0%（428人中的274人），和61.9%(428人中的265人)，分别。在第52到66周，临床反应，临床缓解，无皮质类固醇的缓解率为62.4%(428例中的267例)，52.6%（428个中的225个），和50.0%（428个中的214个），分别。在第16周至第20周和第52周至第66周，综合有效性（临床反应+生化反应）分别为40.0％（428中的171）和41.6％（428中的178）。未接受生物治疗的患者的综合有效率明显高于接受生物治疗的患者（16-20周为50.3%vs30.7%，P<.001；52-66周为47.7%vs36.0%，P=.014）。伴随使用免疫调节剂没有观察到额外的益处。与第52至66周的结肠或回肠结肠位置相比，回肠位置与更高的临床缓解概率独立相关。不良和严重不良事件分别为28.2%(457个中的129个)和12.7%(457个中的58个)。分别,没有与UST治疗相关的新安全信号。
结论：Ustekinumab耐受性良好，有效,在韩国作为CD的诱导和维持治疗是安全的。
Ustekinumab对患有克罗恩病的可兰经患者具有良好的耐受性和安全性，没有新的安全信号作为诱导和维持治疗。未接受生物治疗的患者表现出更好的疗效，而免疫调节剂联合治疗并不优于ustekinumab单药治疗.
