Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme.

Silvio Danese, Axel Dignass, Katsuyoshi Matsuoka, Marc Ferrante, Millie Long, Isabel Redondo, Richard Moses, Sebastian Maier, Theresa Hunter Gibble, Nathan Morris, Catherine Milch, Maria T Abreu
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Abstract

Background and aims: Ulcerative colitis [UC], a chronic inflammatory bowel disease, may manifest with symptoms of increased stool frequency [SF], rectal bleeding [RB], bowel urgency [BU], abdominal pain [AP], and fatigue. Mirikizumab, an anti-IL-23p19 antibody, demonstrated efficacy and safety in patients with moderately to severely active UC in the LUCENT Phase 3 trials. We evaluated mirikizumab's efficacy in achieving symptom control and time to symptom improvement during induction, maintenance of sustained symptom control, 'comprehensive symptom control', defined according to a combination of individual patient-reported outcomes, and prognostic baseline indicators of early symptomatic remission at Week 4.

Methods: The results of LUCENT-1/-2 have previously been reported. Treatment differences for symptomatic endpoints were compared over 52 weeks versus placebo [PBO] and comprehensive symptomatic endpoints at 12 and 52 weeks of continuous treatment. Subgroup analyses were conducted for prior biologic or tofacitinib treatment failure. Prognostic analyses were run using regression analysis.

Results: By Week [W] 2, mirikizumab-treated patients achieved greater reductions in SF, RB, BU, and fatigue versus PBO. At W4, there was a higher rate of AP improvement. At W12, a greater proportion of mirikizumab-treated patients achieved symptomatic remission, RB remission, SF remission, and BU remission/clinically meaningful improvement. Mirikizumab-treated patients sustained symptom control versus placebo patients in maintenance until W52. This treatment effect was shown in patients regardless of prior biologic or tofacitinib failure. Additionally, mirikizumab achieved comprehensive symptom control versus PBO at W12 and W52.

Conclusions: Mirikizumab demonstrated efficacy in achieving and sustaining symptom control and comprehensive symptom control over 52 weeks [NCT03518086; NCT03524092].

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LUCENT项目3期中,米利珠单抗对溃疡性结肠炎患者的早期和持续症状控制。
背景和目的:溃疡性结肠炎(UC)是一种慢性炎症性肠病,可表现为大便次数增多(SF)、直肠出血(RB)、肠紧迫感(BU)、腹痛(AP)和疲劳等症状。米利珠单抗是一种抗IL-23p19抗体,在LUCENT 3期试验中,它对中度至重度活动性UC患者的疗效和安全性都得到了证实。我们评估了米利珠单抗在诱导期间实现症状控制和症状改善时间、维持持续症状控制、"综合症状控制"(根据患者个人报告结果和第4周早期症状缓解的预后基线指标综合定义)方面的疗效:LUCENT-1/-2的研究结果已在之前报道过。比较了52周症状终点与安慰剂(PBO)的治疗差异,以及连续治疗12周和52周的综合症状终点。对既往生物制剂或托法替尼治疗失败者进行了分组分析。采用回归分析法进行预后分析:到第2周时,米利珠单抗治疗患者的SF、RB、BU和疲劳感较PBO治疗患者有更大的降低。在第 4 周,AP 改善率更高。在 W12 期,更多的 Mirikizumab 治疗患者实现了症状缓解、RB 缓解、SF 缓解和 BU 缓解/有临床意义的改善。与安慰剂患者相比,接受米利珠单抗治疗的患者在维持治疗到第52天时症状得到了控制。无论患者之前是否服用生物制剂或托法替尼失败,都能显示出这种治疗效果。此外,在第12个月和第52个月时,米利珠单抗与安慰剂相比实现了全面的症状控制:结论:米利珠单抗在实现和维持症状控制以及综合症状控制52周方面具有疗效。[NCT03518086;NCT03524092]。
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