In pivotal Phase III trials, remibrutinib – a highly selective, oral Bruton’s tyrosine kinase inhibitor – demonstrated clinically meaningful and statistically significant reduction in urticaria activity vs placebo1 Treatment with remibrutinib led to significant improvement in symptom control, as early as Week 2 and sustained up to Week 121 Remibrutinib was well-tolerated and demonstrated a favorable safety profile with rates of overall adverse events comparable to placebo and balanced liver function tests across both studies1 REMIX-1 and REMIX-2 studies are ongoing, with final (52-week) readout and regulatory submissions in 2024 Basel, November 9, 2023 — Novartis today announced new positive data from the Phase III REMIX-1 and REMIX-2 studies investigating remibrutinib – a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor – in people with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines1.

在关键的III期临床试验中，remibrutinib是一种高度选择性的口服Bruton酪氨酸激酶抑制剂，与安慰剂相比，remibrutinib治疗荨麻疹活性具有临床意义和统计学意义，可显着改善症状控制，早在第2周并持续至第121周，瑞米布鲁替尼耐受性良好，并显示出良好的安全性，总体不良事件发生率与安慰剂相当，并且两项研究的平衡肝功能检查1 REMIX-1和REMIX-2研究正在进行中，最终（52周）读数和监管提交于2024年巴塞尔，11月9日，2023年-诺华今天宣布了来自III期REMIX-1和REMIX-2研究的新的阳性数据，这些研究调查了remibrutinib-一种高度选择性的口服布鲁顿酪氨酸激酶（BTK）抑制剂-用于慢性自发性荨麻疹（CSU）患者，其症状不足由H1-抗组胺药控制1。

In the studies, remibrutinib met all primary and secondary endpoints at Week 121. Remibrutinib demonstrated superiority in change from baseline vs placebo in weekly urticaria activity (UAS7), itch (ISS7) and hives (HSS7) at Week 121. Significantly more patients achieved well-controlled disease (UAS7≤6) with remibrutinib vs placebo, as early as Week 2 which was sustained at Week 12, and about one third of patients achieved complete absence of itch and hives at Week 121.

在研究中，remibrutinib在第121周达到了所有主要和次要终点。Remibrutinib在第121周的每周荨麻疹活动（UAS7），瘙痒（ISS7）和荨麻疹（HSS7）中表现出优于基线与安慰剂的变化。早在第12周持续的第2周，瑞米替尼与安慰剂相比，显着更多的患者获得了良好控制的疾病（UAS7≤6），并且在第121周时约三分之一的患者完全没有瘙痒和荨麻疹。

Data are being presented at the 2023 American College of Allergy, Asthma and Immunology Scientific Meeting in Anaheim, California, November 9–13. “These findings could be significant for the millions of people who suffer from CSU and are still symptomatic,” said Marcus Maurer, M.D., Professor of Dermatology and Allergy, Executive Director of the Institute .

数据正在11月9日至13日在加利福尼亚州阿纳海姆举行的2023年美国过敏，哮喘和免疫学科学会议上公布。该研究所执行主任皮肤病与过敏教授Marcus Maurer博士说：“这些发现对于数百万患有CSU并且仍然有症状的人来说可能是重要的。