▎WuXiEdited by Kant Content Team

Recently, Novartis announced the latest long-term efficacy data from the pivotal Phase 3 REMIX-1 and REMIX-2 trials, which evaluated its investigational Bruton's tyrosine kinase (BTK) inhibitor remibrutinib in patients with chronic spontaneous urticaria (CSU) whose symptoms were not adequately controlled by H1 antihistamines.Analysis shows that patients' CSU symptoms improved as early as one week after starting remibrutinib treatment and continued to improve up to 52 weeks.Novartis plans to begin submitting remibrutinib for CSU approval applications to global regulatory authorities in the second half of 2024, while continuing to evaluate the drug's potential in treating various immune-mediated diseases.

Chronic Spontaneous Urticaria: A Severe and Unpredictable Skin ConditionChronic spontaneous urticaria (CSU) is a severe and unpredictable skin condition that affects 0.5-1% of the global population. It is characterized by the appearance of itchy, painful hives, and/or swelling, lasting for at least six weeks, with an unknown cause. Due to the severity and unpredictability of CSU, it significantly impacts patients' quality of life. H1 antihistamines are the first-line treatment for CSU; however, approximately 60% of patients experience poor symptom control with antihistamines alone, with CSU symptoms persisting despite medication. Bruton’s tyrosine kinase (BTK) is a key enzyme in histamine release, playing a critical role in the debilitating symptoms associated with CSU when spontaneously activated.

The latest Phase 3 REMIX-1 and REMIX-2 long-term data assessed at Week 52 of the trial show:

• As with the data from Week 12, at Week 24, remibrutinib significantly improved patient symptoms compared to placebo, including improvements in the weekly Urticaria Activity Score (UAS7), weekly Itch Severity Score (ISS7), and weekly Hives Severity Score (HSS7).

• At week 24, patients receiving placebo switched to receive remibrutinib treatment;Patients observed disease relief as early as the first week after switching medications, which persisted until the end of the study (28 weeks of treatment).

• According to the evaluation in Week 52,Nearly half of the patients were completely free of itching and urticaria symptoms (UAS7=0).

  
  

• Remibrutinib was well tolerated and demonstrated favorable and consistent safety profiles over a period of up to 52 weeks.

▲RMolecular structure of emibrutinib (Source: PubChem)

References:

[1] Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria. Retrieved May 31, 2024 from https://www.globenewswire.com/news-release/2024/05/30/2891212/0/en/Novartis-Phase-III-data-confirm-sustained-efficacy-and-long-term-safety-of-oral-remibrutinib-in-chronic-spontaneous-urticaria.html

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