Positive Phase III Results Emerge for Remibrutinib in Chronic Spontaneous Urticaria Treatment
USA: In a significant development for patients suffering from chronic spontaneous urticaria (CSU), Novartis has released promising Phase III trial data confirming the sustained efficacy and long-term safety of oral remibrutinib as a potential treatment option. This breakthrough offers hope to individuals grappling with the debilitating symptoms of CSU, which include recurrent hives and severe itching, by providing a novel therapeutic approach.
In the pivotal Phase III studies, REMIX-1 and REMIX-2, treatment with remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, showed significant symptom improvement early, which sustained up to Week 52 in CSU patients who remained symptomatic despite second-generation H1-antihistamine use.
These findings were presented at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Congress in Valencia, Spain, May 31–June.
“A large majority of people with CSU are living with uncontrolled and debilitating symptoms, often trying to manage the condition by cycling through antihistamines at higher doses with no lasting respite, impacting heavily on their day-to-day lives,” said Martin Metz, Professor of Dermatology, Charité – Universitätsmedizin Berlin, Germany.
“Remibrutinib has become an important investigational treatment for CSU as it blocks the BTK cascade and inhibits histamine release. These data show that remibrutinib has the potential to offer patients and physicians a well-tolerated oral treatment that provides early and lasting efficacy.”
The following were the key findings of the study:
· Significant improvements with remibrutinib versus placebo, as previously shown at Week 12, were confirmed at Week 24, including in weekly urticaria activity score (UAS7), weekly itch severity score (ISS7), and weekly hive severity score (HSS7).
· At Week 24, patients receiving placebo transitioned to remibrutinib; responses with remibrutinib were observed as early as the first week after switching and were sustained until the study's end (28 weeks of treatment).
· Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52.
Remibrutinib was well-tolerated and demonstrated a favorable and consistent safety profile up to 52 weeks, including balanced liver function tests versus placebo.
During the 24-week placebo-controlled period, adverse events (AEs), including severe AEs and treatment discontinuations due to AEs, were comparable between remibrutinib and placebo. In addition, there was no increase in exposure-adjusted rates with long-term treatment. Liver transaminase elevations were balanced across the remibrutinib and placebo treatment groups; all were transient, asymptomatic, and reversible. None of the severe AEs were related to study medication by investigators.
“Urticaria is a disease that significantly impacts patients' quality of life and there is an urgent need for new treatment options,” said Angelika Jahreis, Global Head, Development, Immunology, Novartis.
“The 52-week REMIX-1 and REMIX-2 Phase III data are significant as many patients who had moderate to severe urticaria at study start were completely free of hives and itch after 52 weeks of treatment and remibrutinib continued to be well tolerated. These exciting long-term data will be submitted to global health authorities later this year.”
In addition to CSU, remibrutinib is being investigated in several other immune-mediated conditions, such as hidradenitis suppurativa, where it met its primary endpoint in a Phase II study. It is also investigated in food allergy, chronic inducible urticaria, and multiple sclerosis.
Novartis will submit remibrutinib for approval in CSU to global health authorities starting in H2 2024.
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