Remibrutinib exhibits long-term favorable safety profile for chronic spontaneous urticaria
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Key takeaways:
- 3.1% of the patients in the treatment group experienced serious adverse events.
- The most common adverse events were infections and infestations.
- 55.8% of patients experienced complete resolution by week 52.
SAN ANTONIO — Remibrutinib displayed sustained efficacy for chronic spontaneous urticaria with a favorable safety profile over 52 weeks, according to data presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
“Treating these patients has a huge, huge impact on the patient’s well-being and quality of life,” Warner W. Carr, MD, FACP, FACAAI, FAAAAI, president and CEO of Allergy and Asthma Associates of Southern California, said during his presentation.
The phase IIb extension study involved 194 patients taking 100 mg of remibrutinib (LOU064, Novartis) twice a day for 52.1 weeks, followed by 4 weeks of follow-up without any treatment. This study followed a core study of 267 patients taking 10 mg, 35 mg or 100 mg once a day or 10 mg, 25 mg or 100 mg twice a day for 12.1 weeks, with 42 patients on placebo.
“At timepoint zero, they started the open-label treatment period,” Carr, who also is medical director of Southern California Research, said. “For that first month, they were allowed no antihistamines and were just on remibrutinib.”
During the study, 139 (71.6%) patients reported treatment-emergent adverse events, and six (3.1%) reported serious adverse events. In the core study, 155 (58.1%) patients in the treatment group and 18 (42.9%) in the placebo group reported treatment-emergent adverse events, whereas five (1.9%) in the treatment group and none in the placebo group reported serious adverse events.
“This is very encouraging data from a safety perspective,” Carr said.
Also, there were no abnormalities in any of the laboratory analysis, according to Carr.
“If you’ve been following this class, you know that there have been issues with liver function tests, and we repeatedly have not seen it with this particular product,” Carr said. “So, that’s probably not going to be a class effect.”
The most frequent adverse events in the extension study included infections and infestations (n = 60; 30.9%), skin tissue disorders (n = 52; 26.8%) and gastrointestinal disorders (n = 32; 16.5%).
Among the core study, these totals included 64 (24%) infections and infestations, 45 (16.9%) skin tissue disorders and 30 (11.2%) gastrointestinal disorders for the treatment group and nine (21.4%) infections and infestations, two (4.8%) skin tissue disorders and five (11.9%) gastrointestinal disorders for the placebo group.
According to Carr, 76% of the infections and skin tissue disorders occurred during the 4 week follow-up period after the 52 week treatment period, and most of these events were related to urticaria.
Bleeding was reported by 12 (6.2%) of the patients in the extension study and by 18 (6.7%) of the patients in the treatment group and by one (2.4%) patient on placebo in the core study.
Similarly, two (1%) patients in the extension study and eight (3%) patients in the treatment group and one (2.4%) patient in the placebo group in the core study reported cytopenia.
“There was a low rate of bleeding and cytopenias,” Carr said. “Most were reported to be minor in nature and mild in their severity. In patients that did have cytopenia, there was no correlation with infection.”
Chronic spontaneous urticaria was reported by 22 (11.3%) of the patients in the extension study, 16 (6%) of the treatment group in the core study and one (2.4%) in the core study’s placebo group. COVID-19, headache, eczema and nasopharyngitis were reported across the groups as well.
“The higher incidence of COVID-19 was related, obviously, to the fact that we did this during the pandemic,” Carr said.
During the extension study, mean changes from baseline in 7-day urticaria activity scores (UAS7) included –14.8 at week 1, –19.4 at week 12 and –21.8 at week 52. Percentages of patients reporting 0 for their UAS7, indicating complete response, included 1.7% at week 1, 43.4% at week 12 and 55.8% at week 52.
“You see rapid improvement in that first week, all the way up to the end of the study,” Carr said. “That’s really supportive, robust efficacy data.”
Concluding that remibrutinib demonstrated long-term efficacy and safety, Carr said that a phase III study will continue the research by examining 25 mg doses in clinical trials.
Perspective
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These findings are significant because they suggest the potential for an effective and safe treatment with a novel mechanism of action for chronic spontaneous urticaria. It will be important to see the results of further clinical trials once they are available, but this treatment is very promising for a condition that can be difficult to treat successfully.
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Carr WW, et al. Abstract 3611. Presented at: AAAAI Annual Meeting; Feb. 24-27, 2023; San Antonio.
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