Remibrutinib Reduces Rescue Medication Use in Adults With Chronic Spontaneous Urticaria



Maurer M, et al. Remibrutinib (LOU064) reduces rescue medication use in patients with chronic spontaneous urticaria: results from a phase 2b study. Presented at: EAACI Hybrid Congress; July 1-3, 2022; Prague (hybrid meeting).

Maurer reports financial relationships with Amgen, Allakos, Aralez Bio, Argenx, AstraZeneca, Celldex Therapeutics, Centogene, CSL Behring, FAES, Genentech, Clinnovations, Innate Pharma, Kyowa Kirin, Lilly, LEO Pharma, Menarini, Novartis, Roche, Sanofi, Third Harmonic, UCB and Uriach.

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Remibrutinib reduced the need for rescue medication and improved symptoms in patients with chronic spontaneous urticaria, according to a study presented at the hybrid congress of the European Academy of Allergy and Clinical Immunology.

Additionally, remibrutinib (LOU064, Novartis) achieved these results despite reduced use of second-generation H1 antihistamines (H1-AH), Marcus Maurer, MD, professor of dermatology and allergy and associate director of the Allergy-Centrum-Charité in Berlin, said in his presentation.

Marcus Maurer

“We now have another treatment option here, which I find very promising,” Maurer said.

H1-AH is generally recommended as a first-line treatment for chronic spontaneous urticaria (CSU), the researchers reported. However, remibrutinib is an oral covalent inhibitor of Bruton’s tyrosine kinase (BTK), which is essential for mast cell and basophil activation.

According to the researchers, the drug is novel, highly selective and potent, making it a potentially attractive drug target for CSU.

“If you block this BTK, the production of autoantibodies in patients with chronic spontaneous urticaria is blocked,” Maurer said.

The multicenter, double-blind, phase 2b study involved 311 adults (71.4% female; median age, 45 years ± 14.9 years) with moderate to severe UC not controlled by H1-AH treatment .

Patients were randomized to receive remibrutinib at daily doses of 10 mg (n=44), 35 mg (n=44), or 100 mg (n=47) or twice daily doses of 10 mg (n=44) , 25 mg (n=44) or 100 mg (n=45), of which 43 received placebo.

These doses were prescribed in addition to background maintenance H1-AH at the indicated dose and another second generation H1-AH as rescue medication as needed to treat unbearable symptoms during periods of screening, treatment and tracking.

Patients recorded the number of H1-AH rescue tablets they used in the previous 24 hours once daily on an eDiary device. The researchers calculated the weekly rescue medication use as the sum of the dose per day for 7 days.

Each of the remibrutinib groups experienced early reductions in weekly H1-AH rescue medication use, which then remained small. Average weekly ranges for doses totaled 2.8 to 8.2 for weeks 1 to 12, compared to 6.4 to 9.4 at baseline. The placebo group experienced no reduction in rescue medication.

At week 12, researchers found that patients on remibrutinib used fewer rescue medication tablets each week, while the placebo group used more.

“Patients, when on ineffective treatment, use more rescue medications,” Maurer said. “That’s not what’s happening with remibrutinib.”

Specifically, among those receiving daily treatment, the 10mg group used 5.8 tablets compared to 8.7 at baseline; the 35 mg group used 3.9 versus 6.6; and the 100mg group used 4 vs. 6.4. Of those receiving twice-daily treatment, the 10 mg group used 5.1 tablets compared to 7.6 at baseline; the 25 mg group used 4.5 vs. 9; and the 100mg group used 7.1 vs. 9.4. The placebo group used 11.9 tablets at week 12, up from 9 at baseline.

“Patients recognize that they don’t need rescue medication. They still significantly improve their disease activity in the absence of additional rescue medications,” Maurer said.

Researchers further found that patients on remibrutinib experienced significant improvements in their 7-day urticaria activity score at weeks 4 and 12 from baseline compared to placebo, in addition to an onset of fast acting, a favorable safety profile and no dose-dependent pattern of adverse effects. events, as well as improvements in control and quality of life.

“My prediction is that once we have remibrutinib in our hands to help our patients, those patients will do very well on remibrutinib monotherapy,” Maurer said.

Although the study period was 12 weeks, Maurer cautioned that real-world treatment will be longer.

“Follow the instruction. Treat the disease until it goes away. It will not be a treatment that people should use or will use for only 12 weeks or 16 weeks. It will be a long-term treatment,” he said. he said, adding that studies are ongoing on the long-term safety and tolerability of BTK inhibition in patients with CSU.However, Maurer remains optimistic.

“The future for chronic spontaneous urticaria is bright,” he said.


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