| Autor: |
Bermel, Robert A., Carr, Warner, Chitnis, Tanuja, Dörner, Thomas, Koremasa Hayama, Michihiro Hide, Maurer, Marcus, Montalban, Xavier, Sussman, Gordon, Wiendl, Heinz, Dahale, Swapnil, De las Heras, Virginia, Haemmerle, Sibylle, Kieseier, Bernd C., Lheritier, Karine, Zharkov, Artem, Willi, Roman, Giménez-Arnau, Ana |
| Předmět: |
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| Zdroj: |
International Journal of MS Care; 2024 Supplement, Vol. 26, p48-48, 3/4p |
| Abstrakt: |
BACKGROUND: Remibrutinib is a highly selective, potent, covalent, oral Bruton tyrosine kinase inhibitor that downregulates myeloid and B-cell activation without depleting B cells. Here, we report immunoglobulin levels in participants with chronic spontaneous urticaria (CSU) exposed to remibrutinib up to 100 mg twice a day for up to 52 weeks. OBJECTIVES: To assess serum immunoglobulin levels over time in a phase 2b core study (NCT03926611) and extension study (NCT04109313) of remibrutinib in CSU, including 100 mg twice a day, the dosing regimen being evaluated in the phase 3 REMODEL-1 (NCT05147220) and REMODEL- 2 (NCT05156281) trials in relapsing multiple sclerosis (MS). METHODS: Participants were randomly assigned to receive various doses of remibrutinib (10-100 mg twice daily) or placebo for up to 12 weeks (core study). Eligible participants entered a 52-week open-label extension study with remibrutinib 100 mg twice a day. Baseline, week 12 (core), and week 52 (extension) total IgA, IgG, and IgM levels were assessed. RESULTS: Of the 309 participants included in the analysis, 194 participants rolled over to the 52-week extension. No relevant numerical changes in the total serum immunoglobulin levels up to weeks 12 and 52 were observed. In the 194 participants receiving remibrutinib 100 mg twice a day in the extension study (mean age, 45.5 years; 71.6% female), mean baseline and week 52 IgG levels were 11 µg/mL (SD, 2.43) and 10.5 µg/mL (SD, 2.49), respectively, and the corresponding mean IgM levels were 1.1 µg/mL (SD, 0.83) and 0.9 µg/mL (SD, 0.74). CONCLUSIONS: Remibrutinib treatment did not affect total immunoglobulin levels in participants with CSU in findings from phase 2 studies, including with long-term treatment up to 52 weeks with 100 mg twice a day, the dose used in MS clinical trials. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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