| アブストラクト | BACKGROUND: Remibrutinib, an oral, highly selective Bruton's tyrosine kinase inhibitor (BTKi), showed sustained efficacy in phase 3 REMIX trials in chronic spontaneous urticaria. OBJECTIVE: To report detailed safety outcomes from the REMIX trials, including key findings pertinent to BTKi safety, such as bleeding, infections, cytopenia, and liver safety. METHODS: This was a pooled analysis of REMIX-1 and REMIX-2 consisting of a 24-week, randomized, double-blind, placebo-controlled period, followed by a 28-week open-label treatment period. Adverse event (AE) frequencies and laboratory parameters were examined through week 52, and differences vs placebo were evaluated in the controlled period. RESULTS: AE frequencies and risk differences (95% confidence intervals) for remibrutinib (n=606) vs placebo (n=306) were as follows: any AE 64.9% vs 64.7%, difference 0.1% (-6.4%, 6.7%); bleeding (including laboratory abnormalities) 10.6% vs 5.2%, difference 5.3% (1.6%, 8.7%); infections 33.5% vs 34.3%, difference -0.8% (-7.4%, 5.6%); cytopenia AEs 3.6% vs 2.0%, difference 1.7% (-0.7%, 3.8%); hepatic disorders 3.3% vs 4.9%, difference -1.6% (-4.6%, 1.1%). Imbalance in bleeding was due to petechia and similar mucocutaneous events (predominantly mild, none severe) occurring in 9.1% of patients on remibrutinib vs 2.0% of patients on placebo. No other AEs with significantly increased frequency occurred on remibrutinib. Findings during the entire study period were consistent with those in the controlled period. CONCLUSION: Remibrutinib showed a favorable safety profile with slightly higher incidence of petechia and similar predominantly mild mucocutaneous events. There were no notable differences in the frequency of other safety outcomes between remibrutinib and placebo in the REMIX trials. |
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| ジャーナル名 | The journal of allergy and clinical immunology. In practice |
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| Pubmed追加日 | 2026/6/5 |
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| 投稿者 | Gimenez-Arnau, Ana Maria; Zharkov, Artem; Yang, Bin; Fukunaga, Atsushi; Hide, Michihiro; Metz, Martin; Mosnaim, Giselle; Staubach, Petra; Gao, Xing-Hua; Jain, Vipul; Burciu, Alis; Cenni, Bruno; Haemmerle, Sibylle; Kuruvilla, Merin; Huang, Songqiao; Ledieu, David; Schuemann, Jens; Scosyrev, Emil; Schneider, Rahel; Incera, Elodie; Lheritier, Karine; Tillmann, Hanns-Christian; Zouater, Hichem; Saini, Sarbjit |
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| 組織名 | Department of Dermatology, Hospital del Mar and Research Institute, Universitat;Pompeu Fabra, Barcelona, Spain. Electronic address:;anamariagimenezarnau@gmail.com.;Novartis Pharma AG, Basel, Switzerland.;Dermatology Hospital of Southern Medical University, Guangdong Provincial;Dermatology Hospital, Guangzhou, China.;Department of Dermatology, Division of Medicine for Function and Morphology of;Sensory Organs, Faculty of Medicine, Osaka Medical and Pharmaceutical University,;Takatsuki, Osaka, Japan.;Department of Dermatology, Hiroshima City Hiroshima Citizens Hospital and;Department of Dermatology, Hiroshima University, Hiroshima, Japan.;Institute of Allergology, Charite - Universitatsmedizin Berlin, corporate member;of Freie Universitat Berlin and Humboldt Universitat zu Berlin, Berlin, Germany;;Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology;and Allergology, Berlin, Germany.;Division of Allergy and Immunology, Endeavor Health, Glenview, IL, USA.;Department of Dermatology, University Medical Center Mainz, Germany.;Department of Dermatology, The First Hospital of China Medical University,;Shenyang, China.;Division of Clinical Immunology and Allergy, Department of Medicine, McMaster;University, Hamilton, ON, Canada.;Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.;IQVIA RDS France, Saint-Ouen-sur-Seine, France.;Johns Hopkins Asthma and Allergy Center, Baltimore, MD, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42242425/ |
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