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001-es BibID:	BIBFORM117457
035-os BibID:	(scopus)85179435080 (wos)001102556900001
Első szerző:	Dörner, Thomas
Cím:	Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjögren's syndrome : results from a randomised, double-blind, placebo-controlled phase 2 trial / Dörner Thomas, Kaul Martin, Szántó Antónia, Tseng Jui-Cheng, Papas Athena S., Pylvaenaeinen Ilona, Hanser Malika, Abdallah Nasri, Grioni Andrea, Santos Da Costa Aida, Ferrero Enrico, Gergely Peter, Hillenbrand Rainer, Avrameas Alexandre, Cenni Bruno, Siegel Richard M.
Dátum:	2023
ISSN:	0003-4967
Megjegyzések:	Objectives: To evaluate the safety and efficacy of remibrutinib in patients with moderate-to-severe Sjögren's syndrome (SjS) in a phase 2 randomised, double-blind trial (NCT04035668; LOUiSSE (LOU064 in Sjögren's Syndrome) study). Methods: Eligible patients fulfilling 2016 American College of Rheumatology/European League Against Rheumatism (EULAR) criteria for SjS, positive for anti-Ro/Sjögren's syndrome-related antigen A antibodies, with moderate-to-severe disease activity (EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (based on weighted score) ? 5, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) ? 5) received remibrutinib (100 mg) either one or two times a day, or placebo for the 24-week study treatment period. The primary endpoint was change from baseline in ESSDAI at week 24. Key secondary endpoints included change from baseline in ESSDAI over time, change from baseline in ESSPRI over time and safety of remibrutinib in SjS. Key exploratory endpoints included changes to the salivary flow rate, soluble biomarkers, blood transcriptomic and serum proteomic profiles. Results: Remibrutinib significantly improved ESSDAI score in patients with SjS over 24 weeks compared with placebo ( "ESSDAI -2.86, p=0.003). No treatment effect was observed in ESSPRI score ( "ESSPRI 0.17, p=0.663). There was a trend towards improvement of unstimulated salivary flow with remibrutinib compared with placebo over 24 weeks. Remibrutinib had a favourable safety profile in patients with SjS over 24 weeks. Remibrutinib induced significant changes in gene expression in blood, and serum protein abundance compared with placebo. Conclusions: These data show preliminary efficacy and favourable safety of remibrutinib in a phase 2 trial for SjS.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Patient Reported Outcome Measures Sjogren's Syndrome Therapeutics
Megjelenés:	Annals Of The Rheumatic Diseases. - [Epub ahead of print] (2023). -
További szerzők:	Kaul, Martin Szántó Antónia (1977-) (belgyógyász, allergológus és klinikai immunológus) Tseng, Jui-Cheng Papas, Athena S. Pylvaenaeinen, Ilona Hanser, Malika Abdallah, Nasri Grioni, Andrea Santos Da Costa, Aida Ferrero, Enrico Gergely Péter (Budapest) Hillenbrand, Rainer Avrameas, Alexandre Cenni, Bruno Siegel, Richard M.
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