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Page 1
Placebo-Controlled Trial of an Oral BTK Inhibitor in Multiple Sclerosis.
Montalban X, Arnold DL, Weber MS, Staikov I, Piasecka-Stryczynska K, Willmer J, Martin EC, Dangond F, Syed S, Wolinsky JS; Evobrutinib Phase 2 Study Group. Montalban X, et al. N Engl J Med. 2019 Jun 20;380(25):2406-2417. doi: 10.1056/NEJMoa1901981. Epub 2019 May 10. N Engl J Med. 2019. PMID: 31075187 Clinical Trial.
The baseline adjusted rate ratios for the total number of lesions over time as compared with placebo were 1.45 in the evobrutinib 25-mg group (P = 0.32), 0.30 in the evobrutinib 75-mg once-daily group (P = 0.005), and 0.44 in the evobrutinib 75-mg twice-daily …
The baseline adjusted rate ratios for the total number of lesions over time as compared with placebo were 1.45 in the evobrutinib 25- …
A plain language summary of what clinical studies can tell us about the safety of evobrutinib - a potential treatment for multiple sclerosis.
Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Bolay CL, Kao AH, Guehring H. Montalban X, et al. Neurodegener Dis Manag. 2023 Aug;13(4):207-213. doi: 10.2217/nmt-2023-0003. Epub 2023 Jun 22. Neurodegener Dis Manag. 2023. PMID: 37345645 Free article. Review.
This summary explains the findings from a recent investigation that combined the results of over 1000 people from three clinical studies to understand the safety of evobrutinib. Evobrutinib is an oral medication (taken by mouth), being researched as a potential trea …
This summary explains the findings from a recent investigation that combined the results of over 1000 people from three clinical studies to …
Evobrutinib pathway to its major metabolite M463-2 and insights from a biotransformation and DDI perspective.
Scheible H, Schieferstein H, Schmidt R, Pusecker K, Gradhand U, Gopalakrishnan S, Iqbal K, Dong J, Jones R, Meli C, Bolleddula J, Dyroff M, Georgi K. Scheible H, et al. Xenobiotica. 2023 Dec;53(8-9):547-558. doi: 10.1080/00498254.2023.2272180. Epub 2023 Nov 26. Xenobiotica. 2023. PMID: 37880944
Evobrutinib is a highly selective, covalent, central nervous system-penetrant Bruton's tyrosine kinase (BTK) inhibitor, currently in Phase III trials for the treatment of relapsing multiple sclerosis. One major circulating metabolite of evobrutinib has been previous …
Evobrutinib is a highly selective, covalent, central nervous system-penetrant Bruton's tyrosine kinase (BTK) inhibitor, currently in …
Comparative Analysis of BTK Inhibitors and Mechanisms Underlying Adverse Effects.
Estupiñán HY, Berglöf A, Zain R, Smith CIE. Estupiñán HY, et al. Front Cell Dev Biol. 2021 Mar 11;9:630942. doi: 10.3389/fcell.2021.630942. eCollection 2021. Front Cell Dev Biol. 2021. PMID: 33777941 Free PMC article. Review.
However, an increasing number of trials instead addresses autoimmunity and inflammation in multiple sclerosis, rheumatoid arthritis, pemphigus and systemic lupus erythematosus with the use of either irreversibly binding inhibitors, e.g., evobrutinib and tolebrutinib, or re …
However, an increasing number of trials instead addresses autoimmunity and inflammation in multiple sclerosis, rheumatoid arthritis, pemphig …
Evobrutinib, a covalent Bruton's tyrosine kinase inhibitor: Mass balance, elimination route, and metabolism in healthy participants.
Scheible H, Dyroff M, Seithel-Keuth A, Harrison-Moench E, Mammasse N, Port A, Bachmann A, Dong J, van Lier JJ, Tracewell W, Mitchell D. Scheible H, et al. Clin Transl Sci. 2021 Nov;14(6):2420-2430. doi: 10.1111/cts.13108. Epub 2021 Aug 10. Clin Transl Sci. 2021. PMID: 34374206 Free PMC article.
Early clinical studies in healthy participants and patients with relapsing MS indicated that evobrutinib is well-tolerated and effective. We undertook a mass balance study in six men who received a single 75-mg oral dose of evobrutinib containing ~ 3.6 MBq (100 muCi …
Early clinical studies in healthy participants and patients with relapsing MS indicated that evobrutinib is well-tolerated and effect …
Bruton's Tyrosine Kinase Inhibition in Multiple Sclerosis.
Schneider R, Oh J. Schneider R, et al. Curr Neurol Neurosci Rep. 2022 Nov;22(11):721-734. doi: 10.1007/s11910-022-01229-z. Epub 2022 Oct 27. Curr Neurol Neurosci Rep. 2022. PMID: 36301434 Free PMC article. Review.
RECENT FINDINGS: There is evidence that some BTKIs cross the blood-brain barrier and may be superior to currently available DMTs at dampening the chronic neuroinflammatory processes compartmentalized within the CNS that contribute to progressive worsening in people withMS (pwMS). …
RECENT FINDINGS: There is evidence that some BTKIs cross the blood-brain barrier and may be superior to currently available DMTs at dampenin …
Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis.
Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Le Bolay C, Kao AH, Guehring H. Montalban X, et al. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):1-9. doi: 10.1136/jnnp-2022-328799. Epub 2022 Nov 23. J Neurol Neurosurg Psychiatry. 2023. PMID: 36418156 Free PMC article. Clinical Trial.
Descriptive statistics and exposure-adjusted incidence rates (EAIR) were used to report treatment-emergent adverse events (TEAEs). RESULTS: Data from 1083 patients were pooled: evobrutinib, n=861; placebo, n=271 (sum >1083 due to MS trial design: n=49 received both plac …
Descriptive statistics and exposure-adjusted incidence rates (EAIR) were used to report treatment-emergent adverse events (TEAEs). RESULTS: …
Bruton's Tyrosine Kinase Inhibitors in Multiple Sclerosis: Pioneering the Path Towards Treatment of Progression?
Geladaris A, Torke S, Weber MS. Geladaris A, et al. CNS Drugs. 2022 Oct;36(10):1019-1030. doi: 10.1007/s40263-022-00951-z. Epub 2022 Sep 30. CNS Drugs. 2022. PMID: 36178589 Free PMC article. Review.
We furthermore summarize all mechanistic, preclinical, and clinical data on the various BTK inhibitors (evobrutinib, tolebrutinib, fenebrutinib, remibrutinib, orelabrutinib, BIIB091) that are currently in development for treatment of MS, with a particular focus on the pote …
We furthermore summarize all mechanistic, preclinical, and clinical data on the various BTK inhibitors (evobrutinib, tolebrutinib, fe …
Human T-bet+ B cell development is associated with BTK activity and suppressed by evobrutinib.
Rijvers L, van Langelaar J, Bogers L, Melief MJ, Koetzier SC, Blok KM, Wierenga-Wolf AF, de Vries HE, Rip J, Corneth OB, Hendriks RW, Grenningloh R, Boschert U, Smolders J, van Luijn MM. Rijvers L, et al. JCI Insight. 2022 Aug 22;7(16):e160909. doi: 10.1172/jci.insight.160909. JCI Insight. 2022. PMID: 35852869 Free PMC article.
Recent clinical trials have shown promising results for the next-generation Bruton's tyrosine kinase (BTK) inhibitor evobrutinib in the treatment of multiple sclerosis (MS). BTK has a central role in signaling pathways that govern the development of B cells. ...Under in vi …
Recent clinical trials have shown promising results for the next-generation Bruton's tyrosine kinase (BTK) inhibitor evobrutinib in t …
Population pharmacokinetic and pharmacodynamic modeling of evobrutinib in healthy adult participants.
Papasouliotis O, Mitchell D, Girard P, Dyroff M. Papasouliotis O, et al. Clin Transl Sci. 2022 Dec;15(12):2899-2908. doi: 10.1111/cts.13417. Epub 2022 Oct 17. Clin Transl Sci. 2022. PMID: 36165192 Free PMC article.
Evobrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has shown therapeutic potential in relapsing multiple sclerosis. ...Data were obtained from two phase I evobrutinib studies in healthy adult participants (Japanese and non-Japanese). ...
Evobrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has shown therapeutic potential in relapsing multiple sclerosis. ...Data wer …
51 results