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Safety and tolerability of inebilizumab (MEDI-551), an anti-CD19 monoclonal antibody, in patients with relapsing forms of multiple sclerosis: Results from a phase 1 randomised, placebo-controlled, escalating intravenous and subcutaneous dose study.
Agius MA, Klodowska-Duda G, Maciejowski M, Potemkowski A, Li J, Patra K, Wesley J, Madani S, Barron G, Katz E, Flor A. Agius MA, et al. Mult Scler. 2019 Feb;25(2):235-245. doi: 10.1177/1352458517740641. Epub 2017 Nov 16. Mult Scler. 2019. PMID: 29143550 Free PMC article. Clinical Trial.
BACKGROUND: B cells may be involved in the pathophysiology of multiple sclerosis (MS). Inebilizumab (formerly MEDI-551) binds to and depletes CD19(+) B cells. ...Infusion/injection (grade 1/2) reactions occurred in 6/15 patients receiving inebilizumab
BACKGROUND: B cells may be involved in the pathophysiology of multiple sclerosis (MS). Inebilizumab (formerly MEDI-551) …
Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. Kaplon H, et al. MAbs. 2020 Jan-Dec;12(1):1703531. doi: 10.1080/19420862.2019.1703531. MAbs. 2020. PMID: 31847708 Free PMC article. Review.
At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had been granted a first approval in either the US or EU, and marketing applications for 13 novel antibody therapeutics (eptinezumab, teprotumu …
At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had …
Pharmacological profile of MEDI-551, a novel anti-CD19 antibody, in human CD19 transgenic mice.
Gallagher S, Turman S, Yusuf I, Akhgar A, Wu Y, Roskos LK, Herbst R, Wang Y. Gallagher S, et al. Int Immunopharmacol. 2016 Jul;36:205-212. doi: 10.1016/j.intimp.2016.04.035. Epub 2016 May 7. Int Immunopharmacol. 2016. PMID: 27163209
MEDI-551 is currently under investigation in multiple clinical trials. ...In summary, the pharmacological profile of MEDI-551 presented in hCD19 Tg mice supports further testing of MEDI-551 in clinical trials involving B cell malignancies
MEDI-551 is currently under investigation in multiple clinical trials. ...In summary, the pharmacological profile of MEDI
Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial.
Cree BAC, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Lublin FD, Drappa J, Barron G, Madani S, Ratchford JN, She D, Cimbora D, Katz E; N-MOmentum study investigators. Cree BAC, et al. Lancet. 2019 Oct 12;394(10206):1352-1363. doi: 10.1016/S0140-6736(19)31817-3. Epub 2019 Sep 5. Lancet. 2019. PMID: 31495497 Clinical Trial.
Inebilizumab or placebo was administered on days 1 and 15. Participants, investigators, and all clinical staff were masked to the treatments, and inebilizumab and placebo were indistinguishable in appearance. ...INTERPRETATION: Compared with placebo, inebilizumab
Inebilizumab or placebo was administered on days 1 and 15. Participants, investigators, and all clinical staff were masked to the tre
MEDI-551 Treatment Effectively Depletes B Cells and Reduces Serum Titers of Autoantibodies in Mice Transgenic for Sle1 and Human CD19.
Gallagher S, Yusuf I, McCaughtry TM, Turman S, Sun H, Kolbeck R, Herbst R, Wang Y. Gallagher S, et al. Arthritis Rheumatol. 2016 Apr;68(4):965-76. doi: 10.1002/art.39503. Arthritis Rheumatol. 2016. PMID: 26606525 Free article.
METHODS: Sle1.hCD19-Tg mice were given either a single intravenous dose of MEDI-551 or repeated doses of MEDI-551 biweekly for up to 12 weeks. ...MEDI-551 treatment resulted in a robust reduction of autoantibodies but had minimal effect o …
METHODS: Sle1.hCD19-Tg mice were given either a single intravenous dose of MEDI-551 or repeated doses of MEDI-551
Immunotherapy in myasthenia gravis in the era of biologics.
Dalakas MC. Dalakas MC. Nat Rev Neurol. 2019 Feb;15(2):113-124. doi: 10.1038/s41582-018-0110-z. Nat Rev Neurol. 2019. PMID: 30573759 Review.
Whether the newer anti-CD20 agents ocrelizumab, ofatumumab, obinutuzumab, ublituximab or inebilizumab will be more effective remains unclear. Belimumab, an antibody against the B cell trophic factor BAFF, was ineffective in phase III trials, and efgartigimod, which deplete …
Whether the newer anti-CD20 agents ocrelizumab, ofatumumab, obinutuzumab, ublituximab or inebilizumab will be more effective remains …
Inebilizumab: First Approval.
Frampton JE. Frampton JE. Drugs. 2020 Aug;80(12):1259-1264. doi: 10.1007/s40265-020-01370-4. Drugs. 2020. PMID: 32729016 Free PMC article. Review.
Inebilizumab (Uplizna; inebilizumab-cdon in the USA) is a humanised anti-CD19 monoclonal antibody being developed by Viela Bio for the treatment of a range of autoimmune diseases associated with CD19-expressing B cells. Inebilizumab targets and depletes CD19-
Inebilizumab (Uplizna; inebilizumab-cdon in the USA) is a humanised anti-CD19 monoclonal antibody being developed by Viela Bio
B-cell depletion in vitro and in vivo with an afucosylated anti-CD19 antibody.
Herbst R, Wang Y, Gallagher S, Mittereder N, Kuta E, Damschroder M, Woods R, Rowe DC, Cheng L, Cook K, Evans K, Sims GP, Pfarr DS, Bowen MA, Dall'Acqua W, Shlomchik M, Tedder TF, Kiener P, Jallal B, Wu H, Coyle AJ. Herbst R, et al. J Pharmacol Exp Ther. 2010 Oct;335(1):213-22. doi: 10.1124/jpet.110.168062. Epub 2010 Jul 6. J Pharmacol Exp Ther. 2010. PMID: 20605905
During in vitro ADCC assays with B-cell lines, MEDI-551 is effective at much lower mAb concentrations than the fucosylated parental mAb anti-CD19-2. ...In summary, MEDI-551 has potent B-cell-depleting activity in vitro and in vivo and may be a promisin …
During in vitro ADCC assays with B-cell lines, MEDI-551 is effective at much lower mAb concentrations than the fucosylated par …
B cells in multiple sclerosis therapy-A comprehensive review.
Rahmanzadeh R, Weber MS, Brück W, Navardi S, Sahraian MA. Rahmanzadeh R, et al. Acta Neurol Scand. 2018 Jun;137(6):544-556. doi: 10.1111/ane.12915. Epub 2018 Mar 7. Acta Neurol Scand. 2018. PMID: 29512131 Review.
In this respect, several B cell-targeted therapies emerged, including anti-CD20 antibodies (rituximab, ocrelizumab, and ofatumumab), anti-CD19 antibody (inebilizumab), and agents targeting the BAFF/APRIL signaling pathway (atacicept, belimumab, and LY2127399). ...
In this respect, several B cell-targeted therapies emerged, including anti-CD20 antibodies (rituximab, ocrelizumab, and ofatumumab), anti-CD …
New therapies for neuromyelitis optica spectrum disorder.
Levy M, Fujihara K, Palace J. Levy M, et al. Lancet Neurol. 2021 Jan;20(1):60-67. doi: 10.1016/S1474-4422(20)30392-6. Epub 2020 Nov 10. Lancet Neurol. 2021. PMID: 33186537 Review.
RECENT DEVELOPMENTS: Four randomised controlled trials have tested the efficacy of three new therapies (eculizumab, satralizumab, and inebilizumab) for patients with neuromyelitis optica spectrum disorder that all showed a benefit in preventing future attacks. ...
RECENT DEVELOPMENTS: Four randomised controlled trials have tested the efficacy of three new therapies (eculizumab, satralizumab, and ine
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