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https://www.readbyqxmd.com/read/29727724/in-situ-quantitative-bioanalysis-of-monomethyl-auristatin-e-conjugated-antibody-drug-conjugates-by-flow-cytometry
#1
Wen-Bin Zhao, Chi-Xiao Qiu, Ying Shen, Wen-Hui Liu, Jie Zhou, Ying-Chun Xu, Zhan Zhou, Shu-Qing Chen
Antibody-drug conjugates (ADCs) consist of cytotoxic agents covalently conjugated to monoclonal antibodies that substantially improve antitumour activity and reduce systemic toxicity. With the growing number of ADCs in clinical applications, more accurate bioanalysis data are urgently needed to facilitate the development and rational use of ADCs. Herein, we used antigen-positive cells as antigen carriers and ofatumumab (OFA-HL) and ofatumumab-based ADC (OFA-HL-MMAE) as examples to establish a new ligand-binding assay (LBA) method based on flow cytometry...
May 1, 2018: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29695594/subcutaneous-ofatumumab-in-patients-with-relapsing-remitting-multiple-sclerosis-the-mirror-study
#2
Amit Bar-Or, Richard A Grove, Daren J Austin, Jerry M Tolson, Susan A VanMeter, Eric W Lewis, Frederick J Derosier, Monica C Lopez, Sarah T Kavanagh, Aaron E Miller, Per S Sorensen
OBJECTIVE: To assess dose-response effects of the anti-CD20 monoclonal antibody ofatumumab on efficacy and safety outcomes in a phase 2b double-blind study of relapsing forms of multiple sclerosis (RMS). METHODS: Patients (n = 232) were randomized to ofatumumab 3, 30, or 60 mg every 12 weeks, ofatumumab 60 mg every 4 weeks, or placebo for a 24-week treatment period, with a primary endpoint of cumulative number of new gadolinium-enhancing lesions (per brain MRI) at week 12...
April 25, 2018: Neurology
https://www.readbyqxmd.com/read/29616868/frontline-treatment-of-diffuse-large-b-cell-lymphoma-in-elderly-a-systematic-review-of-clinical-trials-in-post-rituximab-era
#3
Sara Beygi, Santhosh Sadashiv, James B Reilly, Cyrus Khan, John Lister
Treatment of diffuse large B cell lymphoma (DLBCL) remains challenging in elderly population and systematic reviews are lacking in this area. Medline and Cochrane Register of Controlled Trials in addition to conference proceedings were searched for therapeutic clinical trials on frontline treatment of DLBCL in adults ≥60 in post-rituximab era. Forty-one out of 713 reviewed papers met our inclusion criteria. Six cycles of rituximab, cyclophosphamide, vincristine, prednisone (R-CHOP) administered every 21 d remain the standard treatment for fit elderly, with no role for maintenance rituximab...
April 4, 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29609506/ublituximab-for-the-treatment-of-cd20-positive-b-cell-malignancies
#4
REVIEW
Hani M Babiker, Ashley E Glode, Laurence S Cooke, Daruka Mahadevan
Non-Hodgkin lymphoma (NHL) is the most common adult hematologic malignancy. Conventional methods of treatment are chemotherapy and radiation, which were associated with toxicities and lack of specificity. Potential cell surface targets for treatment of B-cell NHL (B-NHL) include CD19, CD20, and CD22 which are highly expressed on malignant B-cells. The development of monoclonal antibody (mAb) therapy directed against CD20 had the most clinical impact in the treatment of B-NHL. Early clinical trials with rituximab (RTX), the first chimeric mAb against CD20, showed efficacy and minimal toxicities...
April 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29575875/assessment-of-the-efficacy-of-ofatumumab-in-patients-with-chronic-lymphocytic-leukaemia-treated-in-the-department-of-haematooncology-and-bone-marrow-transplantation-of-the-medical-university-in-lublin-prelimary-results
#5
Ewa Wąsik-Szczepanek, Agnieszka Szymczyk, Małgorzata Kowal, Adam Nogalski, Marek Hus
INTRODUCTION: Despite significant recent advances in the treatment of chronic lymphocytic leukaemia (CLL), most cases of the disease are still incurable. Treatment with monoclonal antibodies, such as ofatumumab, is one of the new therapeutic options. OBJECTIVE: Retrospective analysis of the efficacy of ofatumumab in patients with chronic lymphocytic leukaemia (CLL) treated in the Haematooncology and Bone Marrow Transplantation Department of the Medical University of Lublin, Poland, during 2011-2013...
March 14, 2018: Annals of Agricultural and Environmental Medicine: AAEM
https://www.readbyqxmd.com/read/29569812/ofatumumab-in-post-transplantation-recurrence-of-a-pediatric-steroid-resistant-idiopathic-nephrotic-syndrome
#6
Josselin Bernard, Alexandra Bruel, Emma Allain-Launay, Jacques Dantal, Gwenaelle Roussey
Treatment of SRNS is a challenge. Antiproliferative agents and depleting antibodies have been reported to be effective. However, these agents are not always successful, and use of ofatumumab could provide a different treatment option. Our patient was diagnosed with a SRNS at 5 years of age. She developed ESRD, with FSGS. This was cause for a first renal transplantation. The NS relapsed, leading to loss of the graft, and a second renal transplantation was performed. Due to the recurrence of the NS, IAds were initiated and led to a complete remission...
March 23, 2018: Pediatric Transplantation
https://www.readbyqxmd.com/read/29564686/ofatumumab-for-acute-treatment-and-prophylaxis-of-a-patient-with-multiple-relapses-of-acquired-thrombotic-thrombocytopenic-purpura
#7
Hanny Al-Samkari, Rachael F Grace, Jean M Connors
Acquired thrombotic thrombocytopenic purpura (TTP) is an autoimmune disorder resulting in potentially life-threating systemic thrombotic microangiopathy due to production of antibodies directed against the von Willebrand factor-cleaving protease ADAMTS13. Typically managed with plasma exchange, glucocorticoids, and the first-generation anti-CD20 monoclonal antibody rituximab, patients with multiple relapses or refractory disease present unique management challenges. We describe a case of a young woman with multiple relapses of TTP despite standard therapy who was treated with ofatumumab, a second-generation anti-CD20 monoclonal antibody, after developing a severe hypersensitivity reaction to rituximab precluding its use...
March 21, 2018: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/29562252/ofatumumab-for-b-cell-depletion-in-patients-with-systemic-lupus-erythematosus-who-are-allergic-to-rituximab
#8
Sherry Masoud, Stephen P McAdoo, Rachna Bedi, Thomas D Cairns, Liz Lightstone
Objective: B cell depletion, most commonly with rituximab, is an evolving therapeutic approach in SLE. Infusion reactions after rituximab are common, and may prevent re-treatment in patients who previously demonstrated beneficial response. We have used ofatumumab, a fully humanized anti-CD20 mAb, as an alternative B cell-depleting agent in patients with SLE who are rituximab-intolerant due to severe infusion reactions. Methods: A single-centre retrospective case series of 16 patients were treated with ofatumumab for SLE between 2012 and 2015...
March 19, 2018: Rheumatology
https://www.readbyqxmd.com/read/29529009/quantification-of-idelalisib-in-human-plasma-by-ultra-performance-liquid-chromatography-coupled-to-mass-spectrometry-in-negative-ionization-mode
#9
Huu H Huynh, Clara Roessle, Hélène Sauvageon, Alain Plé, Isabelle Madelaine, Catherine Thieblemont, Samia Mourah, Lauriane Goldwirt
BACKGROUND: Idelalisib is the first orally active selective phosphatidylinositol 3-kinase delta inhibitor approved by Food and Drug Administration and European Medicines Agency in 2014 for the treatment of several types of blood cancer. Idelalisib is widely used as a monotherapy or in combination with rituximab, bendamustine, or ofatumumab with a significant efficacy. However, idelalisib has shown increased risk of infection and a higher frequency of serious adverse events. It may be useful to determine idelalisib concentration in human plasma to adjust dose and to manage adverse effects in clinical practice...
April 2018: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29517616/a-dose-escalation-study-of-recombinant-human-interleukin-18-in-combination-with-ofatumumab-after-autologous-peripheral-blood-stem-cell-transplantation-for-lymphoma
#10
Michael J Robertson, Christopher W Stamatkin, David Pelloso, Jill Weisenbach, Nagendra K Prasad, Ahmad R Safa
Interleukin-18 (IL-18) is an immunostimulatory cytokine that augments antibody-dependent cellular cytotoxicity mediated by human natural killer cells against antibody-coated lymphoma cells in vitro and that has antitumor activity in animal models. Ofatumumab is a CD20 monoclonal antibody with activity against human B-cell lymphomas. A phase I study of recombinant human (rh) IL-18 given with ofatumumab was undertaken in patients with CD20 lymphoma who had undergone high-dose chemotherapy and autologous peripheral blood stem cell transplantation...
April 2018: Journal of Immunotherapy
https://www.readbyqxmd.com/read/29512131/b-cells-in-multiple-sclerosis-therapy-a-comprehensive-review
#11
REVIEW
R Rahmanzadeh, M S Weber, W Brück, S Navardi, M A Sahraian
For decades, B cells were ignored in multiple sclerosis (MS) pathogenesis, and the disease was always regarded as a T cell-mediated disorder. Recent evidence shows that there is an antigen-driven B-cell response in the central nervous system of patients with MS, and memory B cells/plasma cells are detectable in MS lesions. The striking efficacy of B cell-depleting therapies in reducing the inflammatory activity of the disease highlights that B cells may play more pathogenetic roles than expected. B cells express several unique characteristic markers on their surface, for example, CD19, CD20 molecules, that provide selective targets for monoclonal antibodies...
June 2018: Acta Neurologica Scandinavica
https://www.readbyqxmd.com/read/29473343/central-nervous-system-relapse-in-patients-over-80-years-with-diffuse-large-b-cell-lymphoma-an-analysis-of-two-lysa-studies
#12
Aurélie Cabannes-Hamy, Frederic Peyrade, Fabrice Jardin, Jean-François Emile, Vincent Delwail, Nicolas Mounier, Corinne Haioun, Aurore Perrot, Olivier Fitoussi, Diane Lara, Richard Delarue, Marc André, Fritz Offner, Hervé Ghesquières, Laurent Pascal, Carole Soussain, Julien Lazarovici, Jean-Marc Schiano, Philippe Gaulard, Hervé Tilly, Catherine Thieblemont
CNS relapse is reported in 2-5% of diffuse large B-cell lymphoma (DLBCL) patients, dramatically decreasing overall survival (OS). Very few studies address incidence and risk factors of CNS relapse in very elderly patients, a challenging population to treat given their commonly associated comorbidities. A retrospective analysis was performed of 270 DLBCL patients >80 years treated between 2004 and 2013 in two multicentre phase II LYSA trials (LNH03-7B, LNH09-7B) evaluating the addition of rituximab or ofatumumab to mini-CHOP as front-line therapy...
March 2018: Cancer Medicine
https://www.readbyqxmd.com/read/29465308/cll2-bxx-phase-ii-trials-sequential-targeted-treatment-for-eradication-of-minimal-residual-disease-in-chronic-lymphocytic-leukemia
#13
Paula Cramer, Julia von Tresckow, Jasmin Bahlo, Anja Engelke, Petra Langerbeins, Anna-Maria Fink, Kirsten Fischer, Clemens-Martin Wendtner, Karl-Anton Kreuzer, Stephan Stilgenbauer, Sebastian Böttcher, Barbara Eichhorst, Michael Hallek
AIM: Four Phase II trials (clinical trials numbers: NCT02345863, NCT02401503, NCT02445131 and NCT02689141) evaluate a different combination of targeted agents in an all-comer population of approximately 60 patients with chronic lymphocytic leukemia irrespective of prior treatment, physical fitness and genetic risk factors. Patients with a higher tumor load start with a debulking treatment with bendamustine. The subsequent induction and maintenance treatment with an anti-CD20 antibody (obinutuzumab or ofatumumab) and a targeted oral agent (ibrutinib, idelalisib or venetoclax) are continued until achievement of a complete response and minimal residual disease negativity...
March 2018: Future Oncology
https://www.readbyqxmd.com/read/29439647/combination-of-ofatumumab-and-fresh-frozen-plasma-in-hypocomplementemic-systemic-lupus-erythematosus-a-case-report
#14
F Speth, C Hinze, R Häfner
No abstract text is available yet for this article.
January 1, 2018: Lupus
https://www.readbyqxmd.com/read/29436729/adverse-events-linked-with-the-use-of-chimeric-and-humanized-anti-cd20-antibodies-in-children-with-idiopathic-nephrotic-syndrome
#15
Alice Bonanni, Marta Calatroni, Matteo D'Alessandro, Sara Signa, Enrica Bertelli, Michela Cioni, Eddi Di Marco, Roberto Biassoni, Gianluca Caridi, Giulia Ingrasciotta, Roberta Bertelli, Armando Di Donato, Maurizio Bruschi, Alberto Canepa, Giorgio Piaggio, Pietro Ravani, Gian Marco Ghiggeri
AIMS: Anti-CD20 antibodies are increasingly being used to treat idiopathic nephrotic syndrome (INS) in children. While they may allow steroid and calcineurin inhibitor withdrawal, repeated infusions of anti-CD20 antibodies are often required to maintain remission. Data on their potential toxicity in INS are needed, to consider repeated infusions. METHODS: We investigated the side effects associated with the use of rituximab (a chimeric antibody; 130 patients) and ofatumumab (a humanized antibody; 37 patients) in children with INS (steroid-dependent and steroid/calcineurin inhibitor-dependent disease) treated at a national referral centre over a 9-year period (400 treatments; follow-up 1-9 years)...
February 13, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29348316/evaluation-of-next-generation-anti-cd20-antibodies-labeled-with-zirconium-89-in-human-lymphoma-xenografts
#16
Jason T Yoon, Mark S Longtine, Bernadette V Marquez-Nostra, Richard L Wahl
Radioimmunotherapies with monoclonal antibodies (mAbs) to the B-lymphocyte antigen 20 (CD20) are effective treatments for B-cell lymphomas, but United States Food and Drug Administration (FDA)-approved radioimmunotherapies exclusively use radiolabeled murine antibodies, potentially limiting re-dosing. The FDA recently approved two unlabeled anti-CD20 monoclonal antibodies, obinutizumab and ofatumumab, termed "next generation" as they are humanized (obinituzumab) or fully human (ofatumumab), thus potentially allowing a greater potential for re-dosing than with previous generation anti-CD20 antibodies, including rituximab (chimeric) and tositumumab (murine) which contain more murine peptide sequences...
January 18, 2018: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/29298144/ofatumumab-for-ttp-in-a-patient-with-anaphylaxis-associated-with-rituximab
#17
LETTER
Maeve P Crowley, Vickie McDonald, Marie Scully
No abstract text is available yet for this article.
January 4, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29284380/potential-cost-savings-by-dose-down-rounding-of-monoclonal-antibodies-in-a-community-cancer-center
#18
Mehmet S Copur, Curtis Gnewuch, Megan Schriner, Mark Tharnish, Mithat Gonen, Monica McDonald, Jami Kezeor, Ryan C Ramaekers, Dron Gauchan, Douglas Clark, Lois Greenwalt, Mary Mickey, Max Norvell
Purpose Increasing new cancer cases and approval of effective but expensive new drugs extending survival have led to unsustainable cancer care costs. Potential cost savings by a hypothetical dose down-rounding project of monoclonal antibodies at a community-based cancer center is presented. Methods From October 2014 through October 2015, metastatic cancer patients receiving monoclonal antibodies at CHI-Health St Francis Cancer Treatment Center in Grand Island, Nebraska, were identified through electronic health records...
March 2018: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/29212732/the-role-of-rituximab-in-chronic-lymphocytic-leukemia-treatment-and-the-potential-utility-of-biosimilars
#19
REVIEW
Jennifer R Brown, Florence Cymbalista, Jeff Sharman, Ira Jacobs, Pilar Nava-Parada, Anthony Mato
Chronic lymphocytic leukemia (CLL) is managed with observation for asymptomatic or clinically silent disease; pharmacologic intervention is generally required for symptomatic patients with clinically significant adenopathy or cytopenia. In the front-line treatment of CLL, the current standard-of-care includes chemotherapy in combination with an anti-CD20 monoclonal antibody (e.g., rituximab, ofatumumab, or obinutuzumab) or ibrutinib as single agent. Despite the evolving treatment paradigm toward targeted therapy, it is likely that rituximab (plus chemotherapy), with or without targeted agents, will retain a significant role in CLL treatment...
December 6, 2017: Oncologist
https://www.readbyqxmd.com/read/29207227/first-case-report-of-using-ofatumumab-in-kidney-transplantation-ab0-incompatible
#20
Nicoletta Mancianti, Giulio Monaci, Fabio Rollo, Paola Buracchi, Andrea Guarnieri, Marina Di Luca, Mauro Martello, Guido Garosi
Modern methods for desensitization protocol rely heavily on combined apheresis therapy and Rituximab, a chimeric (murine and human) anti-CD20 antibody used in AB0 incompatible kidney transplants. Severe infusion related reactions due to the administration of Rituximab are reported in 10% of patients. These adverse reactions may hinder the completion of the desensitization protocol. Therefore, it's useful to test alternative B cell depleting therapies. Our clinical case focuses on a 41-year-old male who developed an adverse infusion reaction following the administration of Rituximab and was given Ofatumumab as an alternative treatment...
December 5, 2017: Giornale Italiano di Nefrologia: Organo Ufficiale Della Società Italiana di Nefrologia
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