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V I Kravchenko, A A Chumak, K M Loganovsky, I S Diagil, V F Kuzmenko
A clinical case of the rituximab («Rituksim», «Mabthera») use to treat a man affected by the Chornobyl NPP acci dent with malignant resistant form of myasthenia gravis in conjunction with chronic mixed infection by Toxoplasma, Epstein Barr virus, Cytomegalovirus and Herpes simplex virus is described. In the dynamics of two year's observa tion the clinical efficacy of monoclonal antibodies was shown as the main symptoms stabilization and reducing doses of glucocorticoid and anticholinergic therapy. The positive effect was marked in the nearest and remote peri ods...
December 2017: Problemy Radiat︠s︡iĭnoï Medyt︠s︡yny Ta Radiobiolohiï
Mats Alheim, Lars Wennberg, Ann-Charlotte Wikström
ABO-incompatible (ABOi) kidney transplantation has become an established strategy to increase the number of available living donors. At our center, the conditioning protocol for ABOi patients is based on anti-A/B antibody removal and depletion of B cells with the anti-CD20 mAb rituximab (Mabthera®). It is known that even low amounts of remaining rituximab in serum of patients results in false positive B cell cross match results, masking detection of potentially harmful donor human leukocyte antigen (HLA) specific antibodies...
November 17, 2017: Human Immunology
Andrew Davies, Claude Berge, Axel Boehnke, Anjum Dadabhoy, Pieternella Lugtenburg, Simon Rule, Mathias Rummel, Christine McIntyre, Rodney Smith, Xavier Badoux
Rituximab (MabThera(®)/Rituxan(®)), a chimeric murine/human monoclonal antibody that binds specifically to the transmembrane antigen CD20, was the first therapeutic antibody to enter clinical practice for the treatment of cancer. As monotherapy and in combination with chemotherapy, rituximab has been shown to prolong progression-free survival and, in some indications overall survival, in patients with various B-cell malignancies, while having a well-established and manageable safety profile and a wide therapeutic window...
October 2017: Advances in Therapy
D Brueckner, S Krähenbühl, U Zuber, G Bonkat, O Braissant
AIMS: Production and release of injectable drug solutions are highly regulated since the administration of injectables bypasses natural body barriers. The sterility test is the last opportunity of product quality assessment. However, sterility is currently assessed by visual inspection (VI) that is time consuming and somewhat subjective. Therefore, we assessed isothermal microcalorimetry (IMC) as a replacement for the VI of the filtration based state-of-the-art sterility control. METHODS AND RESULTS: We used ATCC strains and house isolates to artificially contaminate frequently produced monoclonal antibodies (Avastin, Mabthera, Herceptin)...
August 4, 2017: Journal of Applied Microbiology
Dena R Howard, Talha Munir, Lucy McParland, Andy C Rawstron, Anna Chalmers, Walter M Gregory, John L O'Dwyer, Alison Smith, Roberta Longo, Abraham Varghese, Alexandra Smith, Peter Hillmen
BACKGROUND: The conventional frontline therapy for fit patients with chronic lymphocytic leukaemia (CLL) is fludarabine, cyclophosphamide and rituximab (FCR). Rituximab (Mabthera(®), Roche Products Ltd) targets the CD20 antigen, which is expressed at low levels in CLL. The standard dose of rituximab in CLL (375 mg/m(2) in cycle 1 and 500 mg/m(2) in cycles 2-6) was selected based on toxicity data only. Small doses of rituximab (as low as 20 mg) have biological activity in CLL, with an immediate reduction in circulating CLL cells and down-regulation of CD20...
May 2017: Health Technology Assessment: HTA
Shalom A Gurjar, Jeremy P Derrick, Rebecca J Dearman, Robin Thorpe, Simon Hufton, Ian Kimber, Meenu Wadhwa
Traditional antibody dependent cellular cytotoxicity (ADCC) assays use donor derived natural killer (NK) or peripheral blood mononuclear cells, but donor genetic variability and the technically challenging nature of the assay means that alternative in vitro assay formats are required. We explored the utility of two reporter gene cell lines, the J2 and J9, as surrogate effector cells for ADCC assays. Both express the ADCC relevant Fcγ receptor CD16, crosslinking of which leads to firefly luciferase expression...
September 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
Elaine Agyemang, Lorna Bailey, John Talbot
INTRODUCTION: Additional risk minimisation measures (aRMMs) for medicinal products are necessary to address specific important safety issues which may not be practically achieved through routine risk management measures alone. The implementation and determination of effectiveness for aRMMs can be a challenge as it involves multiple stakeholders. It is therefore important to have concise objectives to avoid undue burden on patients, healthcare professionals and the healthcare system. AIM: The aim of this study was to examine how aRMMs are implemented and how effectiveness is assessed in the European Union (EU) using practical examples from Roche Products Limited in the United Kingdom (UK) (referred to as the 'Company')...
2017: Pharmaceutical Medicine
Christina Theodore-Oklota, Louise Humphrey, Christof Wiesner, Gabriel Schnetzler, Stacie Hudgens, Alicyn Campbell
BACKGROUND: A subcutaneous (SC) formulation of rituximab (MabThera(®)/Rituxan(®)) has been developed that could reduce administration time and improve patient satisfaction with treatment. The Rituximab Administration Satisfaction Questionnaire (RASQ) was created to assess patients' perceptions and satisfaction with rituximab SC (RASQ-SC) or rituximab intravenous (RASQ-IV). We assessed the content validity and psychometric properties of RASQ in patients with non-Hodgkin lymphoma. METHODS: Face and content validity of RASQ-SC and RASQ-IV were qualitatively assessed using 60-minute combined concept elicitation and cognitive debriefing interviews...
2016: Patient Preference and Adherence
Norbert Schmitz, Samira Zeynalova, Maike Nickelsen, Roopesh Kansara, Diego Villa, Laurie H Sehn, Bertram Glass, David W Scott, Randy D Gascoyne, Joseph M Connors, Marita Ziepert, Michael Pfreundschuh, Markus Loeffler, Kerry J Savage
PURPOSE: To develop and validate a risk score for relapse in the CNS in patients with diffuse large B-cell lymphoma (DLBCL). PATIENTS AND METHODS: A total of 2,164 patients (18 to 80 years old) with aggressive B-cell lymphomas (80% DLBCL) treated with rituximab and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)-like chemotherapy, who were enrolled in studies from the German High-Grade Non-Hodgkin Lymphoma Study Group and the MabThera International Trial, were analyzed for occurrence of relapse/progression in the CNS...
September 10, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Vikram Gota, Ashwin Karanam, Sanhita Rath, Akanksha Yadav, Prashant Tembhare, P Subramanian, Manju Sengar, Reena Nair, Hari Menon
PURPOSE: Rituximab (MabThera™, Roche) is a chimeric IgG1 monoclonal antibody targeting the CD20 surface antigen on normal and neoplastic B cells. It revolutionized the treatment of non-Hodgkin's lymphoma with superior progression-free and overall survival. However, its prohibitively high cost makes it inaccessible to majority of patients in developing countries. Reditux™ (Dr. Reddy's Laboratories, India), a biosimilar, was introduced in India in 2007 at nearly half the price of the innovator...
August 2016: Cancer Chemotherapy and Pharmacology
Claudia Mueller, Elke Dietel, Severin R Heynen, Heiko Nalenz, Pierre Goldbach, Hanns-Christian Mahler, Johannes Schmidt, Ulla Grauschopf, Karin Schoenhamnmer
MabThera is an essential component of the standard-of-care regimens in the treatment of non-Hodgkin lymphoma and Chronic Lymphatic Leukemia. MabThera for subcutaneous injection is a novel line extension that has been approved by the European Medicines Agency for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. This study aimed to evaluate in-use stability data of MabThera subcutaneous drug-product solution in single-use syringes for subcutaneous administration according to the European Medicines Agency guideline...
May 2015: International Journal of Pharmaceutical Compounding
S Walzer, S Era, A Profico, M Canciani, M Farina, C Ponzetti
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
S Walzer, S Era, A Profico, M Canciani, M Farina, C Ponzetti
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Zdeněk Adam, Jarmila Kissová, Luděk Pour, Marta Krejčí, Eva Ševčíková, Renata Koukalová, Zdeňka Čermáková, Marta Černá, Zdeněk Král, Jiří Mayer
Waldenströms macroglobulinemia which was manifested by muscle pain and anemia. The female patient had suffered from back pain for about 3 years before she came to our clinic. In the last year pain in the muscles of the upper and lower extremities developed in addition to back pain. This led to the suspicion of polymyositis. However this was not confirmed by a special examination. The patient was diagnosed with clearly established infiltration of lympho-plasmacytic lymphoma and 10.8 g/l of type IgM monoclonal immunoglobulin in the bone marrow...
September 2015: Vnitr̆ní Lékar̆ství
(no author information available yet)
Granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis are two types of rapidly fatal necrotizing vasculitis. The standard induction therapy consists of cyclophosphamide (an immunosuppressant) plus a corticosteroid. This treatment significantly prolongs survival but has burdensome adverse effects. After an induction phase lasting 3 to 6 months, cyclophosphamide is replaced by another immunosuppressant such as azathioprine for 2 to 5 years in order to prevent relapse. There is no consensus on an alternative treatment for patients who cannot receive cyclophosphamide...
June 2015: Prescrire International
Minoru Tada, Ken-ichiro Tatematsu, Akiko Ishii-Watabe, Akira Harazono, Daisuke Takakura, Noritaka Hashii, Hideki Sezutsu, Nana Kawasaki
In response to the successful use of monoclonal antibodies (mAbs) in the treatment of various diseases, systems for expressing recombinant mAbs using transgenic animals or plants have been widely developed. The silkworm (Bombyx mori) is a highly domesticated insect that has recently been used for the production of recombinant proteins. Because of their cost-effective breeding and relatively easy production scale-up, transgenic silkworms show great promise as a novel production system for mAbs. In this study, we established a transgenic silkworm stably expressing a human-mouse chimeric anti-CD20 mAb having the same amino acid sequence as rituximab, and compared its characteristics with rituximab produced by Chinese hamster ovary (CHO) cells (MabThera®)...
2015: MAbs
Wei Guo, Wenxian Zhang, Chunshui Liu, Yuanyuan Song, Ou Bai
OBJECTIVES: This study aimed to determine the HBV infection status of 135 patients with DLBCL (diffuse large B cell lymphoma), to analyze the overall survival (OS) and progression-free survival (PFS) of the different HBV infection status groups, and to discuss the relationship between HBV serological test results and the prognosis of DLBCL patients. METHODS: A retrospective analysis was performed of the clinical data, HBV serological test results, and PFS/OS of 135 DLBCL patients who were initially diagnosed and treated with more than 3 cycles of an R-CHOP/CHOP/CHOP-like regimen at our center from January 1, 2008 to December 31, 2012...
2015: PloS One
Željka Škunca, Mara Domimis, Ana Plninc-Peraica, Branimir Jakšić
Diffuse large B-cell lymphoma (DLBCL) is classified as lymphoma and various entities using the gene expression of proteins are classified into three groups. The aim of this study was to clarify the clinical, biological, immunophenotypic and cytogenetic features of DLBCL with translocation t (14; 18) and 8q24/c-MYC. Eleven DLBCL patients with dual translation were monitored during the 2000-2009 period. The characteristics of these patients included morphological, immunohistochemical and cytogenetic analysis...
June 2014: Acta Medica Croatica: C̆asopis Hravatske Akademije Medicinskih Znanosti
C von Frenckell, P Delanaye
Three recently published randomized studies have demonstrated the efficacy of rituximab in the induction and maintenance therapy of ANCA vasculitis. This is a major advance since these types of vasculitis entail a high morbity and mortality.
February 2015: Revue Médicale de Liège
J Meissner, D Tichy, V Katzke, T Kühn, S Dietrich, T Schmitt, M Ziepert, E Kuhnt, T Rixecker, M Zorn, M Witzens-Harig, M Pfreundschuh, A D Ho
BACKGROUND: Chemotherapy-associated ovarian damage comprises not only infertility, but also premature menopause. The latter has been reported as a consequence of alkylating chemotherapy for breast cancer or Hodgkin's lymphoma. In this study, we assessed the long-term impact of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like regimens on ovarian function in patients with aggressive non-Hodgkin lymphoma (NHL). PATIENTS AND METHODS: Long-term survivors after CHOP or CHOP plus etoposide (CHOEP) treatment within the Mabthera International Trial or the NHL-B1 trial of the German NHL Study Group were requested to respond to a questionnaire and to consent to blood sampling for hormone assessment...
August 2015: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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