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Rituximab biology

Lieke Tweehuysen, Alfons A den Broeder, Kiki Schraa, Mihai G Netea, Frank H J van den Hoogen, Leo A B Joosten
OBJECTIVES: To investigate ex-vivo drug-inhibited cytokine production before the start of a biological DMARD (bDMARD) as predictor of treatment response in rheumatoid arthritis (RA). METHODS: In a prospective RA cohort study [BIO-TOP], blood samples were obtained from patients before the start of a bDMARD (abatacept, adalimumab, etanercept, rituximab or tocilizumab). Peripheral blood mononuclear cells were pre-incubated for 1 hour with the therapeutic in-vivo concentration of the bDMARD and stimulated for 24 hours with heat-killed Candida albicans or Pam3Cys...
February 7, 2019: Clinical and Experimental Rheumatology
Su Jung Kim, Kwang Woo Kim, Yeon Kyeong Shin, Ji Woong Kwon, Hye Young Kang, Yoon A Park, Ji Young Shin, So Young Kim, Won Yong Han
BACKGROUND: CT-P10 is the first biosimilar of the anti-CD20 monoclonal antibody, rituximab. CT-P10 is currently available in over 51 countries worldwide, where it is approved in the same indications as its reference product rituximab. In-use stability studies are conducted for biologics to determine how conditions (e.g., temperature, light, humidity, length of time stored) affect drug quality following dilution and storage in infusion bags. OBJECTIVE: We evaluated the in-use stability of CT-P10 for intravenous infusion stored diluted in infusion bags over longer periods than currently recommended by manufacturer guidelines...
February 11, 2019: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Charlotte Lees, Colm Keane, Maher K Gandhi, Jay Gunawardana
Primary mediastinal B-cell lymphoma (PMBCL) is a distinct disease closely related to classical nodular sclerosing Hodgkin lymphoma. Conventional diagnostic paradigms utilising clinical, morphological and immunophenotypical features can be challenging due to overlapping features with other B-cell lymphomas. Reliable diagnostic and prognostic biomarkers that are applicable to the conventional diagnostic laboratory are largely lacking. Nuclear factor kappa B (NF-κB) and Janus kinase/signal transducers and activators of transcription (JAK-STAT) signalling pathways are characteristically dysregulated in PMBCL and implicated in several aspects of disease pathogenesis, and the latter pathway in host immune evasion...
February 10, 2019: British Journal of Haematology
Alessio Buonavoglia, Patrizia Leone, Rosanna Dammacco, Giuseppe Di Lernia, Massimo Petruzzi, Domenico Bonamonte, Angelo Vacca, Vito Racanelli, Franco Dammacco
Pemphigus diseases (PDs) and mucous membrane pemphigoid (MMP) are a group of immune-mediated mucocutaneous disorders clinically characterized by the formation of blisters, erosions and ulcers. The skin and mucous membranes are predominantly affected, with the oropharyngeal mucosa as the initially involved site. Ocular involvement is also a frequent feature of these diseases. Because of the considerable overlap in their clinical presentations, the diagnosis of PDs vs. MMP can be challenging. A recognition of their specific immunological and histopathologic features is crucial in the differential diagnosis...
February 7, 2019: Autoimmunity Reviews
Sanne E Detiger, A Faiz Karim, Robert M Verdijk, P Martin van Hagen, Jan A M van Laar, Dion Paridaens
IgG4-related disease (IgG4-RD) is an immune-mediated systemic fibro inflammatory disease. Treatment of IgG4-related orbital disease (IgG4-ROD) is often indicated to relieve the symptoms and to prevent complications. For IgG4-ROD, no international formal treatment guidelines are available and the optimal treatment strategy is uncertain. In this systematic review, we describe the efficacy of conventional and biologic disease-modifying antirheumatic drugs (DMARDs) in IgG4-ROD. A systematic search of Embase, Medline, Web-of-Science, PubMed publisher, Cochrane and Google Scholar was performed for treatment outcomes in IgG4-ROD...
February 7, 2019: Acta Ophthalmologica
Yannick Degboé, Benjamin Rauwel, Michel Baron, Jean-Frédéric Boyer, Adeline Ruyssen-Witrand, Arnaud Constantin, Jean-Luc Davignon
Macrophages contribute to the pathogenesis of rheumatoid arthritis (RA). They can display different states of activation or "polarization," notably the so-called inflammatory "M1" and the various alternative "M2" polarizations, characterized by distinct functions. Data regarding the effects of RA anti-cytokine biological disease-modifying anti-rheumatic drugs (bDMARDs) on macrophage polarization are scarce. We aimed to assess in vitro modulation of macrophage polarization by bDMARDs targeting pro-inflammatory cytokines in RA...
2019: Frontiers in Immunology
Çağlar Çağlayan, Jordan S Goldstein, Turgay Ayer, Ashish Rai, Christopher R Flowers
BACKGROUND: Despite effective therapies, outcomes for diffuse large B-cell lymphoma (DLCBL) remain heterogeneous in older individuals due to comorbid diseases and variations in disease biology. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, the authors conducted a multistate survival analysis of 11,780 patients with DLBCL who were aged ≥65 years at the time of diagnosis (2002-2009). Cox proportional hazards models were used to specify the impact of prognostic factors on overall survival and cause-specific deaths, and the Aalen-Johansen estimator was used to project the course of DLBCL over time with or without standard therapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)...
February 1, 2019: Cancer
Durga Prasanna Misra, Anupam Wakhlu, Vikas Agarwal, Debashish Danda
Takayasu arteritis (TA) is a challenging large vessel vasculitis to treat. Distinguishing disease activity from vascular damage is difficult, often relying on clinician judgement aided by composite clinical disease activity indices with angiographic evidence of vessel wall thickening or vessel wall hypermetabolism demonstrable on positron emission tomography computerized tomography (PET CT). Glucocorticoids form the mainstay of remission induction. While other conventional disease modifying anti-rheumatic drugs (cDMARDs) or biologic DMARDs (bDMARDs) are commonly used, evidence supporting their usefulness is sparse and generally of low quality...
January 2019: International Journal of Rheumatic Diseases
E Baudry, S Huguet, A L Couderc, P Chaibi, F Bret, C Verny, S Weill, O Madar, S Urien, Keyvan Rezai
BACKGROUND: Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma in elderly patients, and R-CHOP chemotherapy is the standard treatment protocol for DLBCL. Elderly patients (often defined as 75 years of age) are treated with anticancer drugs with precaution; however, the pharmacokinetics and pharmacodynamics (PK and PD) of these agents have not been thoroughly investigated in this population. In this study, we investigated the PK of cyclophosphamide (CP) and doxorubicin (DOXO) in elderly patients in order to verify if there is an influence of age on the PK of these anticancer drugs...
January 28, 2019: Cancer Chemotherapy and Pharmacology
José Luis Andréu Sánchez, Mónica Fernández Castro, Petra Díaz Del Campo Fontecha, Héctor Corominas, Francisco Javier Narváez García, José Rosas Gómez de Salazar, Íñigo Rua-Figueroa Fernández de Larrinosa, Miguel Ángel Abad Hernández, María Noelia Álvarez Rivas, Javier Del Pino Montes, Félix Manuel Francisco Hernández, María Ángeles Gantes Pedraza, Martín Gerardo Greco Merino, María Vanesa Hernández, María Victoria Navarro Compán, Juan Alberto Paz Solarte, Fredeswinda I Romero Bueno, Hye Sang Park, Francisca Sivera Mascaró
OBJECTIVE: To formulate SER recommendations for the use of biological agents in primary Sjögren's syndrome (pSS). METHODS: Relevant clinical research questions were identified on the use of biological agents in pSS. The clinical questions were reformulated into 4PICO questions. A search strategy was designed and a review of the scientific evidence of studies published until May 2017 was carried out. The scientific evidence available was systematically reviewed...
January 22, 2019: Reumatología Clinica
Jacques-Eric Gottenberg, Jacques Morel, Elodie Perrodeau, Thomas Bardin, Bernard Combe, Maxime Dougados, Rene-Marc Flipo, Alain Saraux, Thierry Schaeverbeke, Jean Sibilia, Martin Soubrier, Olivier Vittecoq, Gabriel Baron, Arnaud Constantin, Philippe Ravaud, Xavier Mariette
OBJECTIVE: To compare the effectiveness and safety of three non-tumour necrosis factor (TNF) α inhibitors (rituximab, abatacept, and tocilizumab) in the treatment of rheumatoid arthritis. DESIGN: Population based prospective study. SETTING: 53 university and 54 non-university clinical centres in France. PARTICIPANTS: 3162 adults (>18 years) with rheumatoid arthritis according to 1987 American College of Rheumatology criteria, enrolled in one of the three French Society of Rheumatology registries; who had no severe cardiovascular disease, active or severe infections, or severe immunodeficiency, with follow-up of at least 24 months...
January 24, 2019: BMJ: British Medical Journal
Thomas Frisell, Mats Dehlin, Daniela Di Giuseppe, Nils Feltelius, Carl Turesson, Johan Askling
Objectives: Current guidelines rank abatacept, rituximab, tocilizumab and TNF-inhibitors (TNFi) as having equal effectiveness for the treatment of RA, at least as second line therapies. These recommendations are mainly based on meta-analysis of randomized controlled trials, with few direct drug-drug comparisons. Our objective was to compare the real-world absolute and relative effectiveness among RA patients starting any of the available biologic DMARDs (bDMARDs). Methods: We used the Swedish Rheumatology Register to identify patients with RA initiating TNFi, rituximab, abatacept or tocilizumab in 2010-2016 as first bDMARD (n = 9333), or after switch from TNFi as first bDMARD (n = 3941)...
January 21, 2019: Rheumatology
Natalia Genere, Marius N Stan
Graves' orbitopathy is a debilitating disorder which occurs in patients with autoimmune thyroid disease, mainly Graves' disease, and adds layers of complexity to management of both conditions. We conducted a comprehensive review of literature for publications relating to established and new management options for Graves' orbitopathy and have summarized key articles in this review. Initial evaluation of patients with Graves' disease should also include clinical evaluation for orbitopathy. If eye disease is present, patients are best managed by a multi-specialty team including an endocrinologist and ophthalmologist...
January 18, 2019: Drugs
A R J V Vossen, C B Ardon, H H van der Zee, E Lubberts, E P Prens
BACKGROUND: Biologics targeting inflammatory mediators are able to clinically improve hidradenitis suppurativa (HS). However, their clinical efficacy shows great inter-patient variability in daily practice. OBJECTIVE: To investigate the anti-inflammatory potency of a selection of currently available biologics for the treatment of HS in an ex vivo skin culture system using lesional HS biopsies. METHODS: Lesional skin samples of ten HS patients and skin samples of five healthy controls were cultured ex vivo and exposed to prednisolone or biologics targeting TNF-α, IL-17A, IL-12/23p40, or CD20, respectively adalimumab, infliximab, secukinumab, ustekinumab and rituximab...
January 18, 2019: British Journal of Dermatology
Juliana Miranda de Lucena Valim, Fernanda Gomes Gonçalves Chaer, Fernanda D'Oliveira Guimarães da Silveira, Verônica Palmiro da Silva E Lima, Branca Dias Batista de Souza
Aim: To assess drug switching, rates of remission and disease activity in Brazilian patients with rheumatoid arthritis (RA) treated with biologic agents. Materials & methods: Using a retrospective method, a total of 94 adult patients were included. Results: Anti-TNF was the first choice therapy in 85 (90.4%) patients. After an average of 8 years of follow-up, 55 (59%) patients were taking anti-TNF, 18 (19%) abatacept, eight (9%) tocilizumab and 13 (14%) rituximab...
January 2019: Future Science OA
Peter Chin-Hong
Individuals with HIV infection are living longer, and are at risk of autoimmune disorders and cancers associated with aging. Many of these conditions are treated with immunobiologic agents that affect immune function and may increase risk of opportunistic infections (OIs) and other immune disorders in individuals with HIV infection. For example, tumor necrosis factor-alpha inhibitors, used to treat such disorders as Crohn's disease, are associated with risk of tuberculosis and histoplasmosis. Rituximab, used to treat lymphoma, has been associated with progressive multifocal leukoencephalopathy due to JC virus and reactivation of other viral infections...
January 2019: Topics in Antiviral Medicine
Vincenzo Venerito, Giuseppe Lopalco, Fabio Cacciapaglia, Marco Fornaro, Florenzo Iannone
The current paradigm in the management of rheumatoid arthritis (RA) is to treat patients in the early stage of the disease (ERA). Previous meta-analysis-based mixed treatment comparisons (MTCs), aimed to identify the most effective drugs in ERA, are biased by the wide "window" of early definition, ranging from 6 months to 2 years. The aim of this study was to estimate through a Bayesian Network Meta-Analysis which biologics or small molecules are more likely to achieve a 1-year good clinical response in ERA patients with disease duration < 1 year...
January 10, 2019: Clinical Rheumatology
Vally Kommineni, Matthew Markert, Zhongjie Ren, Sreenath Palle, Berenice Carrillo, Jasmine Deng, Armando Tejeda, Somen Nandi, Karen A McDonald, Sylvain Marcel, Barry Holtz
N-glycosylation has been shown to affect the pharmacokinetic properties of several classes of biologics, including monoclonal antibodies, blood factors, and lysosomal enzymes. In the last two decades, N-glycan engineering has been employed to achieve a N-glycosylation profile that is either more consistent or aligned with a specific improved activity (i.e., effector function or serum half-life). In particular, attention has focused on engineering processes in vivo or in vitro to alter the structure of the N-glycosylation of the Fc region of anti-cancer monoclonal antibodies in order to increase antibody-dependent cell-mediated cytotoxicity (ADCC)...
January 7, 2019: International Journal of Molecular Sciences
Nizar Abdulateef Al Ani, Faiq I Gorial, Saad Al-Sulaitti, Jasmine Abbas Humadi, Nabaa Ihsan Awadh, Mohamed Mounir, Yasser El Dershaby, Heather Jones, Nancy Sunna
Biologic therapies are an important option in the treatment of patients with rheumatic disease. As the development of potential biosimilars increases, many countries are following the guidelines developed by the WHO, European Medicines Agency, or US Food and Drug Administration to create country-specific regulations for the review and approval of these products. Iraq does not yet have such regulations, and this presents a potential safety concern for patients. The analytical, nonclinical, and clinical data requirements for approval of a potential biosimilar are specific and scientifically rigorous...
2019: Open Access Rheumatology: Research and Reviews
A Heiligenhaus, K Minden, C Tappeiner, H Baus, B Bertram, C Deuter, I Foeldvari, D Föll, M Frosch, G Ganser, M Gaubitz, A Günther, C Heinz, G Horneff, C Huemer, I Kopp, C Lommatzsch, T Lutz, H Michels, T Neß, U Neudorf, U Pleyer, M Schneider, H Schulze-Koops, S Thurau, M Zierhut, H W Lehmann
BACKGROUND: Uveitis in juvenile idiopathic arthritis (JIAU) is frequently associated with the development of complications and visual loss. Topical corticosteroids are the first line therapy, and disease modifying anti-rheumatic drugs (DMARDs) are commonly used. However, treatment has not been standardized. METHODS: Interdisciplinary guideline were developed with representatives from the German Ophthalmological Society, Society for Paediatric Rheumatology, Professional Association of Ophthalmologists, German Society for Rheumatology, parents' group, moderated by the Association of the Scientific Medical Societies in Germany...
December 4, 2018: Seminars in Arthritis and Rheumatism
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