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Rituximab biology

Eva-Maria Didden, Yann Ruffieux, Noemi Hummel, Orestis Efthimiou, Stephan Reichenbach, Sandro Gsteiger, Axel Finckh, Christine Fletcher, Georgia Salanti, Matthias Egger
BACKGROUND: Decision makers often need to assess the real-world effectiveness of new drugs prelaunch, when phase II/III randomized controlled trials (RCTs) but no other data are available. OBJECTIVE: To develop a method to predict drug effectiveness prelaunch and to apply it in a case study in rheumatoid arthritis (RA). METHODS: The approach 1) identifies a market-approved treatment ( S) currently used in a target population similar to that of the new drug ( N); 2) quantifies the impact of treatment, prognostic factors, and effect modifiers on clinical outcome; 3) determines the characteristics of patients likely to receive N in routine care; and 4) predicts treatment outcome in simulated patients with these characteristics...
August 2018: Medical Decision Making: An International Journal of the Society for Medical Decision Making
Vladimira V Boyadzieva, Nikolay Stoilov, Rumen M Stoilov, Konstantin Tachkov, Maria Kamusheva, Konstantin Mitov, Guenka I Petrova
Biological medicines are considered as a cornerstone in the therapy of rheumatoid arthritis (RA). They change the course of the disease and improve the quality of life of patients. To this date there has been no study comparing the quality of life of and cost of RA therapy in Bulgaria. This fact is what provoked our interest toward this research. The aim of this study is to analyse the cost and quality of life of patients with RA threated with biological medicines in Bulgaria. This is an observational, real life study of 124 patients treated with biological medicines during 2012-2016 at the University hospital "St...
2018: Frontiers in Pharmacology
Samanan Intongkam, Parinya Samakarnthai, Rattapol Pakchotanon, Pongthorn Narongroeknawin, Paijit Assavatanabodee, Sumapa Chaiamnuay
OBJECTIVES: The aims of this study were to assess efficacy and safety of the hepatitis B vaccination in rheumatoid arthritis (RA) patients receiving conventional and/or biological disease-modifying antirheumatic drugs (DMARDs). METHODS: A prospective open-label study was conducted. Of 46 RA patients, 33 received only conventional synthetic DMARDs, and 13 received both conventional synthetic DMARDs and biological DMARDs, and 9 healthy age- and sex-matched control subjects were vaccinated with 20 μg recombinant hepatitis B vaccine (EuVax B) at weeks 0, 4, and 24...
July 27, 2018: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
Ioannis Parodis, Angie H Lopez Benavides, Agneta Zickert, Susanne Pettersson, Sonia Möller, Elisabet Welin Henriksson, Anne Voss, Iva Gunnarsson
OBJECTIVE: Accumulating evidence supports an impaired health-related quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE). We investigated the effects of two biologic treatments on SLE patients' HRQoL. METHODS: SLE patients from the Karolinska University Hospital treated with belimumab (n=34) or rituximab (n=35) were included; Swedish population-based age- and sex-matched norms served as controls. Data were collected prospectively at treatment initiation and at months 3, 6, 12 and 24; these included the SF-36, FACIT-Fatigue, EQ-5D, and Stanford HAQ-DI...
July 28, 2018: Arthritis Care & Research
Carolin Beuker, Antje Schmidt, Daniel Strunk, Peter B Sporns, Heinz Wiendl, Sven G Meuth, Jens Minnerup
Primary angiitis of the central nervous system (PACNS) represents a rare inflammatory disease affecting the brain and spinal cord. Stroke, encephalopathy, headache and seizures are major clinical manifestations. The diagnosis of PACNS is based on the combination of clinical presentation, imaging findings (magnetic resonance imaging and angiography), brain biopsy, and laboratory and cerebral spinal fluid (CSF) values. PACNS can either be confirmed by magnetic resonance angiography (MRA)/conventional angiography or tissue biopsy showing the presence of typical histopathological patterns...
2018: Therapeutic Advances in Neurological Disorders
Kohei Okubo, Koji Ikeda, Ayaka Oaku, Yuki Hiruta, Kenichi Nagase, Hideko Kanazawa
Recently, the importance of biopharmaceuticals in medical treatments has been increasing, and effective protein purification methods are strongly required for their production. In the present study, a temperature-responsive solid-phase extraction (SPE) column was developed for the purification of proteins without affecting their bioactivity. A temperature-responsive polymer hydrogel-modified stationary phase was prepared by coating aminopropyl silica beads (average diameter, 40-64 μm) with poly(N-isopropylacrylamide) (PNIPAAm)-based thermoresponsive hydrogels...
July 9, 2018: Journal of Chromatography. A
Tao Gu, Alex Mutebi, Bradley S Stolshek, Hiangkiat Tan
OBJECTIVES: To estimate total costs among patients with rheumatoid arthritis (RA) who persisted on or switched from newly initiated biologic therapy. STUDY DESIGN: A retrospective claims database analysis. METHODS: This analysis included adults in the HealthCore Integrated Research Database with RA who initiated treatment with a biologic for RA (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, or tocilizumab) between January 2009 and November 2014...
July 2018: American Journal of Managed Care
Iciar Cañamares-Orbis, Leticia Merino, Jorge López, Irene Llorente, Alberto García-Vadillo, Esther Ramirez, Juan Pedro López-Bote, Juana Benedí, Cecilia Muñoz-Calleja, José M Álvaro-Gracia, Santos Castañeda, Isidoro González-Álvaro
BACKGROUND/OBJECTIVE: There is evidence supporting that there are no relevant clinical differences between dosing rituximab 1000 mg or 2000 mg per cycle in rheumatoid arthritis (RA) patients in clinical trials, and low-dose cycles seem to have a better safety profile. Our objective was to describe the pattern of use of rituximab in real-life practice conditions. METHODS: Rituximab for RA in clinical practice (RITAR) study is a retrospective cohort study from 2005 to 2015...
July 19, 2018: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
L Missounga, J Iba Ba, I R Nseng Nseng Ondo, M I C Nziengui Madjinou, D Mwenpindi Malekou, E G Mouendou Mouloungui, J B Boguikouma
OBJECTIVE: to clarify the eligibility criteria for biotherapies in patients with chronic inflammatory rheumatism (CIR) in sub-Saharan Africa and to describe the characteristics of the first 8 patients treated with biotherapy in Gabon. MATERIALS AND METHODS: Patients who responded inadequately to treatments by cDMARDs (EULAR criteria) had a face-to-face interview to inform them about and obtain their consent to biotherapy for at least 3 months, with details of the cost and side effects of each available biotherapy and a certificate of "necessity of biotherapy"...
May 1, 2018: Médecine et Santé Tropicales
James L Rubenstein, Huimin Geng, Eleanor J Fraser, Paul Formaker, Lingjing Chen, Jigyasa Sharma, Phoebe Killea, Kaylee Choi, Jenny Ventura, John Kurhanewicz, Clifford Lowell, Jimmy Hwang, Patrick Treseler, Penny K Sneed, Jing Li, Xiaomin Wang, Nianhang Chen, Jon Gangoiti, Pamela N Munster, Bertil Damato
There is an unmet need for effective biological therapies for relapsed central nervous system (CNS) lymphoma. Lenalidomide is active in activated B-cell type diffuse large B-cell lymphoma and rituximab is effective in CNS lymphoma. These observations are the basis for this first trial of an immunomodulatory drug as monotherapy in CNS lymphoma, and, in patients with inadequate responses to lenalidomide, with rituximab. In an independent cohort, we evaluated lenalidomide maintenance after salvage with high-dose methotrexate or focal irradiation in relapsed primary CNS lymphoma (PCNSL)...
July 10, 2018: Blood Advances
Christina G Katsiari, Theodora Simopoulou, Ioannis Alexiou, Lazaros I Sakkas
Systemic sclerosis (SSc) is a chronic systemic disease characterized by microvasculopathy, immune activation, and extensive collagen deposition. Microvasculopathy and immune activation occur very early in the disease process. Evidence from animal models and in vitro studies indicate that T-cells and B-cells activate fibroblasts to produce collagen. Traditional immunosuppressants, cyclophosphamide(CyP), methotrexate(MTX), and more recently mycophenolate mofetil(MMF), may prove more effective if used very early in the disease course...
July 9, 2018: Human Vaccines & Immunotherapeutics
Naoya Toriu, Naoki Sawa, Masahiko Oguro, Hiroki Mizuno, Yoichi Oshima, Eiko Hasegawa, Keiichi Sumida, Tatsuya Suwabe, Masahiro Kawada, Toshiharu Ueno, Noriko Hayami, Akinari Sekine, Rikako Hiramatsu, Masayuki Yamanouchi, Junichi Hoshino, Kenmei Takaichi, Kenichi Ohashi, Takeshi Fujii, Motoko Yanagita, Yoshifumi Ubara
Cryoglobulinemic vasculitis (CV) presents with systemic manifestations, including renal disease, arthritis, peripheral neuropathy, and muscle weakness. We encountered two patients who developed severe nephrotic range proteinuria; however, extrarenal manifestations were not noted during the clinical course. A renal biopsy revealed typical membranoproliferative glomerulonephritis (MPGN) with huge thrombus-like endothelial deposits and predominant IgM positivity, but electron microscopy did not reveal any definite microtubules...
2018: Internal Medicine
Thomas A Ollila, Adam J Olszewski
Diffuse large B cell lymphoma (DLBCL) arises from extranodal organs in about 30% of cases. Its prognosis and risk of recurrence in the central nervous system (CNS) vary according to the primary site of origin. Recent studies begin to clarify these differences using molecular classification. Testicular, breast, and uterine DLBCL (as well as possibly primary cutaneous DLBCL, leg-type) share a high prevalence of the non-germinal center B cell (non-GCB) phenotype and the MYD88/CD79B-mutated (MCD) genotype. These biologic features, which resemble primary CNS lymphoma, may underlie their stage-independent propensity for CNS involvement...
June 21, 2018: Current Treatment Options in Oncology
Peter S Linsley, Carla J Greenbaum, Mario Rosasco, Scott Presnell, Kevan C Herold, Matthew J Dufort
Biologic treatment of type 1 diabetes (T1D) with agents including anti-CD3 (otelixizumab and teplizumab), anti-CD20 (rituximab), LFA3Ig (alafacept), and CTLA4Ig (abatacept) results in transient stabilization of insulin C-peptide, a surrogate for endogenous insulin secretion. With the goal of inducing more robust immune tolerance, we used systems biology approaches to elucidate mechanisms associated with C-peptide stabilization in clinical trial blood samples from new-onset T1D subjects treated with the B cell-depleting drug, rituximab...
June 21, 2018: Genes and Immunity
Diego Strianese
PURPOSE: To present an update on the efficacy and safety of immunosuppressive therapy for thyroid eye disease (TED) and to offer a general recommendation for management of TED, in light of these reports. METHODS: Data were retrieved from a literature search on PubMed, using the following words: thyroid eye disease, immunosuppressant, corticosteroid, methotrexate, azathioprine, cyclosporine, cyclophosphamide, rituximab, etanercept, adalimumab, tocilizumab, teprotumumab, adverse effects, side effects, and complications...
July 2018: Ophthalmic Plastic and Reconstructive Surgery
Timothy M Pierpont, Candice B Limper, Kristy L Richards
Rituximab is a chimeric mouse/human monoclonal antibody (mAb) therapy with binding specificity to CD20. It was the first therapeutic antibody approved for oncology patients and was the top-selling oncology drug for nearly a decade with sales reaching $8.58 billion in 2016. Since its initial approval in 1997, it has improved outcomes in all B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. Despite widespread use, most mechanistic data have been gathered from in vitro studies while the roles of the various response mechanisms in humans are still largely undetermined...
2018: Frontiers in Oncology
Sarah Brown, Colin C Everett, Kamran Naraghi, Claire Davies, Bryony Dawkins, Claire Hulme, Christopher McCabe, Sue Pavitt, Paul Emery, Linda Sharples, Maya H Buch
BACKGROUND: Rheumatoid arthritis (RA), the most common autoimmune disease in the UK, is a chronic systemic inflammatory arthritis that affects 0.8% of the UK population. OBJECTIVES: To determine whether or not an alternative class of biologic disease-modifying antirheumatic drugs (bDMARDs) are comparable to rituximab in terms of efficacy and safety outcomes in patients with RA in whom initial tumour necrosis factor inhibitor (TNFi) bDMARD and methotrexate (MTX) therapy failed because of inefficacy...
June 2018: Health Technology Assessment: HTA
Shreeya Patel, Laura Ross, Shereen Oon, Mandana Nikpour
Primary angiitis of the central nervous system (PACNS) is a rare autoimmune vasculitis affecting the brain and spinal cord. Treatment with biological agents has revolutionised the treatment of many rheumatic conditions but there is scant literature regarding the use of biological agents in PACNS. We present three cases of PACNS treated with rituximab, including two cases of relapsed disease, and a literature review suggesting a role for rituximab in this condition.
June 2018: Internal Medicine Journal
W Ennis James, Robert Baughman
Treatment of sarcoidosis recommendations are often based on clinical experience and expert opinion. However, there are an increasing number of studies which are providing evidence to support decisions regarding treatment. Areas covered: Several studies have identified factors associated with increased risk for organ failure or death ('danger'). There have been several studies focused on the role of treatment to improve quality of life for the patient. Sarcoidosis treatment often follows a progression, based on response...
July 2018: Expert Review of Clinical Pharmacology
Iñigo Bermejo, Shijie Ren, Emma Simpson, Mark Clowes, David L Scott, Adam Young, Matt Stevenson
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (Sanofi Genzyme) of sarilumab (SAR; Kevzara® ) to submit evidence of its clinical effectiveness and cost-effectiveness for previously treated moderate or severe rheumatoid arthritis (RA). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a detailed review of the evidence for the clinical effectiveness and cost-effectiveness of the technology, based upon the company's submission to NICE...
June 8, 2018: PharmacoEconomics
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