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https://www.readbyqxmd.com/read/28331294/spotlight-on-blisibimod-and-its-potential-in-the-treatment-of-systemic-lupus-erythematosus-evidence-to-date
#1
REVIEW
Aleksander Lenert, Timothy B Niewold, Petar Lenert
B cells in general and BAFF (B cell activating factor of the tumor necrosis factor [TNF] family) in particular have been primary targets of recent clinical trials in systemic lupus erythematosus (SLE). In 2011, belimumab, a monoclonal antibody against BAFF, became the first biologic agent approved for the treatment of SLE. Follow-up studies have shown excellent long-term safety and tolerability of belimumab. In this review, we critically analyze blisibimod, a novel BAFF-neutralizing agent. In contrast to belimumab that only blocks soluble BAFF trimer but not soluble 60-mer or membrane BAFF, blisibimod blocks with high affinity all three forms of BAFF...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28326845/the-use-of-biologics-in-pregnant-patients-with-rheumatic-disease
#2
Monika Østensen
An increasing number of female patients with autoimmune diseases are treated with biologic drugs. Concerns in regard to safety of biologics during pregnancy arise in patients who have not completed their families. Areas covered: A review of the literature dealing with child outcomes of pregnancies exposed to biologics shows that TNF inhibitors (TNFi) are the best studied in regard to human pregnancy. In studies comparing exposed pregnancies to disease-matched controls no increased risk of spontaneous abortion, low birth weight, prematurity or congenital malformations has been observed...
March 22, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28301792/systemic-lupus-erythematosus-an-update
#3
Vera Golder, Alberta Hoi
Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune disease predominantly affecting women of childbearing age. New classification criteria for SLE have greater sensitivity and therefore improve the diagnostic certainty for some patients, especially those who may previously have been labelled as having undifferentiated symptoms. Uncontrolled disease activity leads to irreversible end-organ damage, which in turn increases the risk of premature death; early and sustained control of disease activity can usually be achieved by conventional immunosuppressant therapy...
March 20, 2017: Medical Journal of Australia
https://www.readbyqxmd.com/read/28281461/type-i-interferon-signature-may-influence-the-effect-of-belimumab-on-immunoglobulin-levels-including-rheumatoid-factor-in-sj%C3%A3-gren-s-syndrome
#4
Luca Quartuccio, Clio P Mavragani, Adrianos Nezos, Saviana Gandolfo, Athanasios G Tzioufas, Salvatore De Vita
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March 8, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28280970/belimumab-use-clinical-outcomes-and-glucocorticoid-reduction-in-patients-with-systemic-lupus-erythematosus-receiving-belimumab-in-clinical-practice-settings-results-from-the-observe-canada-study
#5
Zahi Touma, Amyn Sayani, Christian A Pineau, Isabelle Fortin, Mark Matsos, George A Ecker, Andrew Chow, Sandra Iczkovitz
To describe the characteristics of patients receiving belimumab, overall patterns of systemic lupus erythematosus (SLE) care, clinical outcomes, and changes in glucocorticoid dose following 6 months of therapy with belimumab, and healthcare resource utilization in belimumab users in Canadian clinical practice settings. Retrospective multicenter medical chart review study of adult patients with SLE who were prescribed belimumab as part of usual care and who received ≥8 infusions or 6 months of treatment...
March 9, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28276955/systemic-lupus-erythematous-exacerbation-following-cessation-of-belimumab-treatment-comments-on-the-article-by-furer-et-al
#6
S Carbajal, C Zamora-Martínez, S Prieto-González, L F Quintana, G Espinosa, R Cervera
No abstract text is available yet for this article.
February 16, 2017: Scandinavian Journal of Rheumatology
https://www.readbyqxmd.com/read/28265845/novel-treatments-in-lupus
#7
REVIEW
Vasileios C Kyttaris
PURPOSE OF REVIEW: The treatment of systemic lupus erythematosus (SLE) still depends on non-specific immunosuppression. Herein, we review promising targeted therapies that have the potential to change this therapeutic paradigm. RECENT FINDINGS: Besides the FDA-approved B lymphocyte stimulator (BLyS) inhibitor, belimumab, interferon-α represents a promising treatment target, albeit with modest effectiveness primarily in non-renal SLE. Preclinical and early-phase clinical trials using biologics and small molecules targeting B and T cell activation as well as the cross-talk between these cells also show promise...
March 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28225511/treatment-satisfaction-in-systemic-lupus-erythematosus-development-of-a-patient-reported-outcome-measure
#8
Susan D Mathias, Pamela Berry, Katie Pascoe, Jane de Vries, Anca D Askanase, Hilary H Colwell, David J Chang
OBJECTIVE: The aim of this study was to develop a patient-reported outcome measure specific for systemic lupus erythematosus (SLE) to assess patient satisfaction with treatment, treatment options, and medical care. METHODS: Patients with SLE were recruited from four US rheumatology practices. Concept elicitation interviews identified aspects that patients considered important and relevant regarding satisfaction with treatment and medical care. Concept elicitation interviews and clinical input were used to draft the Lupus Satisfaction Questionnaire (LSQ)...
March 2017: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
https://www.readbyqxmd.com/read/28216072/smoking-and-pre-existing-organ-damage-reduce-the-efficacy-of-belimumab-in-systemic-lupus-erythematosus
#9
REVIEW
Ioannis Parodis, Christopher Sjöwall, Andreas Jönsen, Daniel Ramsköld, Agneta Zickert, Martina Frodlund, Azita Sohrabian, Laurent Arnaud, Johan Rönnelid, Vivianne Malmström, Anders A Bengtsson, Iva Gunnarsson
OBJECTIVES: Belimumab is the first biologic drug approved for Systemic Lupus Erythematosus (SLE). Here, we aimed to investigate the effects of belimumab on clinical and serologic outcomes, and sought to identify predictors of treatment response in three Swedish real-life settings. METHODS: Fifty-eight patients were enrolled at initiation of belimumab and followed longitudinally for up to 53months. Surveillance outcomes included the SLE Disease Activity Index 2000 (SLEDAI-2K), 100mm Visual Analogue Scales for Physician"s Global Assessment (PGA), fatigue, pain and general health, and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI)...
February 12, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28215100/targeting-baff-and-april-in-systemic-lupus-erythematosus-and-other-antibody-associated-diseases
#10
Eileen Samy, Stephen Wax, Bertrand Huard, Henry Hess, Pascal Schneider
The B cell-stimulating molecules, BAFF (B cell activating factor) and APRIL (a proliferation-inducing ligand), are critical factors in the maintenance of the B cell pool and humoral immunity. In addition, BAFF and APRIL are involved in the pathogenesis of a number of human autoimmune diseases, with elevated levels of these cytokines detected in the sera of patients with systemic lupus erythematosus (SLE), IgA nephropathy, Sjögren's syndrome, and rheumatoid arthritis. As such, both molecules are rational targets for new therapies in B cell-driven autoimmune diseases, and several inhibitors of BAFF or BAFF and APRIL together have been investigated in clinical trials...
January 2, 2017: International Reviews of Immunology
https://www.readbyqxmd.com/read/28173737/failure-of-a-systemic-lupus-erythematosus-response-index-developed-from-clinical-trial-data-lessons-examined-and-learned
#11
L J Forbess, C Bresee, D J Wallace, M H Weisman
Background Our primary goal was to create an outcome change score index similar to a standard rheumatoid arthritis (RA) model utilizing real-world data in systemic lupus erythematosus (SLE) patients that occurred during their phase 3 trials with a Food and Drug Administration-approved drug. Methods We utilized raw data from trials of belimumab for the treatment of SLE. Data were split 80/20 into training/validation sets. Index variables present in a majority of patients and with face validity were selected...
January 1, 2017: Lupus
https://www.readbyqxmd.com/read/28164726/inhibition-of-b-cell-activating-factor-baff-in-the-management-of-systemic-lupus-erythematosus-sle
#12
William Stohl
The anti-BAFF monoclonal antibody, belimumab, was approved 5+ years ago by the US Food and Drug Administration for the treatment of adult SLE patients. Although BAFF is now a proven therapeutic target in SLE, the limited clinical efficacy both in the clinical trials setting and in "real-life" experience begs for further therapeutic improvement. Areas covered: In addition to belimumab, three other BAFF antagonists (atacicept, blisibimod, tabalumab) that biologically differ from belimumab are being or have been evaluated in SLE late-stage clinical trials...
February 4, 2017: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/28162031/successful-treatment-of-refractory-systemic-lupus-erythematosus-using-proteasome-inhibitor-bortezomib-followed-by-belimumab-description-of-two-cases
#13
C Sjöwall, M Hjorth, P Eriksson
Although the putative therapeutic options for patients with systemic lupus erythematosus (SLE) are steadily increasing, refractory disease is indeed a major challenge to many clinicians and patients. The proteasome inhibitor bortezomib - approved for the treatment of multiple myeloma since the beginning of this century - was recently reported successful in twelve cases of refractory SLE by German colleagues. Herein, we describe two Swedish SLE cases with refractory renal and pulmonary manifestations that were rescued by bortezomib as induction of remission followed by monthly doses of belimumab...
January 1, 2017: Lupus
https://www.readbyqxmd.com/read/28161408/anti-blys-antibody-reduces-the-immune-reaction-against-enzyme-and-enhances-the-efficacy-of-enzyme-replacement-therapy-in-fabry-disease-model-mice
#14
Yohei Sato, Hiroyuki Ida, Toya Ohashi
Formation of antibodies against a therapeutic enzyme is an important complication during enzyme replacement therapy (ERT) for lysosomal storage diseases. Fabry disease (FD) is caused by a deficiency of alpha-galactosidase (GLA), which results in the accumulation of globotriaosylceramide (GL-3). We have shown immune tolerance induction (ITI) during ERT in FD model mice by using an anti-B lymphocyte stimulator (anti-BlyS) antibody (belimumab). A single dose of the anti-BlyS antibody temporarily lowered the percentage of B cells and IgG antibody titer against recombinant human GLA...
February 2, 2017: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/28149666/a-case-of-central-nervous-system-nocardiosis-in-a-patient-with-lupus-treated-with-belimumab
#15
Richard Hc Lai, Deborah Kim, Florina Constantinescu
Belimumab was approved by the United States Food and Drug Administration in March 2011 as the first biological agent for treating active systemic lupus erythematosus (SLE). To the best of our knowledge, this is the first case report regarding a patient with SLE treated with belimumab who was diagnosed with central nervous system nocardiosis.
December 2016: European Journal of Rheumatology
https://www.readbyqxmd.com/read/28148586/systemic-lupus-erythematosus
#16
Maliha F Shaikh, Natasha Jordan, David P D'Cruz
Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune disease that is highly heterogeneous in its presentation. This can pose significant challenges for physicians responsible for the diagnosis and treatment of such patients. SLE arises from a combination of genetic, epigenetic and environmental factors. Pathologically, the disease is primarily driven by loss of immune tolerance and abnormal B- and T-cell function. Major organ involvement may lead to significant morbidity and mortality. Classification criteria for SLE have been developed largely for research purposes; however, these are also widely used in clinical practice...
February 2017: Clinical Medicine: Journal of the Royal College of Physicians of London
https://www.readbyqxmd.com/read/28147262/efficacy-of-belimumab-on-renal-outcomes-in-patients-with-systemic-lupus-erythematosus-a-systematic-review
#17
REVIEW
S Sciascia, M Radin, J Yazdany, R A Levy, D Roccatello, M Dall'Era, M J Cuadrado
Both BLISS-52 and BLISS-76 international phase III trials in Systemic Lupus Erythematosus (SLE) met their primary outcomes; however, they were not designed to assess the efficacy of belimumab for the treatment of lupus nephritis (LN). LN is a frequent cause of SLE-associated morbidity and mortality, and emerging evidence suggests a potential therapeutic role for agents that target B lymphocyte stimulator (BLyS). We conducted a systematic review to identify data on the effect of belimumab on LN. A total of 2004 patients with SLE were identified from 11 studies...
January 29, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28118533/efficacy-and-safety-of-subcutaneous-belimumab-in-systemic-lupus-erythematosus-a-randomized-double-blind-placebo-controlled-52-week-study
#18
William Stohl, Andreas Schwarting, Masato Okada, Morton Scheinberg, Andrea Doria, Anne E Hammer, Christi Kleoudis, James Groark, Damon Bass, Norma Lynn Fox, David Roth, David Gordon
Objective To assess the efficacy and safety of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE). Methods Patients with moderate-to-severe SLE (SELENA-SLEDAI ≥8) were randomized (2:1) to weekly belimumab 200 mg SC or placebo by prefilled syringe, plus standard SLE therapy (SoC), for 52 weeks. Primary endpoint was SLE Responder Index (SRI4) at Week 52. Secondary endpoints were time to severe flare and reduction in corticosteroid dose. Safety was assessed by adverse event (AE) reporting and laboratory testing...
January 24, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/27916006/budget-impact-analysis-of-belimumab-in-treating-systemic-lupus-erythematosus
#19
Francesca Pierotti, Iaria Palla, Lara Pippo, Valentina Lorenzoni, Giuseppe Turchetti
OBJECTIVES: The study evaluates the costs of systemic lupus erythematosus (SLE) and the budget impact due to the introduction of belimumab in the Italian setting. METHODS: Adaptation to the Italian setting of a budget impact model with a time horizon of 4 years (year 0 without belimumab, years 1-3 with belimumab) to compare treatment, administration, and clinical monitoring costs of standard therapy and of the alternative scenario in which belimumab is administered in addition to the standard therapy to the subgroup of patients selected according to the label approved by the European Medicines Agency...
January 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27913749/belimumab-in-primary-antiphospholipid-syndrome
#20
A Yazici, B Yazirli, D Erkan
Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thrombosis and/or pregnancy morbidity with persistently positive antiphospholipid antibodies (aPL). Patients with aPL may also experience thrombocytopenia, cardiac valve disease, nephropathy, skin ulcer, or cognitive dysfunction, which are collectively known as non-criteria manifestations of APS. A description is provided of two primary APS patients who received belimumab (10 mg/kg) for an aPL-related manifestation.
December 2, 2016: Lupus
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