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https://www.readbyqxmd.com/read/28434948/international-and-multidisciplinary-expert-recommendations-for-the-use-of-biologics-in-systemic-lupus-erythematosus
#1
REVIEW
Jean-François Kleinmann, Florence Tubach, Véronique Le Guern, Alexis Mathian, Christophe Richez, David Saadoun, Karim Sacre, Jérémie Sellam, Raphaèle Seror, Zahir Amoura, Emmanuel Andres, Sylvain Audia, Brigitte Bader-Meunier, Gilles Blaison, Bernard Bonnotte, Patrice Cacoub, Sophie Caillard, Laurent Chiche, Olivier Chosidow, Nathalie Costedoat-Chalumeau, Claire Daien, Eric Daugas, Nairouz Derdèche, Andrea Doria, Olivier Fain, Fadi Fakhouri, Dominique Farge, Cem Gabay, Sylvie Guillo, Eric Hachulla, Najia Hajjaj-Hassouni, Mohamed Hamidou, Frédéric A Houssiau, Noémie Jourde-Chiche, Isabelle Koné-Paut, Aïcha Ladjouz-Rezig, Olivier Lambotte, Dan Lipsker, Xavier Mariette, Nicolas Martin-Silva, Thierry Martin, François Maurier, Roderich Meckenstock, Arsène Mékinian, Olivier Meyer, Shirine Mohamed, Jacques Morel, Bruno Moulin, Denis Mulleman, Thomas Papo, Vincent Poindron, Xavier Puéchal, Leonardo Punzi, Pierre Quartier, Laurent Sailler, Amar Smail, Martin Soubrier, Agnès Sparsa, Zoubida Tazi-Mezalek, Leith Zakraoui, Stéphane Zuily, Jean Sibilia, Jacques-Eric Gottenberg
BACKGROUND/PURPOSE: Despite conventional immunosuppressants, active and steroid-dependent systemic lupus erythematosus (SLE) represents a therapeutic challenge. Only one biologic, belimumab, has been approved, but other biologics are sometimes used off-label. Given the lack of evidence-based data in some clinical situations encountered in real life, we developed expert recommendations for the use of biologics for SLE. METHODS: The recommendations were developed by a formal consensus method...
April 18, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28431104/the-potential-overlapping-populations-for-treatment-with-belimumab-and-rituximab-using-current-nhs-england-and-national-institute-for-health-and-care-excellence
#2
Eoghan M McCarthy, Emily Sutton, Stephanie Nesbit, Ben Parker, David Jayne, Bridget Griffiths, David A Isenberg, Anisur Rahman, Caroline Gordon, David P D'Cruz, Benjamin Rhodes, Peter Lanyon, Edward M Vital, Chee-Seng Yee, Christopher J Edwards, Lee-Suan Teh, Mohammed Akil, Neil J McHugh, Asad Zoma, Ian N Bruce
No abstract text is available yet for this article.
April 18, 2017: Rheumatology
https://www.readbyqxmd.com/read/28420056/treatment-with-belimumab-in-systemic-lupus-erythematosus-does-not-impair-antibody-response-to-13-valent-pneumococcal-conjugate-vaccine
#3
J Nagel, T Saxne, P Geborek, A A Bengtsson, S Jacobsen, C Svaerke Joergensen, J-Å Nilsson, L Skattum, A Jönsen, M C Kapetanovic
Background/purpose The objective of this study was to explore the impact of systemic lupus erythematosus and belimumab given in addition to standard of care therapy on 13-valent conjugated pneumococcal vaccine (PCV13) response. Methods Forty-seven systemic lupus erythematosus patients and 21 healthy controls were immunized with a single dose of 13-valent conjugated pneumococcal vaccine. Forty systemic lupus erythematosus patients were treated with traditional disease-modifying anti rheumatic drugs, 11 of those received belimumab in addition, and 32 patients were treated with concomitant prednisolone...
January 1, 2017: Lupus
https://www.readbyqxmd.com/read/28399927/bk-viruria-and-viremia-in-children-with-systemic-lupus-erythematosus
#4
Nirupama Gupta, Cuong Q Nguyen, Renee F Modica, Melissa E Elder, Eduardo H Garin
BACKGROUND: BK virus (BKV) is a ubiquitous polyoma virus that lies dormant in the genitourinary tract once acquired in early childhood. In states of cellular immunodeficiency, the virus can reactivate to cause hemorrhagic cystitis and nephritis. Children with systemic lupus erythematosus (SLE) have an increased risk of developing infectious complications secondary to their immunocompromised state from the administration of several immuno-modulatory drugs. Currently, there are no data regarding the prevalence of BK viruria or viremia in children with SLE...
April 11, 2017: Pediatric Rheumatology Online Journal
https://www.readbyqxmd.com/read/28344669/belimumab-in-systemic-lupus-erythematosus-sle-evidence-to-date-and-clinical-usefulness
#5
REVIEW
Sara Guerreiro Castro, David A Isenberg
Systemic lupus erythematosus (SLE) is a complex autoimmune rheumatic disease with multiple presentations, whose management presents many challenges. Many disease modifying or immunosuppressive drugs have been used with limited success, especially in patients with more severe disease activity. Belimumab is the first drug to be approved specifically for the treatment of SLE in more than 50 years. By blocking the B-cell activating factor, it interferes in B-cell differentiation and survival. Here we consider the results of the clinical trials that led to its approval, as well as the post-hoc analyses, follow-up studies and the current trials...
March 2017: Therapeutic Advances in Musculoskeletal Disease
https://www.readbyqxmd.com/read/28331294/spotlight-on-blisibimod-and-its-potential-in-the-treatment-of-systemic-lupus-erythematosus-evidence-to-date
#6
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
#7
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
#8
REVIEW
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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)...
April 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28215100/targeting-baff-and-april-in-systemic-lupus-erythematosus-and-other-antibody-associated-diseases
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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