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https://www.readbyqxmd.com/read/29671280/efficacy-and-safety-of-subcutaneous-belimumab-in-anti-dsdna-positive-hypocomplementemic-patients-with-systemic-lupus-erythematosus
#1
A Doria, W Stohl, A Schwarting, M Okada, M Scheinberg, R van Vollenhoven, A E Hammer, J Groark, D Bass, N L Fox, D Roth, D Gordon
OBJECTIVE: To investigate the efficacy and safety of belimumab, a human immunoglobulin monoclonal antibody against B lymphocyte stimulator, in a subset of patients with systemic lupus erythematosus (SLE) who were hypocomplementemic (C3 [<90 mg/dL] and/or C4 [<10 mg/dL]) and anti-double-stranded(ds)DNA-positive (≥30 IU/mL) at baseline. METHODS: This Phase III, double-blind, placebo-controlled study (BEL112341; NCT01484496) randomized patients (2:1) with moderate-to-severe SLE (Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index ≥8) to weekly subcutaneous (SC) belimumab 200 mg or placebo, plus standard SLE therapy, for 52 weeks...
April 18, 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29661905/randomized-study-of-adjunctive-belimumab-in-participants-with-generalized-myasthenia-gravis
#2
Karen Hewett, Donald B Sanders, Richard A Grove, Christine L Broderick, Todd J Rudo, Ashlyn Bassiri, Marina Zvartau-Hind, Vera Bril
OBJECTIVE: To investigate the efficacy and safety of belimumab, a fully human immunoglobulin G1λ monoclonal antibody against B-lymphocyte stimulator, in participants with generalized myasthenia gravis (MG) who remained symptomatic despite standard of care (SoC) therapy. METHODS: Eligible participants with MG were randomized 1:1 to receive IV belimumab 10 mg/kg or placebo in this phase II, placebo-controlled, multicenter, double-blind study (NCT01480596; BEL115123)...
April 17, 2018: Neurology
https://www.readbyqxmd.com/read/29660084/recent-developments-in-biologic-therapies-for-the-treatment-of-patients-with-systemic-lupus-erythematosus
#3
Pedro L Carreira, David A Isenberg
SLE has a complex pathogenesis, and multiple therapeutic targets have been discovered in recent years. In spite of belimumab being approved by the US Food and Drug Administration and the widespread use of rituximab, there have been many failed attempts to treat SLE successfully using biologic agents. In this review, we consider newer biologic approaches that might offer the hope of improving the outcome of SLE patients. These include the fully humanized anti-CD20 mAbs, PEGylated anti-CD40L, IFNα inhibitors, rigerimod and immune complexes blockade...
April 5, 2018: Rheumatology
https://www.readbyqxmd.com/read/29648686/development-and-validation-of-a-novel-evidence-based-lupus-multivariable-outcome-score-for-clinical-trials
#4
Michal Abrahamowicz, John M Esdaile, Rosalind Ramsey-Goldman, Lee S Simon, Vibeke Strand, Peter E Lipsky
BACKGROUND: Trials of new SLE treatments are hampered by the lack of effective outcome measures. To address this, we developed a new Lupus Multivariable Lupus Outcome Score (LuMOS). METHOD: The LuMOS formula was developed by analyzing raw data of two pivotal trials: BLISS-52 and BLISS-76, the basis for approval of belimumab (Bel). Using data from BLISS-76 as the learning dataset, we optimized discrimination between outcomes for patients treated with 10mg/kg Bel versus placebo over the first 52 weeks of follow-up using multivariable logistic regression analyses...
April 12, 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29595281/-novel-trends-in-monitoring-and-therapy-of-anca-associated-vasculitides
#5
Radim Bečvář
Vasculitides with positivity of autoantibodies to neutrophil leukocytes cytoplasm (ANCA, AAV) belong to primary vasculitides involving small and less commonly medium size blood vessels. Three different clinical types of AAV can be distinguished: granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis and microscopic polyangiitis. Since these autoantibodies seem to be weak activity biomarkers of AAV new molecules and factors start to come up, e.g. neutrophil extracellular traps NET, several T-lymphocyte subpopulations and different immunoglobulins classes of ANCA...
2018: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/29572471/baff-neutralizing-interaction-of-belimumab-related-to-its-therapeutic-efficacy-for-treating-systemic-lupus-erythematosus
#6
Woori Shin, Hyun Tae Lee, Heejin Lim, Sang Hyung Lee, Ji Young Son, Jee Un Lee, Ki-Young Yoo, Seong Eon Ryu, Jaejun Rhie, Ju Yeon Lee, Yong-Seok Heo
BAFF, a member of the TNF superfamily, has been recognized as a good target for autoimmune diseases. Belimumab, an anti-BAFF monoclonal antibody, was approved by the FDA for use in treating systemic lupus erythematosus. However, the molecular basis of BAFF neutralization by belimumab remains unclear. Here our crystal structure of the BAFF-belimumab Fab complex shows the precise epitope and the BAFF-neutralizing mechanism of belimumab, and demonstrates that the therapeutic activity of belimumab involves not only antagonizing the BAFF-receptor interaction, but also disrupting the formation of the more active BAFF 60-mer to favor the induction of the less active BAFF trimer through interaction with the flap region of BAFF...
March 23, 2018: Nature Communications
https://www.readbyqxmd.com/read/29572442/a-loop-region-of-baff-controls-b-cell-survival-and-regulates-recognition-by-different-inhibitors
#7
Michele Vigolo, Melissa G Chambers, Laure Willen, Dehlia Chevalley, Klaus Maskos, Alfred Lammens, Aubry Tardivel, Dolon Das, Christine Kowalczyk-Quintas, Sonia Schuepbach-Mallepell, Cristian R Smulski, Mahya Eslami, Antonius Rolink, Edith Hummler, Eileen Samy, Yves Fomekong Nanfack, Fabienne Mackay, Maofu Liao, Henry Hess, Xuliang Jiang, Pascal Schneider
The B cell survival factor (TNFSF13B/BAFF) is often elevated in autoimmune diseases and is targeted in the clinic for the treatment of systemic lupus erythematosus. BAFF contains a loop region designated the flap, which is dispensable for receptor binding. Here we show that the flap of BAFF has two functions. In addition to facilitating the formation of a highly active BAFF 60-mer as shown previously, it also converts binding of BAFF to TNFRSF13C (BAFFR) into a signaling event via oligomerization of individual BAFF-BAFFR complexes...
March 23, 2018: Nature Communications
https://www.readbyqxmd.com/read/29555348/low-disease-activity-irrespective-of-serologic-status-at-baseline-associated-with-reduction-of-corticosteroid-dose-and-number-of-flares-in-patients-with-systemic-lupus-erythematosus-treated-with-belimumab-a-real-life-observational-study
#8
Antonis Fanouriakis, Christina Adamichou, Sofia Koutsoviti, Stylianos Panopoulos, Chrysanthi Staveri, Anastasia Klagou, Christina Tsalapaki, Lamprini Pantazi, Styliani Konsta, Clio P Mavragani, Despoina Dimopoulou, Styliani Ntali, Georgios Katsikas, Kyriaki A Boki, Dimitrios Vassilopoulos, Pinelopi Konstantopoulou, Stamatis-Nick Liossis, Antonia Elezoglou, Maria Tektonidou, Prodromos Sidiropoulos, Abdulsamet Erden, Petros P Sfikakis, George Bertsias, Dimitrios T Boumpas
BACKGROUND: Low disease activity is a validated target of current systemic lupus erythematosus (SLE) therapy. The aim of this study was to assess the ability of belimumab to achieve low disease activity states in real-life settings. METHODS: Multicentre prospective observational study of consecutive SLE patients receiving belimumab for at least 3 months, due to active disease refractory to at least one conventional immunosuppressant. Disease activity, including the recently defined lupus low disease activity state (LLDAS) and remission (clinical SLEDAI-2K = 0), accrual of organ damage, flares and side effects were documented...
February 23, 2018: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/29542345/epratuzumab-for-the-treatment-of-systemic-lupus-erythematosus
#9
Daniel Geh, Caroline Gordon
Systemic lupus erythematosus (SLE) is a multi-system autoimmune disease. There are three drugs licensed for the treatment of lupus: corticosteroids, hydroxychloroquine and belimumab. Immunosuppressants such as azathioprine, methotrexate and mycophenolate are also used. Despite these treatments there is still considerable morbidity. New treatments are needed for the management of active lupus. Epratuzumab a humanized IgG1 monoclonal antibody that targets CD22 resulting in selective B cell modulation that has been considered a potential treatment for SLE...
March 20, 2018: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/29533753/successful-sequential-therapy-with-rituximab-and-belimumab-in-patients-with-active-systemic-lupus-erythematosus-a-case-series
#10
Roberta Gualtierotti, Maria Orietta Borghi, Maria Gerosa, Tommaso Schioppo, Paola Larghi, Jens Geginat, Pier Luigi Meroni
OBJECTIVES: B cells play an important role in the initiation and progression of systemic lupus erythematosus (SLE). Accordingly, B cell-targeted therapy has been suggested as a new rational approach for treating lupus. Belimumab, a human monoclonal antibody directed against B lymphocyte stimulator (BLyS), was reported as the first biological treatment effective in reducing mild-to-moderate SLE disease activity by using different scoring systems and endpoints. Conversely clinical trials with rituximab, a chimeric monoclonal antibody directed against the CD20 expressed by B cells, have failed to achieve primary endpoints in spite of a number of reports showing its beneficial effects...
February 27, 2018: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/29523211/pediatric-rheumatology-infusion-center-report-on-therapeutic-protocols-and-infusions-given-over-4-years-with-focus-on-adverse-events-over-1-year
#11
Surabhi S Vinod, Annelle B Reed, Jamelle Maxwell, Randy Q Cron, Matthew L Stoll
BACKGROUND: Children with chronic rheumatic disease often require intravenous (IV) therapy. Our center has instituted standardized protocols for use of IV medications in rheumatology patients. Herein, we introduce the therapeutic protocols and report on their short-term safety. METHODS: This was an institutional review board (IRB) approved retrospective chart review of all patients who had received IV infusions between the years 2012 and 2015 at a single center, prescribed by a pediatric rheumatologist...
March 9, 2018: Pediatric Rheumatology Online Journal
https://www.readbyqxmd.com/read/29514612/belimumab-and-low-doses-of-mycophenolate-mofetil-as-induction-therapy-of-class-iv-lupus-nephritis-case-series-and-literature-review
#12
Domenico Paolo Emanuele Margiotta, Fabio Basta, Veronica Batani, Antonella Afeltra
BACKGROUND: The treatment of Lupus Nephritis (LN) is an unmet need in the management of patients with Systemic Lupus Erythematosus (SLE). CASE PRESENTATION : We report two cases of women affected by Lupus Nephritis (LN) ISN/RNP Class IV with serological active disease, high disease activity and marked fatigue. In both cases, Mycophenolate mofetil (MMF), as induction therapy, was poorly tolerated because of gastrointestinal toxicity. Belimumab, together with low-doses of MMF, was effective as induction treatment leading to early achievement of complete renal response in these two selected cases of LN...
March 7, 2018: BMC Nephrology
https://www.readbyqxmd.com/read/29512131/b-cells-in-multiple-sclerosis-therapy-a-comprehensive-review
#13
REVIEW
R Rahmanzadeh, M S Weber, W Brück, S Navardi, M A Sahraian
For decades, B cells were ignored in multiple sclerosis (MS) pathogenesis, and the disease was always regarded as a T cell-mediated disorder. Recent evidence shows that there is an antigen-driven B-cell response in the central nervous system of patients with MS, and memory B cells/plasma cells are detectable in MS lesions. The striking efficacy of B cell-depleting therapies in reducing the inflammatory activity of the disease highlights that B cells may play more pathogenetic roles than expected. B cells express several unique characteristic markers on their surface, for example, CD19, CD20 molecules, that provide selective targets for monoclonal antibodies...
March 7, 2018: Acta Neurologica Scandinavica
https://www.readbyqxmd.com/read/29512034/effectiveness-tolerability-and-safety-of-belimumab-in-patients-with-refractory-sle-a-review-of-observational-clinical-practice-based-studies
#14
REVIEW
Francesca Trentin, Mariele Gatto, Margherita Zen, Larosa Maddalena, Linda Nalotto, Francesca Saccon, Elisabetta Zanatta, Luca Iaccarino, Andrea Doria
To date, belimumab is the only biological drug approved for the treatment of patients with active refractory SLE. We compared and critically analyzed the results of 11 observational clinical-practice-based studies, conducted in SLE referral centers. Despite the differences in endpoints and follow-up duration, all studies remarked that belimumab provides additional benefits when used as an add-on to existing treatment, allowing a higher rate of patients to reach remission and to taper or discontinue corticosteroids...
March 6, 2018: Clinical Reviews in Allergy & Immunology
https://www.readbyqxmd.com/read/29510235/treatment-of-antiphospholipid-syndrome-beyond-anticoagulation
#15
Chrisanna Dobrowolski, Doruk Erkan
Antiphospholipid syndrome (APS) is a systemic autoimmune disorder marked by thrombosis and/or pregnancy morbidity in the presence of antiphospholipid antibodies (aPL). At the present time, treatment is primarily focused on anticoagulation. However, there is increasing awareness of the mechanisms involved in APS pathogenesis, which has led to the trial of novel therapies targeting those mechanisms. Following a brief review of the etiopathogenesis of and current management strategies in APS, this paper focuses on the evidence for these potential, targeted APS treatments, e...
March 3, 2018: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/29496892/renal-remission-status-and-longterm-renal-survival-in-patients-with-lupus-nephritis-a-retrospective-cohort-analysis
#16
Julie E Davidson, Qinggong Fu, Beulah Ji, Sapna Rao, David Roth, Laurence S Magder, Michelle Petri
OBJECTIVE: This observational study was a retrospective analysis of prospectively collected Hopkins Lupus Cohort data to compare longterm renal survival in patients with lupus nephritis (LN) who achieved complete (CR), partial (PR), or no remission following standard-of-care LN induction therapy. METHODS: Eligible patients with biopsy-proven LN (revised American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) were identified and categorized into ordinal (CR, PR, or no remission) or binary (response or no response) renal remission categories at 24 months post-diagnosis [modified Aspreva Lupus Management Study (mALMS) and modified Belimumab International Lupus Nephritis Study (mBLISS-LN) criteria]...
March 1, 2018: Journal of Rheumatology
https://www.readbyqxmd.com/read/29426575/systematic-review-and-meta-analysis-of-steroid-sparing-effect-of-biologic-agents-in-randomized-placebo-controlled-phase-3-trials-for-systemic-lupus-erythematosus
#17
REVIEW
Shereen Oon, Molla Huq, Timothy Godfrey, Mandana Nikpour
OBJECTIVES: To systematically review, and conduct a meta-analysis of steroid-sparing effect in, phase 3 randomized, placebo-controlled trials of biologic therapies for systemic lupus erythematosus (SLE). METHODS: Studies were identified by searching Medline (via Pubmed), EMBASE, CINAHL and SCOPUS databases, the Cochrane library, and clinicaltrials.gov. Adult human studies published in English in the last ten years (until 18/04/2017) were included. A random-effects meta-analysis comparing a common corticosteroid-reduction endpoint in the trials of rituximab, belimumab, tabalumab and epratuzumab in SLE, was conducted...
January 6, 2018: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/29409143/long-term-safety-and-efficacy-of-belimumab-in-patients-with-systemic-lupus-erythematosus-a-continuation-of-the-phase-3-united-states-bliss-76-trial
#18
Richard A Furie, Daniel J Wallace, Cynthia Aranow, James Fettiplace, Barbara Wilson, Prafull Mistry, David A Roth, D Gordon
OBJECTIVE: This US multicenter continuation study (GSK Study BEL112233; NCT00724867) assessed long-term safety and efficacy of belimumab in patients with SLE who completed BLISS-76 (NCT00410384). METHODS: Patients continued to receive the same belimumab dose plus standard of care; patients previously receiving placebo received belimumab 10 mg/kg. Primary outcome measures included long-term safety (AE frequency and damage assessed by Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [SDI] evaluated every 48 weeks [study year])...
February 6, 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29403543/when-myasthenia-gravis-is-deemed-refractory-clinical-signposts-and-treatment-strategies
#19
REVIEW
Renato Mantegazza, Carlo Antozzi
The prognosis for patients with myasthenia gravis (MG) has improved significantly over the past half century, including substantial reductions in mortality and morbidity. However, approximately 10% of patients fails to respond adequately to current therapies and are considered treatment refractory, or treatment intolerant, and up to 80% have disease that fails to achieve complete stable remission. Although patients with autoantibodies to muscle-specific tyrosine kinase (anti-MuSK positive) are more likely to become treatment refractory than those with autoantibodies to the acetylcholine receptor (anti-AChR positive), each of these serotypes is substantially represented in the refractory MG population...
2018: Therapeutic Advances in Neurological Disorders
https://www.readbyqxmd.com/read/29396833/belimumab-a-review-in-systemic-lupus-erythematosus
#20
Hannah A Blair, Sean T Duggan
Belimumab (Benlysta® ) is a human immunoglobulin G1λ monoclonal antibody that inhibits the binding of soluble B lymphocyte stimulator to B cells. It is the only biological agent currently approved for the treatment of non-renal systemic lupus erythematosus (SLE). Belimumab is approved in the EU, the USA and other countries as add-on therapy in adult patients with active, autoantibody-positive SLE despite standard therapy. In phase III trials, treatment with IV or SC belimumab plus standard therapy was effective in terms of reducing overall disease activity and reducing the incidence and severity of flares, without worsening of patients' overall condition or the development of significant disease activity in new organ systems...
March 2018: Drugs
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