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https://www.readbyqxmd.com/read/27916006/budget-impact-analysis-of-belimumab-in-treating-systemic-lupus-erythematosus
#1
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...
December 5, 2016: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/27913749/belimumab-in-primary-antiphospholipid-syndrome
#2
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
https://www.readbyqxmd.com/read/27903029/-lupus-erythematosus-update-2016
#3
Martin Aringer, Reinhard Edmund Voll
Meanwhile, five years have passed since the approval of the anti-BAFF antibody belimumab as a first biological for SLE, but no further SLE drug candidate is even close to approval. There are still no clinical trial data available for the use of new oral anticoagulants in antiphospholipid syndrome. In spite of convincing evidence for the use of mycophenolate mofetil (MMF) in lupus nephritis, the German "Gemeinsame Bundesausschuss" (GBA) has not yet decided on its reimbursement. However, several of the ongoing clinical trials have potential to lead to important advances in SLE treatment in the future...
November 2016: Deutsche Medizinische Wochenschrift
https://www.readbyqxmd.com/read/27804088/first-real-world-insights-into-belimumab-use-and-outcomes-in-routine-clinical-care-of-systemic-lupus-erythematosus-in-germany-results-from-the-observe-germany-study
#4
Andreas Schwarting, Johann O Schroeder, Tobias Alexander, Marc Schmalzing, Christoph Fiehn, Christof Specker, Alessandra Perna, Constanze Cholmakow-Bodechtel, Volker B Koscielny, Heike Carnarius
OBSErve Germany was the first observational study of belimumab as add-on treatment for systemic lupus erythematosus (SLE) in routine clinical care in Germany, retrospectively collecting data from 102 SLE patients, 6 months before and after belimumab initiation. Most patients had moderate or severe SLE and several SLE manifestations. After 6 months of belimumab treatment, 78% of patients showed an improvement in overall disease activity of at least 20% in their physician's judgment and for 42% of patients the improvement was at least 50%...
December 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27793432/new-onset-of-lupus-nephritis-in-two-patients-with-sle-shortly-after-initiation-of-treatment-with-belimumab
#5
Chrysanthi Staveri, Dimitrios Karokis, Stamatis-Nick C Liossis
PURPOSE: Belimumab is currently approved for the treatment of patients with active SLE despite standard treatment. However, it has not been formally tested for patients with lupus nephritis because such patients had been excluded from the clinical trials. In this report, we present two patients with SLE who developed lupus nephritis de novo shortly after belimumab treatment initiation; both patients improved rapidly upon belimumab discontinuation. RESULTS: The first patient (a 30-year-old female, with a 15-year disease duration, receiving prednisolone, hydroxychloroquine, and azathioprine, with no previous history of nephritis that was repeatedly anti-dsDNA negative) had exacerbation of a facial butterfly-like rash developed after 3 months of belimumab treatment initiation...
September 28, 2016: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/27688447/belimumab-in-systemic-lupus-erythematosus
#6
Ankita Srivastava
Belimumab is the only approved biological agent for the treatment of systemic lupus erythematosus (SLE). It is a fully humanized IgG1γ monoclonal antibody directed against soluble B lymphocyte stimulator (BLyS). It is indicated as an add-on therapy for the treatment of adult patients with active, autoantibody-positive SLE, who are receiving standard therapy. Belimumab is generally well-tolerated, common adverse effects include infections, infusion reactions, hypersensitivity, headache, nausea, and fatigue...
September 2016: Indian Journal of Dermatology
https://www.readbyqxmd.com/read/27687023/biological-therapies-in-the-treatment-of-cutaneous-lupus-erythematosus
#7
J K Presto, E Z Hejazi, V P Werth
Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease occurring in association with or without systemic lupus erythematosus (SLE). Although antimalarials are widely used as the first-line systemic agent, refractory cases may benefit from additional immunomodulators, immunosuppressives, and biologics. An interest in biological therapies for CLE has emerged in recent years due to novel insight into the pathogenesis of CLE. These targets include B cells, T cells, and cytokines that are involved in immune system pathways...
September 29, 2016: Lupus
https://www.readbyqxmd.com/read/27670650/-management-of-systemic-lupus-erythematosus
#8
M Aringer, M Schneider
In the last few decades a number of small, often largely unrecognized steps have fundamentally changed the management of systemic lupus erythematosus (SLE). The current goal is to stop all disease activity without long-term use of more than 5 mg prednisolone per day. Remission, i.e. absence of activity in the SLE activity score of choice, is the defined target in the treat to target approach. The essential basic measures include life-long hydroxychloroquine as well as protection from sunlight (UV) and vitamin D substitution...
September 26, 2016: Der Internist
https://www.readbyqxmd.com/read/27668697/evaluation-of-a-novel-autoinjector-for-subcutaneous-self-administration-of-belimumab-in-systemic-lupus-erythematosus%C3%A2
#9
Saira Z Sheikh, Anne E Hammer, Norma Lynn Fox, James Groark, Herbert Struemper, David Roth, David Gordon
OBJECTIVE: To study self-administration and pharmacokinetics (PK) of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE). METHODS: Patients previously treated with belimumab self-administered belimumab 200 mg SC weekly for 8 weeks using an autoinjector. The primary endpoint was the proportion of patients able to self-administer their first and second dose (weeks 1 and 2) in the clinic. The proportion able to self-administer at weeks 4 and 8 (clinic) and weeks 3, 5, 6, and 7 (home) were secondary endpoints...
November 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27663753/biotherapies-in-systemic-lupus-erythematosus-new-targets
#10
Estibaliz Lazaro, Marc Scherlinger, Marie-Elise Truchetet, Laurent Chiche, Thierry Schaeverbeke, Patrick Blanco, Christophe Richez
Systemic lupus erythematosus (SLE) is an autoimmune disease with a polymorphic presentation. The variability in the clinical expression and severity of SLE makes new treatments both essential and challenging to develop. Several biotherapies targeting different pathophysiological pathways have been developed over the past 15 years. The results of Phase II trials were encouraging but rarely borne out by Phase III trials. Recent data, which are discussed in detail in this review, allowed belimumab - a monoclonal antibody against BLyS (B-lymphocyte stimulator) - to become the first biotherapy approved for use in SLE...
September 20, 2016: Joint, Bone, Spine: Revue du Rhumatisme
https://www.readbyqxmd.com/read/27633749/therapeutic-interventions-of-tissue-specific-autoimmune-onset-in-systemic-lupus-erythematosus
#11
Subhajit Dasgupta
Systemic lupus erythematosus (lupus) is a female predominant autoimmune disease. The auto reactive B cells and T helper cells together are known to develop self-reactive immune responses in different tissues like kidney, bone, cardiovascular and central nervous system. Progression of disease is associated with deposition of immune complex which initiates tissue damage. The therapy for lupus still includes corticosteroids to reduce allergic manifestations and inflammatory immune responses. Recent observations suggested that, mycophenolate mofetil and cyclophosphamide treatment in combination with corticosteroids have benefit in lupus therapy...
September 12, 2016: Mini Reviews in Medicinal Chemistry
https://www.readbyqxmd.com/read/27627085/-adverse-effects-of-biological-therapy-in-rheumatology
#12
Marta Olejárová
UNLABELLED: The biological treatment which is the most effective type of therapy for inflammatory rheumatic diseases, has become part of a standard clinical rheumatology practice in recent years. Thousands of patients in the Czech Republic with rheumatoid arthritis, different forms of spondyloarthritides and with psoriatic arthritis are now successfully treated in this way. The following medications are registered in the Czech Republic for the treatment of rheumatic diseases: infliximab, adalimumab, golimumab, certolizumab pegol, etanercept, abatacept, rituximab, tocilizumab and belimumab, newly also secukinumab...
2016: Vnitr̆ní Lékar̆ství
https://www.readbyqxmd.com/read/27587201/a-review-of-clinical-trials-of-belimumab-in-the-management-of-systemic-lupus-erythematosus
#13
Alexis Garcia, Juan B De Sanctis
There have been few changes over the last 50 years in the treatment of Systemic lupus erythematosus (SLE), using non-specific anti-inflammatory agents such as: non-steroidal anti-inflammatory drugs along with the immune cell modulating agent hydroxychloroquine for mild disease, and broad spectrum immunosuppressants plus anti-inflammatories such as corticosteroids, azathioprine, cyclophosphamide, or mycophenolate during flares or severe disease with organ involvement. In some patients, the response is inadequate and side effects appear from mild unpleasant up to severe toxicity...
August 31, 2016: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/27536671/lupus-nephritis-a-different-disease-in-european-patients
#14
REVIEW
Vladimir Tesar, Zdenka Hruskova
BACKGROUND: Lupus nephritis (LN) is still associated with significant mortality and substantial risk of progression to end-stage renal failure. Its outcome is related to the class and severity of LN and response to treatment, and it is poorer in patients with renal relapses. Ethnicity has a relatively well-defined impact on the outcome of the patients and their response to treatment and must always be taken into consideration in treatment decisions. SUMMARY: In this article, we provide a review of the impact of ethnicity on the prevalence of systemic lupus erythematosus (SLE), the proportion of patients with SLE developing LN, outcomes of SLE and LN and response of LN to treatment...
September 2015: Kidney Diseases
https://www.readbyqxmd.com/read/27536670/lupus-nephritis-in-asia-clinical-features-and-management
#15
REVIEW
Desmond Y H Yap, Tak Mao Chan
BACKGROUND: Lupus nephritis (LN) is a common and severe organ involvement manifesting itself in systemic lupus erythematosus (SLE). There is a considerable difference in prevalence, severity, treatment response and outcomes between Asian LN patients and LN patients from other racial backgrounds. SUMMARY: Asian SLE patients have a higher prevalence of LN than Caucasian SLE patients and often present with a more severe disease. Increasing data from genetic studies, accompanied by progress in high-throughput genotyping, have advanced our knowledge about genetic predispositions that might partly contribute to the clinical variations observed...
September 2015: Kidney Diseases
https://www.readbyqxmd.com/read/27529058/current-and-emerging-treatment-options-in-the-management-of-lupus
#16
REVIEW
Natasha Jordan, David D'Cruz
Systemic lupus erythematosus (SLE) is a complex autoimmune disease with variable clinical manifestations. While the clearest guidelines for the treatment of SLE exist in the context of lupus nephritis, patients with other lupus manifestations such as neuropsychiatric, hematologic, musculoskeletal, and severe cutaneous lupus frequently require immunosuppression and/or biologic therapy. Conventional immunosuppressive agents such as mycophenolate mofetil, azathioprine, and cyclophosphamide are widely used in the management of SLE with current more rationalized treatment regimens optimizing the use of these agents while minimizing potential toxicity...
2016: ImmunoTargets and Therapy
https://www.readbyqxmd.com/read/27505709/generation-and-characterization-of-human-b-lymphocyte-stimulator-blocking-monoclonal-antibody
#17
Weiliang Zhuang, Jianjun Zhang, Lili Pei, Shuping Fang, Honghao Liu, Ruixue Wang, Yunpeng Su
The cytokine, B lymphocyte stimulator (Blys) is essential for activation and proliferation of B cells and is involved in the pathogenesis of B-cell mediated autoimmune diseases. Based on its essential activity, Blys may be a potential therapeutic target for human autoimmune diseases. In this article, we have described the development of a novel humanized anti-Blys antibody, NMB04, that binds with high affinity and specificity to both soluble and membrane bound Blys. This monoclonal antibody has the potential to block Blys binding to all its three receptors, TACI, BCMA and BR-3...
September 2016: Molecular Immunology
https://www.readbyqxmd.com/read/27497257/a-critical-review-of-clinical-trials-in-systemic-lupus-erythematosus
#18
M A Mahieu, V Strand, L S Simon, P E Lipsky, R Ramsey-Goldman
One challenge in caring for patients with systemic lupus erythematosus (SLE) is a paucity of approved therapeutics for treatment of the diverse disease manifestations. In the last 60 years, only one drug, belimumab, has been approved for SLE treatment. Critical evaluation of investigator initiated and pharma-sponsored randomized controlled trials (RCTs) highlights barriers to successful drug development in SLE, including disease heterogeneity, inadequate trial size or duration, insufficient dose finding before initiation of large trials, handling of background medications, and choice of primary endpoint...
September 2016: Lupus
https://www.readbyqxmd.com/read/27497253/targeted-b-cell-therapies-in-the-treatment-of-adult-and-pediatric-systemic-lupus-erythematosus
#19
J S Hui-Yuen, S C Nguyen, A D Askanase
Belimumab (Benlysta) is a fully-humanized monoclonal antibody that inhibits B-lymphocyte stimulator (also known as B cell activating factor) and was approved by the U.S. Federal Drug Administration and European Medicines Evaluation Agency for treatment in adults with autoantibody-positive systemic lupus erythematosus (SLE). Rituximab (Rituxan) is a chimeric anti-CD20 monoclonal antibody targeting B lymphocytes. This review discusses the key findings of the phase III trials in adults with SLE and of real-world use of belimumab and rituximab in the care of both adult and pediatric SLE patients...
September 2016: Lupus
https://www.readbyqxmd.com/read/27497251/why-targeted-therapies-are-necessary-for-systemic-lupus-erythematosus
#20
L Durcan, M Petri
Systemic lupus erythematosus (SLE) continues to have important morbidity and accelerated mortality despite therapeutic advances. Targeted therapies offer the possibility of improved efficacy with fewer side effects. Current management strategies rely heavily on nonspecific immunosuppressive agents. Prednisone, in particular, is responsible for a considerable burden of later organ damage. There are a multitude of diverse mechanisms of disease activity, immunogenic abnormalities and clinical manifestations to take into consideration in SLE...
September 2016: Lupus
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