Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus

Wallace, DJ; Navarra, S; Petri, M.; Gallacher, Alberto; Thomas, Mathew; Furie, Richard; Levy, RA; Vollenhoven, R. van; Cooper, Simon; Zhong, Z. John; Freimuth, William W.; Cervera, Ricard; Groups, Lbsl Study

doi:10.1177/0961203312469259

Cited by 112 publications

(92 citation statements)

References 27 publications

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“…The percentage of patients experiencing AEs was lower in the open-label pSS trial than in SLE trials (54% of pSS patients versus 93% of SLE patients), which might be due to the larger percentage of SLE patients receiving co-treatment with immunosuppressants. [111,112] A 52-week extension study of belimumab treatment in 19 pSS patients did not show any additional serious AEs or infusion reactions. [113] In summary, belimumab is effective and well tolerated in SLE.…”

Section: Belimumabmentioning

confidence: 93%

Safety of treatments for primary Sjögren’s syndrome

Nimwegen

Moerman

Smitt

et al. 2016

Expert Opinion on Drug Safety

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Introduction: Primary Sjögren's syndrome (pSS) is a disabling auto-immune disease, affecting exocrine glands and several organs. Areas covered:In this review we analyze the safety of therapies used in pSS. Symptomatic treatment is widely applied due to the good supportive effect and good safety profile. Systemic stimulation of tears and saliva can be successful in pSS. However, cumbersome adverse events can influence the tolerability of this therapy. Evidence for the effectiveness of synthetic DMARDs therapies in pSS is limited, while there is a risk of adverse events. Several studies on biologic DMARD treatment of pSS patients have shown promising efficacy and safety results. Expert opinion: The safety of symptomatic treatment of pSS is very good. However, systemic therapy is necessary to achieve long-term relieve and prevention of organ-damage. Synthetic DMARDs have not shown much efficacy in earlier studies, and their benefits do not weigh up to the possible harms, while biologic DMARDs show promising results regarding efficacy and cause mostly mild adverse events. Many questions remain unanswered regarding safety of DMARDs in pSS. There is a need for well designed studies, in which safety should be evaluated in a uniform manner to be able to compare the results between studies.ARTICLE HISTORY

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Section: Belimumabmentioning

confidence: 93%

Safety of treatments for primary Sjögren’s syndrome

Nimwegen

Moerman

Smitt

et al. 2016

Expert Opinion on Drug Safety

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“…Uygulama esnasında veya uygulamadan birkaç saat sonra ciddi/hayatı tehdit edici seviyede hipersensitivite ve infüzyon reaksiyonları (anafilaktik reaksiyonlar, bradikardi, hipotansiyon, anjiyoödem, dispne) görülebilir. Bu etkilerin görülme sıklığı klinik çalışmalarda %1'in altında saptanmıştır (42). Raş, bulantı, miyalji, başağrısı gibi gecikmiş tip, akut olmayan semptomlar da oluşabilir.…”

Section: Türk Nefroloji Diyaliz Ve Transplantasyon Dergisi Turkish Neunclassified

Böbrek Naklinde Kullanılan Yeni İmmünsupresif İlaçlar

Güngör¹,

Alp²,

Pembegül³

et al. 2017

Turk Neph Dial Transpl

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ÖzSon dönem böbrek yetmezliğinin en seçkin tedavi yöntemi böbrek naklidir. Ne yazıkki akut-kronik rejeksiyonlar ve ilaç toksisiteleri nakil sonrası dönemde organ sağ kalımını kısaltmaktadır. Bu yüzden son yıllarda rejeksiyonları ve ilaç toksisitelerini azaltabilecek yeni ilaçların bulunması amaçlanmıştır. Biz bu derlemede son yıllarda böbrek naklinde kullanıma girmiş yeni immünsupresif ilaçların başlı-calarını özetlemeyi amaçladık. AnAhTAR sÖzcükleR: Böbrek nakli, Yeni, İmmünsupresif ilaçlar AbsTRAcTRenal transplantation is the most prominent treatment of end-stage renal failure. Unfortunately, acute and chronic rejections and drug toxicities reduce graft survival in the post-transplantation period. An attempt has therefore been made in recent years to develop new drugs that can reduce rejections and drug toxicities. In this review, we intended to summarize the new immunosuppressive drugs that have entered use in recent years. GİRİŞSon dönem böbrek yetmezliğinin en seçkin tedavi yöntemi böbrek naklidir. Başarılı bir böbrek nakli için, gerek indüksiyon, gerekse idame immünsupresif tedavinin hasta bazında bireyselleştirilmesi gerekir. Halen dünyada indüksiyon tedavisi için en sık Antitimosit globulin (ATG), idame tedavide ise kortikosteroid-kalsinörin inhibitörü-antimetabolit ilaç kombinasyonu tercih edilmektedir. Günümüzde halen akut hücresel ve humoral rejeksiyonlar ne yazıkki böbrek sağ kalımını olumsuz etkileyen önemli sorunlar olarak karşımıza çıkmaya devam etmektedir. bir yıllık graft sürveyi %90'ların üzerinde iken beş yıllık sürvey %72 civarındadır. Uzun süreli kullanımda ilaçların toksik etkilerinin ortaya çıkması son 10 yıl içerisinde böbrek naklinde indüksiyon ve idame tedavide farklı ajanların bulunması için bir gereklilik doğurmuştur. Özellikle böbrek nakli tedavisinin köşetaşı ilacı olan kalsinörin inhibitörlerinin iki yıldan uzun süre kullanımında yüksek oranda toksisite gelişimi bu ihtiyacı zorunlu hale getirmiştir. Biz bu yazıda böbrek nakli hastalarında son yıllarda deneme aşamasında olan ve/veya kullanılmaya başlanan yeni immünsupresif ilaçların genel özelliklerini ve böbrek naklindeki deneyimlerini sunmayı amaçladık. eculizumabEculizumab insanlaştırılmış bir monoklonal IgG2/4 antikordur. Kompleman C5 proteinine bağlanarak C5 konvertaz ile C5a ve C5b'ye yıkımını önleyerek membran atak kompleksi oluşumunu engeller ve kompleman aracılı hücre hasarına engel olur (1). Eculizumab temelde terminal kompleman kaskadını hedefler, ancak proksimal kompleman yolaklarının etkisini ortadan kaldıramayabilir.

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“…The rate of adverse events ranged from 6 to 38% [Ginzler et al 2014;Wallace et al 2013;Andreoli et al 2014] and included infusion reactions, hypersensitivity, headache, nausea and fatigue, in addition to infections as mentioned above. Over 16% of patients were reported to have a psychiatric adverse event while on belimumab by Wallace and colleagues [Wallace et al 2013], which is higher than the reported rates with standard SLE therapy alone. Over half of those experienced insomnia or anxiety; however, there were 6% of the patients who experienced severe depression and 0.1% reported suicidal ideation while on belimumab.…”

Section: Adverse Eventsmentioning

confidence: 99%

Belimumab in systemic lupus erythematosus: a perspective review

Hui-Yuen

Askanase

2015

Therapeutic Advances in Musculoskeletal

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Belimumab (Benlysta ® ) is a fully humanized monoclonal antibody that inhibits B-lymphocyte stimulator (also known as B cell activating factor of the tumor necrosis factor family) and was approved by the US Food and Drug Administration and the European Medicines Evaluation Agency for treatment of autoantibody-positive systemic lupus erythematosus (SLE) in adults. This review discusses the key findings of the phase III trials, post hoc analyses, and real-world postmarketing use of belimumab in the routine care of SLE patients. It also highlights the safety profile of belimumab and gives insight into its potential use to treat childhood-onset SLE. It concludes with a discussion of the current clinical trials investigating belimumab in specific SLE disease states and a look to the future with novel targeted B-cell therapies.

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Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus

Cited by 112 publications

References 27 publications

Safety of treatments for primary Sjögren’s syndrome

Safety of treatments for primary Sjögren’s syndrome

Böbrek Naklinde Kullanılan Yeni İmmünsupresif İlaçlar

Belimumab in systemic lupus erythematosus: a perspective review

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