Belimumab: First targeted biological treatment for systemic lupus erythematosus

Dubey, Ashok Kumar; Handu, Shailendra; Dubey, Suparna; Sharma, Prashant; Sharma, KK

doi:10.4103/0976-500x.85930

Cited by 65 publications

(49 citation statements)

References 18 publications

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“…Currently, it is the only approved biological for the treatment of systemic lupus erythematosus (SLE). [ 1 2 ]…”

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confidence: 99%

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Belimumab in systemic lupus erythematosus

Srivastava

2016

Indian J Dermatol

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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. Psychiatric events including suicidal tendency, progressive multifocal leukoencephalopathy and malignancies too have been reported. Apart from SLE, the drug is also being tried for other autoimmune disorders.

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“…Currently, it is the only approved biological for the treatment of systemic lupus erythematosus (SLE). [ 1 2 ]…”

mentioning

confidence: 99%

“…Answer: Belimumab was approved by the US Food and Drug Administration (FDA) on March 9, 2011, and it became the first targeted therapy for the treatment of SLE. [ 1 ] It was also approved by the European Medicines Agency in July 2011. [ 3 ] Before belimumab, the last drug to be approved by the FDA was hydroxychloroquine in 1955.…”

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confidence: 99%

Belimumab in systemic lupus erythematosus

Srivastava

2016

Indian J Dermatol

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“…After 50 years of research and development, in modern era, belimumab is the first ever biological agent (Hydroxychloroquine, approved in 1955) that has been approved by the USFDA in March 2011 and subsequently by European Medicines Agency in July 2011 for the treatment of SLE. Belimumab is a complete human IgG1λ recombinant monoclonal antibody which directs against BAFF and also indicated as an add-on therapy for the treatment of adult patients with active autoantibody positive, SLE and for patients receiving standard therapy, however, not indicated for severe active lupus nephritis or active Central Nervous System (CNS) lupus patients [24,25].…”

Section: Belimumab (Benlysta ® )mentioning

confidence: 99%

“…Belimumab can also block BAFF-induced T cell secretion INF-γ and IL-2 and also IL-2 dependent T cell proliferation. These unique mechanisms made belimumab as a promising therapeutic option for SLE patients [15,24,27,28].…”

Section: Therapeutic Mechanism and Dosagementioning

confidence: 99%

Belimumab: therapeutic mechanism and current status of clinical trials

Vana¹

2018

biomedicalresearch

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Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder with diverse clinical features and involving multiple organs leading to highest mortality rate among rheumatic diseases. B cells are responsible and central to the pathogenesis of SLE progression by means of over-aggressive immune response. The complexity of clinical manifestations and unpredictability of the disease are the main hurdles in optimizing treatment for SLE. Recent developments in biological therapy generated hope in SLE patients. Belimumab (Benlysta ®) is a complete human monoclonal antibody that is approved for SLE treatment. More or less, belimumab is the first approved biological drug from the Food and Drug Administration, United States (FDA), inhibiting B-cell activating factor/B-lymphocyte stimulator. The present review elucidates the cellular mechanism involved in SLE progression and therapeutic effective of belimumab including clinical trials and clinical outcomes.

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“…The treatment of SLE consists primarily of immunosuppressive drugs, most often hydroxychloroquine and corticosteroids. Both the European Medicines Agency (4) and the United States Food and Drug Administration (FDA) (3) approved belimumab for the treatment of SLE in 2011, thus becoming the first targeted therapy for this disease. Before belimumab, the last drug to be approved by the FDA for the treatment of SLE was hydroxychloroquine in 1955 (5).…”

Section: Introductionmentioning

confidence: 99%

One case of toxic epidermal necrolysis after treatment with belimumab in a patient with systemic lupus erythematosus

Duna¹,

Balanescu²,

Iosif³

et al. 2019

Ro J Rheumatol.

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Belimumab is a human immunoglobulin G1-lambda-1 (IgG1-λ) monoclonal antibody that targets the soluble BLyS human protein, also known as B-cell activating factor (BAFF) approved for the treatment of systemic lupus erythematosus (SLE). Serious and sometimes fatal infections have been reported in patients receiving novel immunosuppressive agents, including belimumab. Thus, physicians should exercise caution when considering belimumab in patients with SLE. A 50-year-old woman with SLE presented with a severe, diffuse rash two months after initiating treatment with belimumab. A skin biopsy revealed epidermal necrolysis with keratinocyte detachment and apoptosis in the basal layer of the epidermis, suggestive for toxic epidermal necrolysis (TEN). Belimumab was discontinued and 500 mg of pulse IV methylprednisolone therapy every day for 3 days were administered, with resolution of the skin lesions in the following days. To the best of our knowledge, this is the first case of belimumab-associated TEN.

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Belimumab: First targeted biological treatment for systemic lupus erythematosus

Cited by 65 publications

References 18 publications

Belimumab in systemic lupus erythematosus

Belimumab in systemic lupus erythematosus

Belimumab: therapeutic mechanism and current status of clinical trials

One case of toxic epidermal necrolysis after treatment with belimumab in a patient with systemic lupus erythematosus

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