Benlysta
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | B-cell activating factor (BAFF, BLyS) |
| Clinical data | |
| Trade names | Benlysta |
| AHFS/Drugs.com | Consumer Drug Information |
| MedlinePlus | a611027 |
| License data | |
| Pregnancy category |
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| Routes of administration |
Intravenous |
| ATC code | |
| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6714H10428O2102S52 |
| Molar mass | 151.8 kg/mol |
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Belimumab (trade name Benlysta, previously known as LymphoStat-B) is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator (BLyS). B cells are responsible for part of the normal immune response, and also for the over-aggressive immune response in autoimmune diseases like systemic lupus erythematosus (SLE).
Belimumab is approved in the United States, Canada and Europe for treatment of SLE. However, the major phase III trials excluded the more severe cases of SLE with kidney and brain damage, so its effectiveness has not been demonstrated in those cases. A Phase III study for SLE patients with kidney disease is now recruiting.
U.S. F.D.A. reviewers were concerned that belimumab is only "marginally" effective, and that there were more deaths in the treatment group.
Belimumab's defenders said that in addition to its modest efficiency, belimumab allowed patients to significantly reduce their use of corticosteroids.
Belimumab is expensive, typically $28,000 for the first year. The UK National Institute for Health and Care Excellence (NICE) calculated the cost of belimumab at £61,200 per quality-adjusted life year (QALY), which is more than the normally accepted £20,000 to £30,000.
Phase II trials of belimumab for rheumatoid arthritis were unsuccessful. Phase II trials for Sjögren’s Syndrome were more successful.
Belimumab was developed by Human Genome Sciences (HGS) and Cambridge Antibody Technology.GlaxoSmithKline acquired HGS, took belimumab through Phase III clinical trials, and markets belimumab.
While belimumab appears safe in systemic lupus erythematosus, the magnitude of benefit is small. Black/African American patients did not show a benefit. The most severe cases, with kidney and central nervous system involvement, were excluded from the trials.
The efficacy and safety of belimumab was demonstrated in 2 Phase III randomized, controlled studies, BLISS-52 and BLISS-76. The 2 studies had a total of 1,684 patients, with scores of ≥6 on the SELENA-SLEDAI assessment. They were divided into a placebo and 2 dosage groups of belimumab, in addition to standard therapy. The primary end point was a reduction of ≥4 on the SELENA-SLEDAI assessment, and several other factors, at 52 weeks. Belimumab significantly improved the response rate, reduced disease activity and severe flares, and was well tolerated. 58% had SELENA-SLEDAI scores reduced by ≥4 points during 52 weeks with belimumab 10 mg/kg compared to 46% with placebo.
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