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Since lupus nephritis is a serious, disabling, and possibly life-threatening illness, it is not surprising to see mortality in lupus nephritis clinical trials. Voclosporin safety information originates from a total of 267 patients who received 23.7 mg BID and an additional 88 patients who received 39.5 mg BID.
Ianalumab (INN; [1] development code VAY736) is a monoclonal antibody that is being investigated for autoimmune hepatitis, multiple sclerosis, pemphigus vulgaris, rheumatoid arthritis, Sjögren syndrome, and systemic lupus erythematosus. [2] [3] [4] This drug is being developed by Novartis. In 2021 ianalumab was undergoing Phase II/III trials.
Lupus nephritis is an inflammation of the kidneys caused by systemic lupus erythematosus (SLE) and childhood-onset systemic lupus erythematosus which is a more severe form of SLE that develops in children up to 18 years old; both are autoimmune diseases.
Belimumab was not effective in Phase II clinical trials for rheumatoid arthritis. [30] It was moderately effective in Phase II trials for Sjögren syndrome. [31] In December 2020, belimumab was approved by the FDA as a treatment for lupus nephritis in combination with standard treatment. [32]
Similar promising results is shown in adults with Membranoproliferative glomerulonephritis treated with Obinutuzumab after resistance to rituximab, tacrolimus and cyclophosphamide. Furthermore, Obinutuzumab showed sustained clinical benefit through 2 years in patients with class III and IV Proliferative Lupus Nephritis compared to rituximab. [12]
Also Read: Biogen/UCB Partnered Autoimmune Disease Candidate Hits Primary Goal In Late-Stage Study, Sets Stage Another Pivotal Trial The Biogen Gains Momentum With Positive Lupus Drug Results ...
The cause of diffuse proliferative glomerulonephritis (DPGN) depends on the severity of the disease. DPGN is a secondary disease, in that a disease that a patient already has causes DPGN to occur. The most common associated disease of DPGN is severe systemic lupus erythematosus(SLE). [4] Specifically, Lupus nephritis class IV. [5]
Biogen and Belgian partner UCB said on Tuesday their experimental lupus treatment met the main goal of a late-stage trial in patients with the chronic disease, a surprise result after the drug ...
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