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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.
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.
It is approved in the United States [8] and Canada, [9] and the European Union [5] to treat systemic lupus erythematosus and lupus nephritis. [ 10 ] The most common side effects include bacterial infections, such as bronchitis (infection in the lungs) and infection of the urinary tract (structures that produce or carry urine), diarrhea and ...
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 ...
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 ...
Systemic Lupus Erythematosus (SLE) - Better known as simply "Lupus", this autoimmune disease can affect nearly every major system in the human body and the kidneys are no exception. Autoantibodies produced in SLE can form immune complexes that deposit along the glomerular basement membrane and cause glomerular inflammation which leads to a ...
Lupus nephritis: Kidneys: Anti-dsDNA, Anti-Sm, Anti-nuclear antibodies Confirmed Up to 60% of those with Lupus [49] Interstitial nephritis: Kidneys: Various autoantibodies Probable Varies widely, often drug-induced [50] Interstitial cystitis: Bladder: Anti-urothelial and anti-nuclear antibodies Probable 100-450 per 100,000 women, less common in ...
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF ...