Recently, the US FDA approved Roche Rituxan (common name: rituximab, rituximab) for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV). It is worth mentioning that this is also FDA approved treatment. The first biological therapy of PV.
It is understood that pemphigus is a group of autoimmune diseases caused by the adhesion of autoantibodies produced by B cells in the immune system to connective proteins between skin epidermal cells. When these connections divide, the cells separate from each other, causing the skin to separate and form blisters, while pemphigus vulgaris is the most common type of pemphigus, and its main feature is the production of desmosome between epithelial cells in the serum. Autoantibodies, clinical manifestations of relaxing blisters, bullae, with intractable, painful mucosal erosions and ulcers, the main challenges of treatment are how to control the disease for a long time, reduce recurrence, avoid long-term application of glucocorticoids and immunosuppressants Adverse reactions reduce the amount of hormones. However, because the disease is rare, large randomized, double-blind, placebo-controlled prospective studies are rare, and there are currently few effective treatments.
Rituxan is a therapeutic monoclonal antibody that targets the CD20 antigen on the surface of normal and malignant B cells, then mobilizes the body's natural defenses, attacks and kills labeled B cells. Previously, the FDA has granted Rituxan priority in the treatment of PV, breakthrough drug qualifications, orphan drug qualifications. Until now, in addition to pemphigus vulgaris, Rituxan has been approved for use in rheumatoid arthritis, granulomatous multivessels Treatment of diseases such as inflammation and microscopic polyangiitis.
The approval was based on data from the clinical study Ritux 3, which enrolled 90 PV patients. In the study, patients were randomized into two protocol groups: CS standard dosing regimen and Rituxan combined dose reduction with short-term low-dose oral CS program group.
The final study showed that Rituxan significantly increased the rate of PV remission while successfully reducing and/or stopping CS therapy. The specific data is: 90% of patients in the Rituxan+CS program group reached the end point, and only 28% in the CS program group.
In addition, Roche is conducting another phase III study, PEMPHIX (NCT02383589), to evaluate the efficacy and safety of the Rituxan combined dose-decreasing CS regimen relative to the immunosuppressive drug Cellcept (mycophenolate mofetil).
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