The FINANCIAL — London, UK — Stiefel, a GSK company, announced the start of a phase III study to evaluate the efficacy and safety of subcutaneous ofatumumab in patients with pemphigus vulgaris, a rare autoimmune skin disorder. The global study will assess disease remission in patients with pemphigus vulgaris treated with subcutaneous ofatumumab as add-on treatment to oral steroids, the global standard-of-care, according to GlaxoSmithKline plc.
Pemphigus vulgaris is a rare, chronic skin disorder in which the immune system malfunctions and produces antibodies that attack healthy cells in the skin and mucous membranes.1 Patients with pemphigus vulgaris develop burn-like blisters, which can first appear in the mouth and then on the skin. Typically occurring between the ages of 30 to 60 years, pemphigus vulgaris can lead to secondary skin infections, dehydration, spread of infection through the blood (sepsis) and death.2 The incidence of pemphigus vulgaris is approximately 7 people per million worldwide. The global standard treatment for pemphigus vulgaris is chronic, high-dose systemic steroids.
“The initiation of this study is an important step towards providing a potential new treatment option for patients suffering from this painful and potentially debilitating skin disease,” said Dr. Kathy Rouan, Senior Vice President and Head of R&D, Stiefel.
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