Efficacy and safety of adjuvant immunoadsorption in pemphigus

• Applicants: Professor Dr. Rüdiger Eming; Professor Dr. Enno Schmidt
• Subject Area: Dermatology
• Term: from 2010 to 2018
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 130378002

Pemphigus is a potentially lethal autoimmune bullous disease characterized by autoantibodies against desmoglein 1 and 3, leading to flaccid blisters and severe erosions of the skin and mucous membranes. Because of its rarity only a few controlled prospective clinical trials have been performed, mostly without significant differences between the treatment groups due to the tow number of included patients. Pemphigus requires long-term use of high-dose corticosteroids combined with adjuvant immunosuppressants. This therapy leads to considerable comorbidity demanding novel treatment modalities. The removal of circulating autoantibodies by immunoadsorption (lA) provides a rational therapeutic option. Adjuvant lA has been shown to induce the rapid removal of circulating autoantibodies followed by dramatic clinical improvement in all and clinical remission in the majority of 40 pemphigus patients reported so far in various cohort studies. The present prospective controlled multicenter trial aims at investigating the clinical efficacy and safety of lA in patients with active pemphigus. Standard treatment with prednisolone (1 mg/kg/d) plus azathioprine or mycophenolate mofetil, respectively, is compared to the same regimen plus adjuvant lA in 82 patients. Two to four cycles of lA, each consisting of lA treatment on four consecutive days, are administered every three weeks. Primary endpoint is the time to remission defined as healing of all blisters and erosions.

• DFG Programme: Clinical Trials