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Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab
Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.
Details
| Lead sponsor | University of Luebeck |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | 2008-01 |
| Completion | 2011-07 |
Conditions
- Pemphigus
Interventions
- Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
Primary outcomes
- Number of Patients Achieving a Short- and Long-term Remission of Pemphigus — up to 43 months
Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.
Countries
Germany