Internationale Therapiestudie zur Behandlung des schweren systemischen Lupus erythematodes mit Plasmapheresen und nachfolgendem Stoss-Cyclophosphamid LPSG-Studie. Schlussbericht

The LPSG trial compared the standard treatment consisting of prednisone plus pulse cyclophosphamide (Cy) with the identical treatment plus 3 plasmaphereses prior to each Cy pulse in patients with severe systemic lupus erythematosus (SLE). The international prospective and randomized multi-center trial (60 participating centers, 151 patients, protocols 'A') did not demonstrate a significant benefit of additional plasmaphereses in this setting, but a tendency towards increased side effects in the plasmapheresis arm of the trial. Thus, there are no controlled trials demonstrating a significant benefit of plasmapheresis in the standard treatment of patients with severe SLE. An additional, uncontrolled observational study investigated a modified and intensified variant of the 'synchronization' approach in SLE patients with very high disease activity. Protocol 'B' achieved for the first time treatment-free long-term remission in 15 out of 23 patients (65%, follow-up: up to 11 years). These have been treated in a single experienced center (Kiel). However, the frequency of severe side effects was high in centers with a lower degree of oncologic experience. Application of protocol 'B' should remain restricted to experienced centers. A possible paradigm shift from palliative treatment goals to curative goals in severe SLE should be discussed. International multi-center trials are feasible, achieving valid results within short time. (orig.)SIGLEAvailable from TIB Hannover: F98B859+a / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekBundesministerium fuer Bildung, Wissenschaft, Forschung und Technologie, Bonn (Germany)DEGerman