Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin : an open-label dose escalation study

  • Introduction: As the immunosuppressive potency of 15-deoxyspergualin (DSG) has been shown in the therapy of renal transplant rejection and Wegener's granulomatosis, the intention of this study was to evaluate the safety of DSG in the therapy of lupus nephritis (LN). Methods: Patients with histologically proven active LN after prior treatment with at least one immunosuppressant were treated with 0.5 mg/kg normal body weight/day DSG, injected subcutaneously for 14 days, followed by a break of one week. These cycles were repeated to a maximum of 9 times. Doses of oral corticosteroids were gradually reduced to 7.5 mg/day or lower by cycle 4. Response was measured according to a predefined decision pattern. The dose of DSG was adjusted depending on the efficacy and side effects. Results: 21 patients were included in this phase-I/II study. After the first DSG injection, one patient was excluded from the study due to renal failure. 5 patients dropped out due to adverse events or serious adverse events including fever, leukopenia, oral candidiasis, herpes zoster or pneumonia. 11/20 patients achieved partial (4) or complete responses (7), 8 were judged as treatment failures and one patient was not assessable. 12 patients completed all 9 cycles; in those patients, proteinuria decreased from 5.88g/day to 3.37g/day (P = 0.028), Selena-SLEDAI decreased from 17.6 to 11.7. In 13/20 patients, proteinuria decreased by at least 50%; in 7 patients to less than 1g/day. Conclusions: Although the number of patients was small, we could demonstrate that DSG provides a tolerably safe treatment for LN. The improvement in proteinuria encourages larger controlled trials.

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Author:Hanns-Martin Lorenz, Wilhelm H. Schmitt, Vladimir Tesar, Ulf Müller-LadnerGND, Ingo Tarner, Ingeborg A. HauserGND, Falk Hiepe, Tobias Alexander, Heike Woehling, Kyuichi Nemoto, Peter A. Heinzel
URN:urn:nbn:de:hebis:30-93229
DOI:https://doi.org/10.1186/ar3268
ISSN:1465-9913
ISSN:1478-6362
ISSN:1478-6354
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/21356124
Parent Title (English):Arthritis Research & Therapy
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Language:English
Date of Publication (online):2011/04/14
Date of first Publication:2011/03/01
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2011/04/14
Volume:13
Issue:2, R36
Page Number:12
First Page:1
Last Page:12
Note:
© 2011 Lorenz et al. ; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Source:Arthritis Research & Therapy 2011, 13:R36 ; doi:10.1186/ar3268 ; http://arthritis-research.com/content/13/2/R36/
HeBIS-PPN:235627208
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung 2.0