Azathioprine/methylprednisolone versus cyclophosphamide in proliferative lupus nephritis. A randomized controlled trial

Autor: Grootscholten, C., Ligtenberg, G., Hagen, E.C., van den Wall Bake, A.W.L., de Glas-Vos, J.W., Bijl, M., Assmann, K.J., Bruijn, J.A., Weening, J.J., van Houwelingen, H.C., Derksen, R.H.W.M., Berden, J.H.M., for the Dutch Working Party on Systemic Lupus Erythematosus
Přispěvatelé: Pathology
Rok vydání: 2006
Předmět:
Male
Lupus nephritis
Anti-Inflammatory Agents
Administration
Oral
OVARIAN FAILURE
Azathioprine
PULSE CYCLOPHOSPHAMIDE
Gastroenterology
chemistry.chemical_compound
Prednisone
MYCOPHENOLATE-MOFETIL
Renal disorder [IGMD 9]
Proteinuria
immunosuppression
Remission Induction
clinical trial
Middle Aged
Treatment Outcome
Methylprednisolone
Nephrology
Creatinine
Injections
Intravenous
Corticosteroid
Drug Therapy
Combination
Female
medicine.symptom
Infection and autoimmunity [NCMLS 1]
Immunosuppressive Agents
medicine.drug
Adult
medicine.medical_specialty
Cyclophosphamide
Adolescent
medicine.drug_class
LONG-TERM
Prednisolone
Auto-immunity
transplantation and immunotherapy [N4i 4]
HERPES-ZOSTER
SUSTAINED AMENORRHEA
INTRAVENOUS CYCLOPHOSPHAMIDE
Internal medicine
medicine
Humans
IMMUNOSUPPRESSIVE THERAPY
TERM-FOLLOW-UP
lupus nephritis
business.industry
RENAL FLARES
Mycophenolic Acid
medicine.disease
clinical nephrology
Surgery
Renal disorders [UMCN 5.4]
chemistry
randomized controlled trial
business
Zdroj: Kidney International. Supplement, 70, 732-42
Kidney International. Supplement, 70, 4, pp. 732-42
Kidney International, 70(4), 732-742. ELSEVIER SCIENCE INC
Kidney international, 70(4), 732-742. Nature Publishing Group
ISSN: 0085-2538
2157-1724
DOI: 10.1038/sj.ki.5001630
Popis: Contains fulltext : 50854.pdf (Publisher’s version ) (Closed access) Until recently, intravenous cyclophosphamide pulses with oral corticosteroids were regarded standard therapy for proliferative lupus nephritis (LN). Azathioprine, a less toxic alternative, was never proven to be inferior. In the first Dutch lupus nephritis study (enrollment between 1995 and 2001), we randomized 87 proliferative LN patients to either cyclophosphamide pulses (750 mg/m(2), 13 pulses in 2 years) combined with oral prednisone (CY) or to azathioprine (2 mg/kg/day in 2 years) combined with intravenous pulses of methylprednisolone (3 x 3 pulses of 1000 mg) and oral prednisone (AZA). After a median follow-up of 5.7 years (interquartile range 4.1-7.2 years), doubling of serum creatinine was more frequent in the AZA group, although not statistically significant (relative risk (RR): 4.1, with 95% confidence interval (95% CI): 0.8-20.4). Relapses occurred more often in the AZA group (RR: 8.8, 95% CI: 1.5-31.8). Creatinine and proteinuria at last visit did not differ between the two treatment arms. Moreover, 88.4% of the patients in the AZA arm were still free of cyclophosphamide treatment. During the first 2 years, the frequency of remission was not different, but infections, especially herpes zoster virus infections (HZV) were more frequent in the AZA group. Parameters for ovarian function did not differ between the two groups. In conclusion, in this open-label randomized controlled trial, cyclophosphamide was superior to azathioprine with regard to renal relapses and HZV. At last follow-up, there were no differences in serum creatinine or proteinuria between the two groups. However, since our study lacked sufficient power, longer follow-up is needed to reveal putative differences.
Databáze: OpenAIRE
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