Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis

Ong, Loke Meng; Hooi, Lai Seong; Lim, Teck Onn; Goh, Bak Leong; Ahmad, Ghazali; Ghazalli, Rozina; Teo, S M; Wong, H.S.; Tan, Si Yen; Shaariah, Wan; Tan, Chwee Choon; Morad, Zaki

doi:10.1111/j.1440-1797.2005.00444.x

Cited by 220 publications

(196 citation statements)

References 19 publications

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“…Evidence from early observational studies suggested that MMF may be efficacious in inducing remission of lupus nephritis (8 -11). More recently, randomized, controlled trials (RCT) comparing MMF and cyclophosphamide as induction agents in lupus nephritis have also been completed (12)(13)(14)(15) with similar results. Conclusions based on these trials, however, are limited given their small sample sizes.…”

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confidence: 64%

“…The mean age of patients ranged from 28 to 42 yr, with most patients of female gender (range 79 to 94%). The most common ethnic group was Asian (18), and three RCT compared MMF with intravenous cyclophosphamide (13,14,19). Dosing of MMF varied across studies, ranging from 1 to 3 g/d.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…A total of 1158 unique citations were identified by our search strategy, 1117 of which were excluded on initial screening. Of the 41 studies that underwent further review, 4 RCT (13,14,18,19) and two nonrandomized trials (12,20) were identified for systematic review. Five of these studies were published in peer-reviewed journals, and one was published in abstract form (19).…”

Section: Identification Of Studiesmentioning

confidence: 99%

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Mycophenolate Mofetil for Induction Therapy of Lupus Nephritis

Walsh¹,

James²,

Jayne³

et al. 2007

Clinical Journal of the American Society of Nephrology

128

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Background and Objectives: Although the accepted standard of care for induction of lupus nephritis has been cyclophosphamide, recent trials suggest that mycophenolate mofetil may be as or more effective and less toxic. A systematic review and meta-analysis were performed to determine the risk for failure to induce remission of lupus nephritis in patients who were treated with mycophenolate mofetil compared with cyclophosphamide.Design, Setting, Participants, & Measurements: Studies were identified by a search of electronic databases, bibliographies, and conference proceedings and by contacting experts. Randomized trials that compared mycophenolate mofetil with cyclophosphamide for induction therapy in adults with biopsy-proven lupus nephritis were eligible. The primary outcome was failure to induce a remission of nephritis as defined by the original studies (based on proteinuria, renal function, and urine sediment).Results: Four studies that included 268 patients and had homogeneous results across studies were identified. In a fixed-effects model, the pooled relative risk for failure to induce remission for mycophenolate mofetil compared with cyclophosphamide was 0.70. The relative risk for the composite outcome of death or end-stage renal disease for mycophenolate mofetil compared with cyclophosphamide was 0.44. Leukopenia and amenorrhea occurred more frequently in cyclophosphamide-treated patients.Conclusions: Treatment of lupus nephritis with mycophenolate mofetil compared with cyclophosphamide reduces the risk for failure to induce remission during induction therapy and may reduce the risk for death or end-stage renal disease. Mycophenolate mofetil may be considered as a first-line induction therapy for the treatment of lupus nephritis in patients without severe renal dysfunction.Clin J Am Soc Nephrol 2: 968-975, 2007.

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confidence: 64%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Identification Of Studiesmentioning

confidence: 99%

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Mycophenolate Mofetil for Induction Therapy of Lupus Nephritis

Walsh¹,

James²,

Jayne³

et al. 2007

Clinical Journal of the American Society of Nephrology

128

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“…In recent years, many studies have showed that CYC may cause leukopenia, thrombocytopenia, and erythropenia. The WBC count showed a saw-tooth pattern with IV CYC as it reached a nadir approximately 2 weeks following administration [24]. Our data showed that the SILD IV CYC would keep the WBC counts at relatively low levels.…”

Section: Discussionmentioning

confidence: 55%

Short-interval lower-dose intravenous cyclophosphamide as induction and maintenance therapy for lupus nephritis: a prospective observational study

Zhang

et al. 2014

Clin Rheumatol

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Cyclophosphamide (CYC) has long been considered a gold standard in inducing renal remission and preventing renal flares for patients with systemic lupus erythematosus (SLE). However, the rational use of CYC has not reached a consensus, such as the timing and length of treatment, the route of administration, and the ideal dosage. The objective of this study was to assess the efficacy and safety of short-interval lower-dose (SILD) intravenous (IV) CYC in the treatment of SLE. A total of 225 patients with lupus nephritis were randomly assigned to a 1-year trial, either the SILD group (12 fortnightly pulses at a fixed dose of 400 mg followed by 6 monthly pulses) or high-dose (HD) group (6 monthly pulses followed by two quarterly pulses at a dose of 0.5~1.0 g/m 2 ). At 6 months of treatment, 28 % (30/107) of patients in the SILD group reached a complete remission (CR), and 51.4 % (55/107) were in partial remission (PR), as compared with 32.7 % (35/107) and 45.8 % (49/107) in the HD group, respectively. Serum albumin, 24-h urinary protein, and the scores of disease activity were significantly improved in both groups at 6 months and maintained at the end of clinical trial. However, the SILD group showed much less menstrual disturbances (11.5 %), gastrointestinal adverse effects (5.3 %), and leukopenia (9.7 %) than the HD group (28.6, 26.8, and 19.8 %, respectively) at the end of clinical trial. The efficacy of the short-interval lower-dose (SILD) IV CYC regimen in the treatment of lupus nephritis is equivalent to that of the high-dose (HD) regimen, whereas the incidence of adverse events is much lower in the SILD group.

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“…MMF is a drug which usually is well tolerated. In patients with auto-immune diseases such as SLE, MMF is effective in inducing remission with short-term efficacy which is comparable with cyclophosphamide (Chanet al, 2000(Chanet al, , 2005Ong et al, 2005;Ginzler etal., 2005). Induction treatment with MMF and oral steroids consisted of oral MMF 1000 mg twice daily and oral prednisolone 1 mg/kg once daily (maximum 60 mg).…”

Section: Mycophenolate Mofetil (Mmf)mentioning

confidence: 99%