Skip to main content

Main menu

  • Home
  • Content
    • Published Ahead of Print
    • Current Issue
    • JASN Podcasts
    • Article Collections
    • Archives
    • Kidney Week Abstracts
    • Saved Searches
  • Authors
    • Submit a Manuscript
    • Author Resources
  • Editorial Team
  • Editorial Fellowship
    • Editorial Fellowship Team
    • Editorial Fellowship Application Process
  • More
    • About JASN
    • Advertising
    • Alerts
    • Feedback
    • Impact Factor
    • Reprints
    • Subscriptions
  • ASN Kidney News
  • Other
    • ASN Publications
    • CJASN
    • Kidney360
    • Kidney News Online
    • American Society of Nephrology

User menu

  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
American Society of Nephrology
  • Other
    • ASN Publications
    • CJASN
    • Kidney360
    • Kidney News Online
    • American Society of Nephrology
  • Subscribe
  • My alerts
  • Log in
  • My Cart
Advertisement
American Society of Nephrology

Advanced Search

  • Home
  • Content
    • Published Ahead of Print
    • Current Issue
    • JASN Podcasts
    • Article Collections
    • Archives
    • Kidney Week Abstracts
    • Saved Searches
  • Authors
    • Submit a Manuscript
    • Author Resources
  • Editorial Team
  • Editorial Fellowship
    • Editorial Fellowship Team
    • Editorial Fellowship Application Process
  • More
    • About JASN
    • Advertising
    • Alerts
    • Feedback
    • Impact Factor
    • Reprints
    • Subscriptions
  • ASN Kidney News
  • Follow JASN on Twitter
  • Visit ASN on Facebook
  • Follow JASN on RSS
  • Community Forum
CLINICAL RESEARCH
You have accessRestricted Access

Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis

Gerald B. Appel, Gabriel Contreras, Mary Anne Dooley, Ellen M. Ginzler, David Isenberg, David Jayne, Lei-Shi Li, Eduardo Mysler, Jorge Sánchez-Guerrero, Neil Solomons, David Wofsy and ; the Aspreva Lupus Management Study Group
JASN May 2009, 20 (5) 1103-1112; DOI: https://doi.org/10.1681/ASN.2008101028
Gerald B. Appel
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Gabriel Contreras
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Mary Anne Dooley
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ellen M. Ginzler
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
David Isenberg
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
David Jayne
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lei-Shi Li
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Eduardo Mysler
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jorge Sánchez-Guerrero
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Neil Solomons
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
David Wofsy
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data Supps
  • Info & Metrics
  • View PDF
Loading

Article Figures & Data

Figures

  • Tables
  • Additional Files
  • Figure 1.
    • Download figure
    • Open in new tab
    • Download powerpoint
    Figure 1.

    Patient disposition. *Hepatitis/cytomegalovirus infection (n = 16) or other illness (n = 4). ACR, American College of Rheumatology.

  • Figure 2.
    • Download figure
    • Open in new tab
    • Download powerpoint
    Figure 2.

    Response rates of study population and by racial group.

Tables

  • Figures
  • Additional Files
    • View popup
    Table 1.

    Demographics and baseline disease characteristicsa

    CharacteristicMMF (n = 185)IVC (n = 185)Total (N = 370)
    Gender (n [%])
        male28 (15.1)29 (15.7)57 (15.4)
        female157 (84.9)156 (84.3)313 (84.6)
    Race (n [%])
        white75 (40.5)72 (38.9)147 (39.7)
        Asian62 (33.5)61 (33.0)123 (33.2)
        otherb48 (25.9)52 (28.1)100 (27.0)
    Ethnicity (n [%])
        Hispanic64 (34.6)67 (36.2)131 (35.4)
        non-Hispanic121 (65.4)118 (63.8)239 (64.6)
    Region (n [%])
        Asia57 (30.8)60 (32.4)117 (31.6)
        Latin America56 (30.3)50 (27.0)106 (28.6)
        United States/Canada37 (20.0)38 (20.5)75 (20.3)
        rest of world35 (18.9)37 (20.0)72 (19.5)
    Renal biopsy class (n [%])
        III/III + V32 (17.3)26 (14.1)58 (15.7)
        IV/IV + V124 (67.0)128 (69.2)252 (68.1)
        V only29 (15.7)31 (16.8)60 (16.2)
    Scarring on renal biopsy (n [%])c66 (35.7)56 (30.3)d122 (33.0)d
    Serum creatinine (μmol/L [mg/dl]; mean ± SD)108.6 ± 1.2 (97.2 ± 1.1)92.7 ± 1.0 (56.9 ± 0.6)d100.6 ± 1.1 (80.0 ± 0.9)d
    Urine protein/creatinine ratio (mean ± SD)4.1 ± 4.2e4.1 ± 3.2f4.1 ± 3.7e,f
    Range of GFR (ml/min per 1.73 m2; n [%])d,g
        ≥9080 (43.2)86 (46.7)166 (45.0)
        ≥60 to <9053 (28.6)52 (28.3)105 (28.5)
        ≥30 to <6032 (17.3)34 (18.5)66 (17.9)
        <3020 (10.8)12 (6.5)32 (8.7)
    Range of anti-dsDNA antibody titer (IU/ml; n [%])h
        <30 (negative)32 (18.4)23 (13.5)55 (15.9)
        30 to 60 (low positive)25 (14.4)24 (14.0)49 (14.2)
        >60 to 200 (positive)52 (29.9)40 (23.4)92 (26.7)
        >200 (strong positive)65 (37.4)84 (49.1)149 (43.2)
    Range of C3 concentration (g/L; n [%])i
        >1.81 (0.6)1 (0.6)2 (0.6)
        0.9 to 1.8 (normal)50 (28.4)34 (19.5)84 (24.0)
        <0.9 (low)125 (71.0)139 (79.9)264 (75.4)
    Range of C4 concentration (g/L; n [%])j
        >0.472 (1.1)1 (0.6)3 (0.9)
        0.16 to 0.47 (normal)70 (39.8)47 (27.2)117 (33.5)
        <0.16104 (59.1)125 (72.3)229 (65.6)
    Age at enrollment (yr; mean ± SD)32.4 ± 11.231.3 ± 10.331.9 ± 10.7
    Age at diagnosis of lupus nephritis (yr; mean ± SD)30.2 ± 11.028.8 ± 10.229.5 ± 10.6
    Time since diagnosis of lupus nephritis (yr; median [range])k1.0 (1 to 21)1.0 (1 to 23)1.0 (1 to 23)
    • ↵a Anti-dsDNA, antibodies reactive to double-stranded DNA; C3, complement factor 3; C4, complement factor 4.

    • ↵b Race self-reported as black (46), Mexican-Mestizo (28), mixed race (9), Hispanic (3), North African (2), Chinese (1), South/Central America/Caribbean (3), Native American (1), Pacific Islander (1), Eritrean (1), East Indian (1), Middle Eastern (1), Latin (1), brown (1), or white (1).

    • ↵c Scarring defined according to ISN classification of class III/IV active/chronic lupus nephritis.20

    • ↵d Data missing for one patient in the IVC group.

    • ↵e n = 180.

    • ↵f n = 181.

    • ↵g GFR was estimated by the Modification of Diet in Renal Disease method.21

    • ↵h Data missing for 11 patients in the MMF group and for 14 patients in the IVC group.

    • ↵i Data missing for nine patients in the MMF group and for 11 patients in the IVC group.

    • ↵j Data missing for nine patients in the MMF group and for 12 patients in the IVC group.

    • ↵k Time since diagnosis was rounded up to 1.0 yr for patients whose time was <1 yr.

    • View popup
    Table 2.

    Summary of reasons for premature withdrawal from treatment (intention-to-treat population)

    ParameterMMF (n = 185; n [%])IVC (n = 185; n [%])
    Completed 24-wk open-label induction phase150 (81.1)156 (84.3)
    Total no. of patients withdrawn prematurely35 (18.9)29 (15.7)
    Reasons for withdrawal from induction phase
        adverse event21 (60.0)12 (41.4)
        deterioration with respect to serum creatinine after 12 and 16 wk of treatment0 (0.0)2 (6.9)
        dosage reduction of MMF <2 g/d for >14 d1 (2.9)0 (0.0)
        lost to follow-up1 (2.9)2 (6.9)
        patient died3 (8.6)1 (3.4)
        patient withdrew consent6 (17.1)5 (17.2)
        physician decision1 (2.9)3 (10.3)
        sponsor decision2 (5.7)1 (3.4)
        noncompliance0 (0.0)1 (3.4)
        reason not noted0 (0.0)2 (6.9)
    • View popup
    Table 3.

    Summary of results of secondary efficacy end pointsa

    ParameterMMF (n = 185)IVC (n = 185)Odds Ratio (95% CI)
    Responders with renal biopsy class III or IV88 (56.4)b83 (53.9)c1.1 (0.7 to 1.8)
    Patients with renal biopsy class V16 (55.2)d15 (48.4)e
    Renal remission criterion metTreatment difference (% [95% CI])
        serum creatinine130 (70.3)125 (67.6)2.7 (−6.7 to 12.1)
        urine protein44 (23.8)50 (27.0)−3.2 (−12.1 to 5.6)
        urine sediment58 (31.4)44 (23.8)7.6 (−1.5 to 16.6)
        all three criteria16 (8.6)15 (8.1)0.5 (−5.1 to 6.2)
    Renal and extrarenal remission
        complete absence of BILAG As and Bs54 (29.7)f45 (24.9)g4.8 (4.3 to 14.0)
    SELENA-SLEDAIDifference between means (95% CI)
        change in score from baseline to end point (mean ± SD)−6.2 ± 10.1h−6.6 ± 8.0i0.41 (−1.48 to 2.30)
    Anti-dsDNA
        patients with dsDNA >60 IU/ml at baselinej117 (67.2)k124 (72.5)l
        patients with dsDNA >60 IU/ml at end point72 (41.4)k91 (53.2)l
    C3
        patients with low C3 at baselinem125 (71.0)n139 (79.9)k
        patients with low C3 at end pointm70 (39.8)n90 (51.7)k
    C4
        patients with low C4 at baselineo104 (59.1)n125 (72.3)p
        patients with low C4 at end pointo51 (29.0)n72 (41.6)p
    • ↵a Data are n(%), unless specified otherwise. BILAG, British Isles Lupus Assessment Group Scale; SELENA-SLEDAI, Safety of Exogenous Estrogens in Lupus Erythematosus National Assessment / Systemic Lupus Erythematosus Disease Activity Index.

    • ↵b n = 156.

    • ↵c n = 154.

    • ↵d n = 29.

    • ↵e n = 31.

    • ↵f n = 182.

    • ↵g n = 181.

    • ↵h n = 179.

    • ↵i n = 178.

    • ↵j The threshold >60 IU/ml was twice the upper limit of the range defined as normal.

    • ↵k n = 174.

    • ↵l n = 171.

    • ↵m Low C3 was defined as <0.9 g/L.

    • ↵n n = 176.

    • ↵o Low C4 was defined as <0.16 g/L in one laboratory and <0.10 g/L in the other; each patient's baseline and end point samples were analyzed at the same laboratory.

    • ↵p n = 173.

    • View popup
    Table 4.

    Incidences of adverse events reported by >10% of patientsa

    ParameterPatients Who Experienced at Least One AE
    MMF (n = 184)IVC (n = 180)
    Deaths9 (4.9)5 (2.8)
    Withdrawals as a result of AEs24 (13.0)13 (7.2)
    All AEs177 (96.2)171 (95.0)
        diarrhea52 (28.3)23 (12.8)
        headache38 (20.7)47 (26.1)
        peripheral edema35 (19.0)30 (16.7)
        arthralgia29 (15.8)43 (23.9)
        nausea27 (14.7)82 (45.6)
        hypertension26 (14.1)25 (13.9)
        nasopharyngitis25 (13.6)29 (16.1)
        vomiting25 (13.6)68 (37.8)
        cough24 (13.0)16 (8.9)
        anemia23 (12.5)12 (6.7)
        alopecia20 (10.9)64 (35.6)
        abdominal pain19 (10.3)13 (7.2)
        back pain19 (10.3)16 (8.9)
        muscle spasms19 (10.3)17 (9.4)
        rash19 (10.3)21 (11.7)
        urinary tract infection19 (10.3)17 (9.4)

Additional Files

  • Figures
  • Tables
  • Mycophenolate Mofetil Versus Cyclophosphamide as Lupus Nephritis Induction Treatment

    Files in this Data Supplement:

    • Supplemental Data - 1
    • Supplemental Data - 2
    • Supplemental Data - 3
    • Supplemental Data - 4
  • Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis

    Files in this Data Supplement:

    • Press Release
PreviousNext
Back to top

In this issue

Journal of the American Society of Nephrology: 20 (5)
Journal of the American Society of Nephrology
Vol. 20, Issue 5
May 2009
  • Table of Contents
  • Table of Contents (PDF)
  • Index by author
View Selected Citations (0)
Print
Download PDF
Sign up for Alerts
Email Article
Thank you for your help in sharing the high-quality science in JASN.
Enter multiple addresses on separate lines or separate them with commas.
Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis
(Your Name) has sent you a message from American Society of Nephrology
(Your Name) thought you would like to see the American Society of Nephrology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis
Gerald B. Appel, Gabriel Contreras, Mary Anne Dooley, Ellen M. Ginzler, David Isenberg, David Jayne, Lei-Shi Li, Eduardo Mysler, Jorge Sánchez-Guerrero, Neil Solomons, David Wofsy
JASN May 2009, 20 (5) 1103-1112; DOI: 10.1681/ASN.2008101028

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Request Permissions
Share
Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis
Gerald B. Appel, Gabriel Contreras, Mary Anne Dooley, Ellen M. Ginzler, David Isenberg, David Jayne, Lei-Shi Li, Eduardo Mysler, Jorge Sánchez-Guerrero, Neil Solomons, David Wofsy
JASN May 2009, 20 (5) 1103-1112; DOI: 10.1681/ASN.2008101028
del.icio.us logo Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like

Jump to section

  • Article
    • Abstract
    • RESULTS
    • DISCUSSION
    • CONCISE METHODS
    • DISCLOSURES
    • Acknowledgments
    • Footnotes
    • REFERENCES
  • Figures & Data Supps
  • Info & Metrics
  • View PDF

More in this TOC Section

  • Kidney Biopsy Features Most Predictive of Clinical Outcomes in the Spectrum of Minimal Change Disease and Focal Segmental Glomerulosclerosis
  • Molecular Characterization of Membranous Nephropathy
  • Long-Term Efficacy and Safety of Repeated Rituximab to Maintain Remission in Idiopathic Childhood Nephrotic Syndrome: An International Study
Show more Clinical Research

Cited By...

  • Infection hospitalisation in systemic lupus in Sweden
  • From sequential to combination and personalised therapy in lupus nephritis: moving towards a paradigm shift?
  • Absence of renal remission portends poor long-term kidney outcome in lupus nephritis
  • Advanced Chronic Kidney Disease in Lupus Nephritis: Is Dialysis Inevitable?
  • Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis
  • Lack of EULAR/ERA-EDTA response at 1 year predicts poor long-term renal outcome in patients with lupus nephritis
  • The Evolving Role of Calcineurin Inhibitors in Treating Lupus Nephritis
  • Lupus patient decisions about clinical trial participation: a qualitative evaluation of perceptions, facilitators and barriers
  • Prediction of prognosis and renal outcome in lupus nephritis
  • Current challenges in the development of new treatments for lupus
  • Urine TWEAK level as a biomarker for early response to treatment in active lupus nephritis: a prospective multicentre study
  • Changing paradigms in the treatment of systemic lupus erythematosus
  • 10 most important contemporary challenges in the management of SLE
  • Engaging African ancestry participants in SLE clinical trials
  • Tacrolimus in non-Asian patients with SLE: a real-life experience from three European centres
  • Serum albumin at 1 year predicts long-term renal outcome in lupus nephritis
  • Complications of Immunosuppression in Glomerular Disease
  • Renal Remission Status and Longterm Renal Survival in Patients with Lupus Nephritis: A Retrospective Cohort Analysis
  • Lupus community panel proposals for optimising clinical trials: 2018
  • Risk of adverse events from different drugs for SLE: a systematic review and network meta-analysis
  • Mycophenolate Mofetil in Combination with Steroids for Treatment of C3 Glomerulopathy: A Case Series
  • European evidence-based recommendations for the diagnosis and treatment of childhood-onset lupus nephritis: the SHARE initiative
  • Multitarget Therapy for Maintenance Treatment of Lupus Nephritis
  • Safety, pharmacokinetics and pharmacodynamics of AMG 811, an anti-interferon-{gamma} monoclonal antibody, in SLE subjects without or with lupus nephritis
  • Enteric-coated mycophenolate sodium versus azathioprine in patients with active systemic lupus erythematosus: a randomised clinical trial
  • Longterm Data on Disease Flares in Patients with Proliferative Lupus Nephritis in Recent Years
  • Early proteinuria response: a valid real-life situation predictor of long-term lupus renal outcome in an ethnically diverse group with severe biopsy-proven nephritis?
  • Update on Lupus Nephritis
  • IgA Nephropathy
  • TAC-TIC use of tacrolimus-based regimens in lupus nephritis
  • Current and Emerging Therapies for Lupus Nephritis
  • Treatments for Lupus Nephritis: A Systematic Review and Network Metaanalysis
  • Long-term follow-up of the MAINTAIN Nephritis Trial, comparing azathioprine and mycophenolate mofetil as maintenance therapy of lupus nephritis
  • Immunosuppressive Medications
  • A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience
  • Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up
  • Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort
  • Immunosuppressive Therapies for the Induction Treatment of Proliferative Lupus Nephritis: A Systematic Review and Network Metaanalysis
  • Is Newer Safer? Adverse Events Associated with First-Line Therapies for ANCA-Associated Vasculitis and Lupus Nephritis
  • New insights into the pathogenesis and management of lupus in children
  • Resolution of Proteinuria in Lupus Nephritis: Hurry Up and Wait
  • National Trends in Pediatric Systemic Lupus Erythematosus Hospitalization in the United States: 2000-2009
  • Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids
  • Recent progress in conventional and biologic therapy for systemic lupus erythematosus
  • Could we abandon cyclophosphamide in systemic vasculitis and lupus nephritis?
  • Lupus Nephritis: Keeping the Wolf at Bay
  • Lupus Nephritis: Treatment of Resistant Disease
  • Lupus Nephritis: Induction Therapy in Severe Lupus Nephritis--Should MMF Be Considered the Drug of Choice?
  • Renal Outcome in Patients with Lupus Nephritis Using a Steroid-free Regimen of Monthly Intravenous Cyclophosphamide: A Prospective Observational Study
  • Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of adult and paediatric lupus nephritis
  • Rituximab versus oral cyclophosphamide for treatment of relapses of proliferative lupus nephritis: a clinical observational study
  • A Prospective Observational Study of Mycophenolate Mofetil Treatment in Progressive Diffuse Cutaneous Systemic Sclerosis of Recent Onset
  • Long-term follow-up of a randomised controlled trial of azathioprine/methylprednisolone versus cyclophosphamide in patients with proliferative lupus nephritis
  • Activated Protein C Attenuates Systemic Lupus Erythematosus and Lupus Nephritis in MRL-Fas(lpr) Mice
  • Three Decades of Progress in Treating Childhood-Onset Lupus Nephritis
  • Targeted therapies in systemic lupus erythematosus: successes, failures and future
  • Systematic Review and Meta-Analysis of Immunosuppressant Therapy Clinical Trials in Membranous Lupus Nephritis
  • Mycophenolate Mofetil for Induction Treatment of Lupus Nephritis: A Systematic Review and Metaanalysis
  • Updates on the Treatment of Lupus Nephritis
  • Azathioprine versus mycophenolate mofetil for long-term immunosuppression in lupus nephritis: results from the MAINTAIN Nephritis Trial
  • A decade of mycophenolate mofetil for lupus nephritis: is the glass half-empty or half-full?
  • Therapeutic opportunities in systemic lupus erythematosus: state of the art and prospects for the new decade
  • The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose and high-dose intravenous cyclophosphamide
  • Biomarkers for Lupus Nephritis: The Quest Continues
  • Oral Cyclophosphamide for Lupus Glomerulonephritis: An Underused Therapeutic Option
  • Google Scholar

Similar Articles

Related Articles

  • PubMed
  • Google Scholar

Articles

  • Current Issue
  • Early Access
  • Subject Collections
  • Article Archive
  • ASN Annual Meeting Abstracts

Information for Authors

  • Submit a Manuscript
  • Author Resources
  • Editorial Fellowship Program
  • ASN Journal Policies
  • Reuse/Reprint Policy

About

  • JASN
  • ASN
  • ASN Journals
  • ASN Kidney News

Journal Information

  • About JASN
  • JASN Email Alerts
  • JASN Key Impact Information
  • JASN Podcasts
  • JASN RSS Feeds
  • Editorial Board

More Information

  • Advertise
  • ASN Podcasts
  • ASN Publications
  • Become an ASN Member
  • Feedback
  • Follow on Twitter
  • Password/Email Address Changes
  • Subscribe to ASN Journals

© 2022 American Society of Nephrology

Print ISSN - 1046-6673 Online ISSN - 1533-3450

Powered by HighWire