Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Current ACR and EULAR evidence based guidelines provide recommendations for therapeutic choices to induce and maintain remission of lupus nephritis, however, the appropriate duration of maintenance treatment remains unclear. Data from the ALMS, MAINTAIN, and NIH-funded clinical trials in support of duration greater than three years is absent. In an effort to balance drug toxicities with the desire to prevent late disease recurrence some authors recommend maintenance therapy for as long as five years. There is an active NIH sponsored clinical trial for randomization of MMF maintenance withdrawal in SLE patients in remission, however, these results are not yet available. We analyzed the prevalence of renal flare after MMF maintenance therapy withdrawal in NYUÕs large, multi-ethnic cohort of SLE patients.
Methods: We queried the NYU SAMPLE Lupus Registry and biorepository to identify SLE nephritis patients with complete response who experienced renal flare within 12 months of discontinuing maintenance MMF therapy. The NYU SLE SAMPLE registry was initiated in September 2013 and includes 612 patients fulfilling ACR and/or SLICC criteria for SLE of which 42% have clinical nephritis.
Results: The NYU SAMPLE registry has 612 SLE patients (90% female; mean age 43.0±0.9 years), 54% Caucasian, 31% African American, 15% Asian; 30% Hispanic white, 5% Hispanic Black and 256 patients (42%) have nephritis. Of the 256 SLE nephritis we identified four patients with renal relapse within 12 months of MMF withdrawal summarized in Table 1. Table 1. Characteristics of patients with renal flare after MMF maintenance treatment withdrawal
|Case 1||Case 2||Case 3||Case 4|
|SLE Diagnosis Date||2001||2008||1995||2007|
|SLE ACR Criteria||Malar rash, photosensitivity, arthritis, GN, AN, DNA||Arthritis, rash, cytopenias, GN, ANA, DNA, Sm||DLE, arthritis, GN, leukopenia, ANA, DNA||malar rash, photosensitivity, arthritis, GN, ANA, DNA|
|WHO Classification of GN||III/V||III/V||II/III||N/A|
|Duration MMF maintenance treatment (years)||4.5||5.8||8||4|
|Time to renal flare after MMF withdrawal (days)||102||288||206||63*|
|At Time of Withdrawal|
|dsDNA Ab (IU/mL)||95||56||33||10*|
|C3 (mg/dL)||87||80||128||70 *|
|C4 (mg/dL)||13.4||7.0||39||11 *|
|Urine Protein:Creatinine (g)||0.1||0.6||0.2||0.4*|
|At Time of Flare|
|dsDNA Ab (IU/mL)||274||340||>300||9|
|Urine Protein:Creatinine (g)||3.9||3.6||7.5||2.2|
|Medications continued after MMF withdrawal||HCQ||HCQ, ARB||ARB||HCQ, ACE|
*Patient with renal flare within 2 months upon the initiation of MMF tapering from 2g to 0.5mg daily.
Conclusion: In the two year period between 3/2014 and 3/2016 we identified 4 patients with a renal relapse within 12 months of maintenance therapy withdrawal. All of the patients were on MMF for maintenance and for a duration >4 years of treatment. Based on this experience we recommend that maintenance of SLE GN with MMF absent contraindication should be at least 5 years and in the interval after withdrawal at any juncture careful monitoring and laboratory studies should be performed no less often than every 3 months for at least 2 years from time of maintenance therapy withdrawal. The occurrence of a renal flare during tapering, also highlights the need for guidelines regarding the rate of withdrawal. Determining risk factors for renal flare after maintenance withdrawal is necessary to facilitate clinicians identifying candidates for discontinuations or instances when to exercise caution.
To cite this abstract in AMA style:Belmont HM, Berhanu A. Withdrawal of Mycophenolate Mofetil after Maintenance Treatment of SLE Nephritis Associated with Renal Relapse [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/withdrawal-of-mycophenolate-mofetil-after-maintenance-treatment-of-sle-nephritis-associated-with-renal-relapse/. Accessed December 2, 2020.
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