Background/Purpose: Mycophenolate mofetil (MMF) is widely used in the treatment of SLE however little is known about factors that may predict response or other outcomes following MMF therapy. We aimed to undertake a systematic review to (1) identify predictors of outcomes to MMF in SLE (in randomized clinical trials (RCTs); and (2) to identify ‘risk factors’ for clinical outcomes following MMF treatment for SLE in observational cohorts.

Methods: We searched Medline, Embase, Web of Science and Cochrane Central Registers for Controlled Trials up to November 2015 for relevant studies. Two reviewers independently assessed the methodological quality of the RCTs using the Cochrane Collaboration risk of bias tool and cohort studies using the Quality In Prognosis Studies tool. The quality of subgroup analysis was also evaluated. The Grading of Recommendations Assessment, Development, and Evaluation working group approach summarized the quality of evidence (QoE), considering the risk of bias, imprecision, inconsistency, indirectness, and publication bias.

Results: The QoE for the prognostic value of age at study entry, gender and race was low, mainly due to exploratory or insufficient subgroup analysis, risk of bias and imprecision. The prognostic value of baseline laboratory parameters (glomerular filtration rate, proteinuria, serum creatinine) and changes during treatment (complement, proteinuria, anti-dsDNA) is very low due to post hoc subgroup analyses, risk of bias, indirectness and imprecision. One low QoE observational study showed that concomitant membranous lupus nephritis (LN) on biopsy may be an independent factor for no remission. This was not confirmed by subgroup analysis of RCT or other observational cohorts. Concomitant HCQ therapy and MMF treatment for less than 18 months were associated with response and relapse, respectively; MMF dose was not associated with adverse events (reduced IgG levels) in very-low to low QoE studies. One small cohort study found that a mycophenolic acid area under the curve ≥30 mg·h·L-1 was associated with renal response but not with side effects (infections).

Conclusion: In SLE, evidence for predictors of outcomes with MMF is limited and is mainly from secondary and post-hoc analyses. We identified between-study heterogeneity and a high risk of bias across studies. Well-designed studies are required to confirm whether demographic factors, LN biopsy class, concomitant therapy or pharmacokinetic markers truly predict MMF responses and adverse events in SLE. Study supported by CONACYT Table 1 Characteristics of studies on prognostic factors

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/can-we-identify-who-benefits-from-mycophenolate-mofetil-in-systemic-lupus-erythematosus-a-systematic-review/