Lupus & antiphospholipid syndrome

Clinical Significance of Therapeutic Drug Level Monitoring for Mycophenolate in Patients With Extrarenal Systemic Lupus Erythematosus—A Systematic Review and Meta‐Analysis

Arthritis Care Res (Hoboken)Published Systematic review and meta-analysis

Pooled result · Overall clinical SLE responseResult — go to the resultOdds (12-fold higher) 12 95% CI 5.44–27.35

Authors' conclusion

This study highlights the clinical utility of TDM to guide MPA dosing to balance efficacy versus safety in all patients with SLE, including those with extrarenal manifestations.

Study context

Population
Patients with systemic lupus erythematosus (SLE), particularly those with extrarenal manifestations, treated with mycophenolic acid24 studies
Comparison
Therapeutic vs lower mycophenolic acid (MPA) levels
Outcome
Clinical SLE response by MPA levels
Methodological detailsforest plots, pooled odds, weighted mean differences, 459 abstracts reviewed
  • Forest plots
  • Pooled odds
  • Weighted mean differences
  • 459 abstracts reviewed

Pooled result

Overall clinical SLE response

Odds (12-fold higher)

12

95% CI 5.44–27.35

P < 0.0001

As reported in the abstract

Further pooled results

MPA levels, responders vs non-responders (overall SLE)

Weighted mean difference (units) (95% CI)
Responders32 (17.35–45.67)

MPA levels, responders vs non-responders (extrarenal manifestations)

Weighted mean difference (units) (95% CI)
Responders39 (15.05–62.53)
OutcomeOdds (15-fold higher) (95% CI)P value
Clinical response in extrarenal manifestationsI2 = 61%15 (4.74–46.89)P < 0.0001

Safety

Pooled analysis did not show a significant increase in adverse events
Individual studies suggested safety concerns at MPA AUC0-12 >60 mg hr/L or Ctrough ≥2.5 to 3 mg/L

Original publication

Clinical Significance of Therapeutic Drug Level Monitoring for Mycophenolate in Patients With Extrarenal Systemic Lupus Erythematosus—A Systematic Review and Meta‐Analysis. Arthritis Care Res (Hoboken). Published 22 April 2026. doi:10.1002/acr.80035

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