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
Pooled result · Overall clinical SLE responseResult — go to the resultOdds (12-fold higher) 12 95% CI 5.44–27.35Authors' 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) | ||
|---|---|---|
| Responders | 32 (17.35–45.67) | |
| −200204060Difference, units (linear scale) |
MPA levels, responders vs non-responders (extrarenal manifestations)
| Weighted mean difference (units) (95% CI) | ||
|---|---|---|
| Responders | 39 (15.05–62.53) | |
| −50050100Difference, units (linear scale) |
| Outcome | Odds (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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