Lupus & antiphospholipid syndrome

Safety of mycophenolate mofetil in systemic lupus erythematosus maintenance therapy: insights from the LUNA registry in a nationwide prospective cohort study

RMD OpenPublished Prospective cohort study

Main finding · Severe infections requiring hospitalisationResult — go to the resultOdds ratio 0.69 95% CI 0.34–1.39

Authors' conclusion

MMF does not significantly increase the risk of severe infections compared with other immunosuppressants in SLE maintenance therapy.

Study context

Population
Patients with systemic lupus erythematosus (SLE) on maintenance therapy, Lupus Registry of Nationwide Institutions in Japan
Participants
1,004 patients
Exposure
Mycophenolate mofetil (MMF) vs other immunosuppressants in SLE maintenance therapy
Outcome
Severe infections requiring hospitalisation
Methodological detailsnationwide, registry-based (LUNA), marginal structural models with stabilised inverse probability of treatment weighting
  • Nationwide
  • Registry-based (LUNA)
  • Marginal structural models with stabilised inverse probability of treatment weighting

Main finding

As reported in the abstract

Odds ratio

0.69

95% CI 0.34–1.39

By group

MMFvs non-MMF
OR 0.69 (95% CI 0.34–1.39)

Observational data: associations, not effects.

Secondary outcomes

OutcomeDifference (mg/day) (95% CI)
Change in prednisolone dose−0.66 (−1.09 to −0.23)
OutcomeDifference (points) (95% CI)
Organ damage scoreModestly reduced in MMF−0.19 (−0.37 to −0.01)
Change in disease activity scoreComparable between the groups−0.10 (−0.74 to 0.55)

All-cause hospitalisation

Rates comparable between the groups

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Safety of mycophenolate mofetil in systemic lupus erythematosus maintenance therapy: insights from the LUNA registry in a nationwide prospective cohort study. RMD Open. Published 22 July 2025. doi:10.1136/rmdopen-2025-005558

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