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. 2025 Jul 22;11(3):e005558.
doi: 10.1136/rmdopen-2025-005558.

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

Naoki Matsuoka  1 , Nobuyuki Yajima  2   3 , Eisuke Inoue  4 , Shuzo Sato  5 , Shotaro Ogawa  5 , Yuya Sumichika  5 , Kenji Saito  6 , Shuhei Yoshida  5 , Haruki Matsumoto  5 , Jumpei Temmoku  5 , Yuya Fujita  5 , Tomoyuki Asano  5 , Jumpei Fukita  2 , Ken-Ei Sada  7   8 , Kunihiro Ichinose  9 , Ryusuke Yoshimi  10   11 , Shigeru Ohno  12 , Hiroshi Kajiyama  13 , Yasuhiro Shimojima  14 , Michio Fujiwara  15 , Takashi Kida  16 , Yoshia Miyawaki  8 , Yusuke Matsuo  17   18 , Takahisa Onishi  19 , Keisuke Nishimura  20 , Kiyoshi Migita  5
Affiliations

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

Naoki Matsuoka et al. RMD Open. .

Abstract

Objective: We aimed to compare the incidence of severe infections between mycophenolate mofetil (MMF) and other immunosuppressants in patients with systemic lupus erythematosus (SLE) on maintenance therapy using data from the Lupus Registry of Nationwide Institutions in Japan.

Methods: This study employed a prospective cohort design, including patients with SLE undergoing maintenance therapy. Exposure was defined as MMF treatment, and the control group included individuals who received other immunosuppressants (non-MMF) treatments. Severe infections requiring hospitalisation were the primary outcomes, whereas secondary outcomes included all-cause hospitalisation, changes in prednisolone dosage, disease activity and organ damage. Statistical analyses employed marginal structural models with stabilised inverse probability of treatment weighting to adjust for confounders.

Results: The analysis included 1004 patients; the incidence of severe infections was 6.5% in the MMF group and 7.5% in the non-MMF group, with no significant difference (OR 0.69, 95% CI 0.34 to 1.39). Similarly, all-cause hospitalisation rates were comparable between the groups (OR 0.72, 95% CI 0.47 to 1.09). Prednisolone dosage was significantly reduced in the MMF group (-0.66 mg/day, 95% CI -1.09 to -0.23). The organ damage score was modestly reduced in the MMF group (-0.19 points, 95% CI -0.37 to -0.01), whereas the change of disease activity score was comparable between the groups (-0.10 points, 95% CI -0.74 to 0.55).

Conclusions: MMF does not significantly increase the risk of severe infections compared with other immunosuppressants in SLE maintenance therapy. MMF may contribute to reducing the dose of prednisolone.

Keywords: Autoimmune Diseases; Lupus Erythematosus, Systemic; Treatment.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1. Flow diagram of the screening process in the present study. MMF, mycophenolate mofetil; SLE, systemic lupus erythematosus.
See this image and copyright information in PMC

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