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Efficacy and safety of tacrolimus for induction therapy in patients with active lupus nephritis

  • Original Article
  • Published:
Modern Rheumatology

Abstract

After the completion of a double-blind placebo-controlled trial, tacrolimus (TAC) was approved for the treatment of lupus nephritis (LN) in Japan. However, the approved maximal dose, 3 mg/day, is almost half the dose used for induction therapy outside Japan. In this study, we retrospectively evaluated the efficacy and safety of low-dose TAC (≤3 mg/day) for induction therapy in 13 adult patients (2 men and 11 women) with active LN. Eight patients were treated for LN flares. Twelve patients underwent renal biopsies: 8 with class IV, 2 with class III + V, 1 with class IV + V, and 1 with class V renal histology, according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification. The mean initial doses of prednisone and TAC were 34.6 ± 14.5 and 2.7 ± 0.6 mg/day, respectively. All the patients achieved a complete remission (CR) at 7.7 ± 6.7 months (mean ± SD) after the last administration of TAC, except for 2 patients who discontinued TAC treatment; 1 because of worsening systemic lupus erythematosus and 1 because of hypertension. Two patients experienced a flare-up after achieving CR. The mean blood TAC concentration 12 h after the last administration (C12) was significantly lower among the patients with flare-ups than among those with a sustained CR (1.5 ± 1.5 vs. 5.1 ± 1.9 ng/mL, P = 0.034). These data showed that low-dose TAC was effective for induction therapy in patients with active LN, although a lower TAC concentration may be associated with a poor outcome.

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Authors and Affiliations

  1. Department of Medicine and Clinical Science, Gunma University Graduate School of Medicine, 3-39-22 Showa, Maebashi, Gunma, 371-8511, Japan

    Satoshi Takahashi, Keiju Hiromura, Noriyuki Sakurai, Takayuki Matsumoto, Hidekazu Ikeuchi, Akito Maeshima, Yoriaki Kaneko, Takashi Kuroiwa & Yoshihisa Nojima

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  1. Satoshi Takahashi
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  2. Keiju Hiromura
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  3. Noriyuki Sakurai
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  4. Takayuki Matsumoto
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Correspondence to Keiju Hiromura.

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Takahashi, S., Hiromura, K., Sakurai, N. et al. Efficacy and safety of tacrolimus for induction therapy in patients with active lupus nephritis. Mod Rheumatol 21, 282–289 (2011). https://doi.org/10.1007/s10165-010-0398-z

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  • DOI: https://doi.org/10.1007/s10165-010-0398-z

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