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AB0530 Efficacy and Safety of Multi-Target Therapy Using a Combination of Cyclophosphamide and Tacrolimus in Patients with Refractory Lupus Nephritis: A Prospective, Single-Arm, Open-Label Study of 13 Patients
  1. R. Sakai,
  2. A. Shibata,
  3. K. Chino,
  4. T. Kondo,
  5. A. Okuyama,
  6. H. Takei,
  7. K. Amano
  1. Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan


Background Pulsed cyclophosphamide (pCYC) for lupus nephritis (LN) has limited effects in some cases; mycophenolate mofetil is an off-label pharmaceutical agent in Japan.

Objectives To assess the effectiveness of multi-target therapy with pCYC and tacrolimus (Tac) for treating LN, including refractory cases.

Methods We have done a prospective, single-arm, open-label study at our center (UMIN4893). Thirteen patients with active LN were enrolled. Prednisolone was started at 1 mg/ kg/day, aiming to reduce the dose to 10 mg/day after 6 months. Intravenous cyclophosphamide was administered as per the Euro-Lupus protocol (500 mg biweekly for 3 months). The trough concentration of Tac was adjusted to 5–10 ng/ml as per National Health Insurance. Complete remission (CR) was defined as a spot urine protein/creatinine (UPCR) ratio of <0.5 g/gCr and normal eGFR or eGFR improvement as per EULAR/ERA-EDTA recommendations and KDIGO guidelines.

Results The mean age was 41.5 years (male:female =2:11); UPCR, 3.4 g/gCr; serum creatinine, 1.00 mg/dl; C3, 44.8 mg/dl (90.0–140.0 mg/dl); and C4, 5.7 mg/dl (18.0–30.0 mg/dl). One, eight and three patients belonged to Classes III, IV, and IV + V, respectively, and one had no data. Eleven out of the 13 patients completed the treatment protocol; 2 patients withdrew. The CR at 6 months was 69.2% (n=9/13). Side effects, including infections, did not increase as compared to conventional therapy with pCYC, except a transient increase in serum creatinine with Tac.

Conclusions Multi-target therapy such as pCYC and Tac can be a therapeutic option for refractory LN.

Disclosure of Interest R. Sakai: None declared, A. Shibata: None declared, K. Chino: None declared, T. Kondo: None declared, A. Okuyama: None declared, H. Takei: None declared, K. Amano Grant/research support from: Astellas, Chugai, Pfizer, Tanabe-Mitsubishi, Consultant for: Zenyaku Kogyo, Paid instructor for: Chugai, Pfizer, Santen, Tanabe-Mitsubishi, Speakers bureau: AbbVie, Actellion, Astellas, Bristol-Myers-Squibb, Chugai, Diichi-Sankyo, Eisai, Pfizer, Tanabe-Mitsubishi

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