ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1571

Efficacy Of Tacrolimus Combination Therapy During The Maintenance Phase Of Systemic Lupus Erythematosus

Kumiko Ohtsuka1, Yusuke Miwa1, Nao Oguro2, Yoko Miura1, Sho Ishii1, Shinya Seki1, Hidekazu Furuya1, Ryo Yanai1, Ryo Takahashi1, Kuninobu Wakabayashi1, Nobuyuki Yajima1 and Tsuyoshi Kasama1, 1Div of Rheumatology, Showa University School of Med, Shinagawa-ku Tokyo, Japan, 2Div of Rhemuatology, Showa University School of Med, Shinagawa-ku Tokyo, Japan

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Systemic Lupus Erythematosus - Clinical Aspects II: Central Nervous System Manifestations, Therapeutics

Session Type: Abstract Submissions (ACR)

Background/Purpose: In Japan, a placebo-controlled clinical trial was undertaken to investigate the efficacy and safety of tacrolimus (TAC) for lupus nephritis. Based on the results obtained, administration of TAC at an oral dose of 3 mg/day was effective for the treatment of lupus nephritis.

Objective: The aim of this study was to prospectively evaluate the efficacy and safety of TAC combination therapy during the maintenance phase of systemic lupus erythematosus (SLE).

Methods: From 2009 to 2012, 38 patients were examined over a 1-year study period. If manifestations of mild active SLE, such as arthritis, skin eruptions, or asymptomatic nephritis, worsened and/or decreasing titers of serum complement (C3c) were observed, TAC combination therapy (from 1 mg to 5 mg once daily) was administered (that is, TAC was added to the patient’s existing treating regimen, and the dosage of prednisolone (PSL) was decreased).. Scores on the SLE Disease Activity Index (SLEDAI), PSL dosage, and serum levels of C3c, anti-dsDNA titers, and proteinuria were examined.

Results: Thirty-eight patients responded to TAC combination therapy. 1) The PSL dose was reduced from 11.7 ± 5.6 to 8.2 ± 4.2 mg/day (P<0.001). 2) The serum concentration of C3c increased from 74.7 ± 21.9 to 86.4 ± 17.8 mg/dl (P=0.006). 3) Titers of anti-dsDNA antibodies decreased from 39.6 ± 68.0 to 24.8 ± 49.1 U/ml (P<0.001). 4) Scores on the SLEDAI improved from 6.2 ± 3.7 to 2.6 ± 2.3 (P<0.001). In particular, the following symptoms improved on the SLEDAI: headache (from 7 patients to 1 patient), arthritis (from 3 patients to 0 patients), rash (from 6 patients to 2 patients), alopecia (from 5 patients to 0 patients), mucosal ulcers (from 2 patients to 0 patients), and fever (from 5 patients to 1 patient) . Although proteinuria decreased from 0.31 ± 0.70 to 0.31 ± 0.85 g/g of Cr, the difference was not significant (P=0.47). In contrast, 8 patients did not respond and/or had worsening SLE and 2 patients discontinued treatment as a result of an adverse effect: muscle cramp or rhabdomyolysis. No patients experienced complications with adverse effects of abnormal urinalysis, and none progressed to renal failure or became candidates for dialysis.

Conclusion: TAC combination therapy therefore is a useful alternative treatment for SLE.

Disclosure:

K. Ohtsuka,
None;

Y. Miwa,

Asteras,

2;

N. Oguro,
None;

Y. Miura,
None;

S. Ishii,
None;

S. Seki,
None;

H. Furuya,
None;

R. Yanai,
None;

R. Takahashi,
None;

K. Wakabayashi,
None;

N. Yajima,
None;

T. Kasama,
None.

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