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Abstract Number: 1795

Long-Term Safety and Efficacy of Tacrolimus for Lupus Nephritis Patients in Real World Setting -Results from 5 Year Interim Analysis of Post Marketing Surveillance of 1376 Patients in Japan-

Tsutomu Takeuchi1 and Naoko Wakasugi2, 1Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, 2Astellas Pharma Inc., Tokyo, Japan

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: lupus nephritis and tacrolimus

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Session Information

Date: Monday, November 9, 2015

Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

Tacrolimus (Tac) is an immunosuppressive macrolide that blocks T cell activation by specifically inhibiting calcineurin. Some randomized controlled studies have shown that TAC is an effective for induction and maintenance treatment for lupus nephritis (LN). However, there are few reports of the long term outcome of TAC for LN patients in the large real clinical setting.To assess the long-term safety and efficacy of TAC for LN patients in the real clinical setting, post-marketing surveillance was conducted (NCT01410747).

Methods:

All the patients TAC administered for LN were registered between 2007 and 2010, and the registered patients will be followed for 10 years, the safety and efficacy were evaluated at the 28 week and each year. The primary efficacy endpoint is renal failure, and secondary endpoints are urine protein creatinine ratio, serum creatinine (estimated glomerular filtration rate (eGFR)), serum component C3, anti-ds DNA and steroid dosage.

Results:

This interim analysis included all the registered 1376 patients from 292 medical sites, and the median follow up period is 1827.0 days (5 years), including 215 patients with biopsy-proven Class IV and 159 patients with Class V. The most common serious adverse drug events (ADRs) were infections, in which herpes zoster, cellulitis and diabetes mellitus, at incidence rates of 1.0%, 0.9% and 0.8%, respectively. The TAC continuation rate was 83.5% at 1 year and 71.3% at 3 years, and 62.9% at 5 years. There was a significant decrease in urine protein creatinine ratio from the 4 weeks later after TAC treatment, also the serum component C3 and anti-ds DNA antibodies were improved from the 4 weeks later and the eGFR was maintained for 5 years in both Class IV and Class V.

Conclusion:

These results show the long term safety and efficacy of TAC for LN maintenance treatment in the real clinical setting.


Disclosure: T. Takeuchi, AbbVie GK., Astellas Pharma, Bristol–Myers K.K., Celtrion, Chugai Pharmaceutical Co,. Ltd., Diaichi Sankyo Co.,Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Nipponkayaku Co.Ltd, Pfizer Japan Inc., Takeda Pharmaceutical, 8,Abbivie GK, Asahi Kasei Medical K.K., Astra Zeneca K.K., Bristol–Myers K.K., Daiichi Sankyo Co.,Ltd., Eli Lilly Japan K.K., Mitsubishi Tanabe Pharma Co., Nipponkayaku Co.Ltd ., Novartis Pharma K.K., 5,Astellas Pharma, AbbVie GK, Asahikasei Pharma Corp., Bristol–Myers K.K., Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Santen Pharmaceutical Co., Ltd., 2,SymBio Pharmaceuticals Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., 2; N. Wakasugi, Astellas Pharma Inc., 3.

To cite this abstract in AMA style:

Takeuchi T, Wakasugi N. Long-Term Safety and Efficacy of Tacrolimus for Lupus Nephritis Patients in Real World Setting -Results from 5 Year Interim Analysis of Post Marketing Surveillance of 1376 Patients in Japan- [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-tacrolimus-for-lupus-nephritis-patients-in-real-world-setting-results-from-5-year-interim-analysis-of-post-marketing-surveillance-of-1376-patients-in-japan/. Accessed .
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