Date: Monday, November 9, 2015
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
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).
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.
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.
These results show the long term safety and efficacy of TAC for LN maintenance treatment in the real clinical setting.
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 February 28, 2021.
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