Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Treatment of Lupus Nephritis with Enteric-Coated Mycophenolate Sodium (EC-MPS)MyLupus Exploratory Study.
The MyLupus study was designed to compare the non-inferior efficacy and safety of EC-MPS using two different oral prednisolone regimens (standard SD or reduced dose RD) for the induction of remission of a lupus nephritis (LN) flare.
A 24-week (W) exploratory, multi-center, open-label study was conducted in patients with a LN flare (ISN/RPS Class III or IV documented by renal biopsy within 24 months of study entry). All patients received EC-MPS 1440 mg/day for the first 2W, followed by 2160 mg/day for the remaining 22W, and methylprednisolone iv. (0.5 g/day) for the first 3 days. Patients were randomized to either SD or RD (starting dose of 1.0 mg/kg/day and 0.5 mg/kg/day for 2W, respectively, followed by pre-specified dose reduction). Primary end-point was the proportion of patients with complete response (urine protein/creatinine [P/C] ratio <0.5, urine sediment normalized, and serum creatinine <10% normal value) of LN after 24W. Partial response was defined as urine P/C ratio reduced by at least 50% from baseline and serum creatinine stable (<10% of baseline value) or improved.
81 patients were enrolled, 42 in SD and 39 in RD group. Baseline characteristics were comparable between groups. After 24 W, a similar proportion of patients achieved complete response in both groups (19% SD vs. 18% RD), although non-inferiority was not demonstrated. A higher proportion of patients achieved partial response in SD (48% SD vs. 33% RD). Index scores decreased in both groups from 4 to 24W (British Isles Lupus Assessment Group [BILAG] index: mean change from baseline -8.6 SD vs. -9.4 RD, Systemic Lupus Erythematosus Disease Activity Index [SLEDAI]: -10.4 SD vs. -9.4 RD). There was greater improvement in glomerular filtration rate (mL/min/1.73m2) in RD (mean change from baseline 9.0 SD vs. 15.2 RD). There were 2 deaths, both in SD group. The incidence of serious adverse events was 16.7% (SD) vs. 10.3% (RD).
This exploratory study suggests that EC-MPS in combination with steroids is a viable therapy for LN. The overall clinical results indicate that RD of CS may offer benefits in terms of tolerability compared to SD of CS while maintaining efficacy.
To cite this abstract, please use the following information:
Doria, Andrea; Treatment of Lupus Nephritis with Enteric-Coated Mycophenolate Sodium (EC-MPS)MyLupus Exploratory Study. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1402