METHODS: An Agilent 1200 series high-performance liquid chromatography (HPLC) unit using a diode-array detector (DAD) has been employed and optimized to detect IPTS in cosmetic products. For the separation, a reverse-phase Hypersil Gold C8 column (5 μm, 4.6 mm i.d. 250 mm) 5 mM tetrabutylammonium phosphate buffer 50 : 50, (v/v) solution in acetonitrile as mobile phase, in isocratic mode and a flow rate of 0.8 mL min(-1) were used. A second method using a gas chromatography/mass selective detector GC-MSD was also developed to confirm the IPTS identity in the cosmetic products.

RESULTS: Recoveries of IPTS from cosmetic matrices such as a lotion, cleansing milk and a cream ranged from 94.0% to 101.1% with <5% relative standard deviation (%RSD) showing good accuracy and repeatability of the method. The six-point calibration curves (determined over the range 0.5-50 μg mL(-1) ) have a correlation coefficient of 0.9999 (based on HPLC peak area) and 0.9998 (based on HPLC peak height). The intra- and interday precisions (measured by the %RSD) of the method were <2% and <5%, respectively, indicating that the developed method is reliable, precise and reproducible. The detection and quantification limit of the method were found to be 0.5 μg mL(-1) and 1.6 μg mL(-1) , respectively. Analyses of 83 commercial cosmetics showed no presence of IPTS.

METHODS: One Hundred thirty biopsy-proven patients with Class III/IV without or with Class V LN were randomized to receive GC (intravenous methylprednisolone for three days then oral prednisolone) with either TAC (target trough level 6 - 8ng/mL) or MMF (1g twice a day) for 96 weeks. Primary endpoint was Sustained Renal Response (SRR) at week 96, defined as proteinuria reduction over 50% and estimated glomerular filtration rate no less than 60mL/min per 1.73m2, and no disease flare or rescue therapies. Secondary endpoints included rates of Complete Renal Remission (CRR) and Partial Renal Remission (PRR) at week 96, SRR at week 48, and adverse events (AE).

RESULTS: TAC and MMF groups (65 patients each) showed no significant difference in the rates of SRR (58.5% vs 69.2% respectively) and CRR (55.4% vs 63.1% respectively) at week 96. SRR rates for TAC and MMF groups were 63.1% vs 66.2% at week 48, respectively. Overall, AE rates did not differ between TAC and MMF groups (80.0% in both). Acute kidney injury and tremors were more frequent in TAC group, while leucopoenia was more frequent in MMF group. Three deaths occurred, all in the MMF group. Treatment-related serious adverse events (SAE) and infection resulting in SAE were significantly more frequent in the MMF group.

CONCLUSIONS: Dual immunosuppressive regimen with TAC and GC showed no difference in efficacy but different safety profile compared with MMF and GC over 96 weeks, when used as continuous induction-maintenance treatment for LN.