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16 results on '"Luo, W. L."'

2. POS0692 IANALUMAB (VAY736) SAFETY AND EFFICACY IN PATIENTS WITH SJOGREN’S SYNDROME: 52 WEEK RESULTS FROM A RANDOMISED, PLACEBO-CONTROLLED, PHASE 2B DOSE-RANGING TRIAL

Author

Dörner, T., primary, Bowman, S. J., additional, Fox, R., additional, Mariette, X., additional, Papas, A., additional, Grader-Beck, T., additional, Fisher, B. A., additional, Barcelos, F., additional, De Vita, S., additional, Schulze-Koops, H., additional, Moots, R. J., additional, Junge, G., additional, Woznicki, J., additional, Sopala, M., additional, Luo, W. L., additional, and Hueber, W., additional

Published
2021
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3. OP0302 IANALUMAB (VAY736), A DUAL MODE OF ACTION BIOLOGIC COMBINING BAFF RECEPTOR INHIBITION WITH B CELL DEPLETION, REACHES PRIMARY ENDPOINT FOR TREATMENT OF PRIMARY SJOGREN’S SYNDROME

Author

Dörner, T., primary, Bowman, S. J., additional, Fox, R., additional, Mariette, X., additional, Papas, A., additional, Grader-Beck, T., additional, Fisher, B. A., additional, Barcelos, F., additional, De Vita, S., additional, Schulze-Koops, H., additional, Moots, R. J., additional, Junge, G., additional, Woznicki, J., additional, Sopala, M., additional, Luo, W. L., additional, and Hueber, W., additional

Published
2020
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5. Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation

Author

Pascual, J., Berger, S. P., Witzke, O., Tedesco, H., Mulgaonkar, S., Qazi, Y., Chadban, S., Oppenheimer, F., Sommerer, C., Oberbauer, R., Watarai, Y., Legendre, C., Citterio, F., Henry, M., Srinivas, T. R., Luo, W. -L., Marti, A., Bernhardt, P., Vincenti, F., Citterio F. (ORCID:0000-0003-0489-6337), Pascual, J., Berger, S. P., Witzke, O., Tedesco, H., Mulgaonkar, S., Qazi, Y., Chadban, S., Oppenheimer, F., Sommerer, C., Oberbauer, R., Watarai, Y., Legendre, C., Citterio, F., Henry, M., Srinivas, T. R., Luo, W. -L., Marti, A., Bernhardt, P., Vincenti, F., and Citterio F. (ORCID:0000-0003-0489-6337)

Abstract

Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation. Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR,50 ml/min per 1.73 m2 at post-transplant month 12 using a 10% noninferiority margin. Results In the intent-to-treat population (everolimus n=1022, MPA n=1015), the primary end point incidence was 48.2% (493) with everolimus and 45.1% (457) with MPA (difference 3.2%; 95% confidence interval, 21.3% to 7.6%). Similar between-treatment differences in incidence were observed in the subgroups of patients who received tacrolimus or cyclosporine. Treated biopsy-proven acute rejection, graft loss, or death at post-transplant month 12 occurred in 14.9% and 12.5% of patients treated with everolimus and MPA, respectively (difference 2.3%; 95% confidence interval, 21.7% to 6.4%). De novo donor-specific antibody incidence at 12 months and antibody-mediated rejection rate did not differ between arms. Cytomegalovirus (3.6% versus 13.3%) and BK virus infections (4.3% versus 8.0%) were less frequent in the everolimus arm than in the MPA arm. Overall, 23.0% and 11.9% of patients treated with everolimus and MPA, respectively, discontinued the study drug because of adverse events. Conclusions In kidney transplant recipients at mild-to-moderate immunologic risk, everolimus was noninferior to MPA for a binary composite end point assessing immunosuppressive efficacy and preservation of graft function.

Published
2018

16. A comparison of the pharmacokinetics of two different formulations of extended-release niacin.

Author

Lauring B, Rosko K, Luo WL, Wenning L, Kissling J, Roupe K, Paolini JF, Wagner J, and Lai E

Subjects
Adult, Area Under Curve, Biological Availability, Cross-Over Studies, Delayed-Action Preparations, Female, Humans, Male, Middle Aged, Niacin administration & dosage, Niacin blood, Niacin urine, Niacin pharmacokinetics
Abstract

Objective: The objective of this study was to compare pharmacokinetic parameters of niacin extended-release tablets (NER uncoated) and niacin extended-release caplet formation (NER coated)., Research Design and Methods: Twenty-five healthy male and female subjects were enrolled in a four-period, open-label, randomized, crossover study. Both NER uncoated and NER coated were given as 1 x 1000 mg or 2 x 500 mg tablets. Similarity of NER coated 1 x 1000 mg and NER uncoated 2 x 500 mg was declared if 90% confidence intervals for the geometric mean ratio (GMR) for nicotinuric acid (NUA) Cmax fell within the pre-specified bounds of [0.7, 1.43]., Results: The GMRs for NUA Cmax demonstrated similarity in the pharmacokinetics of NER uncoated 2 x 500 mg, NER coated 1 x 1000 mg, and NER coated 2 x 500 mg. Although less stringent comparability bounds were prespecified for the primary pharmacokinetic endpoint (i.e., Cmax of plasma NUA), inspection of the primary comparison of interest indicated that a hypothesis with more stringent bioequivalence bounds of [0.8, 1.25] would have been satisfied. The NUA Cmax for NER uncoated 1 x 1000 mg was approximately 40% higher than that seen for the other three treatments. In contrast, total urinary excretion of niacin and its metabolites, an approximate measure of bioavailability, was similar for all four treatments., Conclusion: The pharmacokinetic profile of the original NER uncoated formulation dosed as 2 x 500 mg was similar to the new film-coated formulation, NER coated, dosed as 1 x 1000 mg.

Published
2009
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