THU0306 Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of The BCL-2 Inhibitor Venetoclax (ABT-199) in A Phase 1 Single and Multiple Ascending Dose Study in Female Patients with Systemic Lupus Erythematosus

2016 ◽  
Vol 75 (Suppl 2) ◽  
pp. 298.1-298
Author(s):  
P. Lu ◽  
R. Fleischmann ◽  
C. Curtis ◽  
S. Ignatenko ◽  
M. Desai ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Phase 1 ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Systemic Lupus ◽  
Female Patients ◽  
Dose Study

Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial

2009 ◽  
Vol 69 (6) ◽  
pp. 1144-1147 ◽  
Author(s):  
A Hartkamp ◽  
R Geenen ◽  
G L R Godaert ◽  
M Bijl ◽  
J W J Bijlsma ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Controlled Trial ◽  
Well Being ◽  
Controlled Study ◽  
Systemic Lupus ◽  
Double Blind ◽  
Female Patients ◽  
General Fatigue ◽  
Mental Well Being

ObjectiveDehydroepiandrosterone (DHEA) has been reported to improve fatigue and reduced well-being. Both are major problems in patients with systemic lupus erythematosus (SLE), even with quiescent disease. Low serum DHEA levels are common in SLE. The present work investigates the effects of DHEA administration on fatigue, well-being and functioning in women with inactive SLE.MethodsIn a double-blind, randomised, placebo-controlled study, 60 female patients with inactive SLE received 200 mg oral DHEA or placebo. Primary outcome measures were general fatigue, depressive mood, mental well-being and physical functioning. Assessments were made before treatment, after 3, 6 and 12 months on medication, and 6 months after cessation of treatment.ResultsPatients from the DHEA and placebo group improved on general fatigue (p<0.001) and mental well-being (p=0.04). There was no differential effect of DHEA. The belief that DHEA had been used was a stronger predictor for improvement of general fatigue than the actual use of DHEA (p=0.04).ConclusionsThe trial does not indicate an effect of daily 200 mg oral DHEA on fatigue and well-being, and therefore DHEA treatment is not recommended in unselected female patients with quiescent SLE.Clinical Trials Registration Number NCT00391924

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