- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Long-term safety data for Revolade in adults with chronic ITP
10 June 2016 • Author: Victoria White, Digital Content Producer
Data from the largest study of its kind confirm the long-term safety profile of Novartis’ Revolade (eltrombopag) in adults with chronic immune (idiopathic) thrombocytopenia (ITP).
Additional data from the EXTEND study showed long-term oral administration of Revolade was effective in increasing and maintaining platelet counts in adult patients who had their spleens removed (splenectomized) as well as those who did not (non-splenectomized).
ITP is a rare and potentially serious blood disorder where the blood doesn’t clot as it should due to a low number of platelets. As a result, patients experience bruising, bleeding and, in some cases, serious hemorrhage that can be fatal. ITP may also affect a patient’s quality of life, as it is often associated with fatigue and depression as well as a fear of bleeding that may limit everyday activities.
Reinforcing Revolade as a trust option
Commenting on the study, Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs: said: “EXTEND is the largest study of its kind and reinforces Revolade as a trusted option that adults with chronic ITP can use for the long-term.”
The safety profile of Revolade seen in the EXTEND trial is consistent with that observed in the pivotal 24-week Phase III RAISE study. Long-term use of Revolade was not associated with a clinically relevant increase in bone marrow reticulin or collagen fibres. The most common adverse events were headache (28%), nasopharyngitis (25%), upper respiratory tract infection (23%), and fatigue (17%).
The efficacy results of EXTEND demonstrated that median platelet counts were elevated to >=50 × 109/L within two weeks of Revolade treatment, with median platelet counts >50 × 109/L maintained for more than four years. Post-baseline, overall bleeding rates declined and the majority of bleeding that occurred during more than six years of the study was Grade 1 according to the World Health Organization bleeding scale. In addition, 91.4% of patients achieved platelet counts >=30 × 109/L without rescue treatment, and 85.8% achieved platelet counts >=50 × 109/L without rescue treatment.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics