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news.Savient Pharmaceuticals has announced positive interim data from the ongoing pegloticase open label extension to the Phase III pivotal trials in patients with treatment-failure gout.
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The interim open label extension (OLE) analyses show that 100% of the patients who were responders for the control of plasma uric acid (PUA) in Phase III and who remained on or joined the every two week dosing group maintained normalization of plasma uric acid (PUA) throughout the OLE. Approximately 70% of the patients who were responders for the control of PUA in Phase III and who were on or joined the every four week dosing group also maintained normalization of PUA throughout the OLE.
Approximately 25% of the patients who were non-responders for the control of PUA in Phase III attained PUA normalization in the OLE with nine months or more of continuous pegloticase treatment either every two or four weeks. 31% of the patients who were non-responders for the resolution of gout tophi at the end of Phase III showed a complete response in the OLE, with additional patients showing a partial response for tophus resolution.
For patients in the OLE from Phase III pegloticase treated groups, a marked reduction in the occurrence of gout flares was observed in the OLE, such that only four gout flares were reported after month two in the every two week group and patients using pegloticase every two weeks for more than five months in the OLE no longer experienced any gout flares in subsequent months of participation.