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Takeda Pharmaceuticals Co., Ltd. today released the interim results of the OLE study, which assessed the long-term safety and ability of Subsulculation Maintenance Therapy in Entyvio (Vedolizumab) to treat moderate to severe active ulcerative colitis (UC).
the results of Vedolizumab's long-term safety studies are consistent with known safety when evaluating the main safety endpoints of the trial.
data were presented at the UEG Week Virtual 2020 conference.
OLE is an ongoing open-label, multi-center Phase IIIb study designed to assess the long-term safety and stability of Theentyvio (Vedolizumab) subsc skin maintenance treatment UC.
During the two-year period of maintenance, 69 per cent of UC patients had adverse events, the most common adverse reactions being disease deterioration (18 per cent), nasopharyngitis (11 per cent), upper respiratory tract infections (9 per cent) and anemia (7 per cent).
reaction at the injection site was reported in 4.5% of patients, with mild or moderate severity.
14% of patients had severe adverse events, no cases of aggressive polyetopic lewd encephalopathy, and no deaths.
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