Jorveza: the first licensed therapy for Eosinophilic Oesophagitis launched in the UK

Jorveza: the first licensed therapy for Eosinophilic Oesophagitis launched in the UK

Efficacy and safety of budesonide orodispersible tablets in active eosinophilic oesophagitis: results from a randomised, double blind, placebo-controlled, pivotal, European multicentre trial (eos-1) A. Straumann1, A. J. Lucendo Villarin2, S. Miehlke3, M. Vieth4, C. Schlag5, U. et al

UEG Journal 2018 (Abstract)

This was a multi-centred randomised clinical trial assessing clinical and histological remission of EoE on Jorveza in comparison with placebo

Aims & Methods: to evaluate in a pivotal Phase 3 trial efficacy and safety of a novel budesonide orodispersible tablet formulation specifically designed for EoE for the induction of clinico-histological remission in adult patients with active EoE.

Eighty-eight patients were randomised to receive a six-week double-blind treatment with either 1mg budesonide orodispersible tablets (BUL 1mg) twice daily (BID) (n = 59) or placebo BID (n = 29). Non-responder could receive a further six-week open-label induction (OLI) treatment with BUL 1mg BID.

Primary endpoint: Rate of clinico-histological remission. Secondary endpoints: Rate of histological remission, change in peak eos/mm2 hpf, rate of clinical remission (resolution of dysphagia and odynophagia), rate of clinical remission defined by EEsAI-PRO _20, rate of endoscopic normalisation. Secondary endpoint (OLI): Rate of clinico-histological remission after 12 weeks of treatment with BUL 1mg BID.

The primary end point clinico-histological remission was achieved by 57.6% of patients on Jorveza compared to 0% on placebo at six weeks (p<0.0001) and by 85% of patients on Jorveza by 12 weeks. Histological remission was 93.2% on Jorveza compared to 0% on placebo (p<0.0001). There was also significant reduction in peak eosinophil counts, resolution of dysphagia and odynophagia and improvement in patient reported outcomes.

The authors concluded that a six-week course of BUL 1mg BID was highly effective and safe in bringing active EoE rapidly in clinical and histological remission, as well as in normalising endoscopic alterations.