Dos nuevos budesonida formulaciones son altamente eficientes para el tratamiento de activo esofagitis eosinofílica: resultados de un ensayo aleatorizado, doble ciego, doble simulación, controlado con placebo multicéntrico

INTRODUCTION:

Eosinophilic Esophagitis (EoE) is a rapidly emerging, chronic-inflammatory disease of the esophagus. So far no approved therapy is available, but swallowed topical corticosteroids have proven efficacy in the treatment of EoE. However, esophageal-adjusted formulation and optimal dosing are not yet determined.

AIMS:

To investigate the efficacy and safety of two different budesonide formulations (effervescent tablet [BET] and viscous suspension [BVS]) and two different doses for short-term treatment of EoE.

METHODS:

Adults with active EoE (n=76) randomly received 14-days treatment with either BET 2x1mg/ d (BET1, n=19) or BET 2x2mg/d (BET2, n=19), or BVS 2x2mg/d (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary endpoint was histological remission (mean of <16 eos/mm2 hpf). Secondary endpoints included endoscopy score, dysphagia score, quality of life (modified SHS), and preference of drug formulation.

RESULTS:

Histological remission occurred in 100%, 93.8%, and 93.3% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the 3 budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, the improvement persisted during the 2-weeks follow-up only in those treated with BET1 and BET2, with BET1 showing a significant difference to placebo (p=0.0196). There was suspected local fungal infection in 3 patients in each of the three budesonide groups, however, hypha were only found in 2 patients in each of the budesonide groups (post-hoc histopathology). Neither serious adverse events nor clinically relevant changes in plasma cortisol were observed. 80% of patients preferred the effervescent tablet.

CONCLUSION:

Budesonide administered as effervescent tablet or as viscous suspension was highly effective and safe for short-term treatment of EoE. The 1mg BID dose was equally effective as the 2mg BID dose. The majority of patients preferred the effervescent tablet formulation.