Budesonide Oral Suspension Effective for Eosinophilic Esophagitis

[dr.j.cardey@wanadoo.fr]

Budesonide Oral Suspension Effective for Eosinophilic Esophagitis

TAKE-HOME MESSAGE

•A cohort of 93 patients aged 11 to 40 years with eosinophilic esophagitis (EoE) was randomized to treatment with twice-daily muco-adherent budesonide oral suspension (BOS) or placebo for 12 weeks. Patients in the BOS group showed a significantly greater reduction in Dysphagia Symptom Questionnaire score, a significantly higher histologic response rate, and a significantly greater change in endoscopic severity score. The rate of adverse events was similar in the two groups.

•BOS is effective and well-tolerated in the treatment of adolescent and young adult patients with EoE.

abstract

Pharmacologic treatment of eosinophilic esophagitis (EoE) is limited to off-label use of corticosteroids not optimized for esophageal delivery. We performed a randomized, controlled phase 2 trial to assess the ability of budesonide oral suspension (BOS), a novel muco-adherent topical steroid formulation, to reduce symptoms and esophageal eosinophilia in adolescents and adults with EoE.

METHODS

In this multicenter, randomized, double-blind, placebo-controlled, parallel-group trial, 93 EoE patients between the ages of 11 and 40 years with dysphagia and active esophageal eosinophilia were randomized to receive either BOS 2 mg or placebo twice daily for 12 weeks. Co-primary outcomes were change in Dysphagia Symptom Questionnaire (DSQ) score from baseline, and proportion of patients with a histologic response (≤6 eosinophils/high-power field) after treatment. Endoscopic severity scores and safety parameters were assessed.

RESULTS

At baseline, mean DSQ scores were 29.3 and 29.0, and mean peak eosinophil counts were 156 and 130 per hpf in the BOS and placebo groups, respectively. After treatment, DSQ scores were 15.0 and 21.5, and mean peak eosinophil counts were 39 and 113 per high-power field, respectively (P < .05 for all). For BOS vs placebo, change in DSQ score was -14.3 vs -7.5 (P = .0096), histologic response rates were 39% vs 3% (P < .0001), and change in endoscopic severity score was -3.8 vs 0.4 (P < .0001). Adverse events were similar between groups.

CONCLUSIONS

Treatment with BOS was well tolerated in adolescent and young adult patients with EoE and resulted in improvement in symptomatic, endoscopic, and histologic parameters using validated outcome instruments.

Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis
Gastroenterology 2017 Mar 01;152(4)776-786.e5, ES Dellon, DA Katzka, MH Collins, M Hamdani, SK Gupta, I Hirano

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