Oral Budesonide Suspension Is Effective in Patients With Eosinophilic Esophagitis
Prateek Sharma, MD, FASGE, reviewing Hirano I, et al. Clin Gastroenterol Hepatol 2021 Apr 18.
Eosinophilic esophagitis (EoE), a chronic inflammatory disorder, can be treated with steroids, proton pump inhibitors, and dietary modifications. There have been advances in the formulations of topical steroids as suspensions, namely orodispersible tablets, to increase the esophageal mucosal exposure time to the medication. Recently, phase 2 trials have shown promising results with budesonide oral suspension (BOS). This study is a phase 3, double-blind, randomized controlled trial that evaluated the efficacy and safety of BOS compared to placebo at 12 weeks in patients with EoE.
A total of 318 patients were randomized to receive either 2 mg of BOS twice daily (n=213; mean age, 33.8 years; 61% males) or placebo (n=105; mean age, 33.9 years; 59% males). At 12 weeks of follow up, histologic response (<15 eosinophils per high-power field [eos/HPF]), stringent histologic response (≤6 eos/HPF), and deep histologic response (≤1 eos/HPF) were significantly higher in the BOS group (62%, 53.1%, 32.4%, respectively) compared to the placebo group (1%, 1%, 0%, respectively) (P<.001). Symptom response (>30% reduction in the dysphagia symptom questionnaire score) was also significantly higher in patients treated with BOS (52.6%) compared to placebo (39.1%) (P=.024). Finally, from baseline to 12 weeks, patients treated with BOS compared to placebo also demonstrated a greater change in the EoE endoscopic reference score (-4 [SEM 0.3] vs -2.2 [SEM 0.4]; P<.001). Both groups reported similar rates of nonserious adverse events that included nasopharyngitis, sinusitis, candidiasis, or other mild, easily managed infections.
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Hirano I, Collins MH, Katzka DA, et al; on behalf of the ORBIT1/SHP621-301 Investigators. Budesonide oral suspension improves outcomes in patients with eosinophilic esophagitis: results from a phase 3 trial. Clin Gastroenterol Hepatol 2021 Apr 18. (Epub ahead of print) (https://doi.org/10.1016/j.cgh.2021.04.022)