A recent study (ES Dellon et al Clin Gastroenterol Hepatol 2019; 17: 666-73) prospectively followed patients in a 24 week open-label extension of a randomized, double-blind, placebo-controlled trial of budesonide oral suspension (BOS) for eosinophilic esophagitis (EoE). The authors defined histologic response as ≤6 eos/hpf. During the extension, the dosage of BOS was reduced from 2 mg twice daily to 2 mg once a day.
- No new safety signals. One patient in placebo/BOS arm (n=37) developed oral candidiasis and one patient in the BOS/BOS arm (n=45) did as well. In addition, four patients in placebo/BOS developed esophageal candidiasis. No clinically relevant changes in morning serum cortisol levels were identified.
- Histologic response was observed in 49% (16/33) in placebo/BOS arm and 23% (9/39) of BOS/BOS arm. 58% of placebo/BOS and 28% of BOS/BOS patients had ≤15 eos/hpf.
- Mean peak eosinophil count decreased in placebo/BOS arm from 119 to 29 and increased in BOS/BOS arm from 38 to 72.
- Overall, only 42% of patients who responded to BOS during double-blind 12 week study maintained a histologic response.
While this study shows that BOS is effective for many patients with EoE, it also shows that many lose a response. In addition, most patients who “did not respond to treatment during the double-blind phase did not gain a histologic or endoscopic response with longer-term treatment.” Only 1 of 26 patients (4%) gained a response. This has several important implications:
- Some patients may develop corticosteroid resistance
- In patients who respond to induction, it may be prudent to continue with the same induction dose rather than reducing the dosage
- In patients who do not respond to induction, further treatment is not beneficial
My take: Though the response to BOS was not very high in this study, the population studied was highly symptomatic and had histologically-severe EoE. Thus, in a more typical population of patients with EoE, the response rate is likely to be more favorable. Also, many patients will not maintain a response to BOS at a lowered dose.
Related blog posts:
- What Happens When Topical Steroids are Stopped in EoE
- Neglibible Effect of Eosinophilic Esophagitis Treatment on Longitudinal Growth
- What is EoE?
- EoE Update 2018 (Dr. Seth Marcus)
- Updated Consensus Guidelines for Eosinophilic Esophagitis
- A Better Budesonide for Eosinophilic Esophagitis
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