In the Journals

Swallowed, inhaled steroids effective in EoE

Initial treatment of eosinophilic esophagitis with oral viscous budesonide or fluticasone from a multi-dose inhaler both produced decreases in eosinophil counts, as well as improved dysphagia and endoscopic features, according to data published in Gastroenterology.

Evan S. Dellon, MD, MPH, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, and colleagues wrote that because there are no FDA-approved medications specifically for EoE, asthma preparations, like fluticasone and budesonide are the first-line options for patients who do not respond to proton pump inhibitor therapy.

“While both medications are effective for decreasing levels of esophageal eosinophilia, there are no clinical trials directly comparing the two,” they wrote. “This comparison is a key question, because the amount of time a medication contacts the esophagus has been shown to directly correlate with histologic response in EoE.”

Since the oral viscous budesonide may provide increased contact time with esophageal mucosa, researchers hypothesized that it would be more effective than the inhaler administered fluticasone.

Dellon and colleagues tested their hypothesis in a double-blind, double-dummy trial comprising 111 patients with newly diagnosed EoE. They randomly assigned patients to receive either the budesonide twice daily plus a placebo inhaler (n = 56) or fluticasone twice daily plus a placebo slurry (n = 55) for eight weeks. The primary outcomes of the study were post-treatment maximum eosinophil count per high-power field and a validated dysphagia score at week eight.

At baseline, patients in the budesonide group had a peak eosinophil count of 73 compared with 77 in the fluticasone group. After treatment, the groups had eosinophil counts of 15 and 21, while 71% and 64% of patients achieved histologic response, respectively.

Dysphagia scores at baseline were 11 for the budesonide group and 8 for the fluticasone group. At week eight, the scores were 5 and 4, respectively.

Dellon and colleagues wrote that their findings did not support their initial hypothesis.

“One possibility is that this study was not a pure comparison of formulation. To do this, we would have needed to test [viscous budesonide] against budesonide [inhaler], not fluticasone [inhaler],” they wrote. “Based on the asthma literature and comparative pharmacology, fluticasone is more potent than budesonide. It is possible, then, that even with less optimal delivery via [inhaler], the higher potency of fluticasone resulted in similar efficacy.”

The authors wrote that their findings show that either form of steroid is acceptable as an initial therapy for EoE, and factors like patient preference, ease of administration and costs can be used in the decision to use one or the other. – by Alex Young

Disclosures: Dellon reports receiving research funding from Adare, Allakos, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos, Regeneron, and Shire; consulting fees from Adare, Alivio, Allakos, AstraZeneca, Banner, Calypso, Enumeral, EsoCap, Celgene/Receptos, GSK, Regeneron, Robarts, Shire; and educational grants from Allakos, Banner, and Holoclara. The other authors report no relevant financial disclosures.

Initial treatment of eosinophilic esophagitis with oral viscous budesonide or fluticasone from a multi-dose inhaler both produced decreases in eosinophil counts, as well as improved dysphagia and endoscopic features, according to data published in Gastroenterology.

Evan S. Dellon, MD, MPH, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, and colleagues wrote that because there are no FDA-approved medications specifically for EoE, asthma preparations, like fluticasone and budesonide are the first-line options for patients who do not respond to proton pump inhibitor therapy.

“While both medications are effective for decreasing levels of esophageal eosinophilia, there are no clinical trials directly comparing the two,” they wrote. “This comparison is a key question, because the amount of time a medication contacts the esophagus has been shown to directly correlate with histologic response in EoE.”

Since the oral viscous budesonide may provide increased contact time with esophageal mucosa, researchers hypothesized that it would be more effective than the inhaler administered fluticasone.

Dellon and colleagues tested their hypothesis in a double-blind, double-dummy trial comprising 111 patients with newly diagnosed EoE. They randomly assigned patients to receive either the budesonide twice daily plus a placebo inhaler (n = 56) or fluticasone twice daily plus a placebo slurry (n = 55) for eight weeks. The primary outcomes of the study were post-treatment maximum eosinophil count per high-power field and a validated dysphagia score at week eight.

At baseline, patients in the budesonide group had a peak eosinophil count of 73 compared with 77 in the fluticasone group. After treatment, the groups had eosinophil counts of 15 and 21, while 71% and 64% of patients achieved histologic response, respectively.

Dysphagia scores at baseline were 11 for the budesonide group and 8 for the fluticasone group. At week eight, the scores were 5 and 4, respectively.

Dellon and colleagues wrote that their findings did not support their initial hypothesis.

“One possibility is that this study was not a pure comparison of formulation. To do this, we would have needed to test [viscous budesonide] against budesonide [inhaler], not fluticasone [inhaler],” they wrote. “Based on the asthma literature and comparative pharmacology, fluticasone is more potent than budesonide. It is possible, then, that even with less optimal delivery via [inhaler], the higher potency of fluticasone resulted in similar efficacy.”

The authors wrote that their findings show that either form of steroid is acceptable as an initial therapy for EoE, and factors like patient preference, ease of administration and costs can be used in the decision to use one or the other. – by Alex Young

Disclosures: Dellon reports receiving research funding from Adare, Allakos, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos, Regeneron, and Shire; consulting fees from Adare, Alivio, Allakos, AstraZeneca, Banner, Calypso, Enumeral, EsoCap, Celgene/Receptos, GSK, Regeneron, Robarts, Shire; and educational grants from Allakos, Banner, and Holoclara. The other authors report no relevant financial disclosures.