Oral viscous budesonide in combination with lansoprazole was significantly more effective for pediatric eosinophilic esophagitis than was the proton pump inhibitor alone, reported Dr. Ranjan Dohil and his colleagues in an article appearing in the August issue of Gastroenterology.

Although patients with negative allergy testing appeared to respond better, “patients testing positive do also respond and should also be considered for OVB [oral viscous budesonide] therapy,” the authors concluded, based on their randomized, double-blind, placebo-controlled trial (Gastroenterology 2010 August [doi: 10.1053/j.gastro.2010.05.001].

According to Dr. Dohil of the University of California, San Diego Medical Center, the symptoms of eosinophilic esophagitis (EoE) are similar to those seen in gastroesophageal reflux disease but the condition is “often refractory to acid-suppression therapy,” and therefore “the optimal therapy for EoE is unclear.”

The current phase II study, sponsored by the maker of OVB, Meritage Pharma Inc., is the first placebo-controlled study to evaluate the drug, which is a viscous liquid consisting of budesonide nebulizer suspension (Pulmicort respules, made by AstraZeneca PLC) mixed with sucralose (Splenda, McNeil Nutritionals, LLC).

Dr. Dohil and colleagues studied 31 children diagnosed with EoE between February 2008 and July 2009; a total of 24 completed the study and were included in the analysis. All had esophageal eosinophil counts greater than or equal to 20 eosinophils/high-powered field (eos/hpf) except for one patient, who had “panesophageal furrowing and exudates on endoscopy but a peak eosinophil count of 15” – this patient was also enrolled.

A total of 20 patients were male, and the mean age was 7.8 years (with a range of 1-17 years).

Of the total 24 children, 15 received OVB and PPI and 9 received placebo and PPI. “Subjects less than 5 feet tall received OVB 1 mg and those greater than or equal to 5 feet tall received OVB 2 mg” every day for 3 months, wrote the authors. The dose of lansoprazole was 15 mg twice daily for children younger than 10 years, and 30 mg twice daily for children aged 10 years and older.

In the treatment group, the mean peak eosinophil count prior to OVB/PPI therapy was 66.6 eos/hpf. After 3 months of therapy, it had decreased significantly to 4.8 eos/hpf (P = .0001), with only one patient classified as a complete nonresponder (the eosinophil count went from 67 to 47 eos/hpf in that patient).

Moreover, the results were seen throughout the esophagus. Indeed, “87% of OVB post-treatment patients [had] less than or equal to 6 eos/hpf in the distal esophageal biopsies and 100% [had] less than or equal to 6 eos/hpf in proximal esophageal biopsies,” wrote the authors.

In contrast, among patients treated with placebo plus the PPI, the mean eosinophil count went from 83.9 to 65.6 eos/hpf, and all patients were classified as nonresponders except for one partial responder, whose counts fell from 75 to 7.

The mean endoscopy score, determined at 3 months, decreased in the OVB group from 4.6 (range 0-9) before treatment to 1.5 (range 0-7) after treatment (P = .0005). The endoscopy score had a maximum value of 15 and was modified from the Endoscopy Scoring Tool (EST), which has been used to differentiate EoE from gastroesophageal reflux disease. No patients in the OVB group were found to have any esophageal strictures.

In comparison, among the placebo patients the mean endoscopy score improved from 7.8 (range 4-9) before treatment to 5.4 (range 1-9) after treatment (P =.041) but “none of the endoscopy scores completely normalized.” One placebo group patient also had an esophageal stricture.

The authors also found that children without allergies did typically respond better to the OVB therapy: 100% of the nine children in the treatment group who had negative allergy scores were responders. In contrast, among the six remaining children who tested positive for allergies or asthma and received OVB, only four were complete responders.

“One was a partial responder and the other a nonresponder,” wrote Dr. Dohil. “The nonresponder and partial responder were older, taller, male allergic children (aged 15 and 17 years, respectively) who returned 30% of [their] study drug vial unopened.”

The authors conceded that the study’s duration of 3 months did not allow for long-term follow-up. However, “data from this study does support the need for a proprietary OVB medication specifically for the treatment of EoE,” they concluded.

In addition to receiving funding from the maker of OVB, Dr. Dohil and two other researchers disclosed having a financial interest in the successful development and marketing of OVB. They also disclosed that the University of California, San Diego, where the investigators are employed, has a financial interest in Meritage Pharma.

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