Variability in Practices of Compounding Budesonide for Eosinophilic Esophagitis.

INTRODUCTION: Little is known about the use of compounded steroids for eosinophilic esophagitis (EoE). METHODS: We conducted a telephone survey of all compounding pharmacies in Michigan and queried about practices and costs of compounded budesonide for EoE. RESULTS: Of 68 Michigan pharmacies, 93% responded, and 20 (29%) offer compounded budesonide suspension for EoE. Formulations, dose, and instructions for use varied across pharmacies. The mean cost for a 30-day supply was $74.50. DISCUSSION: Although few compounding pharmacies offer budesonide suspension and there are substantial variations in formulations, this may be a significantly more affordable treatment option for many.

Treatment with compounded fluticasone suspension improves the clinical, endoscopic, and histologic features of eosinophilic esophagitis.

No approved medication exists for the treatment of eosinophilic esophagitis (EoE) in the United States, which forces patients to utilize off-label drugs and/or create their own formulations. We assessed the efficacy of a standardized compounded fluticasone suspension. To do this, we performed a retrospective cohort study identifying all EoE patients treated with compounded fluticasone. Compounded fluticasone was prescribed during routine clinical care and dispensed by a specialty compounding pharmacy. Clinical data were extracted from medical records. Outcomes (symptomatic, endoscopic, and histologic) were assessed after the initial and last compounded fluticasone treatment in our system. There were 27 included patients (mean age 34.2; 67% male; 96% white) treated for a mean length of 5.4 ± 4.4 months. The majority (89%) previously utilized dietary elimination or topical corticosteroids, and many (75%) had primary non-response or secondary loss of response to these treatments. After starting compounded fluticasone, symptoms and endoscopic findings improved [dysphagia (89 vs. 56%, P = 0.005), food impaction (59 vs. 4%, P = 0.003), heartburn (26 vs. 4%, P = 0.01), chest pain (26 vs. 8%, P = 0.05), white plaques (63 vs. 32%; P = 0.005), furrows (81 vs. 60%; P = 0.06), and edema (15 vs. 4%; P = 0.16)]. The median of the peak eosinophil counts decreased from 52 to 37 eos/hpf (P = 0.10) and 35% of patients achieved <15 eos/hpf. In conclusion, compounded fluticasone provided a significant improvement in symptoms and endoscopic findings, with more than a third achieving histologic response in a treatment refractory EoE population. Compounded fluticasone should be considered as an EoE management option.

Compounded Oral Viscous Budesonide is Effective and Provides a Durable Response in Eosinophilic Esophagitis.

AIM: Because no approved medications exist for eosinophilic esophagitis (EoE), patients must use off-label drugs or create their own formulations. We assessed the efficacy of a standardized compounded budesonide suspension for treatment of EoE. MATERIALS AND METHODS: We conducted a retrospective cohort study of EoE patients at the University of North Carolina treated with compounded budesonide dispensed by a specialty compounding pharmacy. Outcomes (symptomatic global response [yes/no], endoscopic response [% with individual findings], and histologic response [absolute eosinophil count; % with <15 eos/hpf])were assessed after the initial and last treatment in our system. RESULTS: We identified 48 patients treated with compounded budesonide (mean age 33.6; 69% male; 96% white; 2.4 mg mean initial dose). After a mean length of follow-up of 17.0 months (range: 4.2 - 56.3), there was a significant decrease in symptoms of dysphagia (95% vs. 32%, p < 0.001), improvements in heartburn (37% vs. 11%, p=0.06) and global symptom response (81%). The median of the peak eosinophil counts decreased from 55 to 20 eos/hpf (p<0.001) with 42% achieving a response of <15 eos/hpf. Esophageal candidiasis was rare (6%). In the 18 patients with prior non-response to corticosteroids or dietary elimination, 83% had symptomatic and 38% had histologic response. CONCLUSION: Compounded budesonide suspension produced a durable symptomatic, endoscopic, and histologic response in a cohort followed for more than a year. Many patients previously refractory to prior therapy responded to compounded budesonide. This formulation can be used clinically until there are approved drugs with esophageal formulations for EoE.