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

Abstract

Summary 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.

Evidence-based treatments for eosinophilic esophagitis: insights for the clinician

“…55,84 Topic corticosteroid therapy: keys to target the esophageal mucosa Shortly after the description of EoE, corticosteroids with reduced bioavailability (beclomethasone and budesonide), swallowed instead of inhaled, were proved for the first time to be as effective as systemic steroids in inducing clinical and histological remission of the disease in a small series of four children. 85 Later on, fluticasone propionate also offered evidence of effectiveness in treating EoE, [86][87][88] and mometasone furoate was recently added to the list of drugs with potential benefit in this disorder. 89,90 An RCT compared swallowed topical corticosteroids (STCs) with oral prednisone: 91 after 4 weeks of treatment, both options were shown to have the same effectiveness in inducing clinical and histological remission of EoE.…”

“…Viscous corticosteroid solutions, especially those containing budesonide 100,101 but also fluticasone 86 and mometasone, 90 have improved STC delivery in EoE, with effervescent orodispersible tablets that use saliva to transport and adhere the drug to the esophageal inner surface being the latest innovation. A budesonide orodispersible tablet (BOT) formulation, that provided an efficacy of almost 100% in achieving histological remission after 2-6 weeks of therapy, 102,103 is already approved by the European Medicines Agency as the first drug to treat EoE in adult patients and is available in several European countries.…”

“…Shortly after the description of EoE, corticosteroids with reduced bioavailability (beclomethasone and budesonide), swallowed instead of inhaled, were proved for the first time to be as effective as systemic steroids in inducing clinical and histological remission of the disease in a small series of four children. 85 Later on, fluticasone propionate also offered evidence of effectiveness in treating EoE, 86–88 and mometasone furoate was recently added to the list of drugs with potential benefit in this disorder. 89,90…”

Formulations of Topical Steroids in Eosinophilic Esophagitis—Current Treatment and Emerging Possibilities

“…Nevertheless, a retrospective cohort study by Ketchem et al indicates that oral viscous fluticasone propionate has clinical and histologic efficacy in EoE. The medication was dispensed by a specialty compounding pharmacy and was prepared as a viscous suspension consisting of powdered fluticasone propionate and methylcellulose (Methocel gel) at a concentration of 1 mg/8 mL [ 66 ].…”

“…An overview of the oral viscous suspensions and aerosolized steroids used in randomised clinical trials and retrospective studies is given in Table 3 and Table 4 [ 10 , 30 , 38 , 39 , 46 , 49 , 54 , 55 , 56 , 60 , 61 , 62 , 63 , 66 , 74 , 75 , 76 , 77 ].…”