1. What is the medical evidence for topical corticosteroids?

The strongest available scientific evidence is on the topical corticosteroids budesonide and fluticasone (Jorveza® [budesonide] is the only approved product in Australia1). Thirteen randomised studies have now been published on these medications (nine of which were placebo-controlled) that demonstrate that topical steroids are highly efficacious in inducing remission of EoE (see table 3). However, the studies did vary greatly in terms of their inclusion criteria, study drug dose and route of administration, length of treatment and definition of histological remission.

To date, the highest rates of histological remission have been achieved using budesonide in the form of an orodispersible tablet with effervescent properties or as a viscous suspension. The formulation of these products was specifically developed to target the oesophagus. The orodispersible tablet is taken by pressing it with the tip of the tongue against the gums for several minutes (2–20 min) until it slowly disintegrates.2

The mild effervescent effects of the tablets stimulate saliva flow. By swallowing multiple times, the active ingredient is gradually transported during the dissolution phase with the saliva to the inflamed mucosa  where it is efficiently absorbed due to the saliva’s adhesive properties. In one clinical study, adult patients preferred this method of administration over a syrup.3

Table 3: Induction of remission of EoE with topical steroids.4
*Topical steroid versus placebo.
2. What is the safety profile of topical corticosteroids when used to treat EoE?

Topical steroid therapy has an overall favourable safety profile. Although more than 10% of patients develop oesophageal candidiasis,5 this infection is asymptomatic in most cases and can be successfully treated with local antifungal therapy. Systemic steroids are not recommended for the treatment of EoE. Although they are indeed effective as short-term therapy, they are also associated with a higher rate of systemic adverse effects.5

3. Are topical steroids sprays suitable for treating EoE?

In the past, topical steroids were also administered as sprays for the treatment of EoE. Patients sprayed the medication into the oral cavity and then swallowed it without breathing in. However, there is no way to measure how much active substance actually reaches the oesophagus with this method as the sprays were not designed to deliver the active substance directly to the oesophagus. An accurate dosage can therefore not be ensured. Furthermore, neither the dosage nor the duration of treatment was ever determined for this pharmaceutical form and evidence points to only a low steroid exposure in the oesophagus: one study with 11 EoE patients used scintigraphy to demonstrate that even when the spray was swallowed as directed (study conditions), a substantial fraction of the active substance was found in the lungs and not in the esophagus.6

 

 

PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING.
COPIES OF THE PRODUCT INFORMATION FOR JORVEZA® CAN BE REQUESTED BY CALLING DR FALK PHARMA AUSTRALIA PTY LTD ON 1800 DRFALK (1800 373 233), OR AT THERAPEUTIC GOODS ADMINISTRATION.

PBS Information: Authority required for the treatment of EoE.
Refer to the PBS Schedule for full authority information.

 

4. References
  • Jorveza® Product Information.
  • Konikoff MR, Noel RJ, Blanchard C, Kirby C, Jameson SC, Buckmeier BK et al. A randomized, double-blind, placebo controlled trial of fluticasone propionate for pediatric eosinophilic oesophagitis. Gastroenterology 2006; 131(5):1381–91.
  • Miehlke S, Hruz P, Vieth M, Bussmann C, von Arnim U, Bajbouj M et al. A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic ooesophagitis. Gut 2016; 65(3):390–9.
  • Miehlke S, Schlag C, Storr M, von Arnim U. Eosinophile Ösophagitis Update 2017: Neue Leitlinien der europäischen Studiengruppe EUREOS. Z Gastroenterol 2018; 56(2):139–50.
  • Lucendo AJ, Molina-Infante J, Arias Á, von Arnim U, Bredenoord AJ, Bussmann C et al. Guidelines on eosinophilic oesophagitis: evidence-based statements and recommendations for diagnosis and management in children and adults. United European Gastroenterol J 2017; 5(3):335–58.
  • Dellon ES, Sheikh A, Speck O, Woodward K, Whitlow AB, Hores JM et al. Viscous topical is more effective than nebulized steroid therapy for patients with eosinophilic oesophagitis. Gastroenterology 2012; 143(2):321–4.e1

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