Long term use of Budesonide oral suspension improves eosinophilic esophagitis,finds study
Continuing budesonide oral suspension (BOS) numerically improved maintenance and efficacy versus withdrawal among eosinophilic esophagitis patients, suggests findings from a recent study. The reports have been published in Clinical Gastroenterology and Hepatology.
Eosinophilic esophagitis (EoE) is a chronic immunemediated disease characterized by esophageal dysfunction and eosinophils/high-power field (eos/hpf) in the esophageal mucosa.The prevalence and incidence of EoE are increasing since the last decade. Budesonide oral suspension (BOS) is a novel mucoadherent topical corticosteroid formulation with a standardized viscosity and concentration, designed specifically for the treatment of EoE.
Researchers evaluated treatment withdrawal, long-term outcomes and safety of budesonide oral suspension (BOS) 2.0 mg b.i.d. in patients with eosinophilic esophagitis who completed a 12-week induction study.
For the study design, Induction full responders (≤6 eosinophils per high-power field [eos/hpf] and ≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] score) to BOS 2.0 mg b.i.d. (ORBIT1/SHP621-301/NCT02605837) were randomized to continue BOS (BOS–BOS) or withdraw to placebo (BOS–PBO) for 36 weeks (ORBIT2/SHP621-302/NCT02736409). Induction partial- and non-responders, and patients who received induction placebo, received BOS for 36 weeks.
The primary endpoint was the proportion of BOS–BOS and BOS–PBO patients who relapsed (≥15 eos/hpf and ≥4 days of dysphagia [DSQ] over 2 weeks) by week 36. The key secondary endpoint was the proportion of induction partial- and non-responders who fully responded after 52 weeks' total BOS therapy. Secondary endpoints included: proportion of induction full responders with histologic responses (≤1, ≤6, <15 eos/hpf) at week 12 of the extension study, and safety outcomes.
Results revealed some interesting facts.
- The randomized withdrawal period enrolled 48 patients (BOS–BOS, n=25; BOS–PBO, n=23); 106 induction partial- and non-responders and 65 induction placebo patients received BOS.
- More BOS–PBO than BOS–BOS patients relapsed over 36 weeks (43.5% vs 24.0%; P=.131) and had histologic responses at week 12 of therapy (P<.001).
- Overall, 13.2% of induction partial- and non-responders fully responded at week 36. BOS was well-tolerated; therapy duration was not associated with new safety concerns.
"Continuing BOS beyond a 12-week induction period improves maintenance and efficacy over withdrawal in patients who are full responders, without additional safety concerns. A subset of patients who are initially partial responders or nonresponders may have full response with extended therapy.Longer therapy duration did not raise safety concern."the team concluded.
For full article follow the link: DOI:https://doi.org/10.1016/j.cgh.2021.06.020o
Source: Clinical Gastroenterology and Hepatology