Eosinophilic esophagitis (EoE) patients are likely to experience histological relapse despite ongoing treatment with swallowed topical corticosteroid (STC), but relapse occurs later with high- than with low-dose STC without any increase in side effects, a study has found.
“Long-term treatment with doses >0.5 mg/d may be considered for EoE maintenance treatment, but the advantage over lower doses appears to be small,” according to the investigators.
The analysis included 82 EoE patients (mean age at diagnosis 37.2 years, 58 males) in histological remission and ongoing STC treatment, 22 with budesonide and 60 with fluticasone. STC adherence was ≥75 percent.
Most of the patients (93 percent) were treated with STCs twice daily at the time of remission, with a median dose of 0.5 mg/d. Fifty-four (66 percent) patients were on low dose (≤0.5 mg/day), while 28 (34 percent) were on high dose (>0.5 mg/day).
Over a median follow-up of 2.2 years, which involved data from 217 endoscopy visits, histological relapse occurred in 67 percent of patients. The difference in relapse rates between the low- and high-dose groups was not significant (72 percent vs 54 percent). However, relapse occurred much sooner among patients on low-dose STC (1.0 vs 1.8 years, p=0.030). [Clin Gastroenterol Hepatol 2021;doi: 10.1016/j.cgh.2020.08.027]
Meanwhile, rates of and time to stricture formation were similar in the two treatment groups. Overall, 6 percent of patients developed esophageal candidiasis, with no significant difference between the low- and high-dose groups (5 percent vs 8 percent). None of the patients had dysplasia or mucosal atrophy.
The better dose
Generally, STCs perform well in terms of inducing clinical, endoscopic, and histological remission in patients with active EoE. However, there is limited data on the medication’s long-term efficacy, in contrast to the plethora of available studies on short-term induction STC treatment. Some reports say that the dose of 0.25 mg twice daily is too low and not enough to maintain remission. [Clin Gastroenterol Hepatol 2019;17:419-428; Allergy 2014;69:1248-1254]
“Here [in this study], we show that both low-dose and high-dose regimens result in histological relapse rates of more than 50 percent. Nonetheless, a higher dose can keep patients longer in disease remission,” the investigators pointed out.
“Intriguingly, th[e] positive effect of higher doses was even observed in patients with deeply controlled histological disease activity (peak eosinophil count of 0–1 eos/hpf) at baseline remission visit. One might assume that these are the patients that could maintain remission on lower doses. However, based on our data, very low peak eosinophil counts at the time of histological remission is not an indication to use lower doses of STCs to maintain histologic remission,” they added.
Additionally, the results on stricture formation and severe bolus impactions do not seem to indicate whether one regimen is better than the other. What the data clearly show, according to the investigators, is that STCs are safe and that the risk of esophageal candida infection is low, even with maintenance doses above 0.5 mg/d.
“Still, no statement can be made about doses of >2,500 mg, as these patients were excluded from our analyses. In addition, as we did not systematically assess serum cortisol levels, we cannot rule out the possibility of subclinical adrenal insufficiency,” according to the investigators.
In closing, the investigators recommended that patients on maintenance treatment with STCs, regardless of the chosen regimen, should undergo regular follow-up (with endoscopies and esophageal biopsies) given high relapse rates.