Introduction
Swallowed Topical Steroids (STCs) originally developed for airway administration have been used off-label for eosinophilic esophagitis (EoE). Recently a new specifically designed formulation of budesonide orodispersible tablet formulation (BOT) has been developed and approved in different European countries. Since 30/08/2022 in our center all patients treated with STCs have been switch to BOT and prospectively followed up clinically and histologically.
Aims & Methods
The aim of our study is to evaluate efficacy, safety and patient’ satisfaction of therapeutic switch from off-label STCs to BOT (NCT05594849). Each patient performed upper GI endoscopy with biopsies under STCs and after 12-16 weeks of BOT to evaluate histologic remission. Moreover, all patients filled up a set of questionnaires before the switch and after 12-16 weeks of BOT evaluating severity of symptoms (DSS, DSQ), quality of life (EoE QoL) and satisfaction of the treatment (19 items scored between 0 to 4 evaluating the modality of assumption, the taste, and the perception of safety; higher values corresponding to higher satisfaction).
Results
The sample consists of 29 EoE patients, PPI non responders, who were receiving STCs (72.41% home-made viscous fluticasone, 27.58% viscous budesonide). Mean treatment-time was 32.53±29.27 months for fluticasone and 23.5±11.01 months for budesonide. Six patients (20.68%) presented strictures previously treated endoscopically. The starting dose of BOT was determined on the previous dosage of STCs and on the presence of histologic remission (89.65% used 1 mg twice daily, 10.34% 1 mg daily). Of 29 enrolled patients, 19 have already repeated the endoscopy under BOT (65.51%). Before therapeutic switch, 8 patients over 19 (42,11%) were active (>15 EOS/HPF) and 11 patients (57.89%) were in histologic deep remission (<6 EOS/HPF). After therapeutic switch, 7 patients over 8 (87.5%), histologically active under STCs, achieved deep remission with BOT, and one remained active (12.5%). Between patients in deep remission with STCs, 10 patients over 11 mantained histologic deep remission (90,91%) and only one relapsed (9,09%) after switch. After the switch to BOT, 3 patients over 29 presented oral/esophageal candida infection. Of these three, two patients have already experienced oral/esophageal candida under off-label STCs. After the therapeutic switch an improvement of symptoms severity was found for DSS score but not for DSQ (STCs-DSQ 0.24±0.63, BOT-DSQ 0.16±0.57, p value=0.60; STCs-DSS 5.14±2.77, BOT-DSS 2.3±2.05, p value=0.012). No differences were found for the quality of life (STCs-EoE QoL 42.07±19.42, BOT EoE QoL 30.72±23.95, p value=0.068). Finally, the satisfaction score showed a significant major willing of assumption of BOT rather than STCs (STCs 38.21±11.61, BOT 55.91±14.30, p value= 0.003).
| STCs | BOT | P-VALUE |
HISTOLOGIC REMISSION
| 11 Remission
8 Active
| 10 deep-remission (90.91%), 1 relapse (9.09%)
7 deep-remission (87.5%), 1 active (12.5%) |
|
| DSQ | 0.24±0.63 | 0.16±0.57 | 0.601 |
| DSS | 5.14±2.77 | 2.3±2.05 | 0.012 |
| EOE QOL | 42.07±19.42 | 30.72±23.95 | 0.068 |
| SATISFACTION | 38.21±11.61 | 55.91±14.30 | 0.003 |
Conclusion
Preliminary data of our study showed that therapeutic switch from off-label STCs to BOT in EoE patients is effective, safe and well tolerated. Most of patients histologically active under off-label STCs achieved histological deep remission with BOT and, if previously acquired with off-label STCs, histological deep remission was maintained in the majority of patients under BOT. The patients reported a significant major willing of assumption of BOT rather than off-label STCs.