Introduction
The I-SEE score, Index of Severity for Eosinophilic Esophagitis (EoE), is a recently developed clinical tool designed to assess the severity of EoE, a chronic, immune-mediated disease characterized by esophageal eosinophilic infiltration. Unlike traditional approaches, the I-SEE score integrates multiple domains, such as symptoms burden, endoscopic features and histo-pathologic activity, to provide a comprehensive evaluation of disease impact. Recent studies have begun to validate the I-SEE score in real-world settings, examining its correlation with treatment outcomes, patient-reported measures, and long-term disease management. Current research are focused on refining the scoring system, exploring its utility across patients’ populations, and determining its reliability for identifying disease activity, thus helping its management.
Aims & Methods
This is a multicentre, prospective, observational study aiming to evaluate the reliability of the I-SEE score in identifying disease activity in patients with EoE, by comparing scores obtained before and after therapeutic interventions with budesonide orodispersible tablet (BOT). Patients diagnosed with EoE, aged > 18 years old, treated with BOT 2 mg, as induction treatment for 12 weeks (T1) and with 0,5/1 mg qd as maintenance for 52 weeks (T2) were enrolled. Clinical and demographic characteristics were collected. I-SEE score was calculated before and after the treatment.
Results
306 patients (241 males, 79%; mean age 38±14) treated with BOT were enrolled, in 8 Italian Centres and 1 Israelian Centre. The most frequent symptoms at diagnosis were dysphagia (82%) and food bolus impaction (70%). Allergic comorbidities were present in 65% of patients. At baseline, all patients had an I-SEE score higher than 2, median value 6 (5-8); 14/306 presented a severe disease (I-SEE score≥15) and 136/306 a moderate active disease (I-SEE score 7-14). At T1, the I-SEE score passed from 6 (5-8) to 2 (1-3) (p<0.0001). Moreover, only 1/276 patients had a persisting severe disease, 5/270 moderate disease, while 40/276 achieved complete remission (I-SEE score<1). After 1 year of treatment (T2), 135 patients were evaluated; the I-SEE score significantly decreased from T0 (6 (5-8) to 1 (0-3), p<0.0001) and from T1 (2 (1-3) to 1 (0-3), p<0.0001). Moreover, 4/135 patients presented moderate-severe disease, while in 40/135 EoE was inactive. Considering only histologic assessment, all patients defined primary non-responder to BOT at T1 (20/270, 8 with moderate-active disease at T0) and secondary non-responder after tapering down the treatment at T2 (12/135, 5 with moderate-active disease at T0), met the criteria of mild disease according to the I-SEE score. All data are resumed in Table 1.
| n, T0 | n, T1 | n, T2 | T0 vs T1 | p | T0 vs T2 | p | T1 vs T2 | p |
I-SEE score,
median value (25-75 perc.) | 306 | 270 | 135 | 6 (5-8) vs 2 (3-1) | <0.0001 | 6 (5-8) vs 1 (0-3) | <0.0001 | 2 (1-3) vs 1 (0-3) | <0.0001 |
Symptoms,
median value (25-75 perc.)
(0-15 points) | 306 | 270 | 135 | 1 (1-2) vs 0 (0-0) | <0.0001 | 1 (1-2) vs 0 (0-0) | <0.0001 | 0 (0-0) vs 0 (0-0) | 0.2 |
Complications,
median value (25-75 perc.)
(0-15 points) | 306 | 270 | 135 | 0 (0-0) vs 0 (0-0) | <0.0001
| 0 (0-0) vs 0 (0-0) | 0.0007 | 0 (0-0) vs 0 (0-0) | 0.0007*
*worsen from T1 |
Inflammatory endoscopic features, median value (25-75 perc.)
(0-2 points) | 306 | 270 | 135 | 1 (1-2)vs 1 (0-1) | <0.0001 | 1 (1-2) vs 0 (0-1) | <0.0001 | 1 (0-1) vs 0 (0-1) | 0.002*
*improved from T1
|
Eosinophil count,
median value (25-75 perc.)
(0-2 points) | 306 | 270 | 135 | 1 (1-2) vs 0 (0-0) | <0.0001 | 1 (1-2) vs 0 (0-0) | <0.0001 | 0 (0-0) vs 0 (0-0) | 0.9 |
Endoscopic fibrostenotic features,
median value (25-75 perc.)
(0-15 points) | 306 | 270 | 135 | 1 (0-1)vs 0 (0-1) | <0.0001 | 1 (0-1) vs 0 (0-1) | <0.0001 | 0 (0-1) vs 1 (0-1) | 0.008*
*improved from T1 |
Histologic fibrostenotic features,
median value (25-75 perc.)
(0-2 points) | 306 | 270 | 135 | 2 (0-2) vs 0 (0-2) | <0.0001 | 2 (0-2) vs 0 (0-2) | <0.0001 | 0 (0-2) vs 0 (0-2) | 0.5 |
Table 1: I-SEE score and features assessment at T0, T1 and T2.Conclusion
In this prospective observational study, the application of the recently developed I-SEE score for EoE assessment confirms the high efficacy of the treatment of BOT. However, baseline I-SEE score calculation was not useful in predicting nor stratifing patients’ response to drug therapy. Further studies are necessary to outline the weighted scoring of each feature involved into score calculation.
References
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