METHODS: The clinical and post-marketing databases were searched for any reports of EoE.
RESULTS: In the clinical program (4,175 subjects in active groups), 2 cases of EoE were reported (~48/100.000). One case was reported by a US, adolescent, male subject with a 3-year history of heartburn, dysphasia, and stomach discomfort. EoE (assessed as moderate) was diagnosed with biopsy 6 months after start of treatment with 12 SQ-HDM. Treatment included PPI and fluticasone. A French woman with medical history of gastrointestinal reflux-symptoms reported another case. This case was diagnosed with biopsy 3 months after start of treatment with 6 SQ-HDM. It was assessed as mild, with a possible causal relation to treatment. Treatment included PPI and antacid. Both subjects completed the 1 year of treatment without changes to investigational treatment. In worldwide post-marketing, 3 cases of EoE have been reported with exposure estimated to 20,102 treatment-years (~15/100,000 TY). 2 cases were reported as confirmed with biopsy.
CONCLUSIONS: The background prevalence of EOE is 57/100,000 persons in the US. Thus, the prevalence of EoE with SQ HDM SLIT-tablet does not support a potential risk related to treatment at this point in time.