The following article is a part of conference coverage from the Digestive Disease Week 2021 Annual Meeting , held virtually from May 21 to 23, 2021. The team at Gastroenterology Advisor will be reporting on the latest news and research conducted by leading experts in gastroenterology. Check back for more from DDW 2021.
Lirentelimab was associated with sustained tissue eosinophil depression among patients with eosinophilic gastritis (EG) and/or duodenitis (EoD). These findings were presented during the Digestive Disease Week annual meeting, held virtually, from May 21-23, 2021.
Data from an open-label extension of the ENIGMA trial, a randomized, double-blind, placebo-controlled phase 2 trial, were analyzed for this study. Patients (N=58) with biopsy-confirmed EG or EoD who received 4 monthly lirentelimab or placebo infusions during the ENIGMA trial were study eligible. The open-label extension consisted of a monthly dose-escalation schedule of 0.3 or 1 mg/kg to 3 mg/kg. Patients were assessed weekly for symptom severity. Histologic remission was defined as ≤4 gastric eosinophils/high-powered field (hpf) or ≤15 duodenal eosinophils/hpf.
As of September of 2020, 45 patients had received ³52 weeks of lirentelimab and 29 patients received 70 weeks of therapy.
Total gastrointestinal symptom severity (TSS) decreased over time. Patients who received longer therapy reported a 68% average TSS reduction at weeks 29-30, 70% at weeks 51-52, and 75% at weeks 69-70.
At weeks 69-70, symptom-specific severity had decreased by 100% for vomiting, 99% for early satiety, 96% for loss of appetite, 94% for diarrhea, 90% for abdominal cramping, 88% for nausea, 87% for abdominal pain, and 65% for bloating.
At endoscopy on day 323, a 98% reduction in gastrointestinal eosinophil counts were found compared with baseline (mean, 2 vs 72 eosinophils/hpf) and histologic remission was achieved by all but 3 patients.
Mild to moderate infusion-related reactions were more frequently reported after the first infusion. No patients who received a prednisone dose the day before the first infusion (n=20) reported an infusion-related reaction.
This study was limited by its small sample size and these results should be validated among a larger cohort.
The study authors concluded that lirentelimab may be a viable treatment option for patients with EG and/or EoD, as it was associated with long-term symptom improvement with sustained tissue eosinophil depression and little risk for treatment-related adverse events.
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Peterson KA, Chehade M, Murray JA, et al. Long-term treatment of patients with eosinophilic gastritis and/or eosinophilic duodenitis with lirentelimab, a monoclonal antibody against SIGLEC-8. Presented at: Digestive Disease Week Annual Meeting; May 21-23, 2021. Abstract 539.