Real-World Evidence of Growth Improvement in Children 1 to 5 Years of Age Receiving Enteral Formula Administered Through an Immobilized Lipase Cartridge

Background/Objectives: RELiZORB immobilized lipase cartridge (ILC) is a single-use digestive enzyme cartridge that connects in-line with enteral feeding circuits to hydrolyze triglycerides in enteral formulas. It is cleared by the FDA for pediatric and adult use. Limited data have been published regarding the effect of ILC use on growth in children younger than 5 years of age. Methods: We performed a retrospective evaluation of real-world data extracted from a third-party reimbursement program database. All patients in the program database who initiated ILC use with enteral formula when 1 to 4 years of age between 2019 and 2023 were included. Baseline and follow-up weight, height/length, and body mass index (BMI) data were collected for up to 12 months. Results: A total of 186 patients from 90 clinics in the United States were included. A subset (143 patients) with baseline and follow-up growth measurements was included in the efficacy analysis population; 76% were diagnosed with cystic fibrosis. Mean weight and BMI z-scores improved significantly (0.63 [p < 0.001] and 0.53 [p = 0.006], respectively) from baseline to 12 months after initiation of ILC use. Significant improvement in the mean weight z-score was observed after 3 months. Among people with cystic fibrosis (pwCF) who initiated ILC use when 2 to 4 years of age, those with a BMI ≥ 50th percentile increased from 22% at baseline to 43% after 12 months (p = 0.021). Improvement in weight-for-length was also observed in 1-year-old pwCF. Conclusions: Real-world evidence showed that initiation of ILC use was associated with significant improvements in mean weight and BMI z-scores among young children.