Association of in-line digestive enzyme cartridge with enteral feeds on improvement in anthropometrics

Karyn Shaw, RD, CSP, LD, CNSC; Stacie Hunter, MPH, RD, CSP, LD; MinJae Lee, PhD; Meghana Sathe, MD University of Texas Southwestern/Children’s Health; Dallas, TX

BackgroundAdministration of pancreatic enzyme replacement therapy (PERT) with nighttime feedings presents a challenge as waking up during the night to take PERT orally is not sustainable. There is significant variation in practice of administration of PERT with nighttime feedings. PERT is available in 3 forms: capsule form taken by mouth (only 1 capsule has FDA-indication to be opened and placed through feeding tube), tablet (which is often used off-label crushed and mixed with water or bicarbonate and placed through feeding tube), and in-line cartridge digestive cartridge (Relizorb) which is the only in-line lipase only cartridge designed to deliver PERT. However, outcomes related to the use of Relizorb are lesser known. The goal of this project was to evaluate our clinical experience in hopes of adding to the limited literature describing the benefits and limitations of Relizorb.

MethodsA retrospective chart review was performed on 29 pediatric patients with cystic fibrosis and pancreatic insufficiency who received supplemental tube feedings and utilized Relizorb for a minimum of 3 months from 2015 to 2019. Anthropometrics were evaluated 12 months before and after initiation of Relizorb.

ResultsThe mean age of patients was 8.41 years (range: 0.5-17) and mean PERT dose with GT feeds prior to Relizorb was 1934 units lipase/kg/feed. Fifteen patients (51.72%) were male, 12 patients (4.38%) were dF508 homozygous, 15 patients (51.72%) were dF508 heterozygous, and 7 patients (24.14%) had advanced lung disease. We found weight, height and BMI z-score changed over time based on multivariable longitudinal regression models after adjusting for clinically/statistically relevant variables identified a priori: including age at start of Relizorb, sex, PERT dose with GT feeds prior to Relizorb, continue PERT with GT feeds after starting Relizorb, and CF mutations. The adjusted mean z-scores of height over time was estimated and plotted in Figure 1. Height z-scores slightly decreased from 12-months-before to 6months-before-Relizorb (adjusted mean: from -1.14 to -1.18) and then significantly increased (adjusted mean at 6-months-after = -0.93; adjusted mean at 12-months-after = -0.92). Compared to mean height z-score at 6-months-before-Relizorb, mean height z-score at 6-months-after-Relizorb (adjusted mean difference=0.2540; 95% CI=[0.0487, 0.4592]; p=0.0153) and mean height z-score at 12-months-after-Relizorb (adjusted mean difference = 0.2684; 95% CI=[0.0203, 0.5166]; p=0.0340) were significantly higher. Age at start of Relizorb was statistically associated with higher height z-score (adjusted mean difference per one year of age=0.0794; p=0.0169), but lower BMI z-score (adjusted mean difference per one year of age = -0.0425; p=0.0436).

DiscussionThe findings of this review are consistent with previous findings (Sathe MN, et al. JPGN. 2021;72:18-23). Height significantly increased after the use of Relizorb. Limitations of this study include a small sample size from a single center. A larger, more diverse sample may provide additional support for the benefits of this unique mechanism to deliver PERT for enterally fed patients.