Abstract
Partial enteral nutritional therapy (PEN, defined as 80% of daily caloric intake from formula) has shown similar efficacy in inducing remission for pediatric Crohn’s Disease (CD) in comparison to exclusive enteral nutrition (EEN, defined as 100% of daily caloric intake from formula). Long-term outcomes of PEN are not well defined in the literature We aimed to study the long-term outcomes of PEN as defined by the number of patients still on maintenance PEN at 1 and 2 years after initiation.
This was a retrospective cohort study using electronic medical record data at a large pediatric academic center. Patients diagnosed with CD between ages 7-19 years at PEN initiation with available follow-up data were included. Exclusion criteria were diagnoses of ulcerative colitis or indeterminate colitis, concomitant treatment with systemic steroids (prednisone (or equivalent) dose > 20 mg daily), biologics, or immunomodulators. Data collected included demographic and IBD characteristics as well as details of PEN therapy. We calculated the one and two-year PEN persistence rates and used Kaplan-Meier methods to produce survival curves of PEN persistence with adjustment for censoring.
Between 2009 and 2021, forty-nine participants met inclusion criteria (out of 114 assessed for inclusion). Participants were mostly white (n = 38, 77%), and male (n = 30, 61%). The mean age at CD diagnosis was 11.4 years (standard deviation, SD: 2.9 years) and the mean age at PEN initiation was 12.1 years (SD: 2.6 years). The most common reasons for PEN initiation were primary induction (n = 30, 61%), family/patient preference to avoid other medications (n = 26, 53%), and failure of primary medical therapy (n = 10, 20%). The most chosen formula type for PEN therapy was partially hydrolyzed formulas (n = 30, 61%), followed by standard formulas with whole intact proteins (n = 16, 33%). The one-year PEN persistence rate was 51% (26/49) and the two-year persistence rate was 25% (12/49) (table1). The median time on PEN was 1.3 years (IQR: 0.6 – 2.2 years) (Figure 1). The most common reasons for discontinuation were disease relapse/progression (n=32/41,78%) and treatment non-adherence (n =8/41, 20%). A small number of individuals discontinued due to formula intolerance (n = 3/41,7%). The most common medical therapies escalated to were infliximab (n =21/41, 51%), and adalimumab (n = 8/41, 20%) when PEN was discontinued.
Our study suggests that PEN therapy can be used as potential long-term treatment strategy for mild pediatric Crohn’s disease while avoiding corticosteroids and side-effects common with other IBD therapies. Secondary analysis is underway to understand predictors of response or failure to PEN therapy such as disease location/ distribution, type of formula, and the amount of calories from food vs. formula.
