Effect of combined ustekinumab and partial enteral nutrition on clinical and nutritional outcomes in Crohn’s disease

Ustekinumab (UST), as a novel biologic agent, is approved globally for the treatment of Crohn's disease (CD). However, a subset of patients exhibit either no response or only a weak response to UST. Compared with normal diet, Partial Enteral Nutrition (PEN) appears to be a more effective dietary intervention for CD patients with failure to respond. A retrospective study was conducted on 34 CD patients and treated with UST at the First People's Hospital of Wuhu between March 2023 and March 2024. These patients were categorized into two groups based on their dietary medical advice: UST group (n = 23) and UST + PEN group (n = 11). The initial administration of UST occurred at week 0, with week 32 serving as observation endpoint. Baseline data, clinical indices, nutritional indices, and blood drug trough concentrations at week 32 were compared both pre-and post-treatment. In UST group, there was a statistically significant change in Crohn's disease activity index (CDAI) score and serum albumin levels before and after treatment (P < .05). Similarly, in UST + PEN group, significant differences were observed in the CDAI, hemoglobin levels, and serum albumin levels (P < .05). The UST group exhibited a reduction in CDAI by (30.15 ± 34.81), while UST + PEN group showed a more pronounced decrease of (82.85 ± 50.96) with this difference being statistically significant. The analysis of inflammatory-nutritional indices indicated that within UST group, only the Onodera's Prognostic Nutritional Index (OPNI) demonstrated significant change (P < .05). However, both Neutrophil-to-Lymphocyte Ratio (NLR) and OPNI showed significant alterations in UST + PEN group (P < .05). A between-group comparison revealed statistically significant difference in change in NLR ratio (P < .05). In all patients with CD, statistically significant differences were observed in CDAI, hemoglobin levels, serum albumin levels, and OPNI between week 0 and week 32 of UST treatment (P < .05). UST blood trough concentration ≥1.975 μg/mL were predictive of effective clinical outcomes at week 32. In terms of improving clinical outcome (CDAI) and nutritional indicators (NLR), PEN appears to enhance the therapeutic effectiveness of UST in CD patients with inadequate response.