Effectiveness of Partial Enteral Nutrition as Add-On to Biologics in Patients With Refractory and Difficult-to-Treat Crohn's Disease: A Pilot Study

Olga Maria Nardone; Giulio Calabrese; Alessia La Mantia; Anna Testa; Antonio Rispo; Lucia Alfonsi; Fabrizio Pasanisi; Fabiana Castiglione

doi:10.1093/crocol/otae011

Effectiveness of Partial Enteral Nutrition as Add-On to Biologics in Patients With Refractory and Difficult-to-Treat Crohn's Disease: A Pilot Study

Crohns Colitis 360. 2024 Feb 22;6(1):otae011. doi: 10.1093/crocol/otae011. eCollection 2024 Jan.

Authors

Olga Maria Nardone¹, Giulio Calabrese², Alessia La Mantia², Anna Testa², Antonio Rispo², Lucia Alfonsi³, Fabrizio Pasanisi³, Fabiana Castiglione²

Affiliations

¹ Gastroenterology, Department of Public Health, University of Naples Federico II, Naples, Italy.
² Gastroenterology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
³ Internal Medicine and Clinical Nutrition Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Abstract

Background: Partial enteral nutrition (PEN) is a well-established treatment for children with Crohn's disease (CD). However, its efficacy in adults with CD remains uncertain. We aimed to assess the effectiveness of PEN as an add-on to escalated biological therapy in adults with CD who have lost response to biologics.

Methods: We conducted a retrospective observational study including patients who had lost response to biologics and received PEN in combination with escalated treatment, compared to those treated only with escalated therapy. The primary endpoint was steroid-free clinical remission (CR) at 24 weeks. Secondary endpoints included transmural healing (TH) and response (TR) rates along with selected clinical outcomes.

Results: Forty-two patients were screened; 12 (28.6%) were excluded for complicated disease and 30 (71.4%) were included in the final analysis. Fourteen (46.7%) patients completed PEN treatment at 8 weeks, while 16 patients (53.3%) discontinued treatment due to intolerance and continued with escalation of biologic (BT group). At 24 weeks, 9 patients (64.3%) in the PEN group achieved CR, compared to 4 patients (25%) in the BT group (P = .03). The TR rate was 64.9% in the PEN group and 25% in the BT group (P = .03). Patients receiving PEN exhibited an increase in albumin levels compared to those in the BT group (Δ = 0.5; P = .02). A higher rate of therapy changes (68.7%) was observed in the BT group compared to 14.2% in the PEN group (P = .004). Prior failure to 2 lines of biological therapy was associated with adherence to PEN (OR = 1.583; CI = 1.06-2.36; P = .01).

Conclusions: In patients who had lost response to biologics, PEN in combination with escalated biologics was associated with CR and TR and improved nutritional status. Hence, the addition of PEN should be considered for patients with difficult-to-treat CD.

Keywords: Crohn’s disease; difficult to treat; loss of response; partial enteral nutrition.