Clinical impacts of immunomodulator withdrawal from anti‐tumor necrosis factor combination therapy in pediatric inflammatory bowel disease

Author:

Iovino Nicholas A.1ORCID,McClinchie Madeline G.2,Abdel‐Rasoul Mahmoud34,Boyle Brendan25,Dotson Jennifer L.256,Michel Hilary K.25,Maltz Ross M.25

Affiliation:

1. Department of Pediatrics Columbus Ohio USA

2. Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital Columbus Ohio USA

3. Center for Biostatistics, Department of Biomedical Informatics, College of Medicine The Ohio State University Columbus Ohio USA

4. Biostatistics Resource Nationwide Children's Hospital Columbus Ohio USA

5. Department of Pediatrics The Ohio State University Wexner Medical Center Columbus Ohio USA

6. Center for Child Health Equity and Outcomes Research, The Research Institute Nationwide Children's Hospital Columbus Ohio USA

Abstract

AbstractObjectivesCombination therapy consists of both anti‐tumor necrosis factor (anti‐TNF) and an immunomodulator (IMM) and has been shown to improve outcomes in patients with inflammatory bowel disease (IBD). This study assesses the impacts of IMM withdrawal from combination therapy to anti‐TNF monotherapy in children with IBD.MethodsThis single‐center retrospective cohort study included children with IBD initiated on combination therapy between 2014 and 2019 who discontinued the IMM. We evaluated whether IMM withdrawal impacts laboratory values and disease activity. Linear mixed effects models with random intercepts were used to compare differences between groups. Chi‐square and Kruskal–Wallis tests were used for comparisons between patients who did and did not require subsequent escalation of therapy.ResultsOne hundred and fifty‐two patients discontinued the IMM which did not significantly affect disease activity. However, 18% of patients escalated therapy after IMM withdrawal, primarily due to low anti‐TNF levels. Lower anti‐TNF and higher erythrocyte sedimentation rate (ESR) and C‐reactive protein (CRP) levels before IMM withdrawal were associated with subsequent escalation of therapy. Overall, there was no statistically significant effect on anti‐TNF drug levels. Patients with Crohn's disease (CD) on infliximab (IFX) and methotrexate (MTX) who discontinued the IMM had an increase in mean ESR and CRP (p < 0.05).ConclusionsIMM withdrawal from anti‐TNF combination therapy may be considered safe in the setting of higher anti‐TNF levels and normal serum inflammatory markers. Clinicians should consider assessing anti‐TNF levels and inflammatory markers after IMM withdrawal, especially in patients with CD receiving IFX who discontinued MTX.

Publisher

Wiley

Reference31 articles.

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3. Assessment of knowledge in adolescents with inflammatory bowel disease using a novel transition tool;Benchimol EI;Inflamm Bowel Dis,2011

4. Therapeutic drug monitoring of biologics for inflammatory bowel disease;Colombel J‐F;Inflamm Bowel Dis,2012

5. Infliximab, azathioprine, or combination therapy for Crohn's disease;Colombel JF;N Engl J Med,2010

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