# Anti‐tumor necrosis factor‐α monotherapy versus combo therapy with immunosuppressant in pediatric inflammatory bowel disease: A real‐life study

## TL;DR

Combining anti-TNF-α therapy with immunosuppressants and using a proactive approach improves treatment outcomes in children with Crohn's disease.

## Contribution

This study identifies combination therapy and proactive monitoring as novel factors for improving anti-TNF-α durability in pediatric IBD.

## Key findings

- Combination therapy reduced anti-TNF-α failure in Crohn's disease children but not in ulcerative colitis patients.
- A proactive approach was associated with increased anti-TNF-α durability in both treatment groups.
- Multivariate analysis showed that combination therapy and proactive monitoring independently improved treatment outcomes.

## Abstract

The aim of the study is to evaluate the efficacy of anti‐tumor necrosis factor (TNF)‐α monotherapy versus combination anti‐TNF‐α and immunosuppressive therapy.

A single‐center, retrospective, observational study was conducted on inflammatory bowel disease (IBD) children. Patients with at least 6 months of follow‐up were enrolled and divided into two groups based on therapy. Combo group included children on combination anti‐TNF‐α and immunosuppressant therapy; children undergoing anti‐TNF‐α monotherapy were assigned to Mono group.

One hundred and seventeen children were enrolled, of whom 74 (63.2%) were affected by Crohn's disease (CD) and 43 (36.8%) by ulcerative Colitis (UC) (median age at diagnosis: 11.6 years; range 2.1–16.9; M/F: 56/61). Eighty patients (68.4%) were included in combo group and 37 (31.6%) in mono group. The median follow‐up was 2.6 years (0.5–11.3). Twenty‐three patients out of 80 (28.7%) in Group 1 showed therapy failure compared with 21/37 (56.8%) children in Mono group (p = 0.04). CD patients in monotherapy showed a significantly increased risk of therapy failure than those treated with combination therapy (p < 0.001). Conversely, no difference was found in UC children (p = 0.7). Children undergoing a reactive approach showed more frequent therapy failure compared to proactive in both groups (combo group: 41.7% vs. 4.3%; p = 0.01; mono group: 87.5% vs. 20%; p = 0.01). In a multivariate regression model, the use of a proactive approach and combination therapy was independently associated with anti‐TNF‐α durability (odds ratio [OR] = 22.1, OR = 12.9).

Combination therapy reduced overall anti‐TNF‐α failure in CD children, but not in UC patients. Additionally, a proactive approach was associated with increased anti‐TNF‐α durability.

The use of anti‐tumor necrosis factor (TNF)‐α biological drugs for the treatment of pediatric inflammatory bowel disease (IBD) is increased, but some patients show loss of response to anti‐TNF‐α inhibitors.The results of studies about combined immunosuppressive and anti‐TNF‐α therapy and anti‐TNF‐α monotherapy in pediatric IBD are conflicting.

The use of anti‐tumor necrosis factor (TNF)‐α biological drugs for the treatment of pediatric inflammatory bowel disease (IBD) is increased, but some patients show loss of response to anti‐TNF‐α inhibitors.

The results of studies about combined immunosuppressive and anti‐TNF‐α therapy and anti‐TNF‐α monotherapy in pediatric IBD are conflicting.

Combination therapy and proactive approach were factors independently associated with increased anti‐TNF‐α durability.The use of combination therapy and proactive therapeutic drug monitoring should be considered to improve clinical and laboratory outcomes in IBD children.

Combination therapy and proactive approach were factors independently associated with increased anti‐TNF‐α durability.

The use of combination therapy and proactive therapeutic drug monitoring should be considered to improve clinical and laboratory outcomes in IBD children.