P-210 Post-induction Serum Infliximab Trough Levels Are Capable of Predicting “En Bloc” Remission in Pediatric Crohn's Disease Patients Under Combined Immunosuppression

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Abstract

Background:

It has been reported that early infliximab (IFX) trough levels at week 14 are associated with persistent remission throughout week 54 in pediatric patients with inflammatory bowel disease (IBD). However, there is limited data regarding the association between serum IFX trough levels at week 14 and mucosal healing (MH) in pediatric IBD. We aimed to investigate whether serum IFX trough levels at week 14 were associated with MH at week 14 and week 54 and furthermore with “en bloc” remission, a composite outcome of clinical, biochemical, and endoscopic remission throughout the period.

Methods:

We performed a multicenter retrospective study of 64 patients with pediatric luminal Crohn's disease (CD) under combined immunosuppression with IFX and azathioprine, who had conducted both ELISA tests for IFX trough levels at week 14, and ileocolonoscopy at week 14 and 54. MH was defined as a Simple Endoscopic Score for Crohn's disease (SES-CD) of 0. “En bloc” remission was defined as MH at both week 14 and 54 plus persistent clinical and biochemical remission from week 14 to 54 in the absence of dose intensification. Clinical remission was defined as a Pediatric Crohn's Disease Activity Index (PCDAI) of 10 points or less and biochemical remission was defined as a CRP level less than 0.5 mg/dL, which were evaluated prior to each infusion. Logistic regression analysis was performed to examine the association between serum IFX trough levels with MH at week 14, MH at week 54, and “en bloc” remission.

Results:

MH was achieved in 28 (43.8%) and 40 patients (62.5%) at week 14 and 54, respectively. “En bloc” remission was observed in 18 patients (28.1%). Serum IFX trough levels at week 14 were significantly higher in patients who had each achieved the outcomes of MH at week 14 (median 6.0 versus 3.0 μg/mL, P < 0.001), MH at week 54 (median 4.9 versus 2.5 μg/mL, P < 0.001), and “en bloc” remission (median 6.2 versus 3.4 μg/mL, P < 0.001). According to logistic regression analysis, serum IFX trough levels at week 14 was significantly associated with MH at week 14 (odds ratio [OR], 1.40, 95% confidence interval [CI], 1.13–1.83, P = 0.006), MH at week 54 (OR, 1.82, 95% CI, 1.35–2.64, P < 0.001), and “en bloc” remission (OR, 1.33, 95% CI, 1.09–2.72, P = 0.015). According to receiver operator characteristic curves, the best cut-off value of serum IFX trough concentration at week 14 required in achieving MH at week 14, MH at week 54, and “en bloc” remission were 4.49 μg/mL [area under the curve (AUC) = 0.819, 95% CI, 0.714–0.924, sensitivity 75%, specificity 77.8%, P < 0.001], 4.01 μg/mL (AUC = 0.812, 95% CI, 0.704–0.92, sensitivity 75%, specificity 79.2%, P < 0.001), and 4.81 μg/mL (AUC = 0.805, 95% CI, 0.691–0.919, sensitivity 77.8%, specificity 76.1%, P < 0.001), respectively.

Conclusions:

Serum IFX trough levels at week 14 were significantly associated with each MH at week 14, MH at week 54, and “en bloc” remission. Post-induction serum IFX levels are capable of predicting “en bloc” remission, a composite outcome of clinical, biochemical, and endoscopic remission from post-induction to 1 year maintenance in pediatric luminal CD patients under combined immunosuppression.

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