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Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial.

Cornillie F, Hanauer SB, Diamond RH, Wang J, Tang KL, Xu Z, Rutgeerts P, Vermeire S - Gut (2014)

Bottom Line: Optimal predictors of durable sustained response to maintenance infliximab 5 mg/kg were week 14 trough level ≥3.5 µg/mL and ≥60% CRP decrease (ORs (95% CI), 3.5 (1.1 to 11.4) and 7.3 (1.4 to 36.7)), respectively, in patients with raised baseline CRP (>8.0 mg/L); area under the ROC curve was 0.75 for both predictors.A ≥3.5 µg/mL week 14 infliximab serum level did not predict durable sustained response to 10 mg/kg maintenance infliximab.Serum infliximab trough levels ≥3.5 µg/mL and ≥60% CRP decrease were significantly associated with durable sustained response.

View Article: PubMed Central - PubMed

Affiliation: Department of Immunology, Janssen Biologics BV, Leiden, The Netherlands.

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Median (IQR) serum infliximab trough levels in patients with and without sustained response to scheduled maintenance infliximab 5 and 10 mg/kg through 54 weeks. (A) Median values (IQR) in the 5 mg/kg maintenance arm are 12.9 (9.0–16.6), 4.0 (1.7–6.8) and 3.0 (1.1–5.6) in patients with sustained response and 8.8 (3.2–16.8), 1.9 (0.4–4.0) and 1.2 (0.5–3.8) in patients without sustained response at weeks 6, 14 and 22, respectively. (B) In the 10 mg/kg maintenance arm, these values are 6.2 (3.0–12.0) and 6.6 (3.9–11.1) in patients with sustained response and 3.3 (1.1–6.6) and 3.7 (0.6–6.7) in patients without sustained response at weeks 22 and 38, respectively.
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GUTJNL2012304094F3: Median (IQR) serum infliximab trough levels in patients with and without sustained response to scheduled maintenance infliximab 5 and 10 mg/kg through 54 weeks. (A) Median values (IQR) in the 5 mg/kg maintenance arm are 12.9 (9.0–16.6), 4.0 (1.7–6.8) and 3.0 (1.1–5.6) in patients with sustained response and 8.8 (3.2–16.8), 1.9 (0.4–4.0) and 1.2 (0.5–3.8) in patients without sustained response at weeks 6, 14 and 22, respectively. (B) In the 10 mg/kg maintenance arm, these values are 6.2 (3.0–12.0) and 6.6 (3.9–11.1) in patients with sustained response and 3.3 (1.1–6.6) and 3.7 (0.6–6.7) in patients without sustained response at weeks 22 and 38, respectively.

Mentions: Serum infliximab trough levels in the 5 and 10 mg/kg groups were largely overlapping between patients with and without sustained response to these maintenance doses. In the 5 mg/kg maintenance group, the difference was significant at weeks 6, 14 and 22, whereas in the 10 mg/kg maintenance dose, the difference was significant at weeks 22 and 38 (figure 3). The proportion of patients with sustained response to 5 and 10 mg/kg infliximab maintenance treatment in relation to immunomodulator use and per quartile of week 14 infliximab trough level is shown in figure 4A–D. Combination treatment with immunomodulator versus monotherapy with infliximab resulted in numerically higher but not significantly different week 14 infliximab trough levels in patients with sustained response to 5 mg/kg infliximab maintenance treatment (4.6 vs 2.6 µg/mL; p=0.6424). As shown in figure 4A,B, sustained response to 5 mg/kg maintenance treatment is associated with week 14 serum infliximab level in patients with—but not those without—immunomodulator use. In the 10 mg/kg maintenance group, however, this association was not found (figure 4C,D). Immunomodulator use was not a significant predictor of sustained response to infliximab 5 mg/kg.


Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial.

Cornillie F, Hanauer SB, Diamond RH, Wang J, Tang KL, Xu Z, Rutgeerts P, Vermeire S - Gut (2014)

Median (IQR) serum infliximab trough levels in patients with and without sustained response to scheduled maintenance infliximab 5 and 10 mg/kg through 54 weeks. (A) Median values (IQR) in the 5 mg/kg maintenance arm are 12.9 (9.0–16.6), 4.0 (1.7–6.8) and 3.0 (1.1–5.6) in patients with sustained response and 8.8 (3.2–16.8), 1.9 (0.4–4.0) and 1.2 (0.5–3.8) in patients without sustained response at weeks 6, 14 and 22, respectively. (B) In the 10 mg/kg maintenance arm, these values are 6.2 (3.0–12.0) and 6.6 (3.9–11.1) in patients with sustained response and 3.3 (1.1–6.6) and 3.7 (0.6–6.7) in patients without sustained response at weeks 22 and 38, respectively.
© Copyright Policy - open-access
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4215276&req=5

GUTJNL2012304094F3: Median (IQR) serum infliximab trough levels in patients with and without sustained response to scheduled maintenance infliximab 5 and 10 mg/kg through 54 weeks. (A) Median values (IQR) in the 5 mg/kg maintenance arm are 12.9 (9.0–16.6), 4.0 (1.7–6.8) and 3.0 (1.1–5.6) in patients with sustained response and 8.8 (3.2–16.8), 1.9 (0.4–4.0) and 1.2 (0.5–3.8) in patients without sustained response at weeks 6, 14 and 22, respectively. (B) In the 10 mg/kg maintenance arm, these values are 6.2 (3.0–12.0) and 6.6 (3.9–11.1) in patients with sustained response and 3.3 (1.1–6.6) and 3.7 (0.6–6.7) in patients without sustained response at weeks 22 and 38, respectively.
Mentions: Serum infliximab trough levels in the 5 and 10 mg/kg groups were largely overlapping between patients with and without sustained response to these maintenance doses. In the 5 mg/kg maintenance group, the difference was significant at weeks 6, 14 and 22, whereas in the 10 mg/kg maintenance dose, the difference was significant at weeks 22 and 38 (figure 3). The proportion of patients with sustained response to 5 and 10 mg/kg infliximab maintenance treatment in relation to immunomodulator use and per quartile of week 14 infliximab trough level is shown in figure 4A–D. Combination treatment with immunomodulator versus monotherapy with infliximab resulted in numerically higher but not significantly different week 14 infliximab trough levels in patients with sustained response to 5 mg/kg infliximab maintenance treatment (4.6 vs 2.6 µg/mL; p=0.6424). As shown in figure 4A,B, sustained response to 5 mg/kg maintenance treatment is associated with week 14 serum infliximab level in patients with—but not those without—immunomodulator use. In the 10 mg/kg maintenance group, however, this association was not found (figure 4C,D). Immunomodulator use was not a significant predictor of sustained response to infliximab 5 mg/kg.

Bottom Line: Optimal predictors of durable sustained response to maintenance infliximab 5 mg/kg were week 14 trough level ≥3.5 µg/mL and ≥60% CRP decrease (ORs (95% CI), 3.5 (1.1 to 11.4) and 7.3 (1.4 to 36.7)), respectively, in patients with raised baseline CRP (>8.0 mg/L); area under the ROC curve was 0.75 for both predictors.A ≥3.5 µg/mL week 14 infliximab serum level did not predict durable sustained response to 10 mg/kg maintenance infliximab.Serum infliximab trough levels ≥3.5 µg/mL and ≥60% CRP decrease were significantly associated with durable sustained response.

View Article: PubMed Central - PubMed

Affiliation: Department of Immunology, Janssen Biologics BV, Leiden, The Netherlands.

Show MeSH
Related in: MedlinePlus