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.
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.
Affiliation: Department of Immunology, Janssen Biologics BV, Leiden, The Netherlands.Show MeSH
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Mentions: At week 14, 96/147 patients had serum infliximab trough levels <3.5 µg/mL and 18% (17/96) had sustained response to 5 mg/kg infliximab maintenance through 54 weeks. Fifty-one of 147 patients had week 14 serum infliximab levels ≥3.5 µg/mL, and 39% (20/51) had sustained response to 5 mg/kg infliximab maintenance through 54 weeks (p=0.0042). Overall, about 90% of patients with week 14 serum infliximab trough levels in quartiles 3 and 4 (>2.2 to ≤5.5 µg/mL and >5.5 µg/mL, respectively) and baseline raised CRP (n=71) demonstrated CRP normalisation (figure 2). Conversely, 87% (20/23) and 38% (5/13) of patients in the lower week 14 serum infliximab level quartiles 1 and 2 (≤0.6 µg/mL and >0.6 to ≤2.2 µg/mL, respectively) did not have a normalised CRP level. Pearson correlation coefficient of week 14 serum infliximab level and CRP change from baseline at week 14 was −0.020 for the 5 mg/kg group and 0.025 for the 10 mg/kg group.
Affiliation: Department of Immunology, Janssen Biologics BV, Leiden, The Netherlands.