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Remicade first trough levels at week 2 helps predict outcomes in UC

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HONOLULU — The first trough level of Remicade at week 2 was found to be predictive of short- and long-term response in patients with ulcerative colitis, according to data presented at ACG 2015.

“Trough level is reported to be inversely correlated with severity of inflammation at each time point, [so] trough-guided dosing may be useful,” Taku Kobayashi, MD, from the Center for Advanced IBD Research and Treatment, Kitasato University, Tokyo, said during his presentation. “It is also reported that early trough level, but mostly at weeks 6 to 14, may be associated with future outcome; however, these time points are not really early enough for clinical decision making when treating acute flares of UC. So we asked if earlier trough level at week 2, which is after just a single first infusion at week 0, can still predict the future outcome.”

Using data from a phase 3 randomized controlled trial of Remicade (infliximab, Janssen) in patients with UC, Kobayashi and colleagues performed a post-hoc analysis of 82 patients who received IV infliximab 5 mg/kg or placebo at weeks 0, 2 and 6 and were followed until week 14. Trough levels were measured by ELISA, which were included in the post-hoc analysis along with clinical outcomes, including a 14-week clinical activity index and 30-week mucosal healing.

They observed a significant association between trough level at week 2 and 14-week clinical activity index (CAI) remission, with an optimal cut-off value for prediction remission of 21.3 µg/mL (AUC = 0.65; 95% CI, 0.52-0.77). They also observed a correlation between week 2 trough level-to-CAI ratio and 14-week CAI remission, with an optimal cut-off value for predicting remission of 4.3 (AUC = 0.76; 95% CI, 0.65-0.86).

Multiple logistic regression analysis (using the following exploratory variables: patient background factors, week 2 CAI remission, week 2 trough levels of at least the median value and week 2 trough level-to-CAI ratio of at least the median value) showed that week 2 trough level-to-CAI was an independent factor correlating with 14-week CAI remission (OR = 8.07; 95% CI, 2.84-27.07). Furthermore, they observed that week 2 trough level and trough level-to-CAI ratio were also associated with mucosal healing at 30 weeks.

“In summary, first trough level of infliximab and the trough level-to-CAI ratio at week 2 predicted 14-week CAI remission and 30-week mucosal healing, which may further suggest favorable long-term outcome,” Kobayashi said. “These results may suggest the usefulness of trough level in early decision making and also may justify the dose intensification strategy, especially if CAI is 5 or above at week 2,” Kobayashi concluded. – by Adam Leitenberger

Reference:

Kobayashi T, et al. Abstract 20. Presented at: ACG 2015; Oct. 19-21, 2015; Honolulu, HI.

Disclosures: Kobayashi reports he received a lecture fee from Mitsubishi Tanabe Pharma Corporation. Please see the abstract for a list of all other researchers’ relevant financial disclosures.