Abstract
Introduction
Loss of response (LOR) to infliximab occurs in ∼30% of IBD patients. At time of LOR,
lower infliximab-trough-levels (TL), in the absence of anti-drug-antibodies (ATI),
have been associated with the need for therapy escalation. Nevertheless, few studies
have examined the outcome of infliximab-therapy intensification, based on different
TL.
Aim
To evaluate the impact of infliximab-TL on efficacy of therapy intensification (dose-elevation/interval-shortening).
Methods
This was a retrospective observational study performed at two tertiary-centers between
2013–2017. Study population included IBD patients who underwent infliximab therapy
escalation (dose elevation/interval shortening) due to clinical LOR. Patients with
TL < 3 μg/ml or positive ATI were excluded. TL and clinical scores before intensification
and after 6, 12 months were obtained prospectively.
Results
Forty-eight IBD patients were included; 23(49%), and 29(60%) reached clinical remission
by 6, 12 months before intensification. TL among patients in clinical remission were
significantly lower than among those clinically active, both at 6 (p = 0.001, median
TL 4.7,8.7 μg/ml, IQR 3.6–8.1, 5.9–16 μg/ml) and 12 months (p = 0.005, median TL 4.6,8.7 μg/ml,
IQR 3.6–8, 5.3–16 μg/ml), respectively.
Conclusions
In IBD patients experiencing clinical LOR to infliximab in the absence of ATI, success
of doubling the dose was inversely associated with baseline TL. Patients with baseline
TL above 9 mcg/ml were very unlikely to reach clinical remission.
Keywords
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Article info
Publication history
Published online: March 05, 2019
Accepted:
February 24,
2019
Received:
December 21,
2018
Identification
Copyright
© 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.