TY - JOUR
T1 - Infliximab therapy intensification upon loss of response
T2 - Is there an optimal trough level?
AU - Ungar, Bella
AU - Ben-Shatach, Zohar
AU - Ben-Haim, Gal
AU - Yavzori, Miri
AU - Picard, Orit
AU - Fudim, Ella
AU - Kopylov, Uri
AU - Veyrard, Pauline
AU - Del Tedesco, Émilie
AU - Paul, Stephane
AU - Eliakim, Rami
AU - Ben-Horin, Shomron
AU - Roblin, Xavier
N1 - Publisher Copyright:
© 2019 Editrice Gastroenterologica Italiana S.r.l.
PY - 2019/8
Y1 - 2019/8
N2 - 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.
AB - 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.
KW - Biologics
KW - IBD
KW - Infliximab
KW - Therapeutic drug monitoring
KW - Therapy
KW - Therapy outcome
UR - http://www.scopus.com/inward/record.url?scp=85063340959&partnerID=8YFLogxK
U2 - 10.1016/j.dld.2019.02.013
DO - 10.1016/j.dld.2019.02.013
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AN - SCOPUS:85063340959
SN - 1590-8658
VL - 51
SP - 1106
EP - 1111
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
IS - 8
ER -