Dataset Information

Rapid Infliximab Infusion in Children with Inflammatory Bowel Disease: A Multicenter North American Experience.

ABSTRACT:

Background

Infliximab (IFX) infusion may lead to development of anti-IFX antibodies, and subsequent infusion reactions (IRs). The safety of rapid IFX infusion administered over 60 minutes has been under-investigated in children with inflammatory bowel disease. In a multicenter study, the frequency and nature of rapid infusion-associated IRs were examined.

Methods

The medical records of all consecutive children with inflammatory bowel disease receiving rapid IFX infusions between January 2014 and December 2016 were reviewed. Poisson regression analysis was used to identify possible associated factors with IRs.

Results

A total of 4120 rapid infusions for 453 children (median age 16 yrs [interquartile range 13.8-17.8], 289 males, 374 with Crohn's disease) were included. One hundred thirty-five participants (29.8%) received rapid IFX infusion for induction and maintenance while the rest received rapid IFX infusion after a median of 5 (interquartile range 4-9) standard infusions. The median dose of IFX using rapid protocol was 8 mg/kg/infusion (interquartile range 6-10). Two hundred sixty-seven (59%) patients received 1 or more premedications and 161 (35.5%) participants received concomitant immunosuppression. Twenty-one participants (4.6%) had IRs with rapid infusions and 2 participants discontinued IFX because of IRs (0.4%). Antihistamine premedications were associated with less frequent IR (adjusted relative risk = 0.30; 95% confidence interval, 0.14-0.64; P = 0.002).

Conclusions

In children with inflammatory bowel disease, rapid IFX infusion administered over 60 minutes is safe and well-tolerated. Antihistamine premedications may reduce frequency of IRs (see Video Abstract, Supplemental Digital Content 1, http://links.lww.com/IBD/B632).

SUBMITTER: El-Matary W

PROVIDER: S-EPMC6551232 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Rapid Infliximab Infusion in Children with Inflammatory Bowel Disease: A Multicenter North American Experience.

El-Matary Wael W Dykes Dana M H DMH Bauman Laura L Elkadri Abdul A Carroll Matthew W MW Izaguirre Marisa R MR deBruyn Jennifer J Samson Charles M CM Crim Alisa Muniz AM Ali Sabina S Grossman Andrew A

Inflammatory bowel diseases 20171201 12

<h4>Background</h4>Infliximab (IFX) infusion may lead to development of anti-IFX antibodies, and subsequent infusion reactions (IRs). The safety of rapid IFX infusion administered over 60 minutes has been under-investigated in children with inflammatory bowel disease. In a multicenter study, the frequency and nature of rapid infusion-associated IRs were examined.<h4>Methods</h4>The medical records of all consecutive children with inflammatory bowel disease receiving rapid IFX infusions between J ...[more]

PMID: 29140940

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Project description:IntroductionPhosphodiesterase type 5 (PDE5) inhibitors, with sildenafil the earliest among them, are widely used in the management of pediatric pulmonary arterial hypertension (PAH). Tadalafil is a PDE5 inhibitor with a long half life (16 h), stable pharmacokinetics and pharmacodynamics, and minimal adverse effects. However, the utility of tadalafil suspensions in this setting has not been widely explored due to a lack of clinical experience. We present a multicenter experience that details the safety and tolerability of a tadalafil suspension, either alone or in combination with another vasodilator, for the management of pediatric pulmonary hypertension (PH).Methods and materialsThis is a retrospective chart review of infants and children at Children's Wisconsin and the Stollery Children's Hospital enrolled in pediatric PH programs between December 2013 and April 2022 managed with a tadalafil suspension. Patients aged six years of age and under who were treated with a tadalafil suspension were included. Demographics, clinical information, echocardiographic and hemodynamic measurements, and laboratory data were collected before and six months after tadalafil initiation.ResultsOver the study period, 154 children with a median age of 1.0 (range 0.0-6.9) years were treated with tadalafil therapy. Of these, 39 (25.3%) were in group 1 (PAH), 79 (51.3%) were in group 3 (lung disease), and 33 (21.4%) were in group 5 (pulmonary hypertensive vascular disease). The median initial dose of tadalafil was 1.0 mg/kg once daily. Eleven (7.1%) patients in the cohort were established on tadalafil therapy de novo. The suspension formulation was necessary for 103 (66.9%) patients due to an inability to take enteral tablets and for 49 (31.8%) due to a need for feeding via gastric or jejunal tubes. We observed a statistically significant increase in tricuspid annular plane systolic excursion as well as significant decreases in right-ventricular systolic pressure and NT-proBNP. Tadalafil therapy was well tolerated over the six-month period: at six months, no adverse effects were reported aside from gastrointestinal disturbances by 2 (1.3%) patients.ConclusionTadalafil, a long-acting PDE5 inhibitor, when administered in a suspension formulation, has a safe and tolerable adverse effect profile. Following six months of therapy, our cohort showed improvements in clinical parameters, echocardiographic measurements, and laboratory results. Patient compliance was good and adverse effects were rare, minor, and manageable with nonpharmacological means.

Project description:Background and aimInfliximab is typically given over an infusion time of 2 hours, leading to a significant burden in inflammatory bowel disease (IBD) patients. We aimed to determine the safety and cost-effectiveness of an accelerated infliximab infusion of 1 hour, compared with the standard 2-hour infusion.MethodsOpen-label randomized trial where IBD patients receiving maintenance infliximab infusions were randomly assigned to 1- and 2-hour infusion groups, corresponding to study and control groups, respectively. The primary outcome was the rate of infusion reactions. Secondary outcomes were assessment of the effect of premedications and immunomodulators on the rate of infusion reactions, and cost-effectiveness analysis. The cost-effectiveness analysis was based on direct nursing costs for the infusion time, indirect infusion center costs, and cost of productivity loss for patients. This trial is registered with ClinicalTrials.gov, NCT05340764.ResultsFrom November 2020 to November 2021, 96 patients were randomly assigned: 51 (53%) to the 1-hour infusion group and 45 (47%) to the 2-hour infusion group. Over a median time of 1 year, 309 infusions were administered in the control group, and 376 in the study group. Fifty-seven (18%) infusions in the control group and 45 (12%) infusions in the study group experienced an infusion reaction. The only infusion reaction was asymptomatic hypotension not requiring infusion discontinuation. No other infusion reactions (mild or moderate/severe) were seen. Diphenhydramine was associated with an increased rate of infusion reactions (OR 2.04 [95% CI 1.18-3.52], P = .01). The average costs were estimated to reduce by 37% in the accelerated infusion group.ConclusionsAccelerated 1-hour infusions are non-inferior in safety and superior in cost-effectiveness compared with standard 2-hour infusions in IBD patients receiving maintenance infliximab infusions.Trial identification numberRegistered with ClinicalTrials.gov, NCT05340764.

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Dataset Information

Rapid Infliximab Infusion in Children with Inflammatory Bowel Disease: A Multicenter North American Experience.

Background

Methods

Results

Conclusions

Publications

Rapid Infliximab Infusion in Children with Inflammatory Bowel Disease: A Multicenter North American Experience.

Similar Datasets

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