番茄社区

ORLANDO – Maintenance doses of the biologic agent infliximab (Remicade) can be safely administered at a patient's home with a very low rate of adverse events (AEs) and serious AEs, a researcher reported here.

Of 863 patients treated at their homes, three individuals over a 2-year period experienced AEs that warranted emergency department visits, translating to a serious AE rate of 0.35%, reported Yvonne Viteri, PharmD, of the specialty pharmacy Accredo/Express Scripts in Memphis, Tennessee.

In one case, a patient experienced an increase in blood pressure; another patient experienced rash, itchiness, and some shortness of breath; and the third patient experienced low blood pressure.

"All of these cases resolved favorably," Viteri told 番茄社区 at the Advances in Inflammatory Bowel Diseases conference, where the research was presented in a poster session. "Our results demonstrate that home infusion services are a safe option for patients to obtain their medication in a familiar and convenient setting."

Viteri oversees the clinical research projects at Accredo, including this observational retrospective study that reviewed data collected by nurses who conducted the in-home infusions. All were maintenance infusions after patients had stabilized from receiving their initial and loading doses in a hospital setting.

"Overall, 94.3% of patients did not report any adverse events from receiving these infusions at home," said Viteri, who noted that the product labeling for infliximab maintenance infusions suggests an AE rate of 9%. "Our rate was half of that, about 4.5%."

From 2020 to 2021, a total of 8,388 infliximab infusions were administered to the 863 patients in the study. Of these, 39 patients experienced 49 AEs. About 22% of those events were reported as fatigue, 20% dermatologic reactions, and 16% were reported as cardiopulmonary reactions.

"The patients do enjoy the experience of having these infusion done at home, but I am not sure the patients understand what can happen if there is a serious adverse reaction and they are not in a facility that can immediately treat those reactions," said Carmen Paniagua EdD, ACNP-BC, an instructor in nursing at University of Arkansas for Medical Sciences in Little Rock, who was not involved in the research.

"I would like to see this type of study done in comparison to adverse event rates that occur in academic settings," she told 番茄社区. "What is good about this study is that it is done among patients who are getting maintenance doses of infliximab. I prefer having the loading doses done in a hospital setting, because that is where the most serious events might occur. "

"We don't want to have any of that initial treatment done in the home setting, either," agreed Viteri. "After the patient has been successfully treated with infliximab and is due for maintenance dosing is where our program begins."

Patients in the study had at least 6 months of infliximab therapy prior to starting home administration, she noted.

In the program, nurses went to patients' homes, assessed their weight, AEs, timing of those events, what action was taken, and recorded that information on a mobile electronic device.

Along with infliximab's approvals in Crohn's disease and ulcerative colitis, the tumor necrosis factor inhibitor also carries indications in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Most of the patients in the current study were from the gastroenterology service.

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