The Safety of Infliximab Infusions in the Community Setting

Ducharme, James; Pelletier, Cindy; Zacharias, Ramesh

doi:10.1155/2010/138456

Cited by 26 publications

(20 citation statements)

References 15 publications

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“…The incidence of infusion reactions observed in this registry (1.3%) was actually lower than the 2.5-6.1% incidence reported in other cohort studies 5,6,7,8,9 . One reason may be that RemiTRAC Infusion is a longterm registry that was ongoing for 7 years.…”

Section: Discussioncontrasting

confidence: 73%

“…Our data show that about two-thirds of infusion reactions were observed during the first year of therapy and the mean number of infusions per patients was about 15, representing over 2 years of exposure. Other studies, and all randomized controlled trials, had a much shorter observation period 5,6,7,8,9 . Most centers in our study had large patient populations.…”

Section: Discussionmentioning

confidence: 99%

“…Indeed, the reduction of infusion reactions over time could also reflect improved experience of the sites or maybe less frequent reporting of insignificant infusion reactions. Patients were being infused following a standardized infusion protocol that was based on Cheifetz, et al's study 5 , and it was already observed that such a protocol was associated with low incidences of infusion reactions 6 . The majority of patients received IFX as an induction dosing followed by regularly scheduled maintenance therapy, a strategy that has been shown to maximize clinical response and minimize the development of antibodies to IFX.…”

Section: Discussionmentioning

confidence: 99%

“…In Canada, IFX is predominantly administered in community clinics using a standardized protocol based on a previous study 5 . Several studies have shown that IFX infusions are safe in this community setting, with a low incidence of infusion reactions 6,7,8,9,10 . However, a large prospective study powered to investigate strategies to minimize the incidence and examine outcomes of these infusion reactions was needed.…”

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confidence: 99%

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Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry

et al. 2015

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Objective.Infliximab (IFX) is a therapeutic monoclonal antibody targeting tumor necrosis factor-α indicated in the treatment of chronic inflammatory diseases. IFX is administered by intravenous infusion and may be associated with different types of infusion reactions.Methods.RemiTRAC Infusion (NCT00723905) is a Canadian observational registry in which patients receiving IFX are followed prospectively to document premedication use, adverse events, infusion reactions, and the management of infusion reactions. The primary endpoint was to assess factors associated with infusion reactions.Results.There were 1632 patients enrolled and 24,852 infusions recorded. Most patients (63.1%) were treated for rheumatologic conditions such as rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis. Of the 1632 patients, 201 (12.3%) reported at least 1 infusion reaction. Three hundred twenty-two infusions were associated with an infusion reaction (1.3%), and most were mild to moderate in severity (95%). The most common infusion reactions were pruritus (19.9%), flushing (9.9%), or dyspnea (6.2%). Multivariate analysis showed that antihistamines premedication, number of previous infusion reactions, and female sex were significantly associated with an increased incidence of infusion reactions (p < 0.0011). The use of any concomitant immunosuppressant or corticosteroids did not influence the incidence of infusion reactions. Antihistamine premedication was associated with an increased incidence of infusion reactions (OR 1.58, p = 0.0007).Conclusion.This registry shows that in community-based infusion clinics, infusion reactions to IFX are uncommon and mild to moderate in nature. Antihistamines, intravenous steroids, and acetaminophen are widely used as preventative premedication, although this study showed an absence of benefit with their use.

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Section: Discussioncontrasting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry

et al. 2015

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“…Acute adverse drug reactions (ADRs) have been well documented in relationship to infliximab infusions 1–4. It has become fairly routine for physicians to provide medications just prior to an infliximab infusion (premedications) in an effort to prevent the recurrence of an ADR in patients who have already had such a reaction.…”

Section: Introductionmentioning

confidence: 99%

Premedications for infliximab infusions do not impact the risk of acute adverse drug reactions

Ducharme

Pelletier²,

Zacharias³

2011

Frontline Gastroenterol

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Objective The purpose of this study was to identify the association of premedication with the adverse drug reaction (ADR) rate in infl iximab infusions. Design A retrospective chart review of 684 patients who received 4077 infusions in a network of community clinics over 16.5 months. Data collected included age, weight, sex, diagnosis, dose, premedications and ADR information, which was coded for time of onset, severity and outcome.

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Current awareness: Pharmacoepidemiology and drug safety

2010

Pharmacoepidemiology and Drug

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of pharmacoepidemiology and drug safety. Each bibliography is divided into 23 sections: 1 Reviews; 2 General; 3 Anti‐infective Agents; 4 Cardiovascular System Agents; 5 CNS Depressive Agents; 6 Non‐steroidal Anti‐inflammatory Agents; 7 CNS Agents; 8 Anti‐neoplastic Agents; 9 Haematological Agents; 10 Neuroregulator‐Blocking Agents; 11 Dermatological Agents; 12 Immunosuppressive Agents; 13 Autonomic Agents; 14 Respiratory System Agents; 15 Neuromuscular Agents; 16 Reproductive System Agents; 17 Gastrointestinal System Agents; 18 Anti‐inflammatory Agents ‐ Steroidal; 19 Teratogens/fetal exposure; 20 Antidiabetic Agents; 21 Contrast Agents; 22 Bone Conservation Agents; 23 Others. Within each section, articles are listed in alphabetical order with respect to author. If, in the preceding period, no publications are located relevant to any one of these headings, that section will be omitted.

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The Safety of Infliximab Infusions in the Community Setting

Abstract: Infliximab infusions are safe in the community setting. Severe ADRs were rare. None required active physician intervention; nurses were able to treat all reactions by following standardized medical directives.

Cited by 26 publications

References 15 publications

Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry

Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry

Premedications for infliximab infusions do not impact the risk of acute adverse drug reactions

Current awareness: Pharmacoepidemiology and drug safety

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