Infusion Reactions In Patients Research Articles

Ironing out the Wrinkles: Low Molecular Weight Iron Dextran and Premedications

Intravenous (IV) iron infusion increases hemoglobin levels and reduces the need for transfusions compared to oral iron in patients with iron deficiency. Low molecular weight iron dextran (LMW ID) has a boxed warning for anaphylactic-type infusion reactions and premedication is commonly given. However, a recent multi-institution cohort study showed similar rates of infusion-related adverse events (AEs) with iron sucrose (4.3%) and iron dextran (3.8%), and a 23-fold higher incidence of AEs among those who received premedication compared with those who did not (38.6% vs 1.7%). There is currently a national shortage of iron dextran. A study during a previous iron dextran shortage in 2016 showed that the increased use of newer IV iron formulations persisted even once the shortage ended. This may in part be due to the concern for infusion reactions, but the use of these formulations comes at a significant cost. An analysis of the US FDA database showed that, based on differences in the average price of iron sucrose and LMW ID, the cost to prevent one life-threatening AE related to the use of LMW ID was estimated to be 5.0-7.8 million dollars. The cost to prevent one LMW ID-related death was estimated to be 33 million dollars. To further evaluate the incidence of infusion reactions and the use of premedication at the University of Kansas Medical Center, we performed a retrospective analysis of all patients who received their first ever infusion of iron dextran between 1/1/2021-12/31/2022. Infusion reactions were characterized as severe if hypoxia (O2<90%), hypotension (<100/80) or hospital admission occurred. Ninety-six patients were identified. 17 (17.7%) were males and 79 (82.3%) were females. There were 49 (51%) Caucasian, 26 (27.1%) African Americans, 12 (12.5%) Hispanic, and 9 (9.4%) others. 8 patients had infusion reaction (8.3%; 95% CI 4.0-15.1%) as determined by review of nursing documentation. Serious infusion reactions with LMW ID were rare (n=2, 2.1%), and neither patient required epinephrine administration nor hospitalization. Patients with history of allergies (n=61, 63.5%) had a higher incidence of AEs compared to those who did not (13.1% [95% CI, 6.4-23.2%] vs 0.0%, P = 0.022). This was even higher in 27 (28.1%) patients with 3 or more allergies (18.5% [95% CI, 7.4-35.9%] vs 0.0%, P = 0.019). In 71 (80.2%) patients who received premedication, there was a lower incidence of AEs compared to those who did not (3.9% vs 26.3%; χ2 = 10.02; P =0.007). The incidence of AEs was compared with individual premedication, and lower incidences were seen in 64 (66.7%) patients with diphenhydramine (3.1% vs 18.8%, χ2 = 6.82; P =0.015), 50 (52.1%) with methylprednisolone (2.0% vs 15.2%, χ2 = 5.48; P =0.022), and 46 (47.9%) with acetaminophen (0.0% vs 16%, χ2 = 8.03; P =0.004). Notably, a variety of premedication combinations and doses were used, indicating a lack of standardization even within a single institution. No patient who received acetaminophen experienced an infusion reaction. By contrast, there was no significant difference in patients receiving famotidine, suggesting that while acetaminophen may be a useful premedication, famotidine may not be beneficial. Further, our data strongly suggests that patients without a history of drug allergies do not require premedication. Our retrospective study demonstrates significant benefit to receiving premedication, which is divergent when compared to previous studies. This may be due to several reasons: the previously mentioned multi-center study included multiple formulations of IV iron, had a much lower rate of premedication (6% vs. 80%), and used a different definition of infusion reaction. In the multi-center cohort study, administration of medications post-iron infusion was used as a surrogate marker of reaction, while in our study it was based on review of nursing documentation. Both our study and the prior multi-center study noted an increased incidence of infusion reactions in patients with a history of allergies, and both demonstrated the rarity of serious reactions. Based on these results and the prior studies indicating the increased cost of other IV iron formulations, consideration of reinstitution of LMW ID with de-escalation of premedication in those without history of drug allergies should be considered once the current drug shortage resolves.

Risk Factors for Infusion Reactions in Patients with Breast Cancer Administered Trastuzumab Therapy.

Trastuzumab is a humanized monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2) that is indicated for the treatment of HER2-positive breast cancer. The administration of biologics, such as trastuzumab, frequently causes infusion reactions (IRs) with fever and chills. This study aimed to clarify the risk factors for IRs in trastuzumab therapy. Between March 2013 and July 2022, 227 patients with breast cancer who started trastuzumab therapy were included in this study. The severity of IRs was graded according to the Common Terminology Criteria for Adverse Events, Version 5.0. The incidence of IRs in trastuzumab therapy was 27.3% (62/227). Dexamethasone administration was significantly different between the IR and non-IR groups in patients receiving trastuzumab therapy (univariate analysis, p < 0.001; multivariate analysis, p = 0.0002). Without dexamethasone, the severity of IRs in the pertuzumab combination group (Grade 1, 8/65; Grade 2, 23/65) was significantly higher than that in the non-pertuzumab group (Grade 1, 9/37; Grade 2, 3/37; p < 0.05). Our findings suggest that the risk of IRs is significantly higher in patients not premedicated with dexamethasone in trastuzumab therapy and that the concomitant use of pertuzumab without dexamethasone increases the severity of IRs caused by trastuzumab.

First-Dose Antimicrobial Infusion Reactions in Patients Enrolled in Outpatient Parenteral Antimicrobial Therapy Services.

After receiving a monitored first-dose antimicrobial infusion at an infusion center, 6 of 93 (6%) patients enrolled in outpatient parenteral antimicrobial therapy services experienced an immediate reaction, none of which were consistent with immunoglobulin E-mediated reactions. These findings suggest it would be reasonable to forgo monitoring for most patients receiving first-dose intravenous antimicrobials outpatient.

Incidence and risk factors of infusion reactions in patients with breast cancer administered trastuzumab plus pertuzumab-based regimen.

Pertuzumab (Per) is a humanized monoclonal antibody used in combination with trastuzumab (Tra) in the treatment of human epidermal growth factor receptor-2 (HER2)-positive breast cancer. The administration of biologics, such as Tra and Per, frequently causes infusion reactions (IRs) with fever and chills. This study aimed to clarify the characteristics of and risk factors for IRs in Tra + Per combination therapy. Between March 2013 and December 2019, 64 patients with breast cancer who started Tra + Per combination therapy were included in the study. The severity of IRs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence of IRs in the Tra + Per combination therapy was 48.4% (31/64). The severity of IRs in the Tra + Per combination therapy was Grade 1 (9 patients) and Grade 2 (22 patients). Lymphocyte counts were significantly different between the IR and non-IR groups in patients receiving Tra + Per combination therapy (univariate analysis, p = 0.006; multivariate analysis, p = 0.050). ROC curve analysis found the cutoff value of lymphocyte counts were 1.60 (× 103/µL). The incidence of IRs in the lymphocyte counts ≥ 1.60 group was significantly higher than that in the lymphocyte counts < 1.60 group (p < 0.001). Our study indicates that the severity of IRs in most patients is moderate or less and the risk of IRs is higher in patients with higher lymphocyte counts (≥ 1.60 × 103/µL).

Same Day Infusion of Iron Therapy Is Associated With No Increased Risk for Adverse Events Among Patients Receiving Biological Infusions for Inflammatory Bowel Disease.

The goal of this study was to compare the relative safety of administering iron infusions on the same day as intravenous (IV) biological therapy to the administration of these treatments on different days in patients with inflammatory bowel disease (IBD). IV iron therapy is often required in patients with IBD. Many patients with IBD who receive IV iron therapy in the outpatient setting also receive biological infusion therapy for treatment of their IBD. Patients with IBD who received IV iron therapy at a single infusion center were included. We compared documented infusion-related reactions in patients with patients receiving an iron infusion on the same day as their biological infusion to those who received their iron infusion on a different day. Among 481 patients, 129 received an iron infusion on the same day as a biologic infusion. There was no significant difference in the incidence of infusion reaction when comparing patients who received biological infusion therapy in the same session as the iron infusion to those patients who received a biological infusion on a different day (5% vs. 7%, P =0.246) or any IBD-related therapy (5% vs. 8%, P =0.206). The frequency and type of infusion reactions in patients receiving IV iron therapy on the same day after IV therapy with biologics was not increased compared with patients who received a biological infusion on a different day. A sequential infusion of biological therapy followed by IV iron therapy may be a safe and cost-effective approach.

Application of Clinical Nursing Pathway Combined with Cluster Nursing Mode in Biologic Treatment of Rheumatoid Immune Disease Patients

Objective: To investigate the effect of clinical nursing pathway (CNP) combined with cluster nursing mode in intravenous biologic treatment of rheumatoid immune disease patients. Methods: Convenience sampling method was used to select inpatients receiving biologics treatment in Rheumatology and Immunology Department of a grade A hospital in Jingzhou city from May 2020 to April 2022. 75 patients from May 2020 to April 2021 were selected as the control group, and 75 patients from May 2021 to April 2022 were selected as the observation group. The control group was given routine care. The observation group was treated with CNP combined with cluster nursing mode on the basis of the control group, and the incidences of adverse infusion reactions, total treatment time, patient satisfaction and nurse satisfaction were compared between the two groups. Results: There were statistically significant differences between the two groups after intervention (P < 0.05). Conclusion: Using CNP combined with cluster nursing mode is beneficial to reduce the incidence of adverse infusion reactions in patients, shorten the total treatment time, and improve the satisfaction of patients and nurses.

PEGylated Liposomal Methyl Prednisolone Succinate does not Induce Infusion Reactions in Patients: A Correlation Between in Vitro Immunological and in Vivo Clinical Studies.

PEGylated nanomedicines are known to induce infusion reactions (IRs) that in some cases can be life-threatening. Herein, we report a case study in which a patient with rare mediastinal and intracardiac IgG4-related sclerosing disease received 8 treatments of intravenously administered PEGylated liposomal methylprednisolone-succinate (NSSL-MPS). Due to the ethical requirements to reduce IRs, the patient received a cocktail of premedication including low dose of steroids, acetaminophen and H2 blockers before each infusion. The treatment was well-tolerated in that IRs, complement activation, anti-PEG antibodies and accelerated blood clearance of the PEGylated drug were not detected. Prior to the clinical study, an in vitro panel of assays utilizing blood of healthy donors was used to determine the potential of a PEGylated drug to activate complement system, elicit pro-inflammatory cytokines, damage erythrocytes and affect various components of the blood coagulation system. The overall findings of the in vitro panel were negative and correlated with the results observed in the clinical phase.

P1.01-76 Randomized Phase II Study of Immunotherapy With or Without Low Dose Chemotherapy for Patients with Performance Status of 2

Combination chemo-immunotherapy has become a standard of care for patients with non-small cell lung cancer (NSCLC) who have performance status (PS) of 0-1. Limited information is available regarding optimal immunotherapy treatment options for patients with PS 2. In the current study, we examined the clinical and immunologic effects of immunotherapy alone or in combination with low dose carboplatin and paclitaxel as a potential treatment option for the PS 2 population. This randomized phase II study will enroll 40 patients total with 1:1 randomization to pembrolizumab 200 mg day 1 every 3 weeks or pembrolizumab 200 mg day 1 with carboplatin AUC 1 and paclitaxel 25 mg/m2 days 1, 8, and 15 every 3 weeks. At the time abstract preparation, 36 evaluable patients have been enrolled with 28 patients having completed response evaluation. Blood for circulating immune cell phenotyping, soluble program death ligand 1 (sPD-L1), and immune-modulatory miRs was collected prior to treatment and at weeks 4 and 7. Investigator assessed irRECIST responses were examined at week 8 and every 12 weeks thereafter. Responses have been observed in 6 out of 16 patients (38%) in the control arm and 7 out of 12 patients (58%) in the experimental arm. Treatment related adverse events have been similar between the two arms with increases in infusion reactions in patients receiving low-dose carboplatin and paclitaxel. Interim biomarker analyses indicate circulating myeloid derived suppressor cells numbers decreased in patients receiving pembrolizumab combined with carboplatin and paclitaxel but not in patients receiving pembrolizumab alone. Accrual is expected to complete soon with updated response rates and progression free survival are anticipated to be mature and will be presented at the time of the meeting. The combination of pembrolizumab with low-dose weekly carboplatin and paclitaxel is well-tolerated and active in the PS 2 population. Comparison of this regimen to pembrolizumab alone will be performed once data have matured.

Evaluation of Infusion Reactions in Patients Receiving Daratumumab Post-Implementation of an Augmented Pre- and Peri-Medication Regimen

Introduction: Daratumumab is a first in class immunoglobin G1 kappa human monoclonal antibody that targets the CD38 antigen on the exterior of myeloma cells. Daratumumab provides an important treatment option and has become standard of care for patients with relapsed/refractory multiple myeloma (MM). While generally well tolerated, daratumumab is associated with a high incidence of IRRs (42-56% of patients; grade 3/4: 2-9%) (Palumbo A et al. New England Journal of Medicine 2016; 375: 754-766, Voorhees P et al. Blood 2015; 126: 1829, Lonial S et al. The Lancet 2016; 387: 1551-60). These reactions predominately occur during the first two infusions. The manufacturer recommends both pre- and post-medications for daratumumab, including steroids, antipyretics, and antihistamines with or without other supplementary agents. Dana-Farber Cancer Center (DFCI) implemented an augmented pre- and peri-infusion medication regimen in November 2015, meant to reduce the occurrence of daratumumab-associated IRRs (table 1).Methods: We conducted an observational, retrospective, single center, medical chart review of MM patients who received at least one dose of daratumumab between November 2015 and October 2017 at DFCI. Data were collected on patient characteristics (age, gender, number of previous treatment regimens, immunoglobulin subtype, and baseline disease burden), pre-/peri-/post-medications, daratumumab infusions (infusion duration and dose), and IRRs (grade of reaction and treatment of reaction). Data was collected for the first two daratumumab infusions (Cycle 1 Day 1 and Cycle 1 Day 8 (C1D1 and C1D8) for each eligible patient. The primary objective was to determine the incidence of IRRs in patients treated with daratumumab post-implementation of an augmented pre- and peri-medication regimen. Secondary objectives were to determine the infusion time of daratumumab and to characterize the use of infusion pre-and peri-infusion medications in patients receiving daratumumab at DFCI.Results: A total of 105 patients who received ≥1 dose of daratumumab during the 2-year study period were identified. Eighty-six patients met inclusion criteria and received a total of 165 evaluable infusions. Twenty-three of the 86 patients (26.7%) experienced any grade IRRs. All IRRs were ≤ grade 3 in severity (grade 1-2: 23.2%; grade 3: 3.5%). Figure 1 highlights categorization of IRRs in the study population based on the total number of infusions. IRRs were managed by supportive care medications and/or briefly stopping the infusion per prescribing information and institutional practice. All reactions occurred during the first dose of daratumumab. The differences in baseline characteristics between the patients with and without reactions are outlined in table 2. More patients that received combination therapy experienced an IRR compared those on monotherapy (65.1 vs 56.5%). Patient comorbidities did not appear to influence IRR incidence (26.1% without IRR vs 41.3% with IRR). Of the patients that received >3 previous treatment regimens, none experienced an IRR. The mean duration of infusion for daratumumab was longer in patients who experienced an IRR compared with those who did not (505.9 vs 355.3 minutes). Seventy-one pre- and peri-infusion medications were omitted during the study period, representing a 95.2% adherence rate to the 9 medications contained within the institutional standard regimen. Details on omitted medications can be found in table 3. Peri-infusion diphenhydramine had the highest incidence of omission and was not given in 36 (21.8%) daratumumab infusions. Rates of medication omission were higher during C1D8, where no IRRs were observed.Conclusions: An augmented regimen of pre- and peri-medications appears to lower the incidence of grade 1-2 IRRs with daratumumab, compared to previously published data. The results also support that most IRRs occur during the first dose of daratumumab. This suggests the benefit of an augmented pre- and peri-medication regimen for at least the first dose of daratumumab. [Display omitted] DisclosuresRichardson:Amgen: Membership on an entity's Board of Directors or advisory committees; BMS: Research Funding; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Research Funding.

Sa1719 - Predictors of Acute and Delayed Vedolizumab Infusion Reactions in Patients with Inflammatory Bowel Disease

Sa1719 - Predictors of Acute and Delayed Vedolizumab Infusion Reactions in Patients with Inflammatory Bowel Disease

Sa1680 - A Novel Scoring System to Predict Acute Infliximab Infusion Reactions in Patients with Inflammatory Bowel Disease

Sa1680 - A Novel Scoring System to Predict Acute Infliximab Infusion Reactions in Patients with Inflammatory Bowel Disease

Premedication Use in Preventing Acute Infliximab Infusion Reactions in Patients with Inflammatory Bowel Disease: A Single Center Cohort Study.

Infliximab (IFX) is commonly used in patients with inflammatory bowel disease. One common side effect of IFX is an acute infusion reaction. Despite the lack of evidence supporting their use, clinicians use various premedications to prevent acute reactions. We evaluated the effectiveness of premedications in the prevention of acute IFX infusion reactions. A retrospective cohort study was performed identifying patients with a diagnosis of inflammatory bowel disease who received IFX at our institution. Information about each IFX infusion was recorded, including the dose, infusion rate, use of premedications, and any reactions. Infusions were stratified into low and high risk. In the high- and low-risk groups, the relative risk was calculated for each premedication combination used in our institution. Seven hundred seventy-three patients were identified; 578 patients (7090 infusions) met inclusion criteria and were included for analysis. Nine hundred eighty-six high-risk infusions were isolated; 620 (62.8%) of these infusions were administered with premedications (diphenhydramine and/or hydrocortisone) and 53 (5.4%) reactions occurred. Six thousand one hundred four low-risk infusions were identified; 2253 (36.9%) of these infusions had premedications and 61 (1.0%) reactions occurred. In both groups, none of the premedications used resulted in a significantly lower reaction rate compared with no premedication use. In both the high- and low-risk cohorts in this study, premedication use was not effective in reducing the rate of acute IFX reactions. Given this, routine premedication use is not recommended without future randomized control trials to demonstrate efficacy.

455 - Comparisons of Premedication Strategies for Preventing Infliximab Related Infusion Reactions in Patients with Inflammatory Bowel Disease

455 - Comparisons of Premedication Strategies for Preventing Infliximab Related Infusion Reactions in Patients with Inflammatory Bowel Disease

Su1887 - Predictors of Acute Infliximab Infusion Reactions in Patients with Inflammatory Bowel Disease

Su1887 - Predictors of Acute Infliximab Infusion Reactions in Patients with Inflammatory Bowel Disease

Risk factors for and pre-medications to prevent cetuximab-induced infusion reactions in patients with squamous cell carcinoma of the head and neck

Cetuximab, a chimeric monoclonal antibody, is the only targeted therapy approved for squamous cell carcinoma of the head and neck (SCCHN). Infusion reactions (IRs) occur in 6-18% of patients pre-medicated with diphenhydramine. Evidence for clinical risk factors for IRs is limited and the benefit of additional pre-medication to prevent IRs is unclear. A retrospective, single institution study of 243 SCCHN patients treated with cetuximab to evaluate potential risk factors for IRs and to assess the efficacy of additional pre-medications (nebulized albuterol and intravenous (IV) corticosteroids and/or H2-blockers) to decrease the risk of IR. IR (grades 1-4) and high grade (grades 3-4 only) IR occurred in 47 (19.3%) and 16 (6.6%) patients, respectively. Multivariate analysis identified Caucasian race (OR7.11, p=0.003), medication allergy (OR3.74, p=0.002), and blood eosinophils >3% (OR2.75, p=0.01) independently increased the risk of IR; Caucasian race (OR5.57, p=0.007) and medication allergy (OR4.10, p=0.0007) increased the risk of high grade IR. IR (grades 1-4) and high grade IR occurred in 31.8% and 22.7% pre-medicated with diphenhydramine alone. Univariate analysis identified albuterol, famotidine, and corticosteroids decreased the risk of high grade IR. Furthermore, there was a significant difference between the possible combinations of the pre-medications and the risk of high grade IR by Fisher Exact test (p=0.003) whereby the combination of albuterol, famotidine and corticosteroids was effective in preventing high grade IR. Thirty (64%) of the 47 patients who developed an IR were re-challenged and did not experience a recurrence of an IR. These data may be used to identify patients at higher risk for cetuximab-induced IR who may be advised to not receive cetuximab or who may benefit from additional pre-medications to decrease the risk of a high grade IR.

Antibodies to Infliximab and Risk of Infusion Reactions in Patients With Inflammatory Bowel Disease

Antibodies to infliximab (ATIs) have been associated with a risk of infusion reactions in some studies of patients with inflammatory bowel disease. However, many factors, such as immunomodulators and dosing schedule, may influence this association. The aim of this article was to provide a pooled estimate of the risk of infusion reactions according to patients' ATI status and analyze the relationship of immunomodulators to this risk. Public databases were searched for eligible studies. Quality assessment was undertaken for all studies using Grading of Recommendations Assessment, Development and Evaluation criteria. Raw data from studies meeting inclusion criteria were pooled for meta-analysis of effect estimates. Sensitivity analysis was performed for all outcomes. Funnel plot was performed to assess for publication bias. Eight studies met the inclusion criteria, with a pooled total of 1351 subjects. Seven of the 8 studies had a high risk of bias in at least 1 quality domain. The cumulative data indicated that there was a higher risk ratio (RR) of any acute infusion reaction (RR 2.4; 95% confidence interval [CI] 1.5-3.8, P < 0.001) and severe infusion reactions (RR 5.8, 95% CI 1.7-19, P = 0.004) in patients with ATIs when compared with patients without ATIs. The RR of delayed hypersensitivity reactions was not significantly different between ATI+ and ATI- patients (RR 2.8, 95% CI 0.2-33, P = 0.4). Patients prescribed immunomodulators during maintenance infliximab therapy had a reduction in their risk for ATI development (RR 0.6, 95% CI 0.4-0.9, P = 0.02) and infusion reactions (RR 0.6, 95% CI 0.4-0.8, P < 0.001). The presence of ATIs is associated with a significantly higher risk of acute infusion reactions, but not delayed hypersensitivity reactions, in patients with inflammatory bowel disease. Concomitant immunomodulators reduce this risk.

FRI0179 Infliximab infusion reactions in patients with rheumatoid arthritis and spondylarthropathies

BackgroundTherapies that target TNF have been successfully used for the treatment of patients with rheumatoid arthritis (RA) and spondylarthropathies (SpA). TNF-α blocking agents have been relatively safe, however intravenous administration...

Infusion Reactions Related to Infliximab Therapy Are Not Usually Associated with Drug Discontinuation

Infliximab has had a major influence on the treatment of a variety of chronic inflammatory diseases since its introduction in the late 1990s and is commonly used in the management of inflammatory arthritis, inflammatory bowel disease (IBD), and psoriasis. Infliximab is administered as an intravenous infusion and, following induction therapy of 3 weight-based doses over 6 weeks, patients receive scheduled therapy every 8 weeks. A major issue for tumor necrosis factor (TNF) inhibitors is their durability. In the major trials of anti-TNF therapy in IBD, only 25% of initial responders remained in remission after 1 year. This dropoff is mostly due to a combination of secondary loss of response to the medication and adverse effects. Infusion reactions to infliximab can be alarming for patients, physicians, and nurses, and, if misunderstood, may unnecessarily limit further use of the drug. Patients who fail anti-TNF therapy may have limited treatment options, so accurate diagnosis and management of infusion reactions is vital in our attempts to fully optimize these important medications. Infusion reactions to infliximab are not uncommon, although the true incidence is difficult to estimate due to variations in the reporting of reactions, differing definitions, and issues with retrospectively collected data. In IBD, it is estimated that infusion reactions affect 5%–20% of patients and are typically mild1,2. The TREAT registry, a large post-marketing registry of patients with Crohn’s disease (CD), reported a 3.1% reaction rate in 48,279 infliximab infusions. However, reactions severe enough to limit further use of the drug occurred in only 0.07%3. In this month’s issue of The Journal , Kelsall and colleagues report their 8-year experience of infusion reactions in patients with inflammatory arthritis treated at a tertiary referral center in Vancouver, Canada4. Data were available on 4399 infliximab infusions in 200 … Address correspondence to Dr. A. Cheifetz, Center for Inflammatory Bowel Disease, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Ave., Boston, MA 02215. E-mail: acheifet{at}bidmc.harvard.edu

Infliximab for the treatment of psoriasis in the U.K.: 9 years’ experience of infusion reactions at a single centre

Infliximab is an antitumour necrosis factor-α chimeric monoclonal antibody that is an established treatment for severe chronic plaque psoriasis. The recommended administration of a 2-h infusion followed by 2 h of monitoring is practised due to the potential occurrence of infusion reactions. However, accelerated infusions and shortened monitoring periods are used in patients with rheumatological disorders and inflammatory bowel disease without an increase in adverse events. To review the standard infliximab infusion protocol, the incidence of acute infusion reactions, the use of concomitant methotrexate and the clinical relevance of the 2-h postinfusion monitoring period. A retrospective case note and pharmacy database review of all infliximab infusions administered to patients with psoriasis at a tertiary dermatology centre was carried out. Fifty-nine consecutive patients received a total of 858 infliximab infusions (range 1-43 infusions per patient) between January 2001 and June 2010. The incidence of infusion reactions was 1.5%, affecting 16.9% of patients and occurring between the first and eleventh infusions. Mild, moderate and severe acute reactions occurred in 0.6% (n=5), 0.3% (n=3) and 0.3% (n=3) of infliximab infusions, respectively. Thirty-three patients (56%) received concomitant systemic treatments during part of or throughout the infliximab treatment, including 24 (41%) on methotrexate (5-20 mg weekly). The prevalence of infusion reactions in patients receiving infliximab alone was 27% compared with 4% in those receiving concomitant methotrexate (P=0.05). All infusion reactions were managed as per our trust protocol with only one infusion reaction occurring in the postinfusion period (10 min after infusion completion). The risk of infusion reactions in our cohort of patients was low, with the majority occurring early in the treatment cycle. Concomitant methotrexate may reduce this risk. A shortened postinfusion monitoring period can be safely considered.

Fcγ receptor IIIb polymorphism and use of glucocorticoids at baseline are associated with infusion reactions to infliximab in patients with rheumatoid arthritis

ObjectiveInfusion reaction is a major adverse event in patients with rheumatoid arthritis (RA) treated with infliximab. The possible factors including Fcγ receptor (FcγR) polymorphism associated with the development of infusion...