Summary

• The company cannot recommend any practices, procedures, dosing, or usage that deviate from the approved labeling.
• REMICADE infusion must be administered intravenously for at least 2 hours.¹
• Published clinical data have evaluated the administration of REMICADE infusion over a period of less than 2 hours in patients who have previously tolerated multiple infusions of REMICADE over a period of 2 hours.^2-15

CLINICAL DATA

Randomized Trials

Abushamma et al (2023)² conducted an open-label, randomized trial to evaluate the safety of accelerated REMICADE infusion over 1 hour vs the standard 2 hours.

Study Design/Methods

• Patients with inflammatory bowel disease (IBD) receiving maintenance REMICADE infusions were included and were randomly assigned (1:1) to REMICADE infusions over 1 hour (study group) and standard 2 hours (control group).
• The primary outcome was the rate of infusion reactions in the study vs control group.
• Secondary outcomes included the effect of premedication and concomitant immunomodulators on the rate of infusion reactions.

Results

• 96 patients were randomly assigned: 53% (n=51) to the study group and 47% (n=45) to the control group.
• Over a median time of 1 year, 685 infusions were administered:
  • Of the 376 infusions in the study group, 12% (45) experienced an infusion reaction.
  • Of the 309 infusions in the control group, 18% (57) experienced an infusion reaction.
• The only infusion reaction experienced was hypotension, all of which were asymptomatic and did not require discontinuation of REMICADE.
• Diphenhydramine was associated with an increased rate of infusion reactions, odds ratio (OR) 2.04 (95% confidence interval [CI], 1.18-3.52), P=0.01.

St Clair et al (2004)^{1, 3, 4} reported results from the ASPIRE (Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset) trial. ASPIRE was a multicenter, randomized, double-blind, international trial that evaluated the safety and efficacy of REMICADE, in combination with methotrexate (MTX), in patients with active, early (disease duration ≤3 years) rheumatoid arthritis (RA).  

Study Design/Methods

• All patients in the trial were MTX-naïve. Stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids were permitted.
• Patients were randomized to receive placebo or REMICADE (3 mg/kg or 6 mg/kg) + MTX at weeks 0, 2, 6, and every 8 weeks thereafter through week 54.

Results

• A total of 1049 patients were enrolled in the trial.
• The safety of a shortened infusion duration with REMICADE was not a prespecified endpoint of the ASPIRE trial; however, a post hoc analysis of this trial was performed to assess the safety of administering REMICADE over a period less than 2 hours.
  • A shortened infusion duration was retrospectively defined as ≤90 minutes or ≤60 minutes; however, the infusion duration could be shortened to not less than 40 minutes.
• In the ASPIRE trial, 66% of all patients (686 out of 1040) received at least 1 shortened infusion of 90 minutes or less, and 44% of the patients (454 out of 1040) received at least 1 shortened infusion of 60 minutes or less.
• Of the REMICADE-treated patients who received at least 1 shortened infusion, infusion-related reactions occurred in 15% of patients (74/494) and serious infusion reactions occurred in 0.4% of patients (2/494).
• Shortened infusions at doses >6 mg/kg have not been studied.

Open-Label Studies

Crane et al (2022)⁵ conducted a prospective, single-center study to determine the safety of accelerated REMICADE infusions.

Study Design/Methods

• Patients with IBD in stable clinical remission who had tolerated at least 3 maintenance REMICADE infusions (up to 10 mg/kg every 8 weeks) were eligible for this study. Patients who experienced previous infusion-related reactions or high levels of anti-REMICADE antibodies were excluded from this study.
• Patients on a standard dosage regimen of REMICADE (5 mg/kg) administered over 1 hour with an additional hour of observation received infusions over 30 minutes with 30 minutes of observation.
• Patients on a dose-intensified regimen of REMICADE (>5 mg/kg to 10 mg/kg) administered over 2 hours with an additional 2 hours of observation received infusions over 1 hour with 1 hour of observation.
• Within 7 days of the infusion, patients received a call to identify any delayed reactions.
• Oral cetirizine and IV hydrocortisone were administered prophylactically only if patients were previously receiving premedication.
• Patients who were dose escalated during the study period were switched back to standard infusion rates.
• Acute infusion reactions were defined as occurring within 1 hour of infusion; delayed infusion reactions were defined as occurring after 1 hour and were assessed via follow-up phone call.

Results

• Of the 79 patients on a stable REMICADE dose, 52 received at least 1 infusion:
  • 31 patients received the standard dosage regimen of REMICADE over 30 minutes (89 total infusions) and 21 patients received the dose-intensified regimen of REMICADE over 1 hour (61 total infusions).
• Infusions reactions were observed in 3/31 patients (in 3/89 infusions) who received the standard dosage regimen of REMICADE over 30 minutes.
  • All reactions were delayed, mild, self-limiting, and did not require medical treatment.
• No infusion reactions were observed among the 21 patients (61 infusions) who were dose-intensified over 1 hour.
• Infliximab trough levels were measured in 39 patients after their first and third infusion. All patients remained on the same REMICADE dose at a constant dosing interval. The mean trough level was 9.3±4.9 mg/L after the first infusion and 7.6±4.1 after the third infusion (mean difference 1.62 mg/L, P=0.02). No patients acquired anti-REMICADE antibodies at either timepoint.

Damon et al (2018)¹⁶ assessed the safety of a 30-minute shortened infusion protocol of REMICADE.

Study Design/Methods

• Eligible patients (on a stable maintenance dose and had no history of infusion reactions to standard 2-hour infusions) were offered to change the infusion time to 30 minutes.
• Adverse reactions during infusions and up to 30 days after infusions were assessed and further classified as drug related or infusion related.

Results

• There were approximately 3-4 infusions per patient during this 6-month period.
• Of 121 patients with IBD, 46 (38%) patients and 75 (62%) patients received 30-minute shortened infusions and standard infusions of REMICADE, respectively.
• REMICADE maintenance doses ranged from 5 mg/kg (69% of patients) to 7.5-10 mg/kg (31% of patients).
• Adverse reactions were reported in 10 (8.3%) patients. Of these patients, 4 were receiving 30-minute shortened infusions of REMICADE.
  • Drug induced paradoxical psoriasis were experienced in 5/10 patients with adverse reactions. Of these 5 patients, 3 patients were receiving 30-minute shortened infusions.
• Infusion-related reactions occurred in 5 patients, none of which were severe or led to changes in infusion rate.
  • Cardiovascular events were experienced in 3 patients including tachycardia and high blood pressure. Of these 3 patients, 1 patient was receiving 30-minute shortened infusions.
  • Self-limiting skin rashes occurred in 2 patients.
• Correlations studies found no association between the incidence of adverse events and REMICADE’s infusion rate, dose, and duration of therapy before the reaction occurred (n=0.893).

de Carvalho et al (2018)⁶ conducted a single-center, prospective, non-randomized study in 34 adult patients with rheumatic diseases to assess the safety of 1-hour accelerated REMICADE infusions.

Study Design/Methods

• Adult patients with RA, ankylosing spondylitis (AS), psoriatic arthritis (PsA), and CD were eligible for this study. Patients with a history of infusion reactions prior to immunobiologic therapy and a history of asthma or severe atopy were excluded.
• Patients with RA received REMICADE 3 or 5 mg/kg (if refractory to previous dose) every 8 weeks and patients with CD, AS, PsA received REMICADE 5 mg/kg every 8 weeks.
• To monitor for infusion-related reactions, the accelerated infusion started at half the rate in the first 15 minutes; the remaining volume was infused for the remaining 45 minutes. Monitoring post-infusion was conducted for 30 minutes.
• If any adverse events were encountered, the infusion was stopped immediately, and the reactions were treated according to the severity.

Results

• Of the 34 patients in this study, 55.5% were female with a mean age of 48.7±18.6 years.
• There were 16 patients with RA, 15 patients with AS, 2 patients with PsA and 1 patient with CD and the mean disease duration was 9.5±9.2 years.
• The mean dose of REMICADE per infusion was 414.2±158.1 mg and the mean duration of treatment was 38.9±27.6 months.
• There were 10 (29.4%) patients receiving concomitant MTX (5 RA, 4 AS, 1 PsA), 3 patients (8.8%) receiving concomitant leflunomide and 2 patients receiving concomitant prednisone.
• Prior to this study, the mean infusion time was 2.2±0.4 hours; premedication was used in 6 patients (3 RA, 3 AS).
• After the accelerated infusion protocol started, premedication was stopped in all patients.
• There were no adverse events during or after infusion in all patients.
• A mean of 2.7±0.7 infusions per patient was performed using the accelerated infusion protocol.

Fukuyo et al (2014)⁷ evaluated the safety and efficacy of reducing the duration of REMICADE infusion for treatment of RA.

Study Design/Methods

• Patients (N=457) were divided into 2 groups: shortened infusion time (n=226) or constant infusion time (n=231).
  • The shortened infusion time group began by receiving six 2-hour infusions. If no reactions were observed, they then received the next 6 infusions over a 1-hour period. Again, if no reactions were observed, the patients received the next 6 infusions over a 30-minute period.
  • The constant infusion time group received all infusions over a 2-hour period.
• All patients were prophylactically treated with chlorpheniramine maleate 2 mg and ibuprofen 200 mg prior to each infusion.
• All patients received a 3 mg/kg infusion for the first 4 doses and were then increased to a maximum dose of 10 mg/kg based upon poor therapeutic effect. Furthermore, patients were started on 8-week interval infusions and were decreased to a minimum of 4-week interval infusions also based upon poor therapeutic effect.
• The primary and secondary endpoints were the percentage of the total number of REMICADE infusions for all patients from the 7^th to 12^th and 13^th to 18^th infusions, respectively.

Results

• Of the 226 patients in the shortened infusion rate group, 138 patients received all six 2-hour infusions, 81 patients received all six 1-hour infusions, and 37 patients received all six 30-minute infusions.
• Infusion reactions were noted in 0.53% (4/756 infusions) and 0.70% (4/570 infusions) of the 1-hour infusion group and the constant infusion group, respectively (P=0.6896).
  • Of the 4 patients who experienced reactions after the 1-hour infusions, adverse events (AEs) were mild and consisted of rashes and fever. Once side effects resolved, subsequent infusions were successfully administered over 2 hours.
• Infusion reactions were noted in 0.58% (2/342) and 0.67% (2/229) in the 30-minute infusions and the constant infusions, respectively (P=0.8934).
  • Of the 2 patients who experienced reactions after the 30-minute infusions, AEs were mild and consisted of rashes, fever, and nausea. Once side effects resolved, subsequent infusions were successfully administered over 1 hour.
• All 6 patients who experienced infusion reactions after a shortened infusion time were receiving REMICADE at a dose of 3 mg/kg.

Clare et al (2009)⁸ prospectively evaluated the rate of infusion reactions with shortened REMICADE infusions in patients with IBD.

Study Design/Methods

• The infusion schedule utilized in the study was as follows: doses 1-4 infused over 2 hours, doses 5-9 infused for 1 hour, and all subsequent doses infused over 0.5 hour.
• Treatment with 200 mg of IV hydrocortisone was administered to patients who were not receiving concomitant immunomodulator therapy and who were receiving <30 mg of prednisone daily. Further, pretreatment with IV hydrocortisone 100 mg and chlorpheniramine 10 mg was administered to patients if they had a previous history of an adverse reaction during an infusion.
• Pulse and blood pressure monitoring were conducted every 30 minutes for all infusions.
• Following the infusion, patients were monitored for 2 hours, 1 hour, and 30 minutes for the 2-hour infusions, 1-hour infusions, and 0.5-hour infusions, respectively.
• The primary endpoint was the occurrence of infusion reactions with a shortened infusion schedule.
• Secondary endpoints included the correlation between the rate of the infusion and infusion reactions, impact of concomitant immunomodulator therapy, AEs occurring during the infusion or postinfusion monitoring period, and the relationship between infusion reactions and the time between infusions (maintenance or periodic infusions).

Results

• A total of 1146 infusions were studied in 144 patients. At the point of data collection, 44.4% (n=96) of patients were still being treated with REMICADE, a majority of which were on maintenance therapy (n=94).
  • Of the total 144 patients, 78 were treated with an induction regimen (infusions at weeks 0, 2, and 6) after regular maintenance infusions, 37 were initially treated episodically and then switched to maintenance therapy, 18 were treated with an induction regimen only, and the remaining patients were treated episodically only.
• The most common reasons for discontinuation of REMICADE included infusion reactions (6.9%), primary nonresponse with no response after induction therapy (6.3%), secondary nonresponse with loss of efficacy at a later stage (0.8%), and patient request after achieving remission (0.8%).
• Infusion reactions were significantly associated with episodic therapy, rather than maintenance therapy (OR: 2.64, [95% CI, 1.05-6.6]; P=0.04) according to a univariate analysis. No significant associations were observed with age, gender, fistulizing or nonfistulizing CD, infusion interval, concomitant immunomodulator therapy, or total number of previous infusions and the occurrence of infusion reactions.
• As shown in Table: Summary of Infusion-Related Reactions, accelerated REMICADE infusions were generally well-tolerated, with no increase in the incidence of infusion-related reactions. The overall rate of infusions with infusion reactions was 3.7% (42/1146).
  • The proportion of infusions with infusion reactions was 5.2% (18/344) among patients receiving 2-hour infusions, compared to 3.7% (14/376) and 2.3% (10/426) among patients receiving 1-hour and 0.5-hour infusions, respectively.

Shergy et al (2002)⁹ conducted an open-label, multicenter study to evaluate the onset of clinical benefit following an initial REMICADE infusion, as well as to further establish the safety of administering REMICADE in an office setting. In addition, the tolerability of reducing the infusion administration time from 2 hours to 1 hour was assessed.

Study Design/Methods

• Patients received 4 infusions of REMICADE 3 mg/kg over 2 hours at weeks 0, 2, 6, and 14, and continued to receive stable doses of MTX ≥7.5 mg/week.  
• Stable doses of corticosteroids, NSAIDs, and/or disease modifying antirheumatic drugs (DMARDs) were permitted.
• Patients from selected study sites were permitted to receive 2 additional 3 mg/kg infusions of REMICADE (given 8 weeks apart) administered over 1 hour if they had tolerated the 4 previous 2-hour infusions without any moderate to severe infusion-related reactions and they had no significant history of cardiac or renal impairment.
• The recommended infusion rate for the 1-hour infusion was 100 mL/hr for 15 minutes followed by 300 mL/hr for 45 minutes if no reaction occurred.
• Safety evaluations included measurements of vital signs during and immediately after the REMICADE infusions and assessment of AEs since the previous infusion and during infusions at each of the evaluation visits.  Infusion-related AEs were defined as those occurring during the infusion or the 1-hour period following completion of the infusion. AEs were classified as mild (caused no limitation of usual activities), moderate (caused some limitation of usual activities), or severe (caused inability to carry out usual activities).

Results

• The study included 553 patients (mean age 57.9 years) who had active RA despite treatment with MTX. Of the 215 eligible patients, 198 chose to participate in the study extension.
• AEs were reported by approximately 62% of patients at any time during the trial. Most AEs were classified as either mild to moderate in nature. The most common AEs were reflective of those that were observed in clinical trials of REMICADE.
  • The incidence of AEs and serious adverse events (SAEs) among patients who received REMICADE infusions over 1 hour were similar to those among patients who received infusions over 2 hours.
  • Similarly, the incidences of AEs resulting in study withdrawal were similar for the 2-hour and 1-hour infusion groups.
• In the cohort of 197 patients who received REMICADE infusions over 1 hour, AEs were reported by 57% of patients through week 16, during which time REMICADE was administered over 2 hours, and by 38% of patients during the extension period when infusions were given over 1 hour.
• When the incidence of AEs was analyzed by concomitant DMARD use, there was no increase in the incidences of all AEs or SAEs among patients receiving multiple DMARDs as compared with patients receiving MTX as the only DMARD.
• Infusion reactions were generally mild to moderate in severity; however, there were 4 cases of severe hypersensitivity reactions, 1 case of severe pruritus, and 1 anaphylactic reaction in 6 patients (3 each in the 1- and 2-hour infusion groups).  In all cases, symptoms resolved rapidly following treatment with diphenhydramine, methylprednisolone, and/or epinephrine.
  • Infusion reactions were reported with 10% of infusions administered over a 2-hour period and 6% of infusions administered over a 1-hour period.
  • Infusion reactions that resulted in discontinuation of treatment occurred in 1% of patients who received 2-hour infusions and 2% of patients who received 1-hour infusions.

Cohort Study

Lee et al (2011)¹⁰ conducted a prospective cohort study to examine the safety and tolerability of 1-hour vs 2-hour REMICADE maintenance infusions.

Study Design/Methods

• All patients received REMICADE induction doses at weeks 0, 2, and 6 (3 mg/kg for patients without IBD, 5 mg/kg for patients with IBD) as a 2-hour infusion.
• Patients who had no infusion-related reaction for three 2-hour infusions at a consistent dose (≤6 mg/kg) and frequency were entered into the 1-hour cohort.
• To remain in the 1-hour cohort, patients must not have had any significant AEs.
• Patients who had an increase in dose or frequency must have received an uneventful 2-hour infusion before reverting back to the 1-hour infusion.

Results

• A total of 2165 infusions were administered to 415 patients.
  • Of the total infusions, 535 were 2-hour induction infusions.
  • There were 1356 maintenance infusions given to 256 patients in the 2-hour cohort, vs 274 infusions given to 54 patients in the 1-hour cohort.
• Of patients receiving 2-hour infusions as part of an induction regimen, 4.1% (22/535) experienced an infusion reaction.
• Of infusions occurring during maintenance therapy, 1.25% (17/1356) of reactions in the 2-hour cohort resulted in an infusion reaction compared with 0.36% (1/274) in the 1-hour infusion cohort.
• The rate of infusion reactions per 1000 person days were 0.08 and 0.28 in the 1-hour and 2-hour cohorts, respectively (P=0.07). Results were similar when stratified by IBD (P=0.22) and non-IBD (P=0.58) patients.
• Infusion reaction rates were similar between the 1-hour and 2-hour cohorts, regardless of concurrent use of immunosuppressant or corticosteroid premedication.
• Of the subset of patients with IBD, 52.7% were receiving concomitant immunosuppressant therapy (azathioprine [AZA], 6-mercaptopurine [6-MP], or MTX).
• Concomitant immunosuppressant therapy was associated with a lower rate of infusion reactions in patients with IBD (P=0.002), but not in patients being treated with REMICADE for other indications (P=NS).

Retrospective Studies

Jagt et al (2023)¹¹ conducted a retrospective, multicenter cohort study with pediatric patients (4-18 years of age) with IBD to assess the frequency and timing of infusion reactions in patients who received a rapid REMICADE (1 hour) vs REMICADE standard (2 hour) infusion.

Study Design/Methods

• The primary outcome was the frequency of acute infusion reactions among rapid vs standard infusions.
• Secondary outcomes included the timing, severity, and management of infusion reactions.

Results

• There were 7500 maintenance infusions (4383 standard infusions, 3117 rapid infusions) in 297 patients.
• There was no significant difference in the occurrence of infusion reactions between the standard and rapid infusion group.
  • Of the 4383 standard infusions, there were 26 (0.6%) infusion reactions.
  • Of the 3117 rapid infusions, there were 9 (0.3%) infusion reactions.
• No significant differences were observed in the frequency of infusion reactions between the patients receiving rapid infusions (1/31, 3.2%), standard infusions (16/115, 13.9%), and both infusion rates (11/151, 7.3%).
• Of the 35 infusion reactions, 74.3% (26) occurred during infusion while 25.7% (9) occurred post-infusion. Post-infusion reactions were mild and did not require medication or medical intervention.

Pusateri et al (2021)¹² assessed the safety of rapid 1-hour REMICADE infusions through a retrospective, single-center study.

Study Design/Methods

• Patients with IBD or rheumatic diseases (RA, PsA, AS) treated with REMICADE at this institution from February 1, 2016 to August 31, 2017 were analyzed in this study.
• Rapid REMICADE infusions were administered at a rate of 100 mL/h for 15 minutes followed by a rate of 300 mL/h over 1 hour.
• Patients were eligible for rapid infusions if they received at least 6 infusions at the standard rate (2 hours including 3 induction doses and 3 maintenance doses).
• Patients with a history of infusion-related reactions that were not prevented with pre-medications and patients receiving doses greater than 1,000 mg were excluded from the study.

Results

• There was a total of 348 patients included in this analysis; 193 (55%) patients and 143 (41.4%) patients were receiving REMICADE solely for IBD and rheumatic diseases, respectively. Only 12 patients were receiving infusions for both IBD and a rheumatic disease.
• The average patient age was 46.07 years and approximately 61% of patients were female.
• Of 348 patients, 140 (40.23%) patients received rapid infusions (68 patients with rheumatic disease, 72 patients with IBD).
• There were 4 (2.9%) patients who switched back to standard infusions from rapid infusions. Of these 4 patients, 3 patients switched due to reactions to REMICADE rapid infusions.
• Mild itching occurred in one patient with rheumatic disease who received 3 rapid infusions and was switched back to standard infusions.
• There were 3 patients receiving rapid infusion for IBD who switched back to standard infusions after their first and only rapid infusion:
  • One patient experienced a mild reaction (“falling ill”).
  • One patient had a reaction noted as “reaction to the rapid infusion”.
  • One patient receiving rapid infusion was then switched back to 2-hour infusion (reason unclear). This same patient had an infusion reaction (injection site erythema) 3 years previously.
• Premedications prior to infusions were administered to 33.6% of patients.
• Patients receiving standard infusions were more likely to receive premedication (41.35% vs 22.14%; P<0.001).

Michielan et al (2015)¹³ conducted a retrospective single-center cohort study to evaluate the efficacy and safety of standard, 2-hour nurse-led, and 1-hour nurse-led REMICADE infusions in patients with IBD.

Study Design/Methods

• Patients in the study were included in 1 of the following groups:
  • Group 1: a standard physician-led procedure with 2-hour infusions, preceded by premedication with hydrocortisone, and followed by clinical observation for 2 hours during the induction phase and 1 hour during the maintenance phase.
  • Group 2: a similar regimen to group 1, with nurse-led supervision. Patients were seen by the physician only on demand.
  • Group 3: a 1-hour nurse-led procedure without routine premedication. Patients were eligible if they had no history of severe infusion reactions and if they received stable doses of REMICADE in recent infusions. The protocol was never used during the induction period and was started with the fifth infusion. Premedication was not given routinely (only if a patient experienced a prior infusion reaction or had taken a drug holiday). Patients were seen by the physician only on demand.

Results

• Groups 1, 2, and 3 consisted of 87 patients (311 infusions), 130 patients (464 infusions), and 178 patients (1356 infusions), respectively.
• There were 18 infusion reactions recorded in group 1 (10 acute [8 mild and 2 moderate] and 8 delayed), 14 in group 2 (3 acute [2 mild and 1 moderate] and 11 delayed), and 30 in group 3 (19 acute [10 mild and 9 moderate] and 11 delayed).
• There was a significant difference between the 3 groups in the rate of infusion reactions (P=0.003). There were significantly fewer infusion reactions in group 3 than in group 1 (2.2% vs 5.8%, respectively; P=0.001).
• In group 3, a significant risk factor for the onset of infusion reactions was steroid premedication (odds ratio: 4.706, 95% CI: 2.211-10.018; P<0.001).
• During infusions, the physician was called in significantly more often in group 2 vs group  3 (3.8% vs 1.1%; P<0.001).

Belhassan et al (2013)¹⁴ conducted a retrospective study to compare the tolerability of 1-hour and 2-hour REMICADE infusions in patients with IBD.

Study Design/Methods

• All REMICADE-treated patients received 2-hour infusions followed by 2 hours of monitoring at the institution until January 2009. Doses ranged from 5-10 mg/kg, with induction therapy given on days 1, 14, and 46. The interval between maintenance infusions ranged from 6-12 weeks.
• Starting in 2009, all patients who received their first 3 infusions without an infusion-related AE were able to receive a 1-hour infusion followed by 1 hour of monitoring.
• The AEs during an infusion were compared between the eligible 1-hour infusion group and the 2-hour infusion group.
• All patients in both groups were premedicated with 200 mg of hydrocortisone.

Results

• A total of 201 patients were evaluated, which represented a total of 3091 infusions: 2102 infusions in the 2-hour infusion group and 989 infusions in the 1-hour infusion group.
• There were 161 patients in the 2-hour infusion group and 95 patients in the 1-hour infusion group (40 patients had a 1-hour infusion for the first time and the remaining 55 were in the 2-hour infusion group before January 2009).
• In the 2-hour infusion group, the incidence of AEs was 17 reactions (10.6%) compared to 6 reactions (6.3%) in the 1-hour infusion group (P=0.36).
• It was reported that there was no increased risk of reaction in the second or third cycle of REMICADE infusion in either of the 2 groups.
• No risk factors were reported in terms of indication, gender, and the number of infusions between patients who had experienced an AE and patients who had not experienced an AE.

Breynaert et al (2011)¹⁵ conducted a retrospective single-center cohort study to compare the tolerability of 1-hour vs 2-hour REMICADE infusion in patients with IBD.

Study Design/Methods

• All patients who received scheduled maintenance REMICADE for at least 6 months were included in the study.
• Patients who tolerated at least four 2-hour infusions were administered 1-hour infusions.

Results

• There were 953 patients with IBD treated with REMICADE in the infusion center. Of these, 474 met the criteria of scheduled maintenance therapy.
• A total of 9155 maintenance infusions were administered, with 4307 of these infused over 1 hour.
• No severe infusion reactions were documented.
• Ninety patients experienced an infusion reaction during 140 REMICADE maintenance infusions. The overall incidence of infusion reactions was 19% per patient and 1.5% per infusion.
• The proportion of 1-hour infusions with an infusion reaction compared to 2-hour infusions was 0.8% and 2.3%, respectively (P=0.0027).
• Mild, acute reactions occurred in 27 of 4307 infusions (0.6%) in the 1-hour group, vs  80 of 4848 infusions (1.7%) in the 2-hour group (P=0.0034).
• Delayed infusion reactions occurred in 0.2% and 0.5% of infusions in the 1-hour and    2-hour groups, respectively (P=0.277).
• No predictors for the occurrence of infusion reactions were identified in this study.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 08 June 2023.