Limiting infusion and observation times for infliximab and vedolizumab in the COVID-19 pandemic: a UK multicentre audit of practice and safety

2020 ◽  
Vol 18 (8) ◽  
pp. 30-36
Author(s):  
Pearl Avery ◽  
Lisa Younge ◽  
Anya St Clair-Jones ◽  
Rachel Campbell ◽  
Deirdre Braim ◽  
...  
Keyword(s):  
Current Practice ◽  
Observation Time ◽  
Supporting Evidence ◽  
Safety Signal ◽  
Time Burden ◽  
Post Infusion ◽  
Infusion Reactions ◽  
Inflammatory Bowel ◽  
The Uk ◽  
Observation Times

Background: Infusions units in the UK are under increasing pressure, and this has been increased by the SARS-COV-2 pandemic. People with inflammatory bowel disease (IBD) are considered vulnerable, requiring enhanced social distancing or shielding, as defined in the UKz government's recommendations for COVID-19. Evidence that post-infusion observation time is unnecessary for infliximab (IFX) and vedolizumab (VDZ) exists in the literature, but the summary of product characteristics for both agents states that anywhere from 0.5 hours to 2 hours of observation post-infusion is required. Methods: A call was put out using the Royal College of Nursing's Facebook page, and IBD nurses from eight trusts in the UK took part. Data were gathered on trusts' current practice, infusion times for IFX and VDZ and reported infusion reactions. Results: Two (25%) trusts reported already having reduced post-infusion observation periods for people receiving IFX infusions 1–3; this increased to three units (37.5%) for infusions 4–9 and six (75%) for infusions >10. No infusion reactions were seen after the first 20 minutes of infusion time in 3934 IFX and 1265 VDZ infusions. Conclusions: The audit results suggested that there is no safety signal reduced post-infusion observation time, supporting evidence already present in the literature, and this can support increased capacity in infusion units. The time burden for people with Crohn's disease (CD) or ulcerative colitis (UC) is reduced, which is increasingly important during the pandemic. The reduced length of time that people need to spend at hospital offers trusts an option to help shield those who need to be protected from COVID-19.

scholarly journals P528 Reducing intravenous monoclonal antibody observation times without compromising patient safety; a single-centre observational study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S503-S505
Author(s):  
F Rees ◽  
A Packham ◽  
A Parmar ◽  
E Hills ◽  
M Smith ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Patient Safety ◽  
Waiting Times ◽  
Outpatient Setting ◽  
Observation Time ◽  
University Hospitals ◽  
Single Centre ◽  
Observation Study ◽  
Post Infusion ◽  
Observation Times

Abstract Background Monoclonal antibodies (MAbs) are integral to manage Inflammatory Bowel Disease (IBD). At Brighton & Sussex University Hospitals, intravenous MAbs, infliximab and vedolizumab, are administered in an outpatient setting. Licensing specifies post-infusion observation times of 1 to 2 hours. This affects waiting lists and capacity, particularly pertinent during the COVID-19 pandemic. Methods A single-centre observation study was conducted. Part 1 Retrospective data was collected for all infliximab and vedolizumab infusions from April to July 2019. Patients seen twice, were included once. For established infusion patients, historical reactions were recorded. Reaction incidence was established by observations, patient questioning and patient record review. To standardise the reactions, we used the cancer Common Terminology Criteria for Adverse Events; grade 3 is ‘severe’. Part 2 Observation time was removed from infusion 4 in April 2020. Prospective data was collected for all infliximab and vedolizumab infusions from April to December 2020. Multiple attendances were included. Results Part 1 130 infliximab patients (2607 infusions) and 69 vedolizumab patients (557 infusions) were reviewed. No severe reactions were recorded. All reactions occurred during induction dosing period. Analysis showed high levels of ‘no reactions observed’ after the first 4 infliximab infusions 97.7% (+1.6%, -4.7%), and the first 3 vedolizumab infusions 96.9% (+2.3%, -8.8%). 121 hours could be saved for infliximab and 64 hours for vedolizumab. Extrapolated this equates to 740 hours per year. Part 2 679 infliximab infusions were administered (including 12 new starters). 418 vedolizumab infusions were administered (16 new starters). No reactions were reported. Table key: Pt – patients, Inf – infusions, MAb – monoclonal antibody, Induct – Induction, Maint – maintenance, IV – intravenous, PO – oral, NC – not collected Conclusion All MAb infusion reactions occurred within 3 infusions, were non-severe and managed in clinic. By removing observation periods from infusion 4, capacity increased in concordance with COVID-19 social distancing, without affecting waiting times or patient safety. Patient experience was anecdotally improved. Further data from other centres are required to prove significance.

scholarly journals P524 Administration and monitoring of biologic therapy in patients with inflammatory bowel disease: A national Danish survey

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S451-S452
Author(s):  
S Volmar ◽  
S Wildt ◽  
L K Munck
Keyword(s):  
Maintenance Treatment ◽  
Literature Search ◽  
Biologic Therapy ◽  
Observation Time ◽  
Outpatient Clinics ◽  
Infusion Time ◽  
Biochemical Control ◽  
Post Infusion ◽  
Discharged Patients ◽  
Inflammatory Bowel

Abstract Background Administration and monitoring of biologic therapy to patients with inflammatory bowel disease (IBD) is an increasing burden in gastroenterology outpatient clinics. The aim of this study was to compare the present organisation of biologic therapy to IBD patients in Denmark with the published evidence. Methods A national online survey using SurveyXact was send to all outpatient clinics administering biologic treatment to IBD patients in Denmark in March 2019. It focused on infusion time, post infusion observation and biochemical control of treatment with biologic drugs. A systematic literature search covering the same topics was performed on PubMed in May 2019. Results 21 of 23 clinics completed the survey. Infusion time for infliximab induction was 2 h in all clinics and was reduced to 30 min or 1 h in 60 % and 40% of clinics respectively after ≥ 10 infusions. Vedolizumab infusion time was 30 min in 90% of clinics from start. Ustekinumab infusion time was 1 h in 90% of clinics. Observation time after intravenously administered biologics varied considerably. Only half of the clinics discharged patients on infliximab without post-infusion observation from the start of maintenance treatment increasing to 80% of clinics after ten infusions. About half of the clinics observed patient on vedolizumab maintenance for at least 30 min after 5 infusions. Ten clinics discharged patients immediately after the initial ustekinumab infusion. In 30–60% of clinics, patients were observed 20–120 min after subcutaneous injection of ustekinumab, adalimumab or golimumab. Twenty clinics controlled laboratory parameters prior to every maintenance treatment with infliximab and vedolizumab, no matter of infusion interval, while patients on injection therapy with adalimumab, golimumab and ustekinumab had biochemical tests taken every second to third months. Only two clinics measured trough values and antibodies against biologics routinely and adjusted the dose accordingly to the trough value. The systematic literature search identified 26 relevant articles. These showed that infliximab infusion time of 30 minutes is safe and questioned the necessity of post-infusion observation. There was no consensus on the frequency of biochemical control in patients on biologics. Conclusion Reduction and harmonisation of infusion time, post-infusion and post-injection observation time for patients on biologics could release patient and staff resources.

P349 Infliximab in inflammatory bowel disease: Is premedication necessary?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S334-S335
Author(s):  
P Núñez ◽  
C Figueroa ◽  
L Flores ◽  
P Ibáñez ◽  
U Kronberg ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Retrospective Cohort ◽  
Maintenance Phase ◽  
Tertiary Centre ◽  
Induction Group ◽  
Secondary Reactions ◽  
Post Infusion ◽  
Infusion Reactions ◽  
Inflammatory Bowel

Abstract Background The use of infliximab (IFX) in inflammatory bowel disease (IBD) has been associated with a 1–6% risk of infusion reactions. The usefulness of premedication with corticosteroids, paracetamol and/or antihistamines is controversial. The aim of this study is to assess, in IBD patients on IFX, whether there are differences in secondary reactions to the infusion between those who use premedication or not. Methods A retrospective cohort study was performed identifying patients with a diagnosis of IBD who received IFX at a tertiary centre in Santiago-Chile, since 2009. Acute reactions were defined as those that occurred in the first 24 h post-infusion and late reactions for more than 24 h. Infusion reactions were classified as mild, moderate and severe. Descriptive and association statistics were used (χ 2; p < 0.05). Results Sixty-four patients were included with 1,263 infusions in total, 52% men (characteristics in Table 1). Median infusions per patient were 22 (2–66). All induction infusions were administered with premedication and in maintenance, 57% of them. Premedication was given with hydrocortisone, chlorphenamine and paracetamol. Flow chart according to premedication use or not is shown in Figure 1. In the maintenance group, there were 10/718 (1.4%) infusion reactions with premedication and 3/358 (0.8%) without it, non-significant differences (p = 0.432). In the induction group, there were 8/187 (4%) infusion reactions, significantly higher when compared with both maintenance groups (Figure 2). Conclusion In this cohort, premedication use in maintenance phase was not effective at reducing the rate of infusion reactions due to IFX. These results suggest that premedication would not be necessary during maintenance.

Intact cord stabilisation and delivery room strategies: current practice in the UK

2020 ◽  
pp. fetalneonatal-2020-321153
Author(s):  
Anne Elizabeth Bean ◽  
Laura Myers ◽  
Catherine Smith ◽  
Tamanna Williams
Keyword(s):  
Current Practice ◽  
Delivery Room ◽  
The Uk

scholarly journals Cutaneous Manifestations in Biological-Treated Inflammatory Bowel Disease Patients: A Narrative Review

2021 ◽  
Vol 10 (5) ◽  
pp. 1040
Author(s):  
Jo L. W. Lambert ◽  
Sofie De Schepper ◽  
Reinhart Speeckaert
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Cutaneous Manifestations ◽  
Cutaneous Infections ◽  
Tnf Α ◽  
Common Skin ◽  
Receptor Blockers ◽  
Infusion Reactions ◽  
Inflammatory Bowel ◽  
Lichenoid Reactions

The biologic era has greatly improved the treatment of Crohn’s disease and ulcerative colitis. Biologics can however induce a wide variety of skin eruptions, especially those targeting the TNF-α and Th17 pathway. These include infusion reactions, eczema, psoriasis, lupus, alopecia areata, vitiligo, lichenoid reactions, granulomatous disorders, vasculitis, skin cancer, and cutaneous infections. It is important to recognize these conditions as treatment-induced adverse reactions and adapt the treatment strategy accordingly. Some conditions can be treated topically while others require cessation or switch of the biological therapy. TNF-α antagonists have the highest rate adverse skin eruptions followed by ustekinumab and anti-integrin receptor blockers. In this review, we provide an overview of the most common skin eruptions which can be encountered in clinical practice when treating IBD (Inflammatory bowel disease) patients and propose a therapeutic approach for each condition.

scholarly journals Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study

2021 ◽  
Vol 10 (14) ◽  
pp. 3177
Author(s):  
Edyta Szymanska ◽  
Maciej Dadalski ◽  
Joanna Sieczkowska-Golub ◽  
Dorota Jarzebicka ◽  
Monika Meglicka ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Pediatric Patients ◽  
Case Control Study ◽  
Case Control ◽  
Chi Square ◽  
Infusion Reactions ◽  
Inflammatory Bowel ◽  
The Difference ◽  
Control Study

Background: Infusion reactions (IRs) are the most common adverse events (AEs) of infliximab (IFX) treatment in patients with inflammatory bowel disease (IBD). Prophylactic premedication (PM) with corticosteroids or antihistamines prior to IFX infusions has been used in clinical practice, but its efficacy is not known. The aim of this study was to assess the influence of steroid PM on IR incidence in pediatric patients with IBD receiving IFX. Methods: We performed a case–control study that included pediatric patients with IBD receiving IFX. Patients were divided into four subgroups according to the agent and PM they received: Remicade (original drug) + PM, and two biosimilars—Reshma +/− PM, and Flixabi—PM. At our site, until 2018, PM with steroids was used as a part of standard IFX infusion (PM+); however, since then, this method has no longer been administered (PM−). IRs were divided into mild/severe reactions. Differences between subgroups were assessed with the appropriate chi-square test. Multivariate logistic regression was used to assess associations between PM and IR incidence, correcting for co-medication usage. Results: There were 105 children (55 PM+, 44 male, mean age 15 years) included in the study who received 1276 infusions. There was no difference between the PM+ and PM− subgroups, either in incidence of IR (18.2% vs. 16.0% of patients, p > 0.05) or in percentage of infusions followed by IR (2.02% vs. 1.02% of infusions, p > 0.5). The OR of developing IR when using PM was 0.34, and the difference in IRs ratio in PM+ and PM− patients was not statistically significant (95% CI, 0.034–1.9). There were 11/18 (61.1%) severe IRs (anaphylactic shock) reported in all patients (both PM+ and PM−). Conclusion: At our site, the incidence of IR was low, and PM did not decrease the incidence of IR in pediatric patients with IBD receiving IFX. These results indicate that PM with steroids should not be a standard part of IFX infusion to prevent IR.

scholarly journals Equity release mortgages (ERM)

2019 ◽  
Vol 24 ◽  
Keyword(s):  
Current Practice ◽  
The Uk

Abstract This abstract relates to the following interim paper: Kenny, T., Golding, C., Craske, G., Dobinson, A., Gunter, S., Griffiths, O., Hayes, N., Mockridge, A., Robertson, S., Saundh, R. and Thorpe, J., Actuarial management of equity release mortgages: current practice and issues in the actuarial management of ERMs in the UK. This paper is available on the Institute and Faculty of Actuaries (IFoA) website at https://ifoa-www.s3.eu-west-2.amazonaws.com/live/s3fs-public/Sessional%20Paper_0.pdf. The final paper will be published in due course.

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