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Published in: Pediatric Rheumatology 1/2018

Open Access 01-12-2018 | Research article

Pediatric rheumatology infusion center: report on therapeutic protocols and infusions given over 4 Years with focus on adverse events over 1 Year

Authors: Surabhi S. Vinod, Annelle B. Reed, Jamelle Maxwell, Randy Q. Cron, Matthew L. Stoll

Published in: Pediatric Rheumatology | Issue 1/2018

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Abstract

Background

Children with chronic rheumatic disease often require intravenous (IV) therapy. Our center has instituted standardized protocols for use of IV medications in rheumatology patients. Herein, we introduce the therapeutic protocols and report on their short-term safety.

Methods

This was an institutional review board (IRB) approved retrospective chart review of all patients who had received IV infusions between the years 2012 and 2015 at a single center, prescribed by a pediatric rheumatologist. Infusion medications included abatacept, belimumab, cyclophosphamide, immune globulin, infliximab, methylprednisolone, N-acetylcysteine, pamidronate disodium, rituximab, and tocilizumab. For calendar year 2015, all adverse infusions reactions were recorded along with treatment strategies used to manage them, and outcomes. Rates of adverse events were calculated per infusion medication.

Results

During calendar years 2012–2015, 7585 IV infusions were administered to 398 unique patients. In the year 2015, 2187 infusions were administered to 224 patients, with 34 patients experiencing 41 infusion reactions (1.9% of all infusions). Rituximab had the highest rate of adverse drug reactions with 10 patients experiencing reactions during 106 infusions (9.4%). None of the reactions were life-threatening, and only 6 resulted in discontinuation of therapy.

Conclusions

In a recent 4-year span, the UAB Pediatric Rheumatology Infusion Center has given thousands of IV infusions with minimal adverse reactions over a one-year reporting period. The combination of standard infusion protocols, experience of and communication between physicians and nurses who staff the center, and safety of the medications themselves, allows for safe IV administration of a variety of therapies for pediatric rheumatology patients.

Trial registration

Not applicable; this was a retrospective study.
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Literature
2.
go back to reference Stoll ML, Cron RQ. Treatment of juvenile idiopathic arthritis in the biologic age. Rheum Dis Clin N Am. 2013;39:751–66.CrossRef Stoll ML, Cron RQ. Treatment of juvenile idiopathic arthritis in the biologic age. Rheum Dis Clin N Am. 2013;39:751–66.CrossRef
4.
go back to reference Mahmoud I, Jellouli M, Boukhris I, Charfi R, Ben Tekaya A, Saidane O, et al. Efficacy and safety of rituximab in the Management of Pediatric Systemic Lupus Erythematosus: a systematic review. J Pediatr. 2017;187:213–9. e2CrossRefPubMed Mahmoud I, Jellouli M, Boukhris I, Charfi R, Ben Tekaya A, Saidane O, et al. Efficacy and safety of rituximab in the Management of Pediatric Systemic Lupus Erythematosus: a systematic review. J Pediatr. 2017;187:213–9. e2CrossRefPubMed
5.
go back to reference Horneff G. Safety of biologic therapies for the treatment of juvenile idiopathic arthritis. Expert Opin Drug Saf. 2015;14:1111–26.CrossRefPubMed Horneff G. Safety of biologic therapies for the treatment of juvenile idiopathic arthritis. Expert Opin Drug Saf. 2015;14:1111–26.CrossRefPubMed
6.
go back to reference Hastings D, Patel B, Torloni AS, Mookadam F, Betcher J, Moss A, et al. Plasmapheresis therapy for rare but potentially fatal reaction to rituximab. J Clin Apher. 2009;24:28–31.CrossRefPubMed Hastings D, Patel B, Torloni AS, Mookadam F, Betcher J, Moss A, et al. Plasmapheresis therapy for rare but potentially fatal reaction to rituximab. J Clin Apher. 2009;24:28–31.CrossRefPubMed
7.
go back to reference Salmon JH, Perotin JM, Morel J, Drame M, Cantagrel A, Ziegler LE, et al. Serious infusion-related reaction after rituximab, abatacept and tocilizumab in rheumatoid arthritis: prospective registry data. Rheumatology (Oxford). 2018;57:134–9. Salmon JH, Perotin JM, Morel J, Drame M, Cantagrel A, Ziegler LE, et al. Serious infusion-related reaction after rituximab, abatacept and tocilizumab in rheumatoid arthritis: prospective registry data. Rheumatology (Oxford). 2018;57:134–9.
8.
go back to reference Krintel SB, Grunert VP, Hetland ML, Johansen JS, Rothfuss M, Palermo G, et al. The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure. Rheumatology (Oxford). 2013;52:1245–53.CrossRef Krintel SB, Grunert VP, Hetland ML, Johansen JS, Rothfuss M, Palermo G, et al. The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure. Rheumatology (Oxford). 2013;52:1245–53.CrossRef
9.
go back to reference Levin AS, Otani IM, Lax T, Hochberg E, Banerji A. Reactions to rituximab in an outpatient infusion center: a 5-year review. J Allergy Clin Immunol Pract. 2017;5:107–13. e1CrossRefPubMed Levin AS, Otani IM, Lax T, Hochberg E, Banerji A. Reactions to rituximab in an outpatient infusion center: a 5-year review. J Allergy Clin Immunol Pract. 2017;5:107–13. e1CrossRefPubMed
10.
go back to reference Aeschlimann FA, Hofer KD, Cannizzaro Schneider E, Schroeder S, Lauener R, Saurenmann RK. Infliximab in pediatric rheumatology patients: a retrospective analysis of infusion reactions and severe adverse events during 2246 infusions over 12 years. J Rheumatol. 2014;41:1409–15.CrossRefPubMed Aeschlimann FA, Hofer KD, Cannizzaro Schneider E, Schroeder S, Lauener R, Saurenmann RK. Infliximab in pediatric rheumatology patients: a retrospective analysis of infusion reactions and severe adverse events during 2246 infusions over 12 years. J Rheumatol. 2014;41:1409–15.CrossRefPubMed
11.
go back to reference Al-Mayouf SM, Alenazi A, AlJasser H. Biologic agents therapy for Saudi children with rheumatic diseases: indications and safety. Int J Rheum Dis. 2016;19:600–5.CrossRefPubMed Al-Mayouf SM, Alenazi A, AlJasser H. Biologic agents therapy for Saudi children with rheumatic diseases: indications and safety. Int J Rheum Dis. 2016;19:600–5.CrossRefPubMed
12.
go back to reference Lahdenne P, Wikstrom AM, Aalto K, Kolho KL. Prevention of acute adverse events related to infliximab infusions in pediatric patients. Arthritis Care Res (Hoboken). 2010;62:785–90.CrossRef Lahdenne P, Wikstrom AM, Aalto K, Kolho KL. Prevention of acute adverse events related to infliximab infusions in pediatric patients. Arthritis Care Res (Hoboken). 2010;62:785–90.CrossRef
13.
go back to reference Woodworth T, Furst DE, Alten R, Bingham CO 3rd, Yocum D, Sloan V, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the rheumatology common toxicity criteria v.2.0. J Rheumatol. 2007;34:1401–14.PubMed Woodworth T, Furst DE, Alten R, Bingham CO 3rd, Yocum D, Sloan V, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the rheumatology common toxicity criteria v.2.0. J Rheumatol. 2007;34:1401–14.PubMed
14.
go back to reference Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54:1390–400.CrossRefPubMed Emery P, Fleischmann R, Filipowicz-Sosnowska A, Schechtman J, Szczepanski L, Kavanaugh A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54:1390–400.CrossRefPubMed
15.
go back to reference Sany J, Kaiser MJ, Jorgensen C, Trape G. Study of the tolerance of infliximab infusions with or without betamethasone premedication in patients with active rheumatoid arthritis. Ann Rheum Dis. 2005;64:1647–9.CrossRefPubMedPubMedCentral Sany J, Kaiser MJ, Jorgensen C, Trape G. Study of the tolerance of infliximab infusions with or without betamethasone premedication in patients with active rheumatoid arthritis. Ann Rheum Dis. 2005;64:1647–9.CrossRefPubMedPubMedCentral
16.
go back to reference Hutsell SQ, Wu M, Park KT. Frequency of severe infusion reactions associated with outpatient infusion of infliximab without Premedications. J Pediatr Gastroenterol Nutr. 2017;65:430–1.CrossRefPubMed Hutsell SQ, Wu M, Park KT. Frequency of severe infusion reactions associated with outpatient infusion of infliximab without Premedications. J Pediatr Gastroenterol Nutr. 2017;65:430–1.CrossRefPubMed
17.
go back to reference Gold SL, Cohen-Mekelburg S, Schneider Y, Shen N, Faggen A, Rupert A, et al. Premedication use in preventing acute infliximab infusion reactions in patients with inflammatory bowel disease: a single center cohort study. Inflamm Bowel Dis. 2017;23:1882–9.CrossRefPubMed Gold SL, Cohen-Mekelburg S, Schneider Y, Shen N, Faggen A, Rupert A, et al. Premedication use in preventing acute infliximab infusion reactions in patients with inflammatory bowel disease: a single center cohort study. Inflamm Bowel Dis. 2017;23:1882–9.CrossRefPubMed
18.
go back to reference Tambralli A, Beukelman T, Weiser P, Atkinson TP, Cron RQ, Stoll ML. High doses of infliximab in the management of juvenile idiopathic arthritis. J Rheumatol. 2013;40:1749–55.CrossRefPubMed Tambralli A, Beukelman T, Weiser P, Atkinson TP, Cron RQ, Stoll ML. High doses of infliximab in the management of juvenile idiopathic arthritis. J Rheumatol. 2013;40:1749–55.CrossRefPubMed
19.
go back to reference Wee JS, Petrof G, Jackson K, Barker JN, Smith CH. Infliximab for the treatment of psoriasis in the U.K.: 9 years' experience of infusion reactions at a single Centre. Br J Dermatol. 2012;167:411–6.CrossRefPubMed Wee JS, Petrof G, Jackson K, Barker JN, Smith CH. Infliximab for the treatment of psoriasis in the U.K.: 9 years' experience of infusion reactions at a single Centre. Br J Dermatol. 2012;167:411–6.CrossRefPubMed
20.
go back to reference Thomas SS, Borazan N, Barroso N, Duan L, Taroumian S, Kretzmann B, et al. Comparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the Management of Autoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs. 2015;29:241–58.CrossRefPubMed Thomas SS, Borazan N, Barroso N, Duan L, Taroumian S, Kretzmann B, et al. Comparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the Management of Autoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs. 2015;29:241–58.CrossRefPubMed
21.
go back to reference Moss IB, Moss MB, dos Reis DS, Coelho RM. Immediate infusional reactions to intravenous immunobiological agents for the treatment of autoimmune diseases: experience of 2126 procedures in a non-oncologic infusion Centre. Rev Bras Reumatol. 2014;54:102–9.CrossRefPubMed Moss IB, Moss MB, dos Reis DS, Coelho RM. Immediate infusional reactions to intravenous immunobiological agents for the treatment of autoimmune diseases: experience of 2126 procedures in a non-oncologic infusion Centre. Rev Bras Reumatol. 2014;54:102–9.CrossRefPubMed
22.
go back to reference Lequerre T, Vittecoq O, Klemmer N, Goeb V, Pouplin S, Menard JF, et al. Management of infusion reactions to infliximab in patients with rheumatoid arthritis or spondyloarthritis: experience from an immunotherapy unit of rheumatology. J Rheumatol. 2006;33:1307–14.PubMed Lequerre T, Vittecoq O, Klemmer N, Goeb V, Pouplin S, Menard JF, et al. Management of infusion reactions to infliximab in patients with rheumatoid arthritis or spondyloarthritis: experience from an immunotherapy unit of rheumatology. J Rheumatol. 2006;33:1307–14.PubMed
Metadata
Title
Pediatric rheumatology infusion center: report on therapeutic protocols and infusions given over 4 Years with focus on adverse events over 1 Year
Authors
Surabhi S. Vinod
Annelle B. Reed
Jamelle Maxwell
Randy Q. Cron
Matthew L. Stoll
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Pediatric Rheumatology / Issue 1/2018
Electronic ISSN: 1546-0096
DOI
https://doi.org/10.1186/s12969-018-0234-0

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