Efficacy and safety of human immunoglobulin monotherapy in pediatric patients with multisystem inflammatory syndrome associated with COVID-19: a critical review of current evidence
DOI:
https://doi.org/10.35434/rcmhnaaa.2022.15Supl.%201.1528Keywords:
COVID-19, Pediatrics, Systemic Inflammatory Response Syndrome, immunoglobulin, Health Technology Assessment, Adrenal Cortex HormonesAbstract
Objective: To determine the efficacy and safety of human immunoglobulin (HI) used as monotherapy, compared with corticosteroids, in pediatric patients with multisystem inflammatory syndrome (MIS) associated with COVID-19. Methods: systematic search carried out with evidence published up to April 20, 2022 in PubMed, The Cochrane Library and LILACS databases, the selection of documents focused on clinical practice guidelines (CPG), ETS, systematic reviews and clinical trials. randomized controlled trials (RCTs) in phase III. This process was complemented with a search on the web pages of organizations that carry out CPG and ETS. RCT registries were also consulted at www.ClinicalTrials.gov to identify any that are ongoing or not yet published. Results: Two CPGs prepared by the WHO and the NIH, an observational study and an ongoing phase III RCT, were analyzed. The WHO and the NIH do not recommend the use of HI in monotherapy for the treatment of SIM. An observational study found no difference between HI and corticosteroids in mortality, morbidity, and adverse events in pediatric MIS patients. Finally, a phase III RCT was identified in the process of recruiting pediatric participants with SIM, and it will seek to compare the effect of corticosteroids with HI. Conclusion: There is no evidence that the use of HI in monotherapy is more effective and safe than the use of corticosteroids in monotherapy for the treatment of pediatric patients with MIS associated with COVID-19.
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Marzano AV, Cassano N, Moltrasio C, Verdoni L, Genovese G, Vena GA. Multisystem Inflammatory Syndrome in Children Associated with COVID-19: A Review with an Emphasis on Mucocutaneous and Kawasaki Disease-Like Findings. Dermatology. 2022;238(1):1. doi:10.1159/000515449
Riphagen S, Gomez X, Gonzalez-Martinez C, Wilkinson N, Theocharis P. Hyperinflammatory shock in children during COVID-19 pandemic. Lancet. 2020;395(10237):1607-1608. doi:10.1016/S0140-6736(20)31094-1
Bohn MK, Yousef P, Steele S, Sepiashvili L, Adeli K. MultiInflammatory Syndrome in Children: A View into Immune Pathogenesis from a Laboratory Perspective. J Appl Lab Med. 2022;7(1):311-321. doi:10.1093/JALM/JFAB114
CDC. Reporting Multisystem Inflammatory Syndrome in Children (MIS-C). Published online 2020. Accessed March 5, 2022. https://www.cdc.gov/mis-c/hcp/index.html
OMS. Multisystem inflammatory syndrome in children and adolescents temporally related to COVID-19 [Internet]. OMS; 2020 [Cited 2022 april 05]. Available from: https://bit.ly/3H6yRrt
Gottlieb M, Bridwell R, Ravera J, Long B. Multisystem inflammatory syndrome in children with COVID-19. Am J Emerg Med. 2021;49:148. doi:10.1016/J.AJEM.2021.05.076
Dufort EM, Koumans EH, Chow EJ, Rosenthal EM, Muse A, Rowlands J, et al. Multisystem Inflammatory Syndrome in Children in New York State. N Engl J Med. 2020;383(4):347-358. doi:10.1056/NEJMOA2021756
Davies P, Evans C, Kanthimathinathan HK, Lillie J, Brierley J, Waters G, et al. Intensive care admissions of children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) in the UK: a multicentre observational study. Lancet Child Adolesc Health. 2020;4(9):669-677. doi:10.1016/S2352-4642(20)30215-7
Yasuhara J, Watanabe K, Takagi H, Sumitomo N, Kuno T. COVID‐19 and multisystem inflammatory syndrome in children: A systematic review and meta‐analysis. Pediatr Pulmonol. 2021;56(5):837-848. doi:10.1002/PPUL.25245
Acevedo L, Piñeres-Olave BE, Niño-Serna LF, Mazzillo L, Ardila IJ, Chacón S, et al. Mortality and clinical characteristics of multisystem inflammatory syndrome in children (MIS-C) associated with covid-19 in critically ill patients: an observational multicenter study (MISCO study). BMC Pediatr. 2021;21(1):1-12. doi:10.1186/S12887-021-02974-9/TABLES/4
Yousaf AR, Cortese MM, Taylor AW, Broder KR, Oster ME, Wong JM, et al. Reported cases of multisystem inflammatory syndrome in children aged 12–20 years in the USA who received a COVID-19 vaccine, December, 2020, through August, 2021: a surveillance investigation. Lancet Child Adolesc Health. 2022;0(0). doi:10.1016/S2352-4642(22)00028-1
Aronoff SC, Hall A, del Vecchio MT. The Natural History of SARS-Cov-2 Related Multisystem Inflammatory Syndrome in Children (MIS-C): A Systematic Review. Journal of the Pediatric Infectious Diseases Society. 2020;9(6):746–51. doi:10.1093/jpids/piaa112/5905175
Alsaied T, Tremoulet AH, Burns JC, Saidi A, Dionne A, Lang SM, et al. Review of Cardiac Involvement in Multisystem Inflammatory Syndrome in Children. Circulation. 2021;143(1):78-88. doi:10.1161/CIRCULATIONAHA.120.049836
Perez EE, Orange JS, Bonilla F, Chinen J, Chinn IK, Dorsey M, et al. Update on the use of immunoglobulin in human disease: A review of evidence. Journal of Allergy and Clinical Immunology. 2017;139(3):S1-S46. doi:10.1016/J.JACI.2016.09.023
Wardle AJ, Connolly GM, Seager MJ, Tulloh RMR. Corticosteroids for the treatment of Kawasaki disease in children. Cochrane Database Syst Rev. 2017;2017(1). doi:10.1002/14651858.CD011188.PUB2
MINSA. Resolucción Ministerial N° 315-2020-MINSA [Internet]. Ministerio de Salud; 2020 [citado el 25 de Marzo del 2022]. Disponible en: https://bit.ly/3UvTQXL
MINSA. Documento técnico de atención y manejo clínico de casos de COVID-19. Resolución Ministerial N° 139-2020-MINSA [Internet]. Ministerio de salud; 2020 [citado el 25 de Marzo del 2022]. Disponible en: https://bit.ly/3OZakq8
MINSA. Resolución Ministerial N° 282-2022-MINSA - Gobierno del Perú [Internet]. Ministerio de salud; 2022 [citado el 25 de Marzo del 2022]. Disponible en: https://bit.ly/3XUnuZy
CPS. Paediatric inflammatory multisystem syndrome temporally associated with COVID-19 (spring 2021 update). The Canadian Paediatric Society [Internet]. 2021 [cited 2022 March 25]. Available from: https://bit.ly/3XUrTf6
AAP. Multisystem Inflammatory Syndrome in Children (MIS-C) Interim Guidance [Internet]. American Academy of Pediatrcs; 2022 [Cited 2022 March 05]. Available from: https://bit.ly/3Fq9cZt
Henderson LA, Canna SW, Friedman KG, Gorelik M, Lapidus SK, Bassiri H, et al. American College of Rheumatology Clinical Guidance for Multisystem Inflammatory Syndrome in Children Associated With SARS-CoV-2 and Hyperinflammation in Pediatric COVID-19: Version 2. Arthritis Rheumatol. 2021;73(4):e13-e29. doi:10.1002/ART.41616
RCPCH. Paediatric multisystem inflammatory syndrome temporally associated with COVID-19 (PIMS) - guidance for clinicians [Internet]. RCPCH; 2020 [Cited 2022 March 05]. Available from: https://bit.ly/3VQNCTu
Navarro D, Tendal B, Tingay D, Vasilunas N, Anderson L, Best J, et al. Guideline summary Clinical care of children and adolescents with COVID-19: recommendations from the National COVID-19 Clinical Evidence Taskforce. Medical Journal of Australia. 2021;216(5):255–63. doi:10.5694/mja2.51305
Son MBF, Murray N, Friedman K, Young CC, Newhams MM, Feldstein LR, et al. Multisystem Inflammatory Syndrome in Children — Initial Therapy and Outcomes. New England Journal of Medicine. 2021;385(1):23-34. doi: 10.1056/NEJMoa2102605.
Ouldali N, Toubiana J, Antona D, Javouhey E, Madhi F, Lorrot M, et al. Association of Intravenous Immunoglobulins Plus Methylprednisolone vs Immunoglobulins Alone With Course of Fever in Multisystem Inflammatory Syndrome in Children. JAMA. 2021;325(9):855-864. doi:10.1001/JAMA.2021.0694
OMS. Living guidance for clinical management of COVID-19 [Internet]. World Health Organization; 2022 [Cited 2022 April 05]. Available from: https://bit.ly/3Upb3C4
Malmivaara A. Methodological considerations of the GRADE method. Ann Med. 2015;47(1):1. doi:10.3109/07853890.2014.969766
McArdle AJ, Vito O, Patel H, Seaby EG, Shah P, Wilson C, et al. Treatment of Multisystem Inflammatory Syndrome in Children. New England Journal of Medicine. 2021;385(1):11-22. doi:10.1056/NEJMOA2102968
NIH. COVID-19 Treatment Guidelines [Internet]. National Institutes of Health; 2022 [Cited 2022 April 06]. Available from: https://bit.ly/3UrwFh7.
DIGEMID. Hizentra 20%. https://www.digemid.minsa.gob.pe/FichasTecnicas.
DIGEMID. I.V. Globulin ® SN 50mg/mL. https://www.digemid.minsa.gob.pe/FichasTecnicas.
DIGEMID. Privigen 10 %. https://www.digemid.minsa.gob.pe/FichasTecnicas.
DIGEMID. Immunorel® 5%. https://www.digemid.minsa.gob.pe/FichasTecnicas.
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Copyright (c) 2022 Ricardo Abraham Gálvez Arévalo, Akram Abdul Hernández Vásquez, José Alfredo Zavala Loayza, Carlos Jesús Toro Huamanchumo, Verónica Victoria Peralta Aguilar, Eric Ricardo Peña Sanchez
This work is licensed under a Creative Commons Attribution 4.0 International License.