{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T07:17:16Z","timestamp":1792048636661,"version":"4.4.0"},"reference-count":28,"publisher":"The Pediatric Pharmacy Association","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,10]]},"abstract":"\n OBJECTIVES<\/jats:title>\n Primary objective: to quantify tocilizumab (TCZ) use in pediatric inpatients. Secondary objectives: to explore safety and clinical outcomes.<\/jats:p>\n <\/jats:sec>\n \n METHODS<\/jats:title>\n This retrospective cohort study took place in a free-standing, 564-bed children\u2019s hospital. Pediatric inpatients who received intravenous TCZ from January 2016 to May 2021 were included. Data collected included demographics, indication, dose, number of administrations, safety events on days 0 to 7 after TCZ, use of extracorporeal support (ES), presence of concurrent infection, and survival to discharge. Exploratory analyses assessed characteristics associated with mortality.<\/jats:p>\n <\/jats:sec>\n \n RESULTS<\/jats:title>\n A total of 103 TCZ courses (n = 87 patients) were analyzed. Median age was 14 years. Tocilizumab indications included cytokine release syndrome (CRS; 56%), autoimmune disease (27%), graft-versus-host disease (GVHD; 5%), and COVID-19 (4%). The median TCZ dose was 8 mg\/kg (IQR, 7.9\u201311.9), 18% of courses were administered during active infection, and ES was used in 15% of courses. New-onset alanine transaminase (ALT) or aspartate transaminase (AST) levels >3 times upper limit of normal (ULN) occurred in 53% and 60% of courses, respectively. Of 29 courses with evaluable hematologic data, 10% resulted in new-onset neutropenia and 3% in severe thrombocytopenia. Overall survival to discharge was 83%. In multivariable analyses, independent associations with mortality were found for the use of ES (OR, 8.68; 95% CI, 1.85\u20134.87), oncologic diagnosis (OR, 7.07; 95% CI, 1.14\u201389.29), and post-TCZ infection (OR, 11.17; 95% CI, 1.50\u2013138.13).<\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS<\/jats:title>\n Tocilizumab is used for many pediatric inpatient indications, most commonly CRS. Newly identified transaminitis was common following TCZ administration. Risk factors for mortality are likely confounded by illness severity. Administration during active infection was not independently associated with increased mortality.<\/jats:p>\n <\/jats:sec>","DOI":"10.5863\/jppt-24-00130","type":"journal-article","created":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T22:03:34Z","timestamp":1763762614000},"page":"638-644","source":"Crossref","is-referenced-by-count":1,"title":["Real-World Tocilizumab Use in Pediatric Inpatients"],"prefix":"10.5863","volume":"30","author":[{"given":"Gideon A.","family":"Stitt","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology (GAS), Department of Pediatrics, University of Utah, Salt Lake City, UT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark W.","family":"Hall","sequence":"additional","affiliation":[{"name":"Division of Pediatric Critical Care Medicine (MWH), Department of Pediatrics, Nationwide Children\u2019s Hospital, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary Ann","family":"Diliberto","sequence":"additional","affiliation":[{"name":"Center for Clinical Pharmacology (MAD), Children\u2019s Hospital of Philadelphia, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athena F.","family":"Zuppa","sequence":"additional","affiliation":[{"name":"Department of Pediatrics (AFZ), Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"3883","reference":[{"issue":"8","key":"i2331-348X-30-5-638-b01","series-title":"Oncologist","first-page":"943","article-title":"FDA approval summary: tocilizumab for treatment of chimeric antigen receptor t cell-induced severe or life-threatening cytokine release syndrome","volume":"23","author":"Le","year":"2018","unstructured":"Le R, Li L, Yuan W, et al. FDA approval summary: tocilizumab for treatment of chimeric antigen receptor t cell-induced severe or life-threatening cytokine release syndrome. Oncologist. 2018;23(8):943\u2013947."},{"key":"i2331-348X-30-5-638-b02","article-title":"ACTEMRA (tocilizumab) [package insert]","year":"2021","unstructured":"ACTEMRA (tocilizumab) [package insert]. San Francisco, CA: Genentech Inc; September 2021."},{"key":"i2331-348X-30-5-638-b03","article-title":"Coronavirus (COVID-19) update: FDA authorizes drug for treatment of COVID-19","unstructured":"Coronavirus (COVID-19) update: FDA authorizes drug for treatment of COVID-19. US Food and Drug Administration. Published June 28, 2021. Accessed September 1, 2021. https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-authorizes-drug-treatment-covid-19"},{"issue":"1","key":"i2331-348X-30-5-638-b04","series-title":"Crit Care","first-page":"524","article-title":"Efficacy of tocilizumab treatment in severely ill COVID-19 patients","volume":"24","author":"Zhao","year":"2020","unstructured":"Zhao J, Cui W, Tian B-p. Efficacy of tocilizumab treatment in severely ill COVID-19 patients. Crit Care. 2020;24(1):524."},{"issue":"3","key":"i2331-348X-30-5-638-b05","series-title":"Lung","first-page":"239","article-title":"Tocilizumab in hospitalized patients with COVID-19: a meta analysis of randomized controlled trials","volume":"199","author":"Selvaraj","year":"2021","unstructured":"Selvaraj V, Khan MS, Bavishi C, et al. Tocilizumab in hospitalized patients with COVID-19: a meta analysis of randomized controlled trials. Lung. 2021;199(3):239\u2013248."},{"issue":"6","key":"i2331-348X-30-5-638-b06","series-title":"Intensive Care Med","first-page":"641","article-title":"Tocilizumab in COVID-19: a meta-analysis, trial sequential analysis, and meta-regression of randomized-controlled trials","volume":"47","author":"Snow","year":"2021","unstructured":"Snow TAC, Saleem N, Ambler G, et al. Tocilizumab in COVID-19: a meta-analysis, trial sequential analysis, and meta-regression of randomized-controlled trials. Intensive Care Med. 2021;47(6):641\u2013652."},{"issue":"1","key":"i2331-348X-30-5-638-b07","series-title":"Clin Microbiol Infect","first-page":"13","article-title":"Effect of tocilizumab, sarilumab, and baricitinib on mortality among patients hospitalized for COVID-19 treated with corticosteroids: a systematic review and meta-analysis","volume":"29","author":"Albuquerque","year":"2023","unstructured":"Albuquerque AM, Eckert I, Tramujas L, et al. Effect of tocilizumab, sarilumab, and baricitinib on mortality among patients hospitalized for COVID-19 treated with corticosteroids: a systematic review and meta-analysis. Clin Microbiol Infect. 2023;29(1):13\u201321."},{"issue":"1","key":"i2331-348X-30-5-638-b08","series-title":"JAMA Intern Med","first-page":"24","article-title":"Effect of tocilizumab vs standard care on clinical worsening in patients hospitalized with COVID-19 pneumonia: a randomized clinical trial","volume":"181","author":"Salvarani","year":"2021","unstructured":"Salvarani C, Dolci G, Massari M, et al. Effect of tocilizumab vs standard care on clinical worsening in patients hospitalized with COVID-19 pneumonia: a randomized clinical trial. JAMA Intern Med. 2021;181(1):24."},{"issue":"24","key":"i2331-348X-30-5-638-b09","series-title":"N Engl J Med","first-page":"2333","article-title":"Efficacy of tocilizumab in patients hospitalized with Covid-19","volume":"383","author":"Stone","year":"2020","unstructured":"Stone JH, Frigault MJ, Serling-Boyd NJ, et al. Efficacy of tocilizumab in patients hospitalized with Covid-19. N Engl J Med. 2020;383(24):2333\u20132344."},{"issue":"16","key":"i2331-348X-30-5-638-b10","series-title":"N Engl J Med","first-page":"1503","article-title":"Tocilizumab in hospitalized patients with severe Covid-19 pneumonia","volume":"384","author":"Rosas","year":"2021","unstructured":"Rosas IO, Br\u00e4u N, Waters M, et al. Tocilizumab in hospitalized patients with severe Covid-19 pneumonia. 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N Engl J Med. 2021;384(1):20\u201330."},{"issue":"1","key":"i2331-348X-30-5-638-b13","series-title":"Pediatr Rheumatol","first-page":"22","article-title":"IL-6 blockade in systemic juvenile idiopathic arthritis\u2014achievement of inactive disease and remission (data from the German AID-registry)","volume":"16","author":"Bielak","year":"2018","unstructured":"Bielak M, Husmann E, Weyandt N, et al. IL-6 blockade in systemic juvenile idiopathic arthritis\u2014achievement of inactive disease and remission (data from the German AID-registry). Pediatr Rheumatol. 2018;16(1):22."},{"issue":"4","key":"i2331-348X-30-5-638-b14","series-title":"Rheumatology","first-page":"732","article-title":"Efficacy and safety of tocilizumab in a real-life observational cohort of patients with polyarticular juvenile idiopathic arthritis","volume":"59","author":"Gr\u00f6nlund","year":"2020","unstructured":"Gr\u00f6nlund MM, Remes-Pakarinen T, Kr\u00f6ger L, et al. 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Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021;397(10285):1637\u20131645."},{"key":"i2331-348X-30-5-638-b17","series-title":"Pediatr Neurol","first-page":"80","article-title":"Favorable outcomes with early interleukin 6 receptor blockade in severe acute necrotizing encephalopathy of childhood","volume":"98","author":"Koh","year":"2019","unstructured":"Koh JC, Murugasu A, Krishnappa J, Thomas T. Favorable outcomes with early interleukin 6 receptor blockade in severe acute necrotizing encephalopathy of childhood. Pediatr Neurol. 2019;98:80\u201384."},{"issue":"6","key":"i2331-348X-30-5-638-b18","series-title":"JAMA","first-page":"499","article-title":"Association between administration of IL-6 antagonists and mortality among patients hospitalized for COVID-19: a meta-analysis","volume":"326","author":"Domingo","year":"2021","unstructured":"The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group, Domingo P, Mur I, et al. Association between administration of IL-6 antagonists and mortality among patients hospitalized for COVID-19: a meta-analysis. JAMA. 2021;326(6):499."},{"issue":"3","key":"i2331-348X-30-5-638-b19","series-title":"J Med Virol","first-page":"1620","article-title":"Efficacy of tocilizumab in COVID-19: a systematic review and meta-analysis","volume":"93","author":"Aziz","year":"2021","unstructured":"Aziz M, Haghbin H, Abu Sitta E, et al. Efficacy of tocilizumab in COVID-19: a systematic review and meta-analysis. J Med Virol. 2021;93(3):1620\u20131630."},{"issue":"2","key":"i2331-348X-30-5-638-b20","series-title":"J Infect Dis","first-page":"312","article-title":"Treatment of Gram-negative septic shock with human IgG antibody to Escherichia coli J5: a prospective, double-blind, randomized trial","volume":"158","author":"Calandra","year":"1988","unstructured":"Calandra T, Glauser MP, Schellekens J, Verhoef J. Treatment of Gram-negative septic shock with human IgG antibody to Escherichia coli J5: a prospective, double-blind, randomized trial. J Infect Dis. 1988;158(2):312\u2013319."},{"issue":"23","key":"i2331-348X-30-5-638-b21","series-title":"JAMA","first-page":"1836","article-title":"Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome: results from a randomized, double-blind, placebo-controlled trial","volume":"271","author":"Fisher","year":"1994","unstructured":"Fisher CJ. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome: results from a randomized, double-blind, placebo-controlled trial. JAMA. 1994;271(23):1836."},{"issue":"7","key":"i2331-348X-30-5-638-b22","series-title":"Crit Care Med","first-page":"1115","article-title":"Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial: The Interleukin-1 Receptor Antagonist Sepsis Investigator Group","volume":"25","author":"Opal","year":"1997","unstructured":"Opal SM, Fisher CJ, Dhainaut JF, et al. Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial: The Interleukin-1 Receptor Antagonist Sepsis Investigator Group. Crit Care Med. 1997;25(7):1115\u20131124."},{"issue":"26","key":"i2331-348X-30-5-638-b23","series-title":"N Engl J Med","first-page":"6","article-title":"Treatment of septic shock with the tumor necrosis factor receptor:fc fusion protein","volume":"334","author":"Fisher","year":"1996","unstructured":"Fisher CJ, Balk RA, Benjamin E. Treatment of septic shock with the tumor necrosis factor receptor:fc fusion protein. N Engl J Med. 1996;334(26):6."},{"issue":"9107","key":"i2331-348X-30-5-638-b24","series-title":"Lancet","first-page":"929","article-title":"Double-blind randomised controlled trial of monoclonal antibody to human tumour necrosis factor in treatment of septic shock: NORASEPT II Study Group","volume":"351","author":"Abraham","year":"1998","unstructured":"Abraham E, Anzueto A, Gutierres G, et al. Double-blind randomised controlled trial of monoclonal antibody to human tumour necrosis factor in treatment of septic shock: NORASEPT II Study Group. 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JAMA J Am Med Assoc. 1997;277(6):482."},{"issue":"11","key":"i2331-348X-30-5-638-b26","series-title":"Crit Care Med","first-page":"2173","article-title":"Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab\u2032)2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels","volume":"32","author":"Panacek","year":"2004","unstructured":"Panacek EA, Marshall JC, Albertson TE, et al. Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab\u2032)2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels. Crit Care Med. 2004;32(11):2173\u20132182."},{"issue":"2","key":"i2331-348X-30-5-638-b27","series-title":"Crit Care Med","first-page":"275","article-title":"Interleukin-1 receptor blockade is associated with reduced mortality in sepsis patients with features of the macrophage activation syndrome: re-analysis of a prior Phase III trial","volume":"44","author":"Shakoory","year":"2016","unstructured":"Shakoory B, Carcillo JA, Chatham WW, et al. Interleukin-1 receptor blockade is associated with reduced mortality in sepsis patients with features of the macrophage activation syndrome: re-analysis of a prior Phase III trial. Crit Care Med. 2016;44(2):275\u2013281."},{"issue":"16","key":"i2331-348X-30-5-638-b28","series-title":"N Engl J Med","first-page":"1491","article-title":"Interleukin-6 receptor antagonists in critically ill patients with Covid-19","volume":"384","year":"2021","unstructured":"The REMAP-CAP Investigators. 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