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Turkish archives of pediatrics
03, 2024;59 (2): 185-192.

How Safe Are Biological Agents in Pediatric Rheumatology?

Emine Nur Sunar Yayla, Çişem Yıldız, Pelin Esmeray Şenol, Nihal Karaçayır, Deniz Gezgin Yıldırım, Sevcan A Bakkaloğlu
Author Information
  1. Emine Nur Sunar Yayla: Division of Pediatric Rheumatology, Department of Pediatrics, Gazi University Faculty of Medicine, Ankara, Turkey, Clinic of Pediatric Rheumatology, Ankara Etlik City Hospital, Ankara, Turkey.
  2. Çişem Yıldız: Division of Pediatric Rheumatology, Department of Pediatrics, Gazi University Faculty of Medicine, Ankara, Turkey.
  3. Pelin Esmeray Şenol: Division of Pediatric Rheumatology, Department of Pediatrics, Gazi University Faculty of Medicine, Ankara, Turkey.
  4. Nihal Karaçayır: Division of Pediatric Rheumatology, Department of Pediatrics, Gazi University Faculty of Medicine, Ankara, Turkey.
  5. Deniz Gezgin Yıldırım: Division of Pediatric Rheumatology, Department of Pediatrics, Gazi University Faculty of Medicine, Ankara, Turkey.
  6. Sevcan A Bakkaloğlu: Division of Pediatric Rheumatology, Department of Pediatrics, Gazi University Faculty of Medicine, Ankara, Turkey.
PMID: 38454228 DOI: 10.5152/TurkArchPediatr.2024.23221

Abstract

OBJECTIVE: Biologic therapy has changed the prognosis of patients with rheumatologic disease. Despite all benefits of the biological agents, adverse events may occur due to their long-term use. The aim of this study is to analyze the adverse events observed in pediatric patients who received biological treatment.
MATERIALS AND METHODS: This retrospective observational cohort study was conducted between January 2010 and January 2022. File records of 139 patients used biological agents for rheumatologic diseases in a pediatric rheumatology clinic were evaluated. Diagnosis, received treatment, the rationale for stopping treatment, requirement of tuberculosis prophylaxis, presence of an adverse event, and results were recorded.
RESULTS: The most used biological therapy was etanercept (41.7%). Anakinra, adalimumab, canakinumab were used in 30.9%, 27.3%, 23.7% of patients, and the others in less than 10%. Totally 491 adverse events (97.9/100 patient-years) were encountered during the duration of biological treatment. The most often adverse event was recurrent upper respiratory tract infection in the patients (31.9/100 patient-years). Elevated aminotransferase levels (10.4/100 patient-years), abdominal pain (7/100 patient-years), and headache (5.2/100 patient-years) were among the other common side effects. Isoniazid (INH) prophylaxis was needed before biological treatment in 20.9% of the patients. Tuberculosis developed in none of the patients followed-up for latent tuberculosis, however, it developed in a patient while receiving etanercept due to noncompliance with his scheduled outpatient visits during etanercept treatment.
CONCLUSION: The most commonly used biological treatments were TNFi and IL-antagonists, and the majority of side effects were infections and laboratory abnormalities. Although the rate of serious adverse events is quite low, close follow-up of patients receiving biological therapy is very important.

References

Arthritis Rheumatol. 2015 Sep;67(9):2487-94 [PMID: 25989609]
Turk J Med Sci. 2018 Dec 12;48(6):1109-1114 [PMID: 30541234]
Curr Rheumatol Rep. 2016 Jul;18(7):45 [PMID: 27306623]
N Engl J Med. 2009 Jun 4;360(23):2416-25 [PMID: 19494217]
Arthritis Res Ther. 2009;11(1):216 [PMID: 19291269]
N Engl J Med. 2001 Oct 11;345(15):1098-104 [PMID: 11596589]
Arthritis Rheum. 2012 Apr;64(4):1263-71 [PMID: 22328538]
Bull NYU Hosp Jt Dis. 2007;65(3):205-11 [PMID: 17922671]
J Clin Aesthet Dermatol. 2009 May;2(5):29-37 [PMID: 20729962]
Ann Rheum Dis. 2015 Oct;74(10):1854-60 [PMID: 24842571]
J Rheumatol. 1993 Feb;20(2):259-62 [PMID: 8474061]
Curr Opin Rheumatol. 2008 Sep;20(5):613-8 [PMID: 18698187]
Pediatr Rheumatol Online J. 2015 Dec 03;13:54 [PMID: 26635208]
Arthritis Rheum. 2013 Sep;65(9):2486-96 [PMID: 23754188]
J Rheumatol. 2011 Apr;38(4):760-3 [PMID: 21239753]
Oral Dis. 2008 Apr;14(3):206-16 [PMID: 18282173]
Rheumatology (Oxford). 2018 Feb 01;57(2):273-282 [PMID: 28431162]
Arthritis Care Res (Hoboken). 2017 Apr;69(4):552-560 [PMID: 27390133]
J Exp Med. 2017 Sep 4;214(9):2547-2562 [PMID: 28747427]
J Rheumatol. 1998 Feb;25(2):203-7 [PMID: 9489807]
JAMA. 2006 May 17;295(19):2275-85 [PMID: 16705109]
Indian J Crit Care Med. 2008 Oct;12(4):181-9 [PMID: 19742267]
Arthritis Rheum. 1990 Mar;33(3):305-15 [PMID: 2180403]
Arthritis Rheum. 2008 Jan 15;59(1):4-13 [PMID: 18163404]
Ann Rheum Dis. 2015 Jun;74(6):1110-7 [PMID: 24834925]
Ann Oncol. 2003 Dec;14(12):1792 [PMID: 14630688]
Arch Rheumatol. 2020 Jun 25;36(1):146-157 [PMID: 34046584]
Arthritis Rheumatol. 2014 Sep;66(9):2570-9 [PMID: 24839206]
Rheumatol Int. 2012 Sep;32(9):2675-9 [PMID: 21789614]
Expert Opin Pharmacother. 2006 Mar;7(4):387-99 [PMID: 16503811]
Ann Rheum Dis. 2013 Apr;72 Suppl 2:ii2-34 [PMID: 23532441]
Curr Opin Rheumatol. 2009 May;21(3):224-30 [PMID: 19365268]
Eur J Pediatr. 2011 Feb;170(2):157-67 [PMID: 20556424]
Turk Arch Pediatr. 2021 May 1;56(3):179-186 [PMID: 34104906]
Ann Rheum Dis. 2018 Jul;77(7):1012-1016 [PMID: 29440001]
Arthritis Res Ther. 2016 Sep 22;18(1):210 [PMID: 27655411]
Expert Rev Clin Immunol. 2019 Feb;15(2):189-198 [PMID: 30451548]
Semin Arthritis Rheum. 2013 Jun;42(6):597-618 [PMID: 23337074]
Arthritis Res Ther. 2020 Oct 29;22(1):258 [PMID: 33121528]
Ann Rheum Dis. 2023 Aug;82(8):1059-1067 [PMID: 37247942]
Expert Opin Biol Ther. 2013 Nov;13(11):1623-30 [PMID: 24070010]
Lancet. 2008 Mar 22;371(9617):998-1006 [PMID: 18358927]
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