PMID- 38415679
OWN - NLM
STAT- MEDLINE
DCOM- 20240424
LR  - 20240425
IS  - 1941-9260 (Electronic)
IS  - 0032-5481 (Linking)
VI  - 136
IP  - 2
DP  - 2024 Mar
TI  - Adverse events of biological agents in pediatric rheumatologic diseases.
PG  - 198-207
LID - 10.1080/00325481.2024.2325333 [doi]
AB  - OBJECTIVES: To evaluate adverse events (AEs) in pediatric patients with 
      rheumatologic diseases being treated with approved or off-label biologic agents 
      (BAs). METHODS: This observational, retrospective, multicenter study was 
      conducted from 2010 to 2022 in patients under 18 years of age with rheumatic 
      diseases who were receiving interleukin-1 antibodies (Anti-IL1), interleukin-6 
      antibodies (Anti-IL6), and tumor necrosis factor alpha inhibitors (anti-TNF). 
      Efficacy, AEs, and timing of AEs were collected from electronic medical records. 
      RESULTS: Three hundred and fifteen BAs were prescribed to 237 patients. Fifty AEs 
      occurred in 44 patients (18.6%). Anti-TNF exposure was present in 8 (72.2%) of 11 
      patients with latent tuberculosis (TB) and in all 7 patients with herpes 
      infections. Four of 6 patients (66.7%) with recurrent upper respiratory tract 
      infections and 7 of 8 patients (87.5%) with local skin reactions were on 
      Anti-IL1. The cutoff value for latent TB development was determined as 
      23.5 months by ROC analysis (AUC: 0.684 +/- 0.072, p = 0.038, 95% CI: 0.54-0.82). 
      In patients who used BA for 23.5 months or more, the risk of latent TB was 
      5.94-fold (p = 0.024, 95% CI: 1.26-27.97). Drug rash with eosinophilia and 
      systemic symptoms (DRESS) occurred in 2 patients on anakinra, and anaphylaxis 
      occurred in 1 patient on anti-IL6. There were no cases of malignancy or death in 
      any patient. CONCLUSION: The physician should be vigilant for latent TB in 
      patients exposed to BA for more than 2 years. While local skin reactions are more 
      prevalent in patients receiving anti-IL1, severe skin reactions such as DRESS may 
      also occur.
FAU - Polat, Merve Cansu
AU  - Polat MC
AUID- ORCID: 0000-0003-3279-8435
AD  - Department of Pediatric Rheumatology, University of Health Sciences, Ankara City 
      Hospital, Cankaya, Turkey.
FAU - Mertek, Saniye
AU  - Mertek S
AUID- ORCID: 0000-0002-6578-1077
AD  - Department of Pediatrics, Ankara University School of Medicine, Ankara, Turkey.
FAU - Ozcakar, Zeynep Birsin
AU  - Ozcakar ZB
AUID- ORCID: 0000-0002-6376-9189
AD  - Department of Pediatric Rheumatology, Ankara University School of Medicine, 
      Ankara, Turkey.
FAU - Celikel, Elif
AU  - Celikel E
AUID- ORCID: 0000-0003-0129-4410
AD  - Department of Pediatric Rheumatology, University of Health Sciences, Ankara City 
      Hospital, Cankaya, Turkey.
FAU - Aydin, Fatma
AU  - Aydin F
AUID- ORCID: 0000-0003-0306-7473
AD  - Department of Pediatric Rheumatology, Ankara University School of Medicine, 
      Ankara, Turkey.
FAU - Tekin, Zahide Ekici
AU  - Tekin ZE
AUID- ORCID: 0000-0002-5446-667X
AD  - Department of Pediatric Rheumatology, University of Health Sciences, Ankara City 
      Hospital, Cankaya, Turkey.
FAU - Elhan, Atilla Halil
AU  - Elhan AH
AUID- ORCID: 0000-0003-3324-248X
AD  - Department of Biostatistics, Ankara University Medical School, Ankara, Turkey.
FAU - Celikel Acar, Banu
AU  - Celikel Acar B
AUID- ORCID: 0000-0002-1808-3655
AD  - Department of Pediatric Rheumatology, University of Health Sciences, Ankara City 
      Hospital, Cankaya, Turkey.
FAU - Cakar, Nilgun
AU  - Cakar N
AUID- ORCID: 0000-0002-1853-0101
AD  - Department of Pediatric Rheumatology, Ankara University School of Medicine, 
      Ankara, Turkey.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20240305
PL  - England
TA  - Postgrad Med
JT  - Postgraduate medicine
JID - 0401147
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Interleukin-1)
RN  - 0 (Interleukin-6)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - 0 (Biological Factors)
SB  - IM
MH  - Humans
MH  - Male
MH  - Female
MH  - *Rheumatic Diseases/drug therapy
MH  - Child
MH  - Retrospective Studies
MH  - Adolescent
MH  - Child, Preschool
MH  - Antirheumatic Agents/adverse effects
MH  - Latent Tuberculosis/drug therapy/epidemiology
MH  - Interleukin-1/antagonists & inhibitors
MH  - Interleukin-6/antagonists & inhibitors
MH  - Tumor Necrosis Factor-alpha/antagonists & inhibitors
MH  - Biological Factors/adverse effects
OTO - NOTNLM
OT  - Adverse events
OT  - biological agents
OT  - optic neuritis
OT  - pediatric rheumatologic disease
OT  - tuberculosis
EDAT- 2024/02/28 12:43
MHDA- 2024/04/24 19:05
CRDT- 2024/02/28 09:28
PHST- 2024/04/24 19:05 [medline]
PHST- 2024/02/28 12:43 [pubmed]
PHST- 2024/02/28 09:28 [entrez]
AID - 10.1080/00325481.2024.2325333 [doi]
PST - ppublish
SO  - Postgrad Med. 2024 Mar;136(2):198-207. doi: 10.1080/00325481.2024.2325333. Epub 
      2024 Mar 5.