PMID- 33452173
OWN - NLM
STAT- MEDLINE
DCOM- 20211021
LR  - 20220627
IS  - 1499-2752 (Electronic)
IS  - 0315-162X (Linking)
VI  - 48
IP  - 7
DP  - 2021 Jul
TI  - Absence of Association Between Abatacept Exposure and Initial Infection in 
      Patients With Juvenile Idiopathic Arthritis.
PG  - 1073-1081
LID - 10.3899/jrheum.200154 [doi]
AB  - OBJECTIVE: To assess the relationship between infection risk and abatacept (ABA) 
      exposure levels in patients with polyarticular-course juvenile idiopathic 
      arthritis (pJIA) following treatment with subcutaneous (SC) and intravenous (IV) 
      ABA. METHODS: Data from 2 published studies (ClinicalTrials.gov: NCT01844518, 
      NCT00095173) of ABA treatment in pediatric patients were analyzed. One study 
      treated patients aged 2-17 years with SC ABA and the other treated patients aged 
      6-17 years with IV ABA. Association between serum ABA exposure measures and 
      infection was evaluated using Kaplan-Meier plots of probability of first 
      infection vs time on treatment by ABA exposure quartiles and log-rank tests. 
      Number of infections by ABA exposure quartiles was investigated. RESULTS: 
      Overall, 343 patients were included in this analysis: 219 patients received SC 
      ABA and 124 patients received IV ABA. Overall, 237/343 (69.1%) patients had >/= 1 
      infection over 24 months. No significant difference in time to first infection 
      across 4 quartiles of ABA exposure levels was observed in the pooled (P = 0.45), 
      SC (2-5 yrs: P = 0.93; 6-17 yrs: P = 0.48), or IV (P = 0.50) analyses. 
      Concomitant use of methotrexate and glucocorticoids (at baseline and throughout) 
      with ABA did not increase infection risk across the ABA exposure quartiles. There 
      was no evidence of association between number of infections and ABA exposure 
      quartiles. No opportunistic infections related to ABA were reported. CONCLUSION: 
      In patients aged 2-17 years with pJIA, no evidence of association between higher 
      levels of exposure to IV ABA or SC ABA and incidence of infection was observed.
CI  - Copyright (c) 2021 by the Journal of Rheumatology.
FAU - Ruperto, Nicolino
AU  - Ruperto N
AUID- ORCID: 0000-0001-8407-7782
AD  - N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e 
      Reumatologia-UOSID Centro Trial, Genoa, Italy; nicolaruperto@gaslini.org.
FAU - Brunner, Hermine I
AU  - Brunner HI
AUID- ORCID: 0000-0001-9478-2987
AD  - H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children's Hospital 
      Medical Center, Cincinnati, Ohio, USA.
FAU - Tzaribachev, Nikolay
AU  - Tzaribachev N
AUID- ORCID: 0000-0001-9215-0783
AD  - N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, 
      Germany.
FAU - Vega-Cornejo, Gabriel
AU  - Vega-Cornejo G
AUID- ORCID: 0000-0001-7637-2933
AD  - G. Vega-Cornejo, MD, CREA Hospital Mexico Americano, Guadalajara, Jalisco, 
      Mexico.
FAU - Louw, Ingrid
AU  - Louw I
AUID- ORCID: 0000-0002-4271-0217
AD  - I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa.
FAU - Cimaz, Rolando
AU  - Cimaz R
AUID- ORCID: 0000-0002-3260-4226
AD  - R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of 
      Clinical Sciences and Community Health, University of Milano, Milan, Italy.
FAU - Dare, Jason
AU  - Dare J
AUID- ORCID: 0000-0003-1538-744X
AD  - J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, 
      USA.
FAU - Espada, Graciela
AU  - Espada G
AD  - G. Espada, MD, Hospital de Ninos Dr Ricardo Gutierrez, Buenos Aires, Argentina.
FAU - Faugier, Enrique
AU  - Faugier E
AD  - E. Faugier, MD, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico.
FAU - Ferrandiz, Manuel
AU  - Ferrandiz M
AUID- ORCID: 0000-0001-6101-8608
AD  - M. Ferrandiz, MD, Instituto Nacional de Salud del Nino, Brena, Peru.
FAU - Gerloni, Valeria
AU  - Gerloni V
AD  - V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy.
FAU - Quartier, Pierre
AU  - Quartier P
AUID- ORCID: 0000-0002-1769-549X
AD  - P. Quartier, MD, Universite de Paris, IMAGINE Institute, RAISE reference centre 
      for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France.
FAU - Silva, Clovis Artur
AU  - Silva CA
AUID- ORCID: 0000-0001-9250-6508
AD  - C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, 
      Universidade de Sao Paulo, Sao Paulo, Brazil.
FAU - Wagner-Weiner, Linda
AU  - Wagner-Weiner L
AUID- ORCID: 0000-0003-0932-2981
AD  - L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA.
FAU - Gandhi, Yash
AU  - Gandhi Y
AUID- ORCID: 0000-0001-7637-9617
AD  - Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Passarell, Julie
AU  - Passarell J
AUID- ORCID: 0000-0002-2034-6274
AD  - J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA.
FAU - Nys, Marleen
AU  - Nys M
AUID- ORCID: 0000-0001-6562-8657
AD  - M. Nys, MSc, Bristol Myers Squibb, Braine-L'Alleud, Belgium.
FAU - Wong, Robert
AU  - Wong R
AUID- ORCID: 0000-0003-2949-8132
AD  - Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA.
FAU - Martini, Alberto
AU  - Martini A
AUID- ORCID: 0000-0001-7642-1459
AD  - A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, 
      Genoa, Italy and Universita di Genova, Genoa, Italy.
FAU - Lovell, Daniel J
AU  - Lovell DJ
AUID- ORCID: 0000-0003-1604-0130
CN  - Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric 
      Rheumatology International Trials Organisation (PRINTO)
LA  - eng
SI  - ClinicalTrials.gov/NCT00095173
SI  - ClinicalTrials.gov/NCT01844518
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210115
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
RN  - 0 (Antirheumatic Agents)
RN  - 7D0YB67S97 (Abatacept)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - *Abatacept/adverse effects
MH  - *Antirheumatic Agents/adverse effects
MH  - *Arthritis, Juvenile/drug therapy
MH  - Child
MH  - Humans
MH  - Infections/*epidemiology
MH  - Methotrexate/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - biological therapy
OT  - disease-modifying antirheumatic drugs
OT  - infection
OT  - juvenile idiopathic arthritis
EDAT- 2021/01/17 06:00
MHDA- 2021/10/26 06:00
CRDT- 2021/01/16 05:32
PHST- 2020/12/18 00:00 [accepted]
PHST- 2021/01/17 06:00 [pubmed]
PHST- 2021/10/26 06:00 [medline]
PHST- 2021/01/16 05:32 [entrez]
AID - jrheum.200154 [pii]
AID - 10.3899/jrheum.200154 [doi]
PST - ppublish
SO  - J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 
      15.