Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension.
OBJECTIVE
To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA).


METHODS
Patients eligible for the open-label extension (OLE, weeks 52-204) received infliximab 3-6 mg/kg every 8 weeks plus methotrexate.


RESULTS
Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively.


CONCLUSIONS
In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate.
Ruperto
Nicolino
N
IRCCS Istituto G Gaslini, Pediatria II-PRINTO, Largo Gaslini 5, EULAR Centre of Excellence in Rheumatology 2008-13, Genoa, Italy. nicolaruperto@ospedale-gaslini.ge.it
Lovell
Daniel J
DJ
Cuttica
Ruben
R
Woo
Patricia
P
Meiorin
Silvia
S
Wouters
Carine
C
Silverman
Earl D
ED
Balogh
Zsolt
Z
Henrickson
Michael
M
Davidson
Joyce
J
Foeldvari
Ivan
I
Imundo
Lisa
L
Simonini
Gabriele
G
Oppermann
Joachim
J
Xu
Stephen
S
Shen
Yaung-Kaung
YK
Visvanathan
Sudha
S
Fasanmade
Adedigbo
A
Mendelsohn
Alan
A
Martini
Alberto
A
Giannini
Edward H
EH
D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004812:Epidemiologic Methods; D006801:Humans; D000069285:Infliximab; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D000069285:Infliximab; D008727:Methotrexate