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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Arthritis+Rheumatol
2014 ; 66
(9
): 2570-9
Nephropedia Template TP
gab.com Text
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English Wikipedia
Randomized, double-blind, placebo-controlled trial of the efficacy and safety of
rilonacept in the treatment of systemic juvenile idiopathic arthritis
#MMPMID24839206
Ilowite NT
; Prather K
; Lokhnygina Y
; Schanberg LE
; Elder M
; Milojevic D
; Verbsky JW
; Spalding SJ
; Kimura Y
; Imundo LF
; Punaro MG
; Sherry DD
; Tarvin SE
; Zemel LS
; Birmingham JD
; Gottlieb BS
; Miller ML
; O'Neil K
; Ruth NM
; Wallace CA
; Singer NG
; Sandborg CI
Arthritis Rheumatol
2014[Sep]; 66
(9
): 2570-9
PMID24839206
show ga
OBJECTIVE: To assess the efficacy and safety of rilonacept, an interleukin-1
inhibitor, in a randomized, double-blind, placebo-controlled trial. METHODS: An
initial 4-week double-blind placebo phase was incorporated into a 24-week
randomized multicenter design, followed by an open-label phase. Seventy-one
children who had active arthritis in ?2 joints were randomized (1:1) to the 2
arms of the study. Patients in the rilonacept arm received rilonacept (loading
dose 4.4 mg/kg followed by 2.2 mg/kg weekly, subcutaneously) beginning on day 0.
Patients in the placebo arm received placebo for 4 weeks followed by a loading
dose of rilonacept at week 4 followed by weekly maintenance doses. The primary
end point was time to response, using the adapted American College of
Rheumatology Pediatric 30 criteria coupled with the absence of fever and taper of
the dosage of systemic corticosteroids, using prespecified criteria. RESULTS: The
time to response was shorter in the rilonacept arm than in the placebo arm (?(2)
= 7.235, P = 0.007). The secondary analysis, which used the same response
criteria, showed that 20 (57%) of 35 patients in the rilonacept arm had a
response at week 4 compared with 9 (27%) of 33 patients in the placebo arm (P =
0.016). Exacerbation of systemic juvenile idiopathic arthritis (JIA) was the most
common severe adverse event. More patients in the rilonacept arm had elevated
liver transaminase levels (including levels more than 3 times the upper limit of
normal) compared with those in the placebo arm. Adverse events were similar in
the 2 arms of the study. CONCLUSION: Rilonacept was generally well tolerated and
demonstrated efficacy in active systemic JIA.
|Adolescent
[MESH]
|Antirheumatic Agents/adverse effects/*therapeutic use
[MESH]
|Arthritis, Juvenile/*drug therapy
[MESH]
|Child
[MESH]
|Child, Preschool
[MESH]
|Double-Blind Method
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Male
[MESH]
|Recombinant Fusion Proteins/adverse effects/*therapeutic use
[MESH]