Efficacy and Safety of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis With and Without Fever at Baseline: Results From an Open-Label, Active-Treatment Extension Study

Επιστημονική δημοσίευση - Άρθρο Περιοδικού uoadl:3193110 50 Αναγνώσεις

Μονάδα:
Ερευνητικό υλικό ΕΚΠΑ
Τίτλος:
Efficacy and Safety of Canakinumab in Patients With Systemic Juvenile
Idiopathic Arthritis With and Without Fever at Baseline: Results From an
Open-Label, Active-Treatment Extension Study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Objective To evaluate the long-term efficacy and safety of canakinumab
and explore prediction of response in patients with systemic juvenile
idiopathic arthritis (JIA) with or without fever at treatment
initiation.
Methods At enrollment, patients with active systemic JIA (ages 2 to <20
years) started open-label canakinumab (4 mg/kg every 4 weeks
subcutaneously). Efficacy measures included the adapted American College
of Rheumatology (ACR) Pediatric 50/70/90 criteria, the Juvenile
Arthritis Disease Activity Score (JADAS), and clinically inactive
disease and clinical remission on medication, evaluated by either the
JADAS or ACR criteria.
Results Of the 123 patients (70 with fever and 52 without fever [fever
status was not reported for 1 patient]), 84 (68.3%) completed the study
(median duration 1.8 years). Comparable efficacy (adapted ACR Pediatric
50/70/90/100) was observed by day 15 in both subgroups
(60.0%/48.6%/37.1%/24.3% in those with fever and
67.3%/48.1%/34.6%/19.2% in those without fever), and further
increased thereafter. By month 6, clinical remission according to the
JADAS or the ACR criteria was achieved in 17 (24.3%) and 26 (37.1%),
respectively, of patients with fever and 9 (17.3%) and 12 (23.1%),
respectively, of patients without fever. Median time to onset of
clinical remission according to the JADAS or ACR criteria was 57 and 30
days, respectively, in those with fever, and 58 and 142 days,
respectively, in those without fever. An adapted ACR Pediatric 50
response by day 15 was the strongest predictor of achieving clinical
remission according to the JADAS (odds ratio [OR] 13 [95%
confidence interval (95% CI) 4, 42]; P < 0.0001) or glucocorticoid
discontinuation (OR 19 [95% CI 3, 114]; P = 0.002). Of the 71 of 123
patients (57.7%) who received glucocorticoids at study entry, 27
(38.0%) discontinued glucocorticoids and 21 (29.6%) reached a dose of
<0.2 mg/kg/day, with no difference between those with and those without
fever; 13 patients (10.6%) tolerated a sustained canakinumab dose
reduction to 2 mg/kg every 4 weeks. No new safety findings were
observed.
Conclusion Canakinumab provided rapid and sustained improvement of
active systemic JIA irrespective of the presence of fever at treatment
initiation.
Έτος δημοσίευσης:
2020
Συγγραφείς:
Brunner, I, Hermine
Quartier, Pierre
Alexeeva, Ekaterina and
Constantin, Tamas
Kone-Paut, Isabelle
Marzan, Katherine and
Schneider, Rayfel
Wulffraat, Nico M.
Chasnyk, Vyacheslav and
Tirosh, Irit
Kallinich, Tilmann
Kuemmerle-Deschner, Jasmin and
Wouters, Carine
Lauwerys, Bernard
Nikishina, Irina
Trachana,
Maria
Vougiouka, Olga
Martini, Alberto
Lovell, Daniel J. and
Levy, Jeremy
Vritzali, Eleni
Ruperto, Nicolino
Paediat
Rheumatology Int Trials Or
Περιοδικό:
Arthritis and Rheumatology
Εκδότης:
Wiley
Τόμος:
72
Αριθμός / τεύχος:
12
Σελίδες:
2147-2158
Επίσημο URL (Εκδότης):
DOI:
10.1002/art.41436
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