A randomized, double-blind clinical trial of two doses of meloxicam compared with naproxen in children with juvenile idiopathic arthritis: short- and long-term efficacy and safety results.
OBJECTIVE
In an international, multicenter, double-blind, randomized clinical trial we evaluated the short-term (3 months) and long-term (12 months) efficacy and safety of 2 different doses of meloxicam oral suspension compared with the efficacy and safety of naproxen oral suspension in children with oligoarticular-course (oligo-course) or polyarticular-course (poly-course) juvenile idiopathic arthritis (JIA).


METHODS
Children ages 2-16 years who had active oligo-course or poly-course JIA and who required therapy with a nonsteroidal antiinflammatory drug were eligible for this trial. Patients were randomly allocated to receive therapy with meloxicam oral suspension, 0.125 mg/kg body weight in a single daily dose; meloxicam oral suspension, 0.25 mg/kg body weight in a single daily dose; or naproxen, 10 mg/kg body weight in 2 daily doses. The trial drugs were administered in a double-blind, double-dummy design for up to 12 months. Response rates were determined according to the American College of Rheumatology pediatric 30% improvement criteria (ACR pediatric 30). Safety parameters were assessed by evaluating the frequency of adverse events in the 3 groups.


RESULTS
Of 232 patients enrolled, 225 received treatment, 6 were not eligible for randomization, and 1 randomized patient was not treated. One hundred eighty-two patients (81%) completed the 12-month treatment period. Response rates according to the ACR pediatric 30 criteria improved from month 3 to month 12, as follows: from 63% to 77% in the meloxicam 0.125 mg/kg group, from 58% to 76% in the meloxicam 0.25 mg/kg group, and from 64% to 74% in the naproxen group. No statistically significant differences in response rates were observed between the groups. There were no differences in the frequency of adverse events or abnormal laboratory values between the 3 groups.


CONCLUSIONS
The short- and long-term safety and efficacy of meloxicam oral suspension appear to be comparable with the safety and efficacy of naproxen oral suspension in the treatment of oligo-course and poly-course JIA. The once-daily administration of meloxicam oral suspension might represent an improvement in the treatment of JIA.
Ruperto
Nicolino
N
IRCCS G. Gaslini, Pediatria II, Reumatologia, Genoa, Italy. nicolaruperto@ospedale-gaslini.ge.it <nicolaruperto@ospedale-gaslini.ge.it>
Nikishina
Irina
I
Pachanov
Evgueni D
ED
Shachbazian
Ynessa
Y
Prieur
Anne Marie
AM
Mouy
Richard
R
Joos
Rik
R
Zulian
Francesco
F
Schwarz
Rudolf
R
Artamonova
Valeria
V
Emminger
Wolfgang
W
Bandeira
Marcia
M
Buoncompagni
Antonella
A
Foeldvari
Ivan
I
Falcini
Fernanda
F
Baildam
Eileen
E
Kone-Paut
Isabelle
I
Alessio
Maria
M
Gerloni
Valeria
V
Lenhardt
Alessandro
A
Martini
Alberto
A
Hanft
Gertraud
G
Sigmund
Ralf
R
Simianer
Stefan
S
D000284:Administration, Oral; D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000077239:Meloxicam; D009288:Naproxen / Q000008:administration & dosage*; D013843:Thiazines / Q000008:administration & dosage*; D013844:Thiazoles / Q000008:administration & dosage*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D013843:Thiazines; D013844:Thiazoles; D009288:Naproxen; D000077239:Meloxicam