Meloxicam Compared to Naproxen Oral Suspension, in Juvenile Idiopathic Arthritis

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A Randomized Trial of Two Dose Regimen of Meloxicam Compared to Naproxen

Oral Suspension in Juvenile Idiopathic Arthritis

PURPOSE: In a multinational randomized trial we investigate the efficacy

and safety of 2 doses of meloxicam oral suspension (0.125 mg/kg/day (Mel

L) and 0.25 mg/kg/day (Mel H)) given once daily versus naproxen oral

suspension (Nap) (10 mg/kg/day as recommended by the manufacturer)

administered twice daily in patients with juvenile idiopathic arthritis

(JIA).

METHODS: This randomized 12 weeks double-blind, double-dummy trial

enrolled 232 JIA patients (140 oligo- and 85 polyarthritis). Response

rates were measured according to the ACR Pediatric 30, 50 or 70%

definition of improvement (Ped 30, 50 or 70). The intention-to-treat

principle with a last observation carried forward approach was applied

for the analysis.

RESULTS: 225 received treatment, 6 were not eligible for randomization

and 1 randomized patient did not receive drugs. 210 patients (93.3%)

were completing the treatment period while the remaining 15 (6.7%)

dropped. Response rate according to Ped 30 were Mel L 63%, Mel H 58%,

Nap 64%. According to Ped 50 rates were: Mel L 52%, Mel H 43%, and Nap

50%. Ped 70 responses were: Mel L 38%, Mel H 26%, Nap 30%. Ped 30

responses rates for poly JIA were: Mel L 68%, Mel H 73%, Nap 70%. There

were no significant differences in the response rates between the 3

groups. The response rates for all treatments were high and exceed a

response rate expected for a placebo. The number of patients with

adverse events did not differ between the 3 groups.

CONCLUSIONS: Efficacy and safety of both doses of meloxicam oral

suspension were comparable with naproxen in the treatment of oligo- and

polyartiarthritis JIA. The benefit of the once daily administration for

meloxicam oral suspension is a significant improvement in the treatment

of JIA.

Nicolino Ruperto1, N. Kuzmina1, E. Pachanov1, Y. Shachbazian1, R. M.

Mouy1, V. Artamonova1, R. Joos1, F. Zulian1, R. Schwarz1, A.

Buoncompagni1, W. Emminger1, I. Foeldvari1, F. Falcini1, E. Baildam1, A.

i1, the Paediatric Rheumatology International Trials Organisation

(PRINTO), R. Sigmund2, S. Simianer2. 1IRCCS G. GASLINI, Genova, Italy;

2Boehringer Ingelheim Pharma KG, Biberach, Germany.