Pediatric Rheumatology Online Journal → June 2003 → Non-steroidal anti-inflammatory drugs→ Abstract #44

A RANDOMIZED TRIAL OF TWO DOSE REGIMEN OF MELOXICAM COMPARED TO NAPROXEN ORAL SUSPENSION IN JUVENILE IDIOPATHIC ARTHRITIS

N. Ruperto,¹ N. Kuzmina,¹ E. Pachanov,¹ Y. Shachbazian,¹ A. M. Prieur,¹ V. Artamonova,¹ R. Joos,¹ F. Zulian,¹ R. Schwarz,¹ A. Buoncompagni,¹ W. Emminger,¹ I. Foeldvari,¹ F. Falcini,¹ E. Baildam,¹ A. Martini for PRINTO,¹ R. Sigmund,² S. Simianer for Boehringer Ingelheim.²

^{1Pediatria II, IRCCS G. Gaslini, Genoa, Italy; 2Boehringer Ingelheim, Biberach an der Riss, Germany}

Objective: 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 polyarthritis JIA. The benefit of the once daily administration for meloxicam oral suspension is a significant improvement in the treatment of JIA.