Phase 3 trial of Lodotra for rheumatoid arthritis

Horizon Pharma announced positive results from its Phase 3 registration study of Lodotra (prednisone tablet), that showed a statistically significant improvement in American College of Rheumatology (ACR) response criteria in patients with rheumatoid arthritis (RA). The CAPRA-2 (Circadian Administration of Prednisone in Rheumatoid Arthritis-2) registration study was a 12-week, double blind, placebo-controlled trial evaluating Lodotra compared to placebo in 350 patients with active RA who were receiving ongoing disease-modifying anti-rheumatic drug (DMARD) therapy.

The primary endpoint, ACR 20 response rate (a 20% improvement in tender and swollen joint counts), was statistically significant for patients treated with Lodotra (48.5%) compared to patients treated with placebo (28.6%, p=0.0002). In addition, ACR 50 response (a 50% improvement) was also statistically significant for patients treated with Lodotra (22.7%) compared to patients treated with placebo (9.2%, p=0.0027). While not statistically significant, and the study was not sized for this assessment, an improvement in ACR 70 response (a 70% improvement), was also demonstrated in patients treated with Lodotra (7%) compared to patients treated with placebo (2.5%, p=0.0955).  The secondary endpoint, relative reduction in morning stiffness compared to baseline (134 minutes), was -56.5% for Lodotra patients and -33.3% in placebo patients at week 12 (p=0.0008).

Lodotra, a circadian cytokine modulator, is a novel modified release, low-dose prednisone tablet.

For more information visit www.horizonpharma.com.