Horizon Pharma announced that data from its Phase 3 study of Lodotra showed a statistically significant improvement in American College of Rheumatology (ACR) response criteria in patients with rheumatoid arthritis (RA). This 12-week, double blind, placebo-controlled trial, also known as CAPRA-2 (Circadian Administration of Prednisone in Rheumatoid Arthritis-2), evaluated Lodotra compared to placebo in 350 patients with active RA who were receiving ongoing disease-modifying anti-rheumatic drug (DMARD) therapy. The primary endpoint of the study was ACR 20 response rate, which signifies a 20 percent improvement in tender and swollen joint counts, as well as other criteria, at week 12. The secondary endpoint was relative reduction of morning stiffness associated with RA at week 12.
ACR 20 responses were statistically significant for patients treated with Lodotra (48.5 percent) compared to patients treated with placebo (28.6 percent, p=0.0002). In addition, ACR 50 response, which signifies a 50 percent improvement, was also statistically significant for patients treated with Lodotra (22.7 percent) compared to patients treated with placebo (9.2 percent, p=0.0027). The relative reduction in morning stiffness compared to baseline (134 minutes) was -56.5 percent for Lodotra patients and -33.3 percent in placebo patients at week 12, which was also statistically significant (p=0.0008).
Lodotra, a circadian cytokine modulator, is a novel modified-release, low-dose prednisone tablet.
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