NORTHBROOK, Ill. An investigational drug for rheumatoid arthritis significantly reduced symptoms in patients, according to results of a late-stage clinical trial announced Wednesday.
Horizon Pharma presented data from two three-month phase 3 studies of Lodotra, a modified-release formulation of the drug prednisone, at the 11th annual congress of the European League Against Rheumatism in Rome. The studies included a 350-patient U.S. trial comparing Lodotra with placebo, while the 288-patient European study compared Lodotra with an immediate-release formulation of prednisone.
In the U.S. study, 48.5% of those receiving the drug had a 20% reduction in symptoms, the study’s primary goal, compared with 28.6% of those taking placebo. In addition, 22.7% of those in the Lodotra group had a 50% reduction in symptoms, compared with 9.2% of those in the placebo group.
In Europe, 22.7% of those taking Lodotra showed a reduction in the duration of morning stiffness, compared with 0.4% of those taking immediate-release prednisone. A 12-month open-label study followed the European trial, with 55% of those taking Lodotra having a reduction in morning stiffness, compared with 45% of those who had switched from immediate-release prednisone to Lodotra.
“Conditions like rheumatoid arthritis follow a very distinct circadian rhythm, in which symptoms are more severe at a specific time of day,” said Frank Buttgereit, a doctor in the Department of Rheumatology and Clinical Immunology at Berlin’s Charite Hospital. “In the case of RA, many patients feel stiff when they wake up, and it has the potential to negatively impact their quality of life.”