Horizon Pharma unveils Lodotra trial

NORTHBROOK, Ill. An investigational drug for rheumatoid arthritis reduced the duration of symptoms in patients over the course of a year, according to results of a late-stage clinical trial presented in Europe recently.

Horizon Pharma announced Friday the presentation of results of the phase 3 “CAPRA-1” study of the drug Lodotra (prednisone) at the European League Against Rheumatism’s annual congress. Results also appeared in the July issue of the journal Annals of Rheumatic Disease. Lodotra is a programmed-release formulation of low-dose prednisone.

According to the study, conducted on 288 patients, the drug produced reduced duration of morning stiffness in RA patients. Symptoms of the disease are connected to circadian rhythms and show the highest severity in the early morning, lead study author Frank Buttgereit, of Berlin’s Charite Hospital, said.

“The results of the open-label portion of the CAPRA-1 study showed that the efficacy of glucocorticoid therapy can be sustained by synchronizing the drug release with the circadian rhythm of the underlying inflammation and resulting symptoms,” Buttgereit said.