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Horizon Pharma, Inc. Announces Results of Phase 3 Study of LODOTRA® Demonstrate 12-Month Sustained Efficacy and Safety in Rheumatoid Arthritis
Date:7/23/2010

NORTHBROOK, Ill., July 23 /PRNewswire/ -- Horizon Pharma, Inc. announced today the results from the extended open label portion of The Circadian Administration of Prednisone in Rheumatoid Arthritis-1 (CAPRA-1) Phase 3 European registration study of LODOTRA®, a programmed release formulation of low-dose prednisone, which showed sustained improvement in reducing the duration of morning stiffness in patients with Rheumatoid Arthritis (RA) over a 12 month period.  The results were published in the July issue of the Annals of Rheumatic Diseases and were also recently presented at the European League Against Rheumatism (EULAR) Annual Congress.

"Symptoms of RA in patients, such as morning stiffness, show pronounced circadian rhythms with the highest severity in the early morning," said Frank Buttgereit, M.D., senior consultant and deputy head of the Department of Rheumatology and Clinical Immunology, Charite Hospital, Berlin and lead author of the study.  "The results from 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."

The CAPRA-1 study of LODOTRA evaluated 288 patients with active RA in a 12-week, randomized, double-blind, placebo-controlled trial comparing bedtime administration of LODOTRA with morning administration of immediate release (IR) prednisone at the same individual dose (an average dose of 6.7 mg).  Following the double-blind portion of the study, 249 patients continued on to an open label extension study for up to nine additional months, during which all patients received only an evening dose of LODOTRA.  Variables assessed included, among other things:  (i) r
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