Horizon Pharma, Inc. (HZNP) announced an additional analysis of data from the pivotal Circadian Administration of Prednisone in Rheumatoid Arthritis-2 or CAPRA-2 clinical trial demonstrating that patients with active rheumatoid arthritis or RA treated with its recently approved RAYOS 5 mg (prednisone) delayed-release tablets had a significant improvement in reduction of fatigue, as determined by the Functional Assessment of Chronic Illness Therapy - Fatigue or FACIT-F questionnaire.
The efficacy of RAYOS in the treatment of RA was assessed in the CAPRA-2 trial, a double-blind, placebo-controlled, randomized, 12-week trial in patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology or ACR criteria.
Enrolled patients were not currently being treated with corticosteroids but did receive non-biologic disease-modifying antirheumatic drug (DMARD) therapy for at least 6 months prior to receipt of study medication.
Patients were randomized in a 2:1 ratio to treatment with RAYOS 5 mg (n=231) or placebo (n=119) administered at 10 p.m. in addition to their DMARD therapy. Patients ranged in age from 27 to 80 years (median age 57 years) old, were predominantly Caucasian and were predominately (84%) female.
The primary endpoint was the proportion of patients achieving ACR20 response after 12 weeks. A key secondary endpoint was to compare treatment with RAYOS 5 mg and placebo in the change from baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire, a 13-item questionnaire that assesses the effect of fatigue on daily activity and function on a 5-point scale.
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