1:20AM Horizon Pharma presents clinical data demonstrating RAYOS delayed-release tablets reduce fatigue in patients with active rheumatoid arthritis (HZNP) 2.29 : Co announces an additional analysis of data from the pivotal Circadian Administration of Prednisone in Rheumatoid Arthritis-2 clinical trial demonstrating that patients with active rheumatoid arthritis treated with its recently approved RAYOS 5 mg delayed-release tablets had a significant improvement in reduction of fatigue, as determined by the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire. 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 questionnaire, a 13-item questionnaire that assesses the effect of fatigue on daily activity and function on a 5-point scale. In CAPRA-2, the mean baseline FACIT-F fatigue score was comparable between patients in the RAYOS 5 mg treatment group and patients in the placebo group (29 vs. 29). The least square mean absolute increase from baseline to Week 12 was greater in patients in the RAYOS 5 mg treatment group compared to patients in the placebo group, which indicated a reduction of fatigue. The difference in FACIT-F score between baseline and Week 12 was viewed as clinically relevant for patients in the RAYOS 5 mg treatment group, but not for patients in the placebo group. At Week 12, the LSM change from baseline was statistically significantly greater for patients in the RAYOS 5 mg treatment group than for patients in the placebo group. The improvement in FACIT-F score was consistent with improvement in ACR20 score. There were no safety concerns for RAYOS 5 mg shown in the study beyond those already established for immediate-release prednisone.
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