A Phase 4 clinical trial evaluating Mallinckrodt's (NYSE:MNK) Acthar Gel (repository corticotropin injection) in patients with patients with persistently active rheumatoid arthritis (RA) who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids met all primary and secondary endpoints. The results were presented at EULAR in Madrid.
62% of patients receiving Acthar Gel experienced sustained low disease activity (LDA) compared to 43% for placebo at week 24 as measured by a scale called DAS28-ESR. 86% of treated patients showed LDA at week 24 versus 66% for placebo as measured by another scale called CDAI.
The proportion of treated patients who achieved ACR70 (70% improvement in RA symptoms) at week 24 was 47% versus 42% for placebo. The proportions achieving ACR50 and ACR20 were 75% and 91%, respectively, compared to 70% and 84%, respectively, for placebo.
No new safety signals were observed.
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