Why carry out this study?

Despite the availability of numerous biologic and nonbiologic disease-modifying antirheumatic drugs (DMARDs) and despite using glucocorticoids, many patients with rheumatoid arthritis (RA) are unable to achieve or maintain remission or low disease activity (LDA) with these agents and, as a result, may sustain irreversible joint damage.

Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone analogues and other pituitary peptides that functions as an agonist of all five melanocortin receptors and has several potential mechanistic pathways that may contribute to its therapeutic effects in RA.

The current study was undertaken to confirm findings from previous small open-label studies by assessing the efficacy, safety, and tolerability of RCI in a larger population of subjects with active RA despite treatment with prednisone (or an equivalent) and one or two conventional synthetic DMARDs or one biologic DMARD via a randomized, double-blind, placebo-controlled withdrawal trial with an open-label run-in period.

What was learned from this study?

> 60% of patients achieved LDA during 12 weeks of open-label RCI therapy, which was maintained with 12 additional weeks of RCI maintenance therapy; most patients who achieved LDA maintained it for 3 months after RCI discontinuation.

In patients with active RA despite corticosteroid/DMARD therapy, RCI was generally safe and was associated with significant, durable, and beneficial effects on disease activity.