Post Hoc Analysis of Predictors of Clinical Response to Repository Corticotropin Injection in Persistently Active Rheumatoid Arthritis

Abstract

Introduction: A phase IV clinical trial confirmed the safety and efficacy of repository corticotropin injection (RCI, Acthar Ò Gel) in patients with refractory rheumatoid arthritis (RA) that was nonresponsive to standard-of-care therapies. The objective of this post hoc analysis was to identify baseline demographics and clinical characteristics that may be predictors of response to RCI. Methods: The phase IV trial was a two-part, randomized, placebo-controlled withdrawal study. Post hoc analysis was conducted with the open-label portion of the trial data, in which all 258 subjects received RCI (80 U

Acthar® Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: An Historical Perspective and Characterization of Clinical Evidence

“…Clinical responses, including Disease Activity Score with 28-Joint Count and erythrocyte sedimentation rate, total joint count, and Clinical Disease Activity Index, were found to directly correlate with patient-reported outcomes [ 33 ]. Predictors of positive response to Acthar in patients with RA included lower baseline levels for swollen joint count, total joint count, Erythrocyte Sedimentation Rate, and Clinical Disease Activity Index, as well as shorter RA duration [ 34 ]. Osteoarthritis and other joint-related conditions were predictive of negative response to Acthar [ 34 ].…”

“…Predictors of positive response to Acthar in patients with RA included lower baseline levels for swollen joint count, total joint count, Erythrocyte Sedimentation Rate, and Clinical Disease Activity Index, as well as shorter RA duration [ 34 ]. Osteoarthritis and other joint-related conditions were predictive of negative response to Acthar [ 34 ].…”