Repository corticotropin injection (RCI; Acthar® Gel) is approved by the US Food and Drug Administration (FDA) for use in 19 indications, including for the treatment of selected patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), symptomatic sarcoidosis, uveitis, and keratitis. Despite treatment with disease-modifying antirheumatic drugs, many patients with RA, SLE, and other chronic inflammatory rheumatic diseases continue to be affected by severe pain and fatigue, indicating a need for other therapies. To examine the clinical data regarding the impact of RCI treatment on pain and fatigue in selected populations, this review included English-language peer-reviewed publications of clinical trials of any size and cohort studies with more than 10 patients that included pain and/or fatigue based on patient-reported outcomes (PROs) and/or physician-assessed measures in adults following treatment with RCI for RA, SLE, symptomatic sarcoidosis, uveitis, or keratitis. Literature searches identified eight studies that met these criteria. Four studies (reported in five publications) were in patients with RA or SLE, two in patients with sarcoidosis, one in patients with uveitis, and one in patients with noninfectious keratitis. Across the different types of studies assessed (clinical trials, chart reviews, real-world evidence), the results were consistent with respect to the impact of RCI treatment on improving pain and fatigue. As summarized in this review, data from patient- and physician-reported outcome measures in eight studies demonstrate that, in addition to improving more traditional efficacy measures, RCI may also improve pain and fatigue in patients with RA, SLE, symptomatic sarcoidosis, uveitis, and noninfectious keratitis.
Keywords: Acthar® Gel; Fatigue; Keratitis; Pain; RCI; Repository corticotropin injection; Rheumatoid arthritis; Sarcoidosis; Systemic lupus erythematosus; Uveitis.
Rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) are chronic autoimmune diseases. Clinical studies of drugs for these diseases do not often ask patients how they feel after treatment. Despite treatment, many people with these diseases have pain and feel tired. Repository corticotropin injection (RCI) is a prescription drug for patients with RA, SLE, and other chronic immune diseases. We reviewed the results of published studies with data on pain and fatigue from patients treated with RCI. Four studies were in patients with RA or SLE. Two studies were in patients with symptomatic sarcoidosis. One study was in patients with uveitis. One study was in patients with noninfectious keratitis. These eight studies show that adding RCI to standard treatment lowers pain and fatigue in some patients. It would be helpful to measure pain and fatigue in future clinical studies of drugs for patients with chronic immune diseases.
© 2022. The Author(s).