Abstract
Acthar Gel is a long-acting formulation of adrenocorticotropic hormone (ACTH) with anti-inflammatory effects thought to be mediated in part through melanocortin receptor activation. This study was initiated to understand the role of Acthar Gel in SLE treatment in rheumatology practices. This is a retrospective case series of nine adult female patients treated with Acthar Gel for at least six months at five academic centers. Treating physicians completed a one-page questionnaire on lupus medications, disease activity, and outcomes. Clinical response was defined using SLEDAI 2K and improvement in the clinical manifestation(s) being treated. The most common clinical SLE manifestations/indications requiring therapy with Acthar Gel were arthritis, rash, and inability to taper corticosteroids. The mean SLEDAI 2K score at baseline was 5.8 ± 5.0 (range 0-16). Six patients were concomitantly treated with corticosteroids (mean dose 18.3mg/day). All patients were on background SLE medications including immunosuppressives. Seven of nine patients had an overall improvement, with a decrease in SLEDAI 2K from 5.8 ± 5.0 at baseline to 3.5 ± 2.7 (range 0-8); four of five patients had improvement or resolution in arthritis, and one of two patients had resolution of inflammatory rash. Four patients discontinued corticosteroids and one patient tapered below 50% of the initial dose by 3 months of treatment with Acthar Gel. No adverse events were reported. This study suggests a role for Acthar Gel as an alternative to corticosteroids in the treatment of SLE. Acthar Gel appears to be safe and well-tolerated after 6 months of treatment, with a significant reduction in disease activity.
Highlights
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of unknown etiology
The following minor edits were made for clarification purposes: 1. The disease activity scores in the Abstract are given with standard deviations and ranges - both at baseline and after 6 months of therapy where available
The release of endogenous adrenocorticotropic hormone (ACTH) is under the influence of the nervous system via the regulatory hormone released from the hypothalamus and by a negative corticosteroid feedback mechanism
Summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of unknown etiology. Current understanding of Acthar Gel indicates that its effectiveness is a result of both its steroidogenic and direct anti-inflammatory effects through activation of different melanocortin receptors (MCRs)[4,5,6]. MCRs are expressed on virtually all the cells; the activations of MC1R, MC3R, and MC5R, in particular, are thought to be responsible for the direct anti-inflammatory effect. This is supported by experiments using MCR-selective synthetic analogs, and animal data[4,7,8,9,10,11]. In a study with adrenalectomized rats, Acthar Gel decreased experimental arthritis, indicating a steroid-independent action[12]
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