Mallinckrodt Plc announced findings from a retrospective medical record analysis to assess practice patterns and outcomes of Acthar Gel (repository corticotropin injection) in the treatment of the immune-mediated diseases rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and dermatomyositis/polymyositis (DM/PM) . Results of the study were recently published online in Open Access Rheumatology: Research and Reviews.
Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. Acthar Gel is approved by the FDA as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in RA, including juvenile RA (selected cases may require low-dose maintenance therapy), and for use during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis). .
The study, titled "Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis," examined 92 adult patients (?18 years of age) – 54 with RA, 30 with SLE and 8 with DM/PM – who were treated at 14 U.S. clinical sites with Acthar Gel between January 1, 2011 and February 15, 2016. Researchers collected data on patient demographics, disease and treatment history; Acthar Gel dosing, frequency and duration; concomitant medication use; and physicians' assessments of outcomes and adverse events.
Results of the analysis showed that across all three patient populations, the most frequently reported reasons for initiating treatment with Acthar Gel were inadequate response to prior therapies, acute exacerbation or flare of disease, and need for an alternative therapy. The findings also suggest that patients' symptoms improved with Acthar Gel as reported by physicians' impression of overall change after treatment initiation and over the course of the study. Among 57 patients with data on physician impression of change, 78.1 percent of patients with RA, 94.7 percent of patients with SLE and 66.7 percent of patients with DM/PM had a rating of improved. Further, the mean time to best impression of change was 3.4±2.5 months for RA, 4.3±2.7 for SLE, and 3.4±1.6 for DM/PM.
"All three immune-mediated diseases examined in this study can be difficult to manage, and patients can often experience debilitating disease flares and exacerbations," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "The study suggests that Acthar Gel may have been associated with an improvement in disease exacerbations and symptoms, and it provides insights into real-world practice patterns and outcomes associated with Acthar Gel therapy that may help inform decision-making among clinicians in managing these conditions."
Further, the study builds on the company's Phase IV study of Acthar Gel in RA patients (open-label portion, n=259; randomized, placebo-controlled, blinded, withdrawal portion, n=154) presented at the European Congress Of Rheumatology 2019 (EULAR), June 12-15 in Madrid. The randomized, placebo-controlled, double-blind two-part study demonstrated that significantly more patients with persistently active RA who met response criteria at week 12 (63 percent of patients in the open-label period who achieved low disease activity (LDA) as assessed by Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) of <3.2 at 12 weeks) maintained lda with acthar gel (62 percent) versus placebo (43 percent, p><0.05) at week 24. in the double-blind period of the study (weeks 12-24), adverse events (aes) were reported in 33 percent of the acthar gel treatment group and 40 percent of the placebo group. in the open-label period of the study (weeks 0-12), aes were reported in 38 percent of patients. overall aes observed in the study were consistent with previous trials of acthar gel. the study was subject to study limitations, including that the results may not be solely attributable to acthar gel.>0.05)>3.2>