Study Design, Safety Findings, and Study Limitation¹

An open-label, single-center, randomized, multiple-dose parallel group study to compare the pharmacodynamics (PD) and safety of intermittent doses of Acthar Gel to daily oral methylprednisolone (MP) in healthy subjects. Subjects between 18 and 50 years old were randomized to receive Acthar Gel 40 or 80 U SC twice weekly for 15 days (n=12/group) or 16 mg of oral MP given once daily for 15 days (n=12), followed by a tapering regimen of 8 mg daily for 2 days, then 4 mg daily for 2 days. The most frequently reported treatment-emergent adverse events (TEAEs) that occurred in 2 or more subjects were (in decreasing order of frequency): injection site hemorrhage, headache, injection site erythema, injection site pruritis, insomnia, acne, infrequent bowel movements, and injection site pain. All TEAEs experienced during this study were considered mild in severity. As this was a healthy-subject, open-label study with no placebo control, the clinical relevance of differences in tolerability is unknown and remains to be investigated for patient populations.

Study Design^5,6

The effects of Acthar Gel on human B-lymphocyte function in vitro were evaluated using highly purified B-cell populations cultured in the absence of glucocorticoids and stimulated by recombinant IL-4 and CD40 ligand (CD40L) as specific B-cell activating signals. IgG was measured in supernatants from healthy human peripheral B cells cultured for 6 days. Percentage of cells that divided and IgG production were assessed under basal conditions (unstimulated), stimulated with IL-4/CD40L alone (vehicle), or stimulated with IL-4/CD40L plus a 1:22 dilution of 80 U/mL stock of Acthar Gel.

Study Design^7,8

An in vitro study to explore the direct effects of Acthar Gel on human macrophages, focusing on induction of proinflammatory mediators following lipopolysaccharide (LPS) stimulation. CD14+ monocytes were selected from human peripheral blood mononuclear cells (PBMCs). Monocytes were then treated with macrophage colony-stimulating factor (M-CSF) to generate monocyte-derived macrophages (MDMs). MDMs were stimulated with LPS and incubated for a minimum of 24 hours with Acthar Gel (1:11 dilution of 80 U/mL stock) or placebo (vehicle). Highest dose tested is presented in graph. Cytokines were measured by enzyme-linked immunosorbent assay (ELISA).

Free Trial Offer Eligibility Terms & Conditions

Program is only for patients whose healthcare provider has diagnosed them with systemic lupus erythematosus (SLE), dermatomyositis/polymyositis (DM/PM), or rheumatoid arthritis (RA), who have not previously used Acthar Gel, and who are covered by a commercial (private) insurance plan. A patient who is participating in Medicare, Medicaid, or any government-funded healthcare program is not eligible to participate in this Program. The patient agrees not to seek reimbursement from any third-party payor for all or any part of Acthar Gel dispensed pursuant to this Program. The Free Trial Offer Program is only for healthcare providers who are eligible to receive prescription samples and have not prescribed Acthar Gel in the previous 12 months or have previously enrolled patients in the PEP program but have not enrolled a maximum of 3 patients. Acthar Gel vials can only be shipped to physician offices or hospitals under the Program. The Free Trial Offer Program is valid for up to 5 vials of Acthar Gel therapy in 2 shipments, prior to expiration date. Void where prohibited by law. Patients must be 18 years of age or older to participate. This Program expires on December 31, 2020. Mallinckrodt reserves the right to rescind, revoke, or amend this Free Trial Offer Program at any time without notice. By participating in this Program, you agree to these eligibility terms and conditions.

Learn More About the Free Trial Offer Program