Patients with Persistently Active SLE Benefit from Mallinckrodt’s Acthar Gel

Mallinckrodt Pharmaceuticals has revealed that H.P. Acthar Gel is effective in the treatment of patients with persistently active systemic lupus erythematosus (SLE) who are under corticosteroid therapy, according to recent study results. Though the study’s primary endpoint was not met, the drug led to attenuation of disease activity in participants and met some  secondary endpoints. The results were presented in a poster session during the 2015 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting and the abstract, entitled “Repository Corticotropin Injection (H.P. Acthar® Gel) Attenuates Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus (SLE) Requiring Corticosteroids,” is available online at the ACR Meeting website.

H.P. Acthar Gel (repository corticotropin injection) is an FDA-approved injectable drug for the treatment of 19 conditions, including as a therapy during exacerbation or as maintenance treatment for selected cases of systemic lupus erythematosus (SLE). Repository corticotropin injection (RCI) has been shown to modulate immune responses, attenuate B cell development, reduce circulating autoantibodies levels, and attenuate disease activity in SLE mouse models.

The eight-week, placebo-controlled study involved 38 patients with persistently active SLE with skin and/or joints symptoms, despite therapy with corticosteroids. Its primary objective was to determine the effects of subcutaneously delivered RCI on the skin and joint scores of the Hybrid SLE Disease Activity Index (hSLEDAI). Secondary endpoints included evaluation of effect on British Isles Lupus Assessment Group-2004 (BILAG), Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), and 28-joint count score. Even though the results indicated the primary endpoint was not met, RCI led to a significant improvement in key secondary efficacy endpoints compared with placebo, including total hSLEDAI and BILAG scores, CLASI Activity and Tender & Swollen Joint Count. Overall, the data indicate that RCI attenuates disease activity in this specific subset of patients within eight weeks of treatment initiation. However, researchers note that the outcomes may not be fully attributed to Acthar as patients were on other therapies, raising the need for further research.

Steven Romano, MD, Senior Vice President and Chief Scientific Officer of Mallinckrodt Pharmaceuticals, said in a press release: “Acthar demonstrated clinically relevant improvement in signs and symptoms of lupus in patients who need an alternative therapy for persistent symptoms. This is one of many studies Mallinckrodt is pursuing related to Acthar. We are encouraged by the results of this small study, and the potential Acthar may hold for patients with persistently active SLE.”

An extension study is currently ongoing to determine Acthar’s tolerability, steroid-sparing effects, and efficacy in long-term disease management.