Acthar Gel Eases SLE Exacerbations and Symptoms, Study Reports

Treatment with Acthar Gel (repository corticotropin injection) may ease exacerbations and symptoms in people with systemic lupus erythematosus (SLE) and other inflammatory disorders, a real-world study reports.

About 95% of those with SLE showed benefits, as rated by physicians.

The study, “Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis,” was published in the journal Open Access Rheumatology: Research and Reviews. 

Acthar Gel is a prolonged-release, injectable form of adrenocorticotropic hormone (ACTH) analogs and other small proteins.

It was developed to control the pro-inflammatory immune response in people with persistently active SLE and other inflammatory diseases such as rheumatoid arthritis (RA), dermatomyositis (DM) and polymyositis (PM).

Marketed by Mallinckrodt Pharmaceuticals, the therapy is approved in the U.S. for multiple conditions, particularly during an exacerbation or as maintenance therapy in select cases of SLE when other therapies have failed. 

Given its sporadic use in the clinic, there is little information about how the therapy is used in a real-world setting, and which patients would benefit most. 

To address this gap, researchers reviewed the medical records of 30 adults (29 women) with SLE treated with Acthar Gel. In addition, the team assessed the outcomes for 54 patients with RA, and eight with DM or PM.

Average age in the SLE group was around 50 years. Patients had started on Acthar Gel from January 2011 February 2016. Those selected had visited a healthcare provider before starting this treatment and at least once up to a  year later. All SLE patients received treatment during an exacerbation or as maintenance therapy.

Demographic, clinical, and socioeconomic information was collected, along with Acthar Gel treatment patterns such as dose, duration, frequency, and other mediation used at the time. Physicians’ impression of change was assessed, as were adverse events (AEs, or side effects)) that resulted in dose reduction or treatment discontinuation.

The most common co-conditions among those with SLE were joint pain (100%), hypertension (40%), depression (33%), Sjogren’s syndrome (33%), and anxiety (27%). 

The most common symptoms were pain (93%), stiffness/pain in joints (90%), fatigue (87%), swollen joints (67%), muscle weakness (63%), morning stiffness (50%), and shortness of breath (50%). 

Most SLE patients had been treated with corticosteroids (80%), conventional disease-modifying anti-rheumatic drugs (73%), and immunosuppressive therapies (57%).

The most common reasons for starting Acthar Gel therapy was prior failure of a different therapy, acute exacerbation, and as an add-on therapy to prior treatment. Similar results were seen in people with RA and DM/PM.

Of the SLE patients, 75% were started on a dose of 80 U twice weekly. The mean length of treatment was 6.5 months, longer than the 4.8 months in those with RA. Six SLE patients discontinued treatment, three due to treatment-related AEs. 

Information regarding the physician’s impression of change was available for 19 SLE patients. All but one (94.7%) had a rating of “improved.” Most patients with the other conditions also had this rating.

AEs were reported in five patients with SLE who experienced diarrhea, gastrointestinal upset, swelling, pain due to irritated nerves (neuralgia), pneumonia, and weight gain. Serious side effects were reported in four patients, which included musculoskeletal pain, dehydration, adrenal insufficiency, pneumonia, kidney failure, and transient ischemic attack.

“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,” Tunde Otulana, MD, senior vice president and chief medical officer at Mallinckrodt, said in a press release.

“The data can inform appropriate use of [Acthar Gel] as well as the clinical expectations when using this medication,” the researchers wrote. “Larger clinical trials are ongoing to add to the body of evidence.”

These results add to those of a Phase 4 clinical trial (NCT02919761) that evaluated Acthar Gel in RA patients with persistently active disease. Most participants (63%) experienced low disease activity at weeks 12 and 24 in the open-label period, when all received the therapy. AEs were consistent with previous trials of Acthar Gel, the company said.

Findings of a Phase 4 trial testing Acthar Gel in 172 active SLE patients (NCT02953821) are expected this year.