Mallinckrodt plc announced the publication of findings from a survey assessing patient perceptions of their experience with Acthar Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect Injector. SelfJect is designed for the administration of Acthar Gel in appropriate patients.² It is approved by the US Food and Drug Administration (FDA) for patients with a range of chronic and acute inflammatory conditions.² The survey collected data on patient perceptions of satisfaction, confidence, convenience, and ease of use, as well as perceptions of anticipated persistence and compliance.¹ The manuscript was recently published online in Advances in Therapy, the company said in a press release.

According to the company, Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone (ACTH) analogs and other pituitary peptides.² Acthar Gel is approved by the FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.² SelfJect is available in 40 USP units/0.5 mL and 80 USP units/1.0 mL injectors and must be administered by adults (18 years of age or older).² SelfJect is not to be used for the treatment of infantile spasms.²

About the Survey

"Real-World Insights on Patient Satisfaction and Experience with Acthar Gel via SelfJect (RISE): A Cross-Sectional Patient Survey" utilized a validated form and was conducted among a cross-section of patients to assess their experience with SelfJect.¹ The survey, conducted between November 2024 and January 2025, collected data from 54 participants with a mean age of 55.4 years.¹ The majority of participants were female 76% (n=41/54), and identified as White/Caucasian 74% (n=40/54) and non-Hispanic/non-Latino 83% (n=45/54).¹ Eligible participants were aged ≥18 years, had a diagnosis of an indication of Acthar Gel based on the prescribing information, and had used Acthar Gel via SelfJect for ≥6 self-injections at the time of the survey.¹ Additionally¹:

• 33% (n=18/54) reported chronic or recurring ocular inflammatory disease, and 26% (n=14/54) had rheumatoid arthritis
• 39% (n=21/54) reported dexterity or visual problems
• 39% (n=21/54) reported having previously used Acthar Gel multi-dose vial and syringe

In this survey, participants reported a favorable experience injecting Acthar Gel via SelfJect, highlighting high levels of satisfaction, confidence, convenience, and ease of use regarding the injector.¹ Participants also reported perceptions of anticipated positive persistence and compliance with the device, which may correlate with improved continuity of care.¹ Findings from this survey included¹:

• 91% (n=49/54) reported they were satisfied or very satisfied injecting Acthar Gel via SelfJect overall
• 89% (n=48/54) felt very or extremely confident administering Acthar Gel via SelfJect to themselves at home
• 91% (n=49/54) found SelfJect to be convenient or very convenient
• 100% (n=54/54) felt that it was moderately, very or extremely easy to self-inject with SelfJect
• 87% (n=47/54) responded that they were likely or very likely to continue taking Acthar Gel via SelfJect for the prescribed period, and 87% (n=47/54) also responded that they were likely or very likely to maintain compliance for the prescribed period, with respect to timing, dosage, and frequency

Summary of limitations of the survey include¹:

• Data collected from the questionnaire are cross-sectional and do not provide long-term information on patient satisfaction.
• Persistence and compliance were assessed based on participant perceptions rather than objective, longitudinal measurement. Future research using longitudinal designs is needed to evaluate these factors accurately.
• Response bias may be present as the findings rely on survey participants' subjective experiences with the device.
• This descriptive study characterizes the experience of survey participants with an alternative delivery device; therefore, it does not include direct comparisons of Acthar Gel via SelfJect with other self-injection devices.

This survey was sponsored by Mallinckrodt Pharmaceuticals.

Acthar Gel is indicated for:

• Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis) and systemic lupus erythematosus
• Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis
• Symptomatic sarcoidosis
• Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
• Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
• Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
• Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age

References

1. Bindra J., Chopra I., Hayes K., et al. Real-World Insights on Satisfaction and Experience with Acthar Gel via SelfJect (RISE): A Cross-Sectional Patient Survey. Advances in Therapy. 2025. https://doi.org/10.1007/s12325-025-03232-5.
2. Acthar Gel (repository corticotropin injection) [Prescribing Information]. Bridgewater, NJ: Mallinckrodt ARD LLC.