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Mallinckrodt's Recent Findings on Acthar Gel Treatment for Arthritis

On September 18, 2025, Mallinckrodt plc, a leading specialty pharmaceutical firm, announced significant findings from a recent research publication that sheds light on treatment patterns and outcomes for patients suffering from ankylosing spondylitis (AS) and psoriatic arthritis (PsA) who were managed with Acthar® Gel (repository corticotropin injection). This study, which was made available through Open Access Rheumatology Research and Reviews, offers real-world insights that had previously been limited in understanding this treatment's efficacy within clinical settings.

Acthar Gel is known for its naturally sourced complex of adrenocorticotropic hormone (ACTH) analogs, indicated for several inflammatory and autoimmune disorders. Despite its approval by the FDA, real-world data regarding its clinical deployment has been sparse until now. Dr. George Wan, Mallinckrodt's Vice President of Evidence Generation and Data Sciences, emphasized that these new insights further inform the use of Acthar Gel as an effective treatment option for patients enduring the complexities of these inflammatory arthritis conditions.

Overview of the Study

The study involved a cross-sectional review of physician-reported charts and insights regarding the patient population receiving treatment. Data was collected from 140 patients diagnosed with AS or PsA between April 2022 and November 2024. Of those, 63 were AS patients and 77 were PsA patients, primarily of Caucasian descent, with a notable gender distribution leaning towards a male population for AS.

The research lacks generalizability due to its specific sample of patients and documented health records. Nevertheless, it reveals crucial findings on the health status of patients before and after treatment with Acthar Gel, indicating necessary improvements in various health metrics. The chart review categorized patient health before treatment, showing that a significant percentage (41% of AS and 44% of PsA patients) reported a fair-to-poor health status.

Treatment Outcomes

Post-treatment evaluations indicated considerable improvements, with 95% of AS and 88% of PsA patients experiencing enhanced health status following the administration of Acthar Gel. The specifics revealed that:

• - 70% of AS and 63% of PsA patients reported a reduction in overall symptoms.
• - 68% of AS patients and 62% of PsA patients experienced decreased pain levels.
• - More than half of the patients witnessed an enhancement in physical function, strength, and a decline in fatigue.
• - Moreover, approximately 30% of the AS and PsA patients could reduce their corticosteroid use as a direct result of the treatment.

These findings highlight the potential of Acthar Gel not only to alleviate specific symptoms linked to AS and PsA but also to significantly improve the quality of life for patients grappling with these chronic conditions.

Collaboration and Insights

Cassie Shafer, CEO of the Spondylitis Association of America, spoke to the importance of ensuring access to effective treatment options for patients suffering from chronic inflammatory conditions. Her collaboration with Mallinckrodt aims to enhance research efforts that make a meaningful difference in patient care.

Limitations of the Research

While the results are promising, the study did acknowledge some limitations. The reliability of the data is dependent on physician documentation accuracy, and discrepancies in recording can impact findings. There was also a notable absence of a control group, necessitating deeper investigations to establish true effectiveness. Moreover, the study primarily outlined short-term effects without analyzing long-term treatment consequences or diagnosing outcomes.

Conclusion

As Mallinckrodt continues to dive deeper into research and collaboration for innovative treatment solutions, the recent findings about Acthar Gel offer hope for those battling ankylosing spondylitis and psoriatic arthritis. These insights reveal a path to enhancing the management of symptoms and improving overall health for individuals impacted by these diseases. For anyone affected by these conditions, ongoing dialogue between healthcare providers and pharmaceutical advances like those from Mallinckrodt underscores the progress being made for better treatment outcomes.

For further details on Acthar Gel, including indications and safety information, visit Mallinckrodt's official communication channels or consult healthcare professionals directly.