Retrospective medical chart review subgroup analysis showed Acthar Gel was associated with overall symptom improvement and reduction in use of concomitant medications in African Americans
Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. Acthar Gel is approved by the
This ad hoc subgroup analysis was based on data from medical charts of 168 (77 male and 91 female) adult African Americans with symptomatic sarcoidosis who had completed a course of Acthar Gel or received Acthar Gel for at least six months at the time of data collection. Patients had a mean of 5.2 years since initial diagnosis of sarcoidosis and 121 (72 percent) patients had at least one comorbidity. The mean duration of Acthar Gel treatment was 31.7 weeks and 105 (62.5 percent) patients continued Acthar Gel therapy for at least six months.
Sarcoidosis is a chronic condition that causes inflammation in the body.4,5 There are health disparities that exist in the
"It's critical that ongoing sarcoidosis research highlights the disparities that exist for African Americans with regards to diagnosis, severity of illness and response to treatments. More studies are required that deepen our understandings of these differences and provide meaningful strategies to improve outcomes among this community," said
The data analysis found a significant reduction in use of any co-medication after Acthar Gel initiation (p<0.0001) and the percentage of patients who used glucocorticoids decreased significantly from 59.5 percent during the three months before initiation of Acthar Gel to 11.9 percent three months after Acthar Gel therapy (p<0.0001). According to physicians' assessments of change in patients' health status after Acthar Gel therapy, most patients (N=160, 95 percent) had improved and 83 patients (49 percent) had at least two types of improvements in sarcoidosis symptoms. The most commonly reported types of sarcoidosis symptom improvements were overall symptoms (N=122, 73 percent), inflammation (N=57, 34 percent), improved patient quality of life (N=53, 32 percent), improved lung function (N=51, 30 percent) and reduction or discontinuation of glucocorticoid (N=48, 29 percent).
"We believe the results of this retrospective medical chart review subgroup analysis support Acthar Gel's role as a viable treatment option for African Americans with advanced symptomatic sarcoidosis and support the importance of continued collection of real-world data to help inform patients' treatment options," said George J. Wan, Ph.D., M.P.H., Vice President Health Economics and Outcomes Research at Mallinckrodt.
The limitations of this retrospective chart review include that the study relied on real-world medical charts which could be missing data or may have used site-specific measurement schedules and procedures. Additionally, outcomes may be influenced by therapies not documented in the chart as most patients were on multiple therapies; the clinical outcomes may not be solely attributable to Acthar Gel. Patient outcomes and safety were not quantified, and physician assessment of patient outcomes may be subjective. Due to the retrospective nature of this analysis, it is hypothesis-generating; no formal conclusions should be drawn.
The study was funded by Mallinckrodt.
Sarcoidosis is a challenging, yet manageable, rare multisystem disease.4,5 In some cases the symptoms may come and go throughout one's lifetime. This is referred to as symptomatic sarcoidosis. In people living with sarcoidosis, the immune system overreacts, forming clumps of cells called granulomas that result in inflammation of the body's tissues.7 The disease can impact any organ but most often impacts the lungs, lymph nodes, eyes, and skin.4 Over 90 percent of people with sarcoidosis suffer lung problems.8 Concomitant involvement of organs outside of the lungs is common, occurring in as many as half of all sarcoidosis cases.8
IMPORTANT SAFETY INFORMATION
Acthar is contraindicated:
Warnings and Precautions
Please see full Prescribing Information for additional Important Safety Information.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel including its potential impact on patients and anticipated benefits associated with its use, as well as related on-going studies. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
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Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2022 Mallinckrodt. US-2200293 05/22
1 Acthar® Gel (repository corticotropin injection) [prescribing information].
2 Baughman RP, Valeyre D, Korsten P, et al. ERS clinical practice guidelines on treatment of sarcoidosis. Eur Respir J. 2021; in press (https://doi.org/10.1183/13993003.04079-2020).
3 Rahaghi FF, Sweiss NJ, Saketkoo LA, et al. Management of repository corticotrophin injection therapy for pulmonary sarcoidosis: a Delphi study. Eur Respir Rev. 2020; 29:190147. https://doi. org/10.1183/16000617.0147- 2019.
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5 Baughman RP, Field S, Costabel U, et al. Sarcoidosis in America. Analysis based on health care use. Ann Am Thorac Soc. 2016;13:1244-1252.
6 Hena, K. M. Sarcoidosis Epidemiology:
7 Baughman RP, Culver DA, Judson MA. A concise review of pulmonary sarcoidosis. Am J Respir Crit Care Med. 2011;183:573-581.
8 Shigemitsu H, Patel HV, Schreiber MP. Extrapulmonary sarcoidosis. In: Judson MA, ed. Pulmonary Sarcoidosis: A Guide for the Practicing Clinician. Vol 17. New
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