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Mallinckrodt
Announces Journal Publication of Real-World Data on Acthar® Gel (repository corticotropin injection) to Treat Symptomatic
Sarcoidosis
in African American and Non-African American Patients
2024-03-11
·
BioSpace
临床结果
上市批准
Retrospective analysis suggests
Acthar Gel
treatment was associated with similar improvement in health status and overall symptom reduction in African Americans and non-African Americans with symptomatic sarcoidosis1 Findings on treatment response and physician-reported outcomes indicate that
Acthar Gel
may be a viable treatment option for both African American and non-African American
sarcoidosis
patients1 DUBLIN, March 11, 2024 /PRNewswire/ --
Mallinckrodt plc
, a global specialty pharmaceutical company, today announced the publication of findings from a retrospective chart review of
Acthar
® Gel (repository corticotropin injection) treatment outcomes for African American and non-African American patients with symptomatic
sarcoidosis
– including treatment patterns, co-medication use, and overall health outcomes.1 This analysis suggested that Acthar Gel treatment was associated with similar improvements in health outcomes, a reduction in symptoms, and reduced co-medication use in both African Americans and non-African Americans with symptomatic
sarcoidosis.1
The manuscript was recently published online in Therapeutics & Clinical Risk Management. This research builds upon findings from a study investigating the clinical and real-world outcomes of Acthar Gel treatment in a subgroup of African Americans with symptomatic
sarcoidosis
, previously presented at the 2022 American Thoracic Society Annual International Conference in San Francisco, CA, and published in Therapeutic Advances in
Respiratory Disease
in 2019.2
Acthar
is a naturally sourced complex mixture of
adrenocorticotropic hormone analogs
and other pituitary peptides.3 Acthar Gel is approved by the
U.S. Food and Drug Administration (FDA)
for the treatment of several
autoimmune disorders
and medical conditions known to cause
inflammation
, including symptomatic
sarcoidosis.3
Please see additional indications and Important Safety Information below. "The results of this retrospective medical chart review highlight unmet needs that exist for African American patients with symptomatic
sarcoidosis
, who are disproportionately affected by the disease, and reinforce Acthar Gel's potential to help improve health outcomes for appropriate patients,"1,4,5 said George Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences,
Mallinckrodt
. "This research reflects
Mallinckrodt
's commitment to collecting real-world data on the relationship between patient characteristics, treatment patterns, and outcomes to support clinicians' treatment decisions and address disparities in symptomatic
sarcoidosis
care."1 About the Study:1 In this retrospective analysis, a national database of Acthar Gel prescribers and the American Medical Association Physician Master were merged to obtain a sample of 98 physicians to provide data on the last 6 consecutive patients seen who met the study's eligibility criteria. The medical records were extracted for adult patients (≥18 years) with a diagnosis of
advanced symptomatic sarcoidosis
, who had ≥1 symptom, and who had either completed at least one course of
Acthar Gel
or had received
Acthar Gel
for at least 6 months during data collection. A total of 272 patients with symptomatic
sarcoidosis
were included in this analysis (African American (AA): n=168; non-African American (non-AA): n=104). Most patients in both race groups were diagnosed with stage 3 or 4
sarcoidosis
based on chest imaging and biopsy (AA: 61.3%, n=103 vs. non-AA: 68.3%, n=71; p=0.2453). Per an assessment of patient characteristics and Acthar Gel treatment patterns, this analysis suggests that the average time since the first diagnosis of
sarcoidosis
was slightly longer among AA than non-AA (mean ± SD: 5.2 ± 7.6 years vs. 4.3 ± 5.1 years; p>0.05).1 Further, a lower proportion of AA vs. non-AA had completed a course of
Acthar
Gel therapy (44%, n=74 vs. 55.8%, n=58; p=0.0602) during the data collection period,1 and the duration of Acthar Gel treatment was slightly longer among AA vs. non-AA (mean ± SD: 31.7 ± 32 vs. 29 ± 27.4 weeks; p>0.05).1 "This research underscores the importance of conducting real-world studies to provide data that helps to recognize the disparities in symptomatic
sarcoidosis
care and address unmet needs to better support health outcomes for all appropriate patients," said Mary McGowan, Chief Executive Officer,
Foundation for Sarcoidosis Research (FSR)
Sarcoidosis
Research (FSR). FSR is the leading international organization dedicated to finding a cure for
sarcoidosis
and improving care for
sarcoidosis
patients through research, education, and support. Key Findings: Co-Medication Utilization Patterns1 Significantly fewer patients among both race groups were on any co-medication after Acthar Gel initiation (p<0.0001): AA before: 88.1%, n=148 vs. after: 20.2%, n=34 Non-AA before: 83.7%, n=87 vs. after: 24%, n=25 More AA had a reduction in any co-medication use after Acthar Gel initiation (AA: -77% vs. non-AA: -71%; p<0.0001). After Acthar Gel initiation, fewer AA (before: 59.5%, n=100 vs. after: 11.9%, n=20; p<0.0001) and non-AA (before: 65.4%, n=68 vs. after: 14.4%, n=15; p<0.0001) were on glucocorticoids. Overall, the mean
prednisone
dose reduced after
Acthar Gel
initiation among AA (before: 18.5 mg/day vs. after: 10.1 mg/day) and non-AA (before: 17.6 mg/day vs. after: 10 mg/day). The proportion of patients on
prednisone
daily dose of <10 mg increased after Acthar Gel initiation among both race groups (AA before: 27.8%, n=27/97 vs. after: 31.6%, n=6/19; non-AA before: 13.6%, n=9/66 vs. after: 60%, n=9/15). Physicians' Assessment of Improvement1 The health status of 95.2% (n=160) of AA and 97.1% (n=101) of non-AA improved following treatment with
Acthar Gel
, based on physician-provided assessments of patient outcomes. Treatment response to overall symptoms was not statistically significantly different between both race groups (AA: 72.6%, n=122 vs. non-AA: 70.2%, n=73) The most frequently reported changes in symptoms following
Acthar Gel
treatment in both race groups were: Reduction in
inflammation
(AA: 33.9%, n=57 vs. non-AA: 32.7%, n=34) Improvement in quality of life (AA: 31.5%, n=53 vs. non-AA: 34.6%, n=36) Improvement in lung function (AA: 30.4%, n=51 vs. non-AA: 53.8%, n=56; p<0.05) Reduction in fatigue (AA: 27.4%, n=46 vs. non-AA: 35.6%, n=37) Limitations:1 Data retrospectively collected from medical charts of patients may have omissions and errors. Completeness of information was assessed to the extent possible to minimize bias resulting from any missing data. In addition, only data available in medical charts or known to be complete to the respondents were extracted. Additional limitations of this study include: Physicians' standards for the interpretation of change in each patient's health status vary which may result in bias due to over- or under-estimation of the effectiveness of
Acthar Gel
. This study was unable to quantify clinical data such as diagnostic and safety measures, clinical and sustained response after treatment, and reasons for discontinuation or dose adjustments related to
Acthar Gel
. Due to the exploratory nature of this analysis, data were not collected for other medications besides
Acthar Gel
. Data on adverse reactions in this population, drivers of the decision to use
Acthar Gel
, and detailed information on prior therapies were not captured. This study was sponsored by
Mallinckrodt Pharmaceuticals
. INDICATIONS
Acthar Gel
is indicated for: Inducing a diuresis or a remission of
proteinuria
in
nephrotic syndrome
without
uremia
of the idiopathic type or that due to lupus erythematosus Monotherapy for the treatment of
infantile spasms
in infants and children under 2 years of age 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 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
Symptomatic
sarcoidosis
Treatment during an exacerbation or as maintenance therapy in selected cases of
systemic lupus erythematosus
Treatment during an exacerbation or as maintenance therapy in selected cases of
dermatomyositis
(
polymyositis
) 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
IMPORTANT SAFETY INFORMATION Contraindications
Acthar
is contraindicated: For intravenous administration In infants under 2 years of age who have suspected
congenital infections
With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of
Acthar
In patients with
scleroderma
,
osteoporosis
,
systemic fungal infections
,
ocular herpes simplex
, recent surgery, history of the presence of a
peptic ulcer
,
congestive heart failure
, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin Warnings and Precautions The adverse effects of Acthar are related primarily to its steroidogenic effects Acthar may increase susceptibility to new
infection
or reactivation of
latent infections
Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for
adrenal insufficiency
after withdrawal of the medication.
Adrenal insufficiency
may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g.,
trauma
or surgery) by the use of corticosteroids. Monitor patients for effects of
HPA axis
suppression after stopping treatment
Cushing's syndrome
may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms Acthar can cause elevation of blood pressure, salt and water retention, and
hypokalemia
. Monitor blood pressure and sodium and potassium levels Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy Acthar can cause
gastrointestinal (GI) bleeding
and
gastric ulcer
. There is also an increased risk for perforation in patients with certain
GI disorders
. Monitor for signs of perforation and
bleeding
Acthar may be associated with central nervous system effects ranging from euphoria,
insomnia
,
irritability
, mood swings, personality changes, and severe
depression
to
psychosis
. Existing conditions may be aggravated Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing
Acthar
in patients with
diabetes
and
myasthenia gravis
Prolonged use of
Acthar
may produce
cataracts
,
glaucoma
, and
secondary ocular infections
. Monitor for signs and symptoms
Acthar
is immunogenic and prolonged administration of
Acthar
may increase the risk of
hypersensitivity reactions
. Cases of
anaphylaxis
have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous
ACTH
and Acthar activity There may be an enhanced effect in patients with
hypothyroidism
and in those with
cirrhosis of the liver
Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy Adverse Reactions Commonly reported postmarketing adverse reactions for Acthar include
injection site reaction
,
asthenic conditions
(including
fatigue
, malaise,
asthenia
, and
lethargy
),
fluid retention
(including
peripheral swelling
),
insomnia
,
headache
, and blood glucose increased The most common adverse reactions for the treatment of
infantile spasms (IS)
are increased risk of
infections
,
convulsions
,
hypertension
,
irritability
, and
pyrexia
. Some patients with IS progress to other forms of
seizures
; IS sometimes masks these
seizures
, which may become visible once the clinical spasms from IS resolve Pregnancy Acthar may cause fetal harm when administered to a pregnant woman Please see full Prescribing Information for additional Important Safety Information. ABOUT SYMPTOMATIC
SARCOIDOSIS
Sarcoidosis
is a challenging and rare multisystem disease.6 In some cases, the symptoms may come and go throughout a lifetime.6 This is referred to as symptomatic
sarcoidosis.6
In people with
sarcoidosis
, the immune system overreacts, forming clumps of cells called granulomas that result in
inflammation
to the body's tissues.7 The disease can impact any organ, but it most often impacts the lungs, lymph nodes, eyes, liver, and skin.8 Nearly 90 percent of people with
sarcoidosis
will suffer lung problems.8 Concomitant involvement of organs outside of the lungs is common, occurring in more than half of all
sarcoidosis
cases, according to one study.2 ABOUT MALLINCKRODT
Mallinckrodt
is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about
Mallinckrodt
, visit CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to
Acthar
® Gel, its potential to improve health and treatment outcomes, its potential impact on patients. 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: the effects of
Mallinckrodt
's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with Acthar Gel; 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. CONTACT Media Inquiries Green Room Communications 908-577-4531 mediainquiries@grcomms.com Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 derek.belz@mnk.com
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. ©2024
Mallinckrodt
. US-2400042 03/24 References ___________________________________ 1 Bindra J, et al. Acthar Gel in African Americans versus Non-African Americans with Symptomatic
Sarcoidosis
: Physician Assessment of Patient Medical Records. Ther Clin Risk Manag. 2024;20:83-94 . 2Chopra I, et al. Repository Corticotropin Injection in Patients with Advanced Symptomatic Sarcoidosis: Retrospective Analysis of Medical Records. Ther Adv Res Dis. 2019(13);1-11. DOI: 10.1177/1753466619888127. 3 Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC. 2023. 4 Judson MA.
Pulmonary Sarcoidosis
: A Guide for the Practicing Clinician. Humana Press, New York, NY. 2014. 8;149-186. 5 Hena, K. M.
Sarcoidosis
Epidemiology: Race Matters. Front Immunol. 2020;11:1-5. 6
Sarcoidosis
. American College of Chest Physicians. Available at: . Accessed February 2024. 7
Sarcoidosis
Overview. 2019. Cleveland Clinic. Available at: . Accessed February 2024. 8 Judson MA, Boan AD, Lackland DT. The Clinical Course of
Sarcoidosis
: Presentation, Diagnosis, and Treatment in a Large White and Black Cohort in the United States.
Sarcoidosis
Vasc Diffuse Lung Dis. 2012. 29(2);119-127. View original content to download multimedia: SOURCE Mallinckrodt plc Company Codes: NYSE:MNK, OTC-BB:MCKPF, OTC-BB:MNKPF, OTC-PINK:MCKPF
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机构
Mallinckrodt Plc
US Food & Drug Administration
Foundation For Sarcoidosis Research
[+1]
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结节病
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自身免疫性疾病
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