– Findings from a retrospective analysis suggest
that treatment with Acthar Gel is associated with significant
reductions in corticosteroid use compared to other fourth-line
alternatives for patients with advanced
sarcoidosis1 –
DUBLIN , March 21,
2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a
global specialty pharmaceutical company, today announced that an
abstract highlighting results from a retrospective analysis
evaluating the corticosteroid-sparing effect and reduction of
corticosteroid burden of Acthar® Gel (repository
corticotropin injection) therapy in patients with advanced
sarcoidosis,1 has been selected for a poster
presentation at the Academy of Managed Care Pharmacy (AMCP) 2023
Annual Meeting taking place in San
Antonio, Texas from March 21-24,
2023.
Acthar Gel is a naturally sourced complex mixture of
adrenocorticotropic hormone analogs and other pituitary peptides.
Acthar Gel is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of symptomatic sarcoidosis and is only
commercially available in the U.S.2 Acthar Gel is also
referenced in the European Respiratory Society (ERS) treatment
guidelines—which list Acthar Gel among the various
anti-inflammatory treatments for pulmonary sarcoidosis and note it
can be used on a case-by-case basis when other therapies are
ineffective or not tolerated—and a U.S. expert panel provided
consensus recommendations on the use of repository corticotropin
injection for the treatment of pulmonary
sarcoidosis.3,4
Please see Important Safety Information for Acthar Gel
below.
The retrospective analysis used data from a large administrative
pharmacy and medical claims database (Symphony Health Solutions),
including a total of 1,361 sarcoidosis patients (n=735 for Acthar
Gel cohort; n=626 for alternative fourth-line cohort) from
2014-2020. Outcomes were compared as change from baseline and
Acthar Gel adherence was determined by proportion of days covered
in the follow-up period. The analysis found that, after treatment
with Acthar Gel, patients had greater reduction from baseline in
any corticosteroid fills (-9.0% vs. -3.2%) and extended use
corticosteroid fills (-10.0% vs. -3.0%) compared to those receiving
fourth-line treatment, with Acthar Gel above average adherence
showing greater reduction than below-average adherence in both
measures (-11.2% vs. -6.1%; -11.6% vs. -7.6%
respectively).1
George J. Wan, Ph.D., M.P.H.,
Vice President Health Economics and Outcomes Research at
Mallinckrodt, said, "We're excited
to share these data that not only provide valuable insight into the
association between use of Acthar Gel and reduction in
corticosteroid use, but also reinforce the importance of treatment
adherence to help improve outcomes for patients with advanced
sarcoidosis.1 We remain committed to addressing the
unmet needs of critically ill patient populations and are proud to
continue the collection of real-world data to help inform patients'
treatment options."
In this retrospective analysis, patients treated with Acthar Gel
also had significantly greater reduction of extended corticosteroid
use at all dose levels compared to fourth-line treatment, with
Acthar Gel above average adherence reduction better than below
average (-9.5% vs. -5.7% for medium corticosteroid dose; -10.0% vs.
-8.6% for high corticosteroid dose, respectively).1
Data collected in a retrospective analysis may have errors or
omissions. Outcomes may be influenced by therapies not evaluated in
the study and the clinical outcomes may not be solely attributable
to Acthar.
This study was funded by Mallinckrodt Pharmaceuticals.
Presentation details are as follows:
Presentation Title: Corticosteroid use and adherence in
patients treated with Acthar Gel for advanced sarcoidosis
Presenter: Kyle Hayes, MS
Presentation Date: Thursday, March 23, 2023, at
11:30am – 1:00pm CT /
12:30pm – 2:00pm ET
Location: Henry B. Gonzalez Convention Center, Hall 2
Additional information is available on the Academy of Managed
Care Pharmacy (AMCP) 2023 Annual Meeting website.
About Sarcoidosis
Sarcoidosis is a challenging and rare multisystem
disease.5,6 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.5 Over 90% of people with sarcoidosis
suffer lung problems.5,8
Concomitant involvement of organs outside of the lungs is common,
occurring in as many as half of all sarcoidosis
cases.8
IMPORTANT SAFETY INFORMATION
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 or
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 post marketing 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 post marketing 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 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; cultured
skin substitutes and gastrointestinal products. Its Specialty
Generics reportable segment includes specialty generic drugs and
active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution
of important company information, such as press releases, investor
presentations and other financial information. It also uses its
website to expedite public access to time-critical information
regarding the company in advance of or in lieu of distributing a
press release or a filing with the U.S. Securities and
Exchange Commission (SEC) disclosing the same information.
Therefore, investors should look to the Investor Relations page of
the website for important and time-critical information. Visitors
to the website can also register to receive automatic e-mail and
other notifications alerting them when new information is made
available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING
STATEMENTS
This release includes forward-looking statements
concerning Acthar Gel® (repository corticotropin injection),
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; issues with product quality, manufacturing or
supply, or patient safety issues; 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
Heather
Guzzi
Senior Vice President, Green Room Communications
973-524-4112
hguzzi@grcomms.com
Investor Relations
Daniel J.
Speciale
Global Corporate Controller & Chief Investor Relations
Officer
314-654-3638
daniel.speciale@mnk.com
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.
©2023 Mallinckrodt. US-2300120 03/23
References
1 Hayes K, et al. Corticosteroid use and adherence in
patients treated with Acthar Gel for advanced sarcoidosis.
Abstract to be presented at Academy of Managed Care Pharmacy
(AMCP) 2023 Annual Meeting. March
2023.
2 Acthar® Gel (repository corticotropin injection)
[prescribing information]. Mallinckrodt ARD LLC.
3 Baughman RP, Valeyre D, Korsten P, et al. ERS clinical
practice guidelines on treatment of sarcoidosis. Eur Respir
J. 2021; in press (doi.org/10.1183/13993003.04079-2020)
4 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. doi.org/10.1183/16000617.0147- 2019.
5 Judson MA. The clinical features of sarcoidosis: a
comprehensive review. Clin Rev Allerg Immunol.
2015;49:63-78.
6 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.
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
York, NY: Springer; 2014:149-186.
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