STAINES-UPON-THAMES, United
Kingdom, Nov. 7, 2019
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a global biopharmaceutical company, today
announced the publication of "Treatment Effectiveness for
Resolution of Multiple Sclerosis Relapse in a U.S. Health Plan
Population" in an electronic publication posted in advance of
print publication in the peer-reviewed journal Neurology and
Therapy. Results from the analysis showed that multiple
sclerosis (MS) relapse patients taking Acthar® Gel
(repository corticotropin injection) had a higher relapse
resolution rate than those taking intravenous immunoglobulin (IVIG)
or plasmapheresis (PMP) treatment.
MS is a chronic, degenerative disease that can cause numerous
impairments including fatigue, balance/coordination issues,
numbness or tingling, vision problems, muscle spasms, tremors and
emotional changes1, and some people with MS experience
relapses while on standard disease-modifying
therapies.2
Acthar Gel is U.S. Food and Drug Administration (FDA)-approved
for the treatment of acute exacerbations of MS in adults.
Controlled clinical trials have shown Acthar Gel to be effective in
speeding the resolution of acute exacerbations of MS. However,
there is no evidence that it affects the ultimate outcome or
natural history of the disease.3 Please see
Important Safety Information for Acthar Gel below.
"The management of MS relapse is an ongoing challenge, in
particular for those patients who need additional treatment options
after first-line agents such as corticosteroids," said
George Wan, Ph.D., Vice
President and Global Head of Health Economics and Outcomes Research
at Mallinckrodt. "We are committed
to working toward a better understanding of the potential clinical
and health economic outcomes associated with Acthar Gel and other
late-line treatments for MS relapse to help guide clinical practice
and potentially improve outcomes for patients. In addition, we look
forward to the results of Mallinckrodt's ongoing, randomized,
double-blind, placebo-controlled OPTIONS study, which we anticipate
will provide data on some of the more difficult-to-treat MS
patients in the future."
"Treatment Effectiveness for Resolution of Multiple Sclerosis
Relapse in a US Health Plan Population" evaluated the rate
of MS relapse occurrence, frequency of use of MS relapse treatments
including corticosteroids, and relapse treatment effectiveness (or
relapse resolution rates) for corticosteroid treatment alternatives
– Acthar Gel, IVIG, and PMP. No minimum health plan enrollment was
required. The data were originally shared in a
poster presentation at MSParis2017, the joint ECTRIMS-ACTRIMS
meeting.4
Key findings5
- 9,574 patients with relapse episodes were identified with
25,162 relapse episodes [mean (SD) of 2.6 (4.0) relapse episodes
per person]. The mean follow-up time per patient was 2.7± 2.1
years.
- The majority of patients (74.0 percent) had <2 relapse
episodes and 26.0 percent of patients experienced two or more
relapse episodes per year. 36.9 percent of patients had ≥1
unresolved relapse events during the study period which required
additional relapse therapy beyond the initial relapse treatment
received.
-
- The frequencies of relapse treatment alternatives used were as
follows: IVIG (6.0 percent), Acthar Gel (2.2 percent), and PMP (1.5
percent).
- 90 percent of initial relapse events within the first relapse
episodes were treated with corticosteroids
- Relapse resolution rates differed by treatment. Acthar Gel had
the highest proportion of patients achieving relapse resolution
(96.9 percent), compared with IVIG (43.9 percent) and PMP (50.7
percent).
Methods5
- A retrospective analysis of patients 18-89 years experiencing
MS relapse from January 1, 2008 to
June 30, 2015 was conducted using
administrative claims data from Humana Inc.
- MS relapse was estimated based on established claims-based
methodology; and was defined as an inpatient admission or
hospitalization with a principal diagnosis of MS or an outpatient
visit or emergency department visit with a diagnosis of MS,
followed by a medical or pharmacy claim for a relapse treatment of
interest (oral corticosteroids, intravenous corticosteroids, Acthar
Gel, PMP or IVIG) within 30 days.
- Treatment was deemed effective in resolving the relapse
(relapse resolution) if no additional relapses followed within the
episode; otherwise, the relapse was considered unresolved.
- A 30-day time frame was used as a marker to correlate MS
relapse as either one unresolved relapse if within 30 days of the
first visit for relapse or a new relapse if greater than 30 days
from the first visit for relapse.
Limitations6
- Administrative claims data are collected for reimbursement
purposes, and thereby may lack important clinical detail, such as
disease severity. Claims are often used in MS relapse studies.
Here, a number of definitions used in prior studies were
implemented in order to mitigate this limitation.
- Relapses were identified based on treatment-seeking behavior
using an established claims-based algorithm; treatment
received/prescribed outside a healthcare visit was not
addressed.
- Index relapse events were first observed, which may/not be the
actual first events. However, relapse resolution was based on the
occurrence of subsequent relapses, not prior relapses.
- Variation in treatment regimens would impact the rate of
relapse resolution.
- Acthar Gel and PMP/IVIG have not been studied head-to-head in
any randomized, controlled clinical trials.
- Not all improvements can be solely attributed to Acthar
Gel.
- The study assessed response to Acthar Gel and did not capture
safety.
The analysis was conducted by Mallinckrodt.
About Multiple Sclerosis
MS is a neurologic disorder
that affects the central nervous system (i.e., the brain and spinal
cord).7 Symptoms can include fatigue,
balance/coordination issues, numbness or tingling, vision problems,
muscle spasms, tremors and emotional changes.1 More than
eight in 10 people with MS will experience a relapse, or flare-up,
that brings new or worsening
symptoms.8
Acthar Gel (repository corticotropin
injection) Indications
Acthar Gel is an injectable drug
approved by the FDA for the treatment of 19 indications.
Of these, today the majority of Acthar use is in these
indications:
- Adjunctive therapy for short-term administration (to tide the
patient over an acute episode or exacerbation) in rheumatoid
arthritis, including juvenile rheumatoid arthritis (selected cases
may require low-dose maintenance therapy)
- The treatment of symptomatic sarcoidosis
- Monotherapy for the treatment of infantile spasms in infants
and children under 2 years of age
- Treatment during an exacerbation or as maintenance therapy in
selected cases of systemic lupus erythematosus
- The treatment of acute exacerbations of multiple sclerosis in
adults. Controlled clinical trials have shown Acthar Gel 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
- Inducing a diuresis or a remission of proteinuria in nephrotic
syndrome without uremia of the idiopathic type or that due to lupus
erythematosus
- Treatment during an exacerbation or as maintenance therapy in
selected cases of systemic dermatomyositis (polymyositis)
- Treatment of 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
IMPORTANT SAFETY INFORMATION
Contraindications
- Acthar should never be administered intravenously
- Administration of live or live attenuated vaccines is
contraindicated in patients receiving immunosuppressive doses of
Acthar
- Acthar is contraindicated where congenital infections are
suspected in infants
- Acthar is contraindicated 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 origins
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-axis (HPA) 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 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. Blood pressure, sodium and potassium
levels may need to be monitored
- 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 GI bleeding and gastric ulcer. There is also
an increased risk for perforation in patients with certain
gastrointestinal disorders. Monitor for signs of bleeding
- Acthar may be associated with central nervous system effects
ranging from euphoria, insomnia, irritability, mood swings,
personality changes, and severe depression, and 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. Neutralizing
antibodies with chronic administration may lead to loss of
endogenous ACTH activity
- There is 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 for patients on long-term therapy
- Pregnancy Class C: Acthar has been shown to have an embryocidal
effect and should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus
Adverse Reactions
- Common adverse reactions for Acthar are similar to those of
corticosteroids and include fluid retention, alteration in glucose
tolerance, elevation in blood pressure, behavioral and mood
changes, increased appetite and weight gain
- Specific adverse reactions reported in IS clinical trials in
infants and children under 2 years of age included: infection,
hypertension, irritability, Cushingoid symptoms, constipation,
diarrhea, vomiting, pyrexia, weight gain, increased appetite,
decreased appetite, nasal congestion, acne, rash, and cardiac
hypertrophy. Convulsions were also reported, but these may actually
be occurring because some IS patients progress to other forms of
seizures and IS sometimes mask other seizures, which become visible
once the clinical spasms from IS resolve
Other adverse events reported are included in the full
Prescribing Information.
Please see full Prescribing
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, nephrology, pulmonology and
ophthalmology; 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 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 including expectations regarding related
clinical trials, its potential impact on patients and anticipated
benefits associated with its use. 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.
CONTACTS
For Trade Media Inquiries
Caren
Begun
Green Room Communications
201-396-8551
caren@greenroompr.com
For Financial/Dailies Media Inquiries
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@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.
© 2019 Mallinckrodt. US-1901843
10/19
References
______________________________
1 Multiple Sclerosis: Hope Through Research. National
Institute of Neurological Disorders and Stroke. 2012. Available at
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-Hope-Through-Research#3215_29.
2 Coyle PK, Krieger S. Managing acute relapses in
multiple sclerosis CME. Medscape Education Neurology &
Neurosurgery. 2013. Available at:
http://www.medscape.org/viewarticle/779270_print.
3 Acthar® Gel (repository corticotropin
injection) (prescribing information). Mallinckrodt ARD
LLC.
4 Nazareth, T., Manasi, D., Sheer, R., Yu, T. &
Schwab, P. (2017, October). MS Relapse Treatments and
Relapse Resolution: Retrospective Study Results from a US Health
Plan. Poster session presented at MSParis2017, the joint
ECTRIMS-ACTRIMS meeting in Paris,
France.
5 Nazareth, T., Datar, M. & Yu, T. Treatment
Effectiveness for Resolution of Multiple Sclerosis Relapse in A US
Health Plan Population. Neurology and Therapy. 2019. Available at:
https://www.ncbi.nlm.nih.gov/pubmed/31564036.
6 Data on File, Mallinckrodt, 2019.
7 Willis BMJ Best Practice Multiple
Sclerosis. October 2018. p. 4.
8 Tillery EE, Clements JN, Howard
Z. What's new in multiple sclerosis? The Mental Health Clinician.
2017; 7(5) 213-220.
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