- Over 400 patients with spasticity or cervical dystonia
responded to online surveys evaluating the disease burden and the
impact on their personal and professional lives
- Results reveal the need for longer-lasting symptoms control to
improve patients’ perceived quality of life
- The results of the two surveys will be presented during the 6th
Congress of the European Academy of Neurology
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today presents the results of
two patient surveys. The surveys involved over 400 respondents from
five countries, living with spasticity or cervical dystonia and
receiving botulinum neurotoxin type A (BoNT-A) injections. The
results show that over 80% of respondents experienced debilitating
symptom recurrence, and revealed that a lack of long-lasting
symptom control between injections has a profound impact on the
personal and professional lives of patients.1-4
“The results from these two important patient surveys provide
significant insight into the real-life burden of the two
conditions; however, they also highlight a worrying disconnect
between patients’ treatment expectations and their actual
experience. The findings, which build on our growing understanding
of spasticity and cervical dystonia, provide us with the potential
to unlock meaningful changes in clinical practice,” said Dr Alberto
Esquenazi, Department of Physical Medicine and Rehabilitation, Gait
and Motion Analysis Laboratory, MossRehab and Albert Einstein
Medical Centre, U.S. and lead investigator on the spasticity
survey.
The first survey1,2 investigated the burden of spasticity on
patients’ lives. Of the 210 respondents from France, Germany,
Italy, the U.K., and the U.S., 83% reported that symptoms of
spasticity returned between two sessions of BoNT-A, with 59% of
these patients experiencing that return within three months of
their last treatment. Symptom recurrence significantly impacted
patients’ quality of life, including sleep, relationships,
performance of daily tasks and working lives. In addition, 47% of
working patients reported being unable to work when symptoms
re-emerge and 45% of working patients felt less efficient at work
than before.1,2
The second survey3,4 adopted a similar approach, analyzing data
from 209 respondents with cervical dystonia from across France,
Germany, Italy, the U.K., and the U.S. Of the respondents, 88%
reported the reappearance of pre-existing symptoms between BoNT-A
injections. The majority of working respondents reported a
significant impact on their professional life, with 66% stating
that they did not feel comfortable at work and 66% did not feel as
efficient at work as usual. Patients’ personal lives were also
significantly compromised by their symptom recurrence, with an
impact on their ability to socialize, sleep well, drive, or perform
daily tasks.3,4
In both surveys, over 70% of patients said they would like
longer lasting benefits from their treatment.1-4
The Carenity 2 surveys reveal the debilitating impact that
symptom recurrence can have across every aspect of life for
patients with spasticity and cervical dystonia, indicating that
more needs to be done to relieve the burden of symptoms for
patients suffering from these neurological conditions.1-4
Full results of the Carenity 2 survey in spasticity were
published in Frontiers in Neurology on 07 May 2020.1
Antony Fulford-Smith, Vice President, Global Medical Affairs,
Ipsen, commented: “Spasticity and cervical dystonia have a
devastating effect on patients’ lives, seriously affecting their
mobility, employment and quality of life. At Ipsen, we are
constantly searching for ways to improve disease management and
comprehensive care with a patient-centered approach. It’s clear
from these surveys that more can be done to relieve the burden of
these challenging diseases on patients’ day-to-day lives.”
Spasticity and cervical dystonia are distinct neurological
conditions, though they share the characteristics of poor muscle
control and spasms and are routinely treated with BoNT-A
injections.3,5,6 Spasticity affects more than 12 million people
worldwide7 and is generally caused by damage to the area of the
brain and spinal cord responsible for controlling muscle and
stretch reflexes due to stroke, traumatic brain and spinal cord
injury, multiple sclerosis and cerebral palsy.5 Cervical dystonia
is a rare disorder of unknown origin in most of the primary cases,
characterized by involuntary contractions of the neck muscles.6
About the Carenity 2 surveys
The two patient surveys, commissioned by Ipsen, were conducted
between May to September 2019 by Carenity, an online patient
community. A total of 419 respondents from France, Germany, Italy,
the U.K and the U.S responded to the surveys via the online
platform Carenity. Eligible participants were over 18 years old and
had (or cared for someone with) spasticity or cervical dystonia
(CD) treated with BoNT-A for at least one year. To assess burden of
spasticity or CD for patients and their caregivers, the Carenity 2
surveys explored the impact of symptom re-emergence on quality of
life.1-4
Ipsen has an ongoing partnership with Carenity, a social media
platform for people living with chronic diseases and presented
findings from the first Carenity international survey which focused
on spasticity at TOXINS 2019.8
About spasticity
Spasticity is estimated to affect more than 12 million people
worldwide.7 It is a condition in which certain muscles are
continuously contracted causing stiffness or tightness of the
muscles, which can interfere with normal movement, gait and
speech.5 Spasticity is usually caused by damage to the parts of the
brain or spinal cord that control voluntary movement,5,9 leading to
a change in the balance of signals between the nervous system and
the muscles which leads to increased activity in the muscles.5
Spinal cord injury, multiple sclerosis, cerebral palsy, stroke,
brain or head trauma and metabolic diseases can all cause
spasticity.9 Spasticity is experienced by 34% of stroke survivors
within 18 months following a stroke.10
About cervical dystonia
Cervical dystonia (CD), also known as spasmodic torticollis, is
a movement disorder in which involuntary muscular contractions
occur primarily in the neck muscles.6,11 This can cause the head to
turn to one side or to be pulled backward or forward.6,12 CD is
relatively uncommon, affecting 57 to 280 people per million.13 It
can occur at any age, although symptoms generally appear in middle
age, often beginning slowly and usually reaching a plateau over a
few months or years.14 The degeneration of the spine, irritation of
nerve roots or frequent headaches can make CD particularly
painful.14 In most cases the cause is unknown and no cure
exists.13
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group
focused on innovation and Specialty Care. The Group develops and
commercializes innovative medicines in three key therapeutic areas
– Oncology, Neuroscience and Rare Diseases. Its commitment to
oncology is exemplified through its growing portfolio of key
therapies for prostate cancer, neuroendocrine tumors, renal cell
carcinoma and pancreatic cancer. Ipsen also has a well-established
Consumer Healthcare business. With total sales over €2.5 billion in
2019, Ipsen sells more than 20 drugs in over 115 countries, with a
direct commercial presence in more than 30 countries. Ipsen’s
R&D is focused on its innovative and differentiated
technological platforms located in the heart of the leading
biotechnological and life sciences hubs (Paris-Saclay, France;
Oxford, UK; Cambridge, US). The Group has about 5,800 employees
worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the
United States through a Sponsored Level I American Depositary
Receipt program (ADR: IPSEY). For more information on Ipsen, visit
www.ipsen.com.
Ipsen—Cautionary Note Regarding Forward-Looking
Statements
The forward-looking statements, objectives and targets contained
herein are based on the Group’s management strategy, current views
and assumptions. Such statements involve known and unknown risks
and uncertainties that may cause actual results, performance or
events to differ materially from those anticipated herein. All of
the above risks could affect the Group’s future ability to achieve
its financial targets, which were set assuming reasonable
macroeconomic conditions based on the information available today.
Use of the words "believes", "anticipates" and "expects" and
similar expressions are intended to identify forward-looking
statements, including the Group’s expectations regarding future
events, including regulatory filings and determinations. Moreover,
the targets described in this document were prepared without taking
into account external growth assumptions and potential future
acquisitions, which may alter these parameters. These objectives
are based on data and assumptions regarded as reasonable by the
Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual
results may depart significantly from these targets given the
occurrence of certain risks and uncertainties, notably the fact
that a promising product in early development phase or clinical
trial may end up never being launched on the market or reaching its
commercial targets, notably for regulatory or competition reasons
and also taking into consideration assessment delays of certain
clinical trials in light of the ongoing COVID-19 pandemic. The
Group must face or might face competition from generic products
that might translate into a loss of market share. Furthermore, the
Research and Development process involves several stages each of
which involves the substantial risk that the Group may fail to
achieve its objectives and be forced to abandon its efforts with
regards to a product in which it has invested significant sums.
Therefore, the Group cannot be certain that favorable results
obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the
product concerned. There can be no guarantees a product will
receive the necessary regulatory approvals or that the product will
prove to be commercially successful. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
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but are not limited to, general industry conditions and
competition; general economic factors, including interest rate and
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The Group also depends on third parties to develop and market some
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Group cannot be certain that its partners will fulfil their
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The Group expressly disclaims any obligation or undertaking to
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estimates contained in this press release to reflect any change in
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Financiers. The risks and uncertainties set out are not exhaustive
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References
- Jacinto et al. Patient perspectives on the therapeutic profile
of botulinum neurotoxin type A in spasticity. Frontiers in
Neurology 2020: DOI 10.3389/fneur.2020.00388.
- Esquenazi A, et al. Impact of spasticity and waning of effect
of botulinum toxin a treatment on patients’ employment and quality
of life: results of a multinational online survey. Abstract
presented at the 6th Congress of the European Academy of Neurology.
23-26th May 2020, Vienna, Austria.
- Ferreira J, et al. How do patients with cervical dystonia (CD)
experience their botulinum neurotoxin type a (BoNT-A) treatment
cycle: results from an international online survey. Abstract
presented at the 6th Congress of the European Academy of Neurology.
23-26th May 2020, Vienna, Austria.
- Comella C, et al. Gaps in the Management of Cervical Dystonia
with Botulinum Toxin A: Findings from an Online Patient Survey.
Poster presented at the 6th Congress of the European Academy of
Neurology. 23-26 May 2020, Vienna, Austria.
- American Association of Neurological Surgeons. Spasticity.
Available at:
https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity.
Accessed April 2020.
- Mayo Clinic. Cervical Dystonia. Available at
https://www.mayoclinic.org/diseases-conditions/cervical-dystonia/symptoms-causes/syc-20354123.
Accessed April 2020.
- John Hopkins Medicine. Spasticity. Available at:
https://www.hopkinsmedicine.org/health/conditions-and-diseases/spasticity.
Accessed April 2020.
- Patel, A. et al. Burden of spasticity among patients and
caregivers: results of a multinational survey. Poster presented at
TOXINS 2019. 16-19th January 2019, Copenhagen, Denmark.
- American Association of Neurological Surgeons. Movement
Disorders. Available at:
https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Movement-Disorders.
Accessed May 2020.
- Kuo C.Post-stroke Spasticity: A review of epidemiology,
pathophysiology, and treatments. Int J Gerontol
2018;12:280-284.
- Claypool D, et al. Epidemiology and outcome of cervical
dystonia (spasmodic torticollis) in Rochester, Minnesota. Movement
Disorders 1995;10: 608-614.
- National Institute of Neurological Disorders and Stroke.
Dystonias Fact Sheet. Available at
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Dystonias-Fact-Sheet.
Accessed May 2020.
- Castelão M, et al. Botulinum toxin type A therapy for cervical
dystonia. Cochrane Database of Systematic Reviews
2017;12:CD003633.
- American Association of Neurological Surgeons. Dystonia.
Available at
http://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Dystonia.
Accessed May 2020.
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version on businesswire.com: https://www.businesswire.com/news/home/20200522005004/en/
For further information:
Media Christian Marcoux, M.Sc. Senior Vice President, Global
Communications +33 (0)1 58 33 67 94 christian.marcoux@ipsen.com
Kelly Blaney Vice President, Global Communications +44 (0) 7903
402275 kelly.blaney@ipsen.com Financial Community Eugenia
Litz Vice President, Investor Relations +44 (0) 1753 627721
eugenia.litz@ipsen.com Myriam Koutchinsky Investor Relations
Manager +33 (0)1 58 33 51 04 myriam.koutchinsky@ipsen.com
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