Neupro (Rotigotine Transdermal System) Significantly Improved Wellbeing and Daily Activities Impaired Due to Limb Pain Associated With Restless Legs Syndrome
- Data presented at major international congress - Additional five year open-label data provided evidence for long-term safety and efficacy of Neupro® (rotigotine transdermal system) in Restless Legs Syndrome (RLS)
BRUSSELS, June 18 /PRNewswire-FirstCall/ -- The first data to
show that Neupro® (rotigotine transdermal system) significantly
improved wellbeing and daily activities that are often impaired by
pain related to Restless Legs Syndrome (RLS) were presented this
week at the 14th International Congress of Parkinson's Disease and
Movement Disorders in Buenos Aires, Argentina. Additional data from
an open-label extension study showed that the efficacy of
rotigotine remained stable over five years of follow up with over a
third of patients remaining symptom free during that time and 96%
categorized as "very much improved" or "much improved."
"Pain has been reported by up to 60% of RLS patients. These new
data showed that by improving the core symptoms of RLS, rotigotine
provided relief from pain and significantly improved patient
wellbeing and daily activities impaired due to RLS-related pain.
Therefore these data may be relevant for RLS patients with painful
symptoms that are not currently being treated effectively," said
Professor Ralf Kohnen, University of Erlangen- Nurembourg,
Germany.
In the 6-month, double-blind study, 458 patients with moderate
to severe RLS were randomised to receive either placebo or
rotigotine (1,2,3 mg/24hrs) by transdermal administration. Patient
impairment of daily activities due to pain was assessed using Item
8 of the Quality of Life Questionnaire for RLS patients (QoL-RLS;
additional exploratory endpoint). At baseline, 456 patients (99.6%)
were assessed and 433 patients (94.5%) were assessed at the end of
the maintenance period.
At each visit, patients were asked to what degree pain in their
arms or legs impaired their wellbeing or normal daytime activities
on a scale of 0-5 points ("not at all" to "extremely"). The mean
value for pain decreased from 2.41 to 1.85 in the placebo group,
and from 2.61 to 1.39 in the rotigotine group (p=0.0003). The
average change was 0 points in the placebo group, and -1 point in
the rotigotine group.
Additionally, at baseline, 55.6% of the placebo group reported
moderate to extreme pain, compared with 61.9% of patients in the
rotigotine group. At the end of maintenance, these figures had
changed to 38.2% and 22.9%, respectively.
Abstract: Rotigotine reduced impairment of daily activities due
to pain in patients with idiopathic Restless Legs Syndrome
Stiasny-Kolster K, Trenkwalder C, Garcia-Borreguero D, Bauer L,
Grieger F, Schollmayer
E, Kohnen R, on behalf of the SP790 study group Poster Session IV, June 17th 2010, 0900-1600 Other rotigotine in RLS presentations at the Congress: 5-year results from an open-label follow-up study
Final results of the longest ever open label prospective
follow-up of a placebo-controlled phase II trial in RLS have shown
the safety and efficacy of rotigotine seen at previous interim
analyses.
This study looked at improvement in symptoms based on the
International Restless Legs Syndrome Study Group Rating Scale
(IRLS)*. The total IRLS score ranges from 0 (no symptoms) to 40
(very severe symptoms). A score of >20 indicates severe RLS. Of
the 295 patients with moderate to severe RLS who entered the study,
126 (43%) completed the 5-year follow up. At the end of the study,
59% of patients were classified as remitters (IRLS score < or =
10), and 39% as symptom-free (IRLS score=0).
Additionally, the Clinical Global Impression (CGI) Improvement
scale was used to assess how much the patient's illness had
improved or worsened relative to baseline. The change in the
condition from baseline to the end of the study was categorized as
"very much improved" or "much improved" in 96% of patients. At the
end of the study 85% of patients were in a less severe illness
category (normal, borderline ill or mildly ill) compared with 3% at
baseline.
The mean dose of rotigotine was 2.43 mg/24 hours after initial
titration and 3.09 mg/24 hours at the end of the study. Most
adverse events (AEs) were mild to moderate in intensity. The most
common AEs were application site reactions (58%), nasopharyngitis
(19%), back pain (14%), nausea (12%) and fatigue (11%)+. Thirty per
cent of patients discontinued the study due to an AE.
* The International Restless Legs Syndrome Study Group Rating
Scale (IRLS) is a ten-item scale developed and validated by The
International Restless Legs Syndrome Study Group and considered to
be the best scale for evaluating the severity and frequency of RLS
symptoms and the degree to which they affect sleep and daily life.
It is administered by clinicians and includes questions related to
the severity of sensory and motor symptoms, sleep disturbance,
daytime somnolence and impact of RLS on activities of daily living
and mood.
Abstract: Long-term safety and efficacy of rotigotine in
patients with idiopathic RLS: 5- year results from a prospective
multinational open-label follow-up study
Hogl B, Trenkwalder C, Garcia-Borreguero D, Kohnen R, Poewe W,
Stiasny-Kolster K, Bauer L, Fichtner A, Schollmayer E, Oertel W, on
behalf of the SP710 study group
Poster Session IV, June 17th 2010, 0900-1600 12-month results from an open-label extension study
The long term safety and efficacy of rotigotine have also been
shown in an additional 12-month open label extension study of two
earlier placebo-controlled trials of rotigotine in idiopathic
RLS.
Of 341 patients who entered the study, 91 (27%) discontinued, 58
(17%) due to adverse events and 17 (5%) due to lack of efficacy.
The most common AEs were application site reaction (33%), nausea
(7%), fatigue (7%), nasopharyngitis (6%) and headache (6%)+. Mean
daily dose at the start of 12-month maintenance was 2.08 mg/24hrs;
after initial dose titration, 70% of patients required no further
dose adjustment; 5% decreased and 25% increased their dose.
At the end of maintenance, mean IRLS score was 10.6, and 65% of
patients were classified as IRLS responders (IRLS score reduced by
> or = 50%), 55% were IRLS remitters (IRLS score of < or = 10
points), and 30% had no RLS symptoms (IRLS score of 0).
+ Please consult the Neupro® Summary of Product
Characteristics for a full listing of adverse events
Abstract: Safety and efficacy of long-term treatment with
transdermal rotigotine in patients with idiopathic restless legs
syndrome: a 12 month open-label extension study
Benes H, Oertal WH, Garcia-Borreguero D, Fichtner A, Schollmayer
E, Trenkwalder C, on behalf of the SP791 study group
Poster Session IV, June 17th 2010, 0900-1600 For further information Eimear O Brien, Associate Director, Global CNS Communications T +32 2 559 9271, eimear.obrien@ucb.com Andrea Levin / Public Relations Manager, CNS, UCB, Inc. Office: 770.970.8352 / Mobile: 404.483.7329 / andrea.levin@ucb.com Notes to Editors About Restless Legs Syndrome
Restless Legs Syndrome (RLS) is a neurological disorder
characterized by unpleasant sensations in the legs and an
uncontrollable urge to move when at rest in order to relieve these
feelings. It affects between 3 and 10% of the population to some
extent. Some researchers estimate that RLS affects as many as 12
million Americans. However, others estimate a much higher
occurrence because RLS is thought to be under-diagnosed and in some
cases mis-diagnosed. Most people with RLS have difficulty falling
asleep and staying asleep. Left untreated the condition causes
exhaustion and daytime fatigue. Many people with RLS report that
their job, personal relations and activities of daily living are
strongly affected as a result of their exhaustion. They are often
unable to concentrate, have impaired memory, or fail to accomplish
daily tasks. Most than 80% of people with RLS also experience a
more common condition known as periodic limb movement disorder
(PLMD).
About Neupro® in Europe
Neupro® (rotigotine) is approved in the European Union for
the treatment of the signs and symptoms of early-stage idiopathic
Parkinson's disease, as monotherapy (i.e. without levodopa) or in
combination with levodopa, i.e. over the course of the disease,
through to late stages when the effect of levodopa wears off or
becomes inconsistent and fluctuations of the therapeutic effect
occurs. Neupro® is also approved in the European Union for the
symptomatic treatment of moderate to severe idiopathic restless
legs syndrome in adults.
Neupro® in Europe Important Safety Information
Neupro® is contraindicated in case of hypersensitivity to
the active substance or to any of its excipients, and in case of
magnetic resonance imaging (MRI) or cardioversion. Neupro®
should be removed if the patient has to undergo MRI or
cardioversion.
It is recommended to monitor blood pressure, especially at the
beginning of treatment, due to the general risk of orthostatic
hypotension associated with dopaminergic therapy.
Neupro® has been associated with somnolence episodes of
sudden sleep onset episodes. Patients treated with dopamine
agonists including Neupro®, have been reported as exhibiting
signs of pathological gambling, increased libido and
hypersexuality.
Symptoms suggestive of neuroleptic malignant syndrome have been
reported with abrupt withdrawal of dopaminergic therapy. Therefore
it is recommended to taper treatment.
Neupro® contains sodium metabisulphite, a sulphite that may
cause allergic-type reactions including anaphylactic symptoms and
life threatening or less severe asthmatic episodes in certain
susceptible people.
Hallucinations have been reported, and patients should be
informed that hallucinations can occur.
Cases of cardiopulmonary fibrotic complications have been
reported in some patients treated with ergot-derived dopaminergic
agents. Neuroleptics given as antiemetic should not be given to
patients taking dopamine agonists. Ophthalmologic monitoring is
recommended at regular intervals or if vision abnormalities
occur.
External heat, from any source should not be applied to the area
of the patch. Exposure of a skin rash or irritation to direct
sunlight could lead to changes in the skin color. If a generalized
skin reaction (e.g. allergic rash) associated with the use of
Neupro® is observed, Neupro® should be discontinued.
Caution is advised when treating patients with severe hepatic
impairment or acute worsening of renal function, a dose reduction
might be needed.
The incidence of some dopaminergic adverse events, such as
hallucinations, dyskinesia, and peripheral oedema generally is
higher when given in combination with L-dopa. This should be
considered when prescribing Neupro®.
Neupro® should not be used during pregnancy. Breast-feeding
should be discontinued.
Augmentation may occur in Restless Legs Syndrome patients.
Augmentation refers to the earlier onset of symptoms in the evening
(or early afternoon), increase in severity of symptoms, and spread
of symptoms to involve other body parts.
Adverse drug reactions reported in more than 10% of Parkinson's
patients treated with Neupro® are nausea, vomiting, application
site reactions, somnolence, dizziness and headache.
Adverse drug reactions reported in more than 10% of RLS patients
treated with Neupro® are nausea, application site reactions,
asthenic conditions and headache.
All Neupro® supply should be stored in a refrigerator. There
is no need for patients to transport Neupro® patches in special
containers and they must not be stored in a freezer
compartment.
Please refer to the European Summary of Product Characteristics
for full prescribing information (Approved 15th March 2010):
http://www.emea.europa.eu/humandocs/PDFs/EPAR/neupro/emea-combined-h626en.pdf
About Neupro® in the U.S.
Neupro® (rotigotine) is indicated in the U.S. for the
treatment of the signs and symptoms of early-stage idiopathic
Parkinson's disease. In April 2008, UCB recalled Neupro® from
the U.S. market after ongoing monitoring revealed that specific
batches of Neupro® had deviated from their approved
specification. Recently the U.S. Food and Drug Administration (FDA)
has recommended that UCB reformulate Neupro® patches and UCB is
working on the development of a new formulation. Patients and
physicians with questions about the status of Neupro®, or about
UCB's Patient Access program for Neupro®, may contact UCB
Medical Information at 1-866-822-0068 (option 9).
Important Safety Information - U.S.
Some patients treated with Neupro® reported falling asleep
while engaged in activities of daily living, including operation of
motor vehicles, which sometimes resulted in accidents. Some
patients perceived no warning signs, such as excessive drowsiness.
Hallucinations were reported in 2.0% of patients treated with
Neupro® compared to 0.7% of patients on placebo. Neupro®
contains metabisulfite. Neupro® should be used with caution in
patients, especially those at risk for cardiovascular disease,
because of the potential for symptomatic hypotension, syncope,
elevated heart rate, elevated blood pressure, fluid retention,
and/or weight gain. All Parkinson's disease patients are at a
higher risk for melanoma and should be monitored regularly. The
most commonly reported side effects in clinical trials were nausea,
application site reactions, somnolence, dizziness, headache,
vomiting, and insomnia. Some subjects who received Neupro®
experienced a decline in blood hemoglobin levels (about 2% relative
to subjects who received placebo). It is not known whether this
change is readily reversible with discontinuation of
Neupro®.
Neupro® is a registered trademark of the UCB Group of
companies.
Neupro® is not approved or available in Argentina for the
treatment of Restless Legs Syndrome.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical
company dedicated to the research, development and
commercialization of innovative medicines with a focus on the
fields of central nervous system and immunology disorders.
Employing more than 9 000 people in over 40 countries, UCB produced
revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext
Brussels (symbol: UCB).
Forward looking statement
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. Such statements
are subject to risks and uncertainties that may cause actual
results to be materially different from those that may be implied
by such forward-looking statements contained in this press release.
Important factors that could result in such differences include:
changes in general economic, business and competitive conditions,
effects of future judicial decisions, changes in regulation,
exchange rate fluctuations and hiring and retention of its
employees.
Source: UCB
CONTACT: Eimear O Brien, Associate Director, Global CNS
Communications,
+32-2-559-9271, eimear.obrien@ucb.com or Andrea
Levin, Public Relations
Manager, CNS, UCB, Inc., office, +1-770-970-8352 or mobile,
+1-404-483-7329,
andrea.levin@ucb.com
Web Site: http://www.ucb.com/
Posted: June 2010
