Novartis real world study shows almost half of chronic urticaria patients are not receiving any treatment despite significant disease burden
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Novartis real world study shows almost half of chronic urticaria patients are
not receiving any treatment despite significant disease burden
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* Urgent need to improve management of chronic urticaria (CU) - a disease that
causes itchy, persistent hives and swelling which last more than 6 weeks or
recur over months or years - highlighted by study of over 3,700
patients[1],[2]
* 42% of CU patients studied are not receiving any treatment for their
debilitating condition and 83% show a negative impact on their quality of
life[1]
* This further confirms that many chronic spontaneous urticaria (CSU) patients
are not treated according to recommended guidelines[3],[4] - Xolair(®)
(omalizumab)* is the only licensed third-line treatment for CSU, a type of
CU[5]
Basel, June 20, 2017 - Novartis announced today new baseline results from a real
world study of 3,733 chronic urticaria (CU) patients showing many are not
receiving adequate care, with almost half (42%) not receiving any treatment at
all for the debilitating disease despite 83% suffering a negative impact on
their quality of life[1]. The findings are consistent with earlier research that
found many chronic spontaneous urticaria (CSU) patients are not treated
according to recommended guidelines[3],[4] that include Xolair(®) (omalizumab) -
the only licensed option for CSU, a type of CU[5]. The findings were presented
at the European Academy of Allergy and Clinical Immunology (EAACI) Annual
Congress in Helsinki, Finland.
The results are part of the worldwide non-interventional AWARE study. These data
from 12 European countries reveal the significant impact of CU - a severe
disease that causes itchy, persistent hives and painful swelling for at least 6
weeks and in a substantial number of cases even years or decades[2]. Symptoms
may occur in visible and highly-sensitive areas of the body, such as around the
eyelids, lips, and mouth[6], and the psychological and social impact of the
disease is significant[7]-[10].
"Chronic urticaria is a serious disease that greatly impacts the quality of
life, yet seems to be severely undertreated," said Vas Narasimhan, Global Head,
Drug Development and Chief Medical Officer, Novartis. "These findings reinforce
the urgent need to improve the management of chronic urticaria in line with
treatment guidelines, calling for a treatment goal of a 'symptom free
patient'."
More than half of the patients reported the effect of CU on their QOL as
moderate, very large, or extremely large. This substantial QOL impact was
observed in 51% in Southern European countries (Belgium, France, Portugal,
Spain, Italy, and Greece), 54% of patients in Nordic countries (Sweden, Norway,
and Denmark), 56% of German patients, 61% of UK patients, and as many as 85% of
Russian patients.
Importantly, many patients receiving treatment still reported a substantial QOL
impact, indicating inadequate symptom relief even in those currently on therapy.
Nordic patients were most likely to be receiving any treatment (74%), followed
by patients in Germany (61%), South European countries (58%), the UK (52%), and
Russia (39%).
About CU
CU is a severe disease that is characterized by the reoccurrence of persistent
hives and/or sometimes painful swelling for six weeks or more[2].
At any given time, the prevalence of CU is up to 1% of the world's population,
and up to two thirds of these patients have CSU[7] - a form of the condition
that can occur unpredictably without an identifiable trigger[6],[7]. In 30 to
50% of cases, CU lasts for up to a year, however in a substantial amount of
patients CU can last anything from 1 to 5 years and in some it can last for
decades[2].
Although CU has a significant impact on patients' quality of life, research has
highlighted that some physicians disregard the disease as a trivial
condition[2],[11].
About AWARE
AWARE (A World-wide Antihistamine-Refractory Chronic Urticaria Patient
Evaluation) is an ongoing prospective observational study designed to assess CU
in the real-life setting. These baseline interim results are from 12 European
countries included in the study. Data was collected from patients aged 18 years
or older and refractory to at least one course of H1-AH, and included
pharmacological treatments and QOL measured by the Dermatology Life Quality
Index (DLQI).
*Xolair(®) is the only licensed third line treatment and is indicated as add-on
therapy for the treatment of CSU, a type of CU, in adult and adolescent (12
years and above) patients with inadequate response to H1 antihistamine
treatment. The study also included ciclosporin and montelukast which are
recommended third-line treatments which are used off-label to treat CU[3].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "recommended," "seems to be," "calling for," "ongoing," or
similar terms, or by express or implied discussions regarding potential new
indications or labeling for Xolair, or regarding potential future revenues from
Xolair. You should not place undue reliance on these statements. Such forward-
looking statements are based on the current beliefs and expectations of
management regarding future events, and are subject to significant known and
unknown risks and uncertainties. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the forward-looking
statements. There can be no guarantee that Xolair will be submitted or approved
for any additional indications or labeling in any market, or at any particular
time. Nor can there be any guarantee that Xolair will be commercially successful
in the future. In particular, management's expectations regarding Xolair could
be affected by, among other things, the uncertainties inherent in research and
development, including clinical trial results and additional analysis of
existing clinical data; regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain proprietary intellectual
property protection; general economic and industry conditions; global trends
toward health care cost containment, including ongoing pricing and reimbursement
pressures; safety, quality or manufacturing issues, and other risks and factors
referred to in Novartis AG's current Form 20-F on file with the US Securities
and Exchange Commission. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic and biosimilar pharmaceuticals, and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
118,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Maurer M, et al. Treatment of patients with chronic urticaria in Europe:
findings from visit 1 of the worldwide prospective observational AWARE study.
Poster presented at The European Academy of Allergy and Clinical Immunology
Annual Congress. June 19, 2017.
[2] Sánchez-Borges M, et al. Diagnosis and Treatment of Urticaria and
Angioedema: A Worldwide Perspective. WAO Journal 2012; 5: 125-147.
[3] Zuberbier T, et al. The EAACI/GA(2)LEN/EDF/WAO Guideline for the definition,
classification, diagnosis, and management of urticaria: the 2013 revision and
update. Allergy 2014; 69: 868-887.
[4] Maurer M, et al. The Burden of Chronic Spontaneous Urticaria Is Substantial:
Real-World Evidence From ASSURE-CSU. Allergy. 2017 May 19. doi:
10.1111/all.13209. [Epub ahead of print]
[5] Xolair Summary of Product Characteristics. Novartis Europharm Limited.
Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/000606/WC500057298.pdf. Last accessed June 2017.
[6] British Association of Dermatologists. Urticaria and angioedema. Available
online at: http://www.bad.org.uk/shared/get-file.ashx?id=184&itemtype=document.
Last accessed June 2017.
[7] Maurer M, et al. Unmet clinical needs in chronic spontaneous urticaria. A
GA2LEN task force report. Allergy 2011; 66: 317-330.
[8] O'Donnell BF, et al. The impact of chronic urticaria on the quality of life.
British Journal of Dermatology 1997; 136: 197-201.
[9] Kang MJ, et al. The Impact of Chronic Idiopathic Urticaria on Quality of
Life in Korean Patients. Annals of Dermatology 2009; 21: 226-229.
[10] Barbosa F, et al. Chronic idiopathic urticaria and anxiety symptoms.
Journal of Health Psychology 2011; 16: 1038-1047.
[11] Weller K, et al. Chronic urticaria. Prevalence, course, prognostic factors
and impact. Hautärzte 2010; 61: 750-757.
# # #
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 20.06.2017 - 07:10 Uhr
Sprache: Deutsch
News-ID 548715
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