ASSURE study results presented by Novartis at WCD demonstrated the negative impact of chronic idiopathic urticaria on quality of life

• ASSURE showed the consistent negative health impact and economic burden of chronic idiopathic urticaria (CIU), including anxiety, depression, impact on work productivity and health system costs^1,2
• ASSURE is a multinational, and multicenter study conducted in Canada, France, Germany, Italy, Spain, Netherlands, and the UK. In Canada, 9 sites participated with 99 Canadian patients participating in the study¹
• CIU is a severe skin condition with symptoms such as persistent itching, swelling hives or wheals that spontaneously presents and re-occurs for more than six weeks^3-5

DORVAL, QC, June 12, 2015 /CNW/ - Novartis announced today results from the ASSURE-CSU study which found that, chronic idiopathic urticaria (CIU), had a consistent negative impact on quality of life of patients and on patients' ability to be productive at work.¹ These findings were presented at the 23rd World Congress of Dermatology (WCD) in Vancouver, Canada.

CIU, also known as chronic spontaneous urticaria (CSU) in Europe is a severe and distressing skin condition with symptoms that include persistent itching, swelling hives or wheals that spontaneously appears on the skin and re-occurs for more than six weeks.^3-5 CIU is associated with a significant and underestimated disease burden that, in several dimensions, is comparable to the impairment suffered by patients with atopic dermatitis and psoriasis.⁶ Patients experience pain, lack of sleep, occupational disabilities and social isolation which results in a negative impact on their daily function, thus drastically lowering their quality of life.^7-9

"Chronic Spontaneous Urticaria is a poorly understood and debilitating skin condition that has a significant adverse impact on patients' day-to-day activities and quality of life," said ASSURE investigator Dr. Charles W. Lynde, MD, FRCPC, Diplomate American Boards Dermatology, Associate Professor, Department of Medicine, University of Toronto. "The ASSURE-CSU study found that, CIU, had a consistent negative impact on the quality of life of patients. This was measured by the Urticaria Activity Score over 7 days (UAS7), Chronic Urticaria Quality of Life Questionnaire (CU-Q₂oL) and Dermatology Quality of Life Index (DLQI)." Dr. Lynde adds: "The findings support the need to measure quality of life scores among CIU patients to ensure a holistic and effective approach to disease management. 

Kayla Creighton, a young woman of 18 from Nova Scotia knows all too well the negative impact on quality of life caused by CIU. "I have lived with itching, scratching, wheals, hives, pain, swelling and anxiety for three quarters of my life. Because of CIU, I live in constant fear and I am ALWAYS in crisis mode," says Kayla. "CIU is not just hives, there's physical and psychological pain caused that comes with it."

Dr. Gina Lacuesta, Allergist and Clinical Immunologist in Halifax, has been treating Kayla: "Kayla has been followed in our clinic for 10 years. She has had increased and severe symptoms of chronic urticaria and angioedema and it proved difficult for her to continue with her studies at university, both from the disease itself and the side effects from her treatment. It is positive and encouraging to see her health beginning to improve. I'm hoping to see her continue to get her life back on track."

About the ASSURE-CSU study
ASSURECSU (ASsessment of the Economic and Humanistic Burden of Chronic Spontaneous/Idiopathic URticaria PatiEnts) is the first international study to assess both the humanistic and economic burden of CIU not adequately controlled with conventional therapy.

Data presented at WCD show that the majority of Canadian patients enrolled in the study had moderate to severe CIU at the time of diagnosis and had been suffering of average for about 5 years prior to being diagnosed.¹ Patients had taken a variety of different treatments including H1 anti-histamines, LTRAs and immunosuppressants but remained symptomatic despite treatment demonstrating available treatments do not provide full-symptom relief.¹ Patients also reported significant impact of health related quality of life which increased with disease severity. Dimensions most affected by CIU are: symptoms and feeling, daily activities and work and school. In fact, 13% of patients had previously taken anti-depressants.¹ UK patients enrolled in the study also reported significant work productivity impairment which increased with disease severity.¹ Many employed patients are affected at work by their disease, either through absenteeism or reduced productivity; approximately 10% of work time is missed due to CIU.¹ Overall, monthly cost of work productivity loss were estimated to be £733 (CAD$1392¹⁰) per employed patient.¹ The ASSURE-CSU study demonstrated the significant impact CIU has on the life of affected patients whether it be on quality of life or work productivity.¹

About CIU
CIU, also referred in some studies as chronic spontaneous urticaria (CSU), is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives or wheals on the skin that spontaneously present and reoccur for more than six weeks.^3,4,11

At any given time, the prevalence of chronic urticaria (CU) is up to 1% of the world's population.⁵ Up to 40% of CIU patients also experience concomitant angioedema, a swelling in the deep layers of the skin.¹² Disfigurement caused by angioedema and discomfort associated with this disorder can often pose long-term hardship for patients and their families.¹³

CIU is described by patients as a very distressing and unpredictable disease. They experience occupational disabilities, depression, lack of sleep, fatigue, pain, social isolation, and a feeling of lack of control over their lives which impart a significant negative impact on their daily functioning, thus drastically lowering their quality of life.^5,14  The majority of studies clearly show that women suffer from urticaria nearly twice as much as men do and that the peak incidence is reported between 20 and 40 years which means that patients are affected in the prime of both their work and family lives.⁵

Although 6 weeks' duration is the requirement to be considered chronic¹⁵, CIU can persist for years: average duration of CIU is between 1 to 5 years but longer disease duration can occur in patients with more severe disease or in patients with concurrent angioedema among other factors.⁵ The chronic aspect of CIU will significantly impact a person's life as it can potentially cause experiencing major disability, emotional distress and decreased productivity.¹⁵

CIU also results in a considerable economic burden. Although most patients with CIU are relatively young and otherwise healthy, their health care costs can be substantial. Medication and outpatient visits (direct costs), and lost productivity due to absence from work (indirect costs) are major cost drivers for CIU and increase with disease severity.^16,17.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2013, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. For further information, please consult www.novartis.ca.

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, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References

1. Sussman, G, Nakonechna A, Lynde C, et al. Impact of chronic idiopathic/spontaneous urticaria on health related quality of life: ASSURE-CSU study results from Canada and the UK. Poster presentation at: 23rd World Congress of Dermatology, Vancouver, Canada; 8-13 June 2015.
2. Balp MM, Jeffrey V, Haijun T, et al. Economic burden and quality of life in patients with chronic idiopathic/spontaneous urticaria from 5 European countries. Poster presentation at: 23rd World Congress of Dermatology, Vancouver, Canada; 8-13 June 2015.   
3. Asthma and Allergy Foundation of America (AAFA) website. "Chronic Urticaria (Hives). "http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed May 2015.
4. American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin Allergy Overview." http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed May 2015.
5. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011;66:317-330.
6. Grob JJ, Revuz J, Ortonne JP, Auquier P, Lorette G. Comparative study of the impact of chronic urticaria, psoriasis and atopic dermatitis on the quality of life. Br J Dermatol. 2005;152:289-95.
7. Yang HY, Sun CC, Wu YC, Wang JD. Stress, insomnia, and chronic idiopathic urticaria--a case-control study. J Formos Med Assoc. 2005;104:254-63.
8. Ozkan M, Oflaz SB, Kocaman N, et al. Psychiatric morbidity and quality of life in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2007;99:29-33.
9. Chung MC, Symons C, Gilliam J, Kaminski ER. Stress, psychiatric co-morbidity and coping in patients with chronic idiopathic urticaria. Psychol Health. 2010;25:477-90.
10. XE Currency Converter website. Accessed June 8, 2015
11. Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. NEJM. 2013; 368(10):924-35.
12. Kanani A, Schellenberg R, Warrington R. Urticaria and angioedema. Allergy, Asthma & Clinical Immunology. 2011; 7(suppl 1):S9.
13. Ben-Shoshan M, Blinderman I, Raz A. Psychosocial factors and chronic spontaneous urticaria: a systematic review. Allergy 2013; 68: 131-141.
14. O'Donnell BF et al. The impact of chronic urticaria on the quality of life. Br J Dermatol. 1997; 136(2): 197–201.
15. Sussman G, Hébert J, Barron C, et al. Real-life experiences with omalizumab for the treatment of chronic urticaria, American College of Allergy, Asthma and Immunology. 2014; 170-174.
16. Zazzali JL, Broder MS, Chang E, Chiu MW, Hogan DJ. Cost, utilization, and patterns of medication use associated with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2012;108:98-102.
17. Delong LK, Culler SD, Saini SS, Beck LA, Chen SC. Annual direct and indirect health care costs of chronic idiopathic urticaria: a cost analysis of 50 nonimmunosuppressed patients. Arch Dermatol. 2008;144:35-9.

SOURCE Novartis Pharmaceuticals Canada Inc.

Image with caption: "Burden of Chronic Idiopathic Urticaria (CIU) (CNW Group/Novartis Pharmaceuticals Canada Inc.)". Image available at: http://photos.newswire.ca/images/download/20150612_C4099_PHOTO_EN_18003.jpg

Novartis Media Relations: Elizabeth Tanguay, Manager, External Communications, Novartis Pharmaceuticals Canada Inc., [phone], [email protected]; Rob McEwan, Vice President, Argyle Communications, + 1 416 968-7311 ext. 242, [email protected]