First-ever Uterine Fibroid Patient Registry Aims to Shed Light on Burden for Thousands of Canadian Women

Over 1,100 symptomatic Canadian women are contributing data to CAPTURE, providing the only real-world data about the common and debilitating condition

MARKHAM, ON, Sept. 15, 2017 /CNW/ - Allergan Canada shared today interim findings from CAPTURE (the first-ever patient registry collecting real-world observational data of women living with symptomatic uterine fibroids). The Canadian multicenter, prospective, non-interventional patient registry aims to enhance understanding of the natural history of uterine fibroids and patient preferences in managing symptoms, to ultimately improve management and outcomes of this condition.

Early analysis of the data from CAPTURE affirms symptomatic patients experience a poor quality of life, with the most troubling symptoms being heavy menstrual bleeding and pain.1 The analysis was presented at CanSAGE, the Annual Conference of the Canadian Society for the Advancement of Gynecologic Excellence.

"CAPTURE provides real-world evidence of the burden that Canadian women with symptomatic uterine fibroids experience, but also helps us better understand how we can improve the treatment of this debilitating condition," says Dr. Nicholas Leyland, Chief of the Department of Obstetrics and Gynaecology at McMaster University. "We now have more than 1,100 patients registered in CAPTURE, meaning we'll have a robust repository of data that will greatly benefit clinicians and patients in Canada, as well as around the world."

Uterine fibroids are the most common non-cancerous tumours in women of reproductive age.2 If left untreated, they may significantly impact women's quality of life.3 In the past, the most common approach to treatment has been surgical removal of the uterus (a hysterectomy).4 In fact, Canada has one of the highest rates of hysterectomies in the world with uterine fibroids being the leading cause.5

Findings Presented at CanSAGE
Early analysis of CAPTURE data underlines the impact of uterine fibroids on women with 82 per cent of patients reporting heavy menstrual bleeding and 30 per cent reporting bleeding between periods. Pelvic discomfort was reported by 79 per cent and pelvic pain by 69 per cent of women.

"The CAPTURE registry is already producing learnings that will help clinicians provide the best care to women with fibroids. For example, early analysis of data reveal patients' desire to better understand non-surgical treatment options with half indicating they do not want a hysterectomy," says Dr. Sony S. Singh, Associate Professor and Vice Chair of Gynaecology at The Ottawa Hospital and University of Ottawa.

The registry also indicates a high absenteeism from work due to symptoms, with 32 per cent of patients reporting they regularly miss work due to heavy bleeding and pain. And these symptoms can last for years. Twenty-seven per cent of patients started experiencing symptoms within the last three years, while 44 per cent have suffered with symptoms for five years or more.

Allergan's Commitment to Women's Health
Allergan has invested $3.3 million in the CAPTURE registry to-date. "We are committed to identifying unmet needs in the healthcare system and bringing to market therapies that address these needs," says Dr. Alain Lamontagne, Executive Medical Director and Head of the Canadian Chief Medical Office for Allergan Canada. "Learnings from CAPTURE will allow us to improve care so that Canadian women with symptomatic uterine fibroids can live full and productive lives, while also creating efficiencies in the health system."

Allergan Inc. markets FIBRISTAL® (ulipristal acetate), a once daily oral medication, and the first and only non-surgical treatment specifically indicated to treat the signs and symptoms of uterine fibroids. It's been shown to safely and effectively control excessive uterine bleeding, shrink fibroid volume and reduce the significant pain and symptom severity scores associated with symptomatic uterine fibroids.6, 7 These benefits appear to improve over repeated courses, returning patients' quality of life measures back to levels of healthy women.

About CAPTURE
CAnadian women wiTUterine fibroids REgistry (CAPTURE) includes 20 academic and non-academic sites across Canada to ensure a representative patient population that reflects disease prevalence amongst Canadian women with symptomatic uterine fibroids seeking treatment. To gather patient information, participants fill out a detailed patient questionnaire at each study visit and are followed for a minimum of two years (four study visits, including with pre-, intra- and post-visits) for those undergoing surgery.

Early analysis of demographic and other patient information indicates the average patient BMI is 26.5 kg/m2, the average age of patients enrolled to date is 43 years, and 65 per cent report to be Caucasian followed by 14 per cent reporting to be black. Many of the women in CAPTURE are otherwise healthy and 60 per cent of patients have no family history of fibroids.

CAPTURE will continue until at least 2019.

About FIBRISTAL®
FIBRISTAL® belongs to a class of medications called selective progesterone receptor modulators (SPRMs). It is an oral partial progesterone antagonist that exerts a direct effect on the endometrium to control excessive bleeding, and on fibroids where it inhibits cell proliferation and induces apoptosis (cell death) to reduce their size.8 A treatment course is three months of continuous use followed by a treatment-free interval of two menstrual cycles and continued with intermittent courses as necessary.9

The efficacy of FIBRISTAL® was evaluated in two long-term Phase III studies, PEARL III and PEARL IV, involving 132 and 451 patients respectively. Both studies confirmed the efficacy and safety of the intermittent long term use of FIBRISTAL®.10, 11

The results of the PEARL IV study included control of uterine bleeding, reduction in fibroid volume, reduction in pelvic pain, correction in anemia and improvement in quality of life. The most common adverse drug reactions (≥ 5 per cent) in the clinical trials for women receiving FIBRISTAL® were hot flashes and headaches. The vast majority of adverse drug reactions were mild or moderate, decreased with repeated courses, and did not lead to discontinuation of the medication.12

To date, more than 500,000 women in over 77 countries have been treated with FIBRISTAL®.13

About Allergan PLC
Allergan plc, headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

About Allergan in Canada
For more information, visit Allergan Canada's website at www.Allergan.ca

Forward-Looking Statement
Statements contained in this press release referring to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

References

1 Nicholas Leyland, MD, et al, Disease Burden Among Canadian Women with Symptomatic Uterine Fibroids:  Interim Results of CAPTURE
2 Vilos GA et al. SOGC Clinical Practice Guidelines: The Management of Uterine Leiomyomas: Introduction and Medical Management. J Obstet Gynaecol Can 2015;37(2):157-178. 
3 Vilos GA et al. SOGC Clinical Practice Guidelines: The Management of Uterine Leiomyomas: Introduction and Medical Management. J Obstet Gynaecol Can 2015;37(2):157-178.
4 Vilos GA et al. SOGC Clinical Practice Guidelines: The Management of Uterine Leiomyomas: Introduction and Medical Management. J Obstet Gynaecol Can 2015;37(2):157-178.
5 Women's Health Matters (2002).  Hysterectomies too Frequent in Canada?
6 Donnez J, Vazquez F, Tomaszewski J, et al. Long-term treatment of uterine fibroids with ulipristal acetate. Fertil Steril 2014;101(6):1565-73.
7 Donnez, J; Hudecek, R; Donnez, O. et al. Efficacy and Safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril 2015; 103(2):519-27.
8 FIBRISTAL® Product Monograph, November 7, 2016.
9 FIBRISTAL® Product Monograph, November 7, 2016.
10 Donnez J, Vazquez F, Tomaszewski J, et al. Long-term treatment of uterine fibroids with ulipristal acetate. Fertil Steril 2014;101(6):1565-73.
11 Donnez, J; Hudecek, R; Donnez, O. et al. Efficacy and Safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril 2015; 103(2):519-27.
12 FIBRISTAL® Product Monograph, November 7, 2016.
13 Allergan data on file.

SOURCE Allergan

For further information: Liana Del Medico, 1-905-940-7327, MR-Canada_Communications@Allergan.com; Janet Kettels, +44 773 850 6476, kettels_janet@allergan.com


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