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48-Week Data, Presented at the Digestive Disease Week (DDW) Meeting Today, Showed Clinical Benefit with Adacolumn® in a Sub-Group of Refractory Patients with Ulcerative Colitis

Data from the 48-week ART trial, presented today at the Digestive Disease Week (DDW) meeting, showed that remission and response rates were 37.2% and 53.2% respectively at week 12, in patients with moderate-to-severe, steroid-dependent active ulcerative colitis (UC) with insufficient response or intolerance to immunosuppressants and / or biologics when treated with between five and eight sessions with Adacolumn® .1

Adacolumn® is a non-pharmacological treatment which reduces inflammation by removing white blood cells from the blood circulation. This reduces the inflammatory burden without the risk of side effects attributed to drugs in patients with inflammatory bowel disease (IBD), such as active UC.2

UC is associated with an imbalance of white blood cells known as leukocytes (granulocytes / monocytes), which play a key role in inflammation.3 In UC, these inflammatory cells migrate into the intestinal mucosa at twice the normal levels causing mucosal inflammation.4 Targeting leukocytes or their communication is the rationale behind most IBD treatments.5

UC is a chronic relapsing and remitting inflammatory condition of the colon affecting up to 246 people per 100,000 population.6 Relapses present with symptoms such as abdominal pain, bloody diarrhoea, weight loss and anaemia, all of which have a significant impact on quality of life.7

Prof. Dr. Axel Dignass, Agaplesion Markus Hospital, Frankfurt, Germany, said: “Ulcerative colitis is a debilitating disease with increasing prevalence and affects many young people. Ultimately, the goal of our treatment is to induce steroid-free clinical remission. However, patients with moderate to severe ulcerative colitis and their healthcare professionals are faced with many hard choices, particularly when it comes to choosing the best treatment, since many have side effects that severely impact quality of life and may even be life-threatening.”

“The ART data have shown that there is an alternative for this difficult-to-treat population with a favourable safety profile that can delay the need for irreversible surgery. In addition, it is important to note that colectomy rates were comparable to those seen in anti-TNFs trials with stricter selection criteria. This shows that Adacolumn ® may be an alternative to elective surgery when compared to anti-TNFs in a less-selected population.”

“Ultimately, these data show that Adacolumn ® provided clinical benefit in a large cohort of steroid-dependent patients with ulcerative colitis with previous failure to biologics.”

The ART study was a single arm, open-label, multicentre trial conducted at 18 centres across the UK, France and Germany among 95 non-preselected patients who were 18–75 years old with moderate-to-severe, steroid-dependent active UC with insufficient response or intolerance to biologics. Patients received 5 to 8 weekly apheresis sessions with Adacolumn® . The primary endpoint was clinical remission rate (Clinical Activity Index ≤4) at week 12. Main secondary efficacy endpoints included clinical response (reduction in CAI of ≥ 3), steroid-free remission, and colectomy rates. Patients were followed-up until week 48 and retrospectively for colectomy events at week 96.

Luisa Avedano, CEO, European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), said: “Ulcerative colitis affects millions of people across Europe, particularly young people. The disease can be extremely debilitating which can seriously affect a patient’s quality of life and limit their life opportunities. Currently there is no cure, with many patients either facing irreversible surgery or treatments with adverse side effects. It is therefore so important that patients have additional treatment options, such as Granulocyte Monocyte Apheresis, that are not only effective but can also help improve their outcomes and quality of life.”

Results from the study also showed that in weeks 24 and 48, remission rates were 34% and 33% respectively and response rates were 44.7% and 39.4%, respectively. Out of 30 patients with prior failure of immunosuppressants and anti-TNFs, 30%, 33.3% and 20% were in remission in weeks 12, 24 and 48 respectively. Steroid-free remission in weeks 12, 24 and 48 was achieved by 19.2%, 19.2% and 18.1% respectively. Sustained remission or response was observed in 27.7% of patients at 48 weeks.

Ole Vahlgren, CEO & President of Otsuka Pharmaceutical Europe Ltd., said: “There is an urgent need for treatments in ulcerative colitis patients who have run out of options. Otsuka are committed to improving the lives of people in Europe and across the globe with ulcerative colitis, particularly in this hard-to-treat population.”

“The ART data represents an important finding in the treatment and management of ulcerative colitis in this group of patients since not only has it shown clinical benefit but also a favourable safety profile.”

The ART study is being presented at DDW in San Diego, California, on 23 May 09:30-16:00 (PDT).

Adacolumn® is not FDA approved for marketing or investigational use in the United States. Adacolumn® is approved for use in the EU (CE marked) and in Japan since 2001.

-ENDS-

NOTES TO EDITORS

About DDW

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW take place May 21-24, 2016, at the San Diego Convention Center, San Diego, CA. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org .

About Adacolumn ®

Adacolumn® is medical device used as a non-pharmacological treatment that induces remission in patients with IBD by removing white blood cells from the blood circulation. This reduces the inflammatory burden, avoiding the risk of side effects attributed to drugs in patients with IBD (active UC and CD).

As blood passes through the Adacolumn® , granulocytes and monocytes / macrophages that are known to promote IBD are adsorbed into the beads and hence removed from the bloodstream.

The treatment is performed using the Adasystem, which consists of the Adacolumn® , Adamonitor and Adacircuit.

Adacolumn® selectively adsorbs granulocytes, monocytes / macrophages by Fcγ and complement receptor bindings. Approximately 65% of granulocytes and 55% of monocytes from the blood that passes through the column are adsorbed. This is followed by cytokine release (IL-1ra, HGF, soluble TNF receptors I and II), down-regulation of L-selectin and upregulation of Mac-1, as well as an increase in circulating levels of the CD4+ CD25high+/FoxP3 regulatory T cells. However, the total number of white blood cells remains unchanged after the apheresis session as the removed cells are rapidly replaced by mobilisation of inactive, CD-10 negative leukocytes.4

About the ART data

The ART trial was an open-label, uncontrolled, multicentre trial conducted in the UK, France and Germany. 95 patients (18-75 years) with steroid-dependent active UC (Clinical Activity Index (CAI) ≥ 6; Endoscopic Activity Index (EAI) ≥ 4) and insufficient response or intolerance to immunosuppressants and/or TNF inhibitors were included. Patients received at least 5 and up to 8 granulocyte monocyte aphereses (GMA) in a single induction series over up to 10 weeks. Primary endpoint was the remission rate (CAI ≤ 4) at week 12; main secondary efficacy endpoints included clinical response (reduction in CAI of ≥ 3), steroid-free remission, and colectomy rates. Patients were followed-up until week 48.

Immunosuppressant medication was kept stable during the trial; steroids were significantly reduced; Quality of Life (QoL) improved throughout the trial. 13 out of 94 (13.8%) patients had colectomy until week 48. No patient died. No life-threatening opportunistic infection occurred. 80 patients (84.2%) experienced mild to moderate adverse events (AEs); mainly UC-related and procedural headache. 22 subjects experienced serious adverse events (SAEs); none related to treatment. 26 patients (27.4%) discontinued the study due to AEs (UC-related, 21.1%; and poor vascular access, 13.7%).

About ulcerative colitis

Inflammatory bowel disease (IBD) is a group of inflammatory conditions that affect all or part the digestive tract. It is a chronic condition that an estimated 2.5–3 million people in Europe suffer from.8 The two main types of IBD are UC and CD.

UC only affects the colon (large intestine). It causes inflammation and ulceration of the inner lining. The tiny ulcers on the lining may bleed and produce pus. The inflammation usually begins in the rectum and lower colon, but it may affect the entire colon.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.'

At Otsuka the emphasis is on ‘super people’ who have a flair for the unconventional not ‘super computers’. This has led us to become a leading firm in the challenging area of mental health. Beyond mental health, this thinking has resulted in the development of first-in-class products to treat kidney, cardiovascular and gastrointestinal disorders and blood-related cancers. Otsuka also has research programmes for several under-addressed diseases including tuberculosis, a significant global public health issue. The Otsuka Group employs approximately 43,000 people globally.

Otsuka established a presence in Europe in 1979. Our 600 European employees focus their passion and energy into ensuring that patients have access to Otsuka’s new products, including in 2015 the first-ever drug treatment in Europe for polycystic kidney disease. Otsuka also received approval in 2014 for the first new anti-tuberculosis drug in Europe in over 40 years.

Our stories all start by taking the road less travelled. Learn more here:

www.otsuka.co.jp/en/ (Global)

www.otsuka-europe.com (European)

References

1 Dignass A et al. Efficacy and Safety of Granulocyte, Monocyte/Macrophage Adsorptive Apheresis in Steroid-Dependent Active UC With Insufficient Response or Intolerance to Immunosuppressants and/or Biological Therapies (The ART trial), DDW 2016 Abstract # 2438905

2 Saniabadi A, Hanai H, Löfberg R et al. Adacolumn, an absorptive carrier based granulocyte and monocyte apheresis device for the treatment of inflammatory and refractory diseases associated with leucocytes. J of Clinical Apheresis 2005; 20: 171-184.

3 Baumgart DC, Carding SR. The Lancet 2007;369:1627-1640.

4 Hanai H et al., Clin Exp Immunol. 2011 Jan;163(1):50-8.

5 Gerner et al.; Dig Dis. 2013;31(3-4):328-35.

6 Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med 2011;365(18):1713–25.

7 Crohn’s and Colitis UK. Ulcerative Colitis Edition 8. Available at: http://s3-eu-west-1.amazonaws.com/files.crohnsandcolitis.org.uk/Publications/ulcerative-colitis.pdf . Accessed March 2016.

8 Burisch J, Jess T, Martinato M, Lakatos P L. The burden of inflammatory bowel disease in Europe. J Crohns Colitis 2013;7(4):322-337. Available at: http://www.sciencedirect.com/science/article/pii/S1873994613000305 . Accessed January 2016.

Contact:

Media:
Otsuka Pharmaceutical Europe Ltd.
Anna Anagnostou
+49 (0) 69 170086-123
or
RM-Eclipse
Emma David
+44 (0) 207 861 2808

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