Business Wire

New Two-Year Data Show Treatment with Janssen’s Stelara® (Ustekinumab) Reduced Rates of Hospitalisation and Surgery in Patients with Moderate-to-Severe Crohn’s Disease, Compared with Placebo

Jaa

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today a new analysis looking at two-year data from the IM-UNITI long-term extension (LTE) STELARA ® (ustekinumab) programme, which demonstrated that two dosing regimens of ustekinumab (90mg administrated every 12 [q12w] and 8 [q8w] weeks), can decrease the risk of Crohn’s disease (CD) related hospitalisation, surgery and the need for alternative biologic treatment in patients with moderate-to-severe CD, when compared to placebo.1 Janssen presented these long-term findings from the Phase III IM-UNITI study (abstract #2913377), alongside 14 other abstracts, at Digestive Disease Week® (DDW) 2018 in Washington DC on Saturday 2 June.

“Crohn’s disease can have a significant impact on patients, with most having multiple relapses and many experiencing complications that require intervention. These long-term data from IM-UNITI are particularly encouraging for clinicians as they demonstrate that treatment with ustekinumab reduced the need for hospitalisation, surgery, or a switch to another treatment,” said study investigator Professor William Sandborn, MD, UC San Diego Health System, Gastroenterology Chief.

This analysis included patients with moderate-to-severe CD from the UNITI-1 and UNITI-2 trials who had achieved clinical response after a single intravenous (IV) dose of ustekinumab and entered five years of long-term observation. Patients were randomised to receive either placebo or subcutaneous (SC) ustekinumab 90mg q12w or q8w. Incidences of hospitalisation, surgery or initiation of an alternative biologic (TNF-antagonist or anti-integrin therapy) were assessed at 96 weeks.1 The IM-UNITI LTE trial is ongoing.

Patients receiving ustekinumab q12w through to two-years were 52% less likely to be admitted to hospital or require surgery than patients treated with placebo (ustekinumab q12w HR=0.477 [0.238, 0.957], p=0.033). Patients receiving ustekinumab q8w were 40% less likely to experience either of these endpoints (ustekinumab q8w HR=0.601 [0.411, 0.879], p=0.006).1

Hospitalisation accounts for ~50–80% of the healthcare costs associated with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), and ~40–60% of these inpatient costs can be attributed to surgery.2 CD patients may require surgery due to the damage that the disease causes to the bowel, presenting as ulcers, scarring, narrowing of the gastrointestinal (GI) tract (strictures) and abnormal connections between different parts of the GI tract (fistulas).3

Patients in the q8w group were 53% less likely to switch to an alternative biologic than the placebo group (ustekinumab q8w HR=0.473 [0.215, 1.040], p=0.042). The q12w group also saw a risk reduction of 33%, however, significance was not reached (ustekinumab q12w HR=0.667 [0.223, 1.999], p=0.467).1

Janssen also presented a new analysis from the UNITI-1 and 2 and IM-UNITI trials assessing which quality of life measures had the greatest impact on health-related quality of life after induction of therapy (abstract #2914355). Quality of life impact was measured via a questionnaire. At the start of the trials factors such as fatigue, sleep, loose stools and emotional and social effects such as feeling unwell and impact on leisure activity were seen to have the greatest negative impact on quality of life, with mean scores of <3.5. By week 8 significant improvements were seen for these measures in patients receiving ustekinumab vs placebo.4

The common (≥ 1/100) adverse reactions reported in controlled periods of the adult psoriasis, psoriatic arthritis and Crohn's disease clinical studies with ustekinumab as well as post-marketing experience were: upper respiratory tract infection, arthralgia, back pain, diarrhoea, dizziness, fatigue, headache, infection site pain, injection site erythema, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus and vomiting.5

Janssen presented a total of 15 abstracts at this year’s DDW annual meeting.

* Ends *

About Digestive Disease Week (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 takes place June 2–5, 2018, at Walter E. Washington Convention Center. 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 Crohn’s disease

Up to one million people across Europe are living with Crohn’s disease, and nearly 33,000 new cases are diagnosed each year.6 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet or other environmental factors. Symptoms of Crohn’s disease can vary but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn’s disease.7

About the IM-UNITI trial

IM-UNITI, a Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel group study, evaluated the efficacy and safety of ustekinumab maintenance therapy in adult patients with moderate-to-severe Crohn’s disease. Patients who had responded to a single intravenous dose of ustekinumab in the UNITI-1 or UNITI-2 induction studies were randomised equally to receive maintenance subcutaneous (SC) ustekinumab 90mg q8w or q12w, or placebo. In patients who met loss of response criteria between weeks 8–32, a one-time dose adjustment to 90mg q8w occurred. All patients completing week 44 were eligible to enter the long-term extension programme, continuing their current regimen up to week 92. Patients will continue in the IM-UNITI trial up to week 252.

About STELARA ® (ustekinumab) 5

In the European Union, ustekinumab is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA), and is also indicated for the treatment of moderate-to-severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies. In addition, ustekinumab is approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. In November 2016, the European Commission approved ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-alpha antagonist or have medical contraindications to such therapies.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to ustekinumab, which is currently approved for the treatment of moderate to severe plaque psoriasis in 90 countries, paediatric psoriasis in 43 countries, psoriatic arthritis in 83 countries and Crohn’s disease in 54 countries.

Important Safety Information

For complete European Union (EU) prescribing information, please visit: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000958/human_med_001065.jsp&mid=WC0b01ac058001d124

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us on Twitter: @JanssenEMEA. Janssen-Cilag International NV (“Janssen”) is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development and potential availability in Europe of ustekinumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

###

References

1. Sandborn WJ, Sands B, Gasink C et al. Reduced rates of Crohn’s-related surgeries, hospitalizations and alternate biologic initiation with ustekinumab in the IM-UNITI study through 2 years. Digestive Disease Week ® (DDW) 2018: 2-5 June 2018. Abstract #2913377. Presentation #Sa1743.

2. Petryszyn PW & Witczak I. Costs in inflammatory bowel diseases. Przegla̜d Gastroenterologiczny. 2016;11(1):6–13.

3. NHS. Crohn’s disease. NHS Choices. Available from: https://www.nhs.uk/conditions/crohns-disease/living-with/#possible-complications (Last accessed May 2018).

4. Sands BE, Pires A, Gasink C et al. Post hoc analysis of the impact of ustekinumab treatment on specific items of the inflammatory bowel disease questionnaire in the UNITI-1&2 programs. Digestive Disease Week ® (DDW) 2018: 2-5 June 2018. Abstract #2914355. Presentation #Mo1811.

5. Ustekinumab Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000958/WC500058513.pdf (Last accessed May 2018).

6. Janssen Disease Lens. Available at https://www.diseaselens.com/v2/index.php (Last accessed May 2018).

7. Crohn’s and Colitis UK. Crohn’s disease. Available at http://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/crohns-disease (Last accessed May 2018).

Contact information

Media Contact
Kathleen Provinciael
Office: +32 49-733-2687
kprovinc@its.jnj.com
or
Media Contact
Kim Rotondo
Office: +1 215-628-7166
Mobile: +1 267-994-1169
krotondo@its.jnj.com
or
Investor Contact
Joseph J. Wolk
Johnson & Johnson
Office: +1 732-524-1142

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Manchester United Shoots for Success with a “Digital Experience Platform” Powered by HCL16.8.2018 22:02Tiedote

Manchester United (NYSE:MANU) has today announced a major milestone on its digital transformation journey with HCL Technologies, with the successful launch of the Manchester United Official app powered by HCL’s digital experience platform. The launch is part of the ongoing digital transformation of the club to provide a real-time, engaging, personalized, and unified experience to Manchester United’s 659 million global followers, which supports the club’s strategy to become a Digital Sports Enterprise. At the heart of this transformation is the digital platform developed by HCL, providing the club with a single view of fans across web and app touchpoints, offering fans a one-stop shop for everything Manchester United. Manchester United’s Group Managing Director Richard Arnold comments: “This app will allow our 659 million Manchester United followers to easily connect to the club they love, wherever they are in the world. Fans will now have the opportunity to follow all Manchester United

4K 4Charity Fun Run Announces Open Registration for IBC201816.8.2018 20:41Tiedote

AWS Elemental, an Amazon Web Services (AWS) company, today announced that the fifth annual 4K 4Charity Fun Run at IBC Show will take place at 7:00 a.m. local time on Saturday, Sept. 15 at Amstelpark in Amsterdam. Registration is open at https://4k4charity.com/ibc. Among the non-profits supported by the 4K 4Charity Fun Run at IBC Show is Amsterdam-based StichtingNewTechKids, which provides computer science education for girls, minorities, and economically challenged youth in the Netherlands. The organization supports a computer science teacher training program for primary school teachers with proceeds from 4K 4Charity. Also supported is Iridescent, a global education non-profit that empowers underrepresented young people to become innovators and leaders through engineering and technology. Through their two programs, Curiosity Machine AI Family Challenge and Technovation, Iridescent introduces underserved communities to new technologies and empowers and equips them to apply those technol

2018 D.I.C.E. Cannes Announced Round 3 Speakers16.8.2018 17:01Tiedote

The Academy of Interactive Arts & Sciences’ D.I.C.E. Cannes event will take place 9-11 September 2018 at the Hotel Barrière Le Majestic Cannes in France. Leading video game executives will participate in the premier networking opportunities, listen to key speakers address the conference theme - Trailblazers - to tackle some of the industry’s biggest ideas and trends. Newly announced speakers include: Craig Duncan, Studio Head at Rare – Duncan will share his studio’s experience and learnings with “A Rare Voyage of Adventure.” Duncan will provide insight into Rare’s bold new IP Sea of Thieves, a game that has inspired friendships and players creating stories together. David Hubert, Animation and Cinematic Director at Eidos Montreal – In Hubert’s talk he will discuss how cinematics are redefining AAA story-driven games and how they will continue to shape the medium to push the envelope throughout the production process. Adam Orth – In a session titled “Digging for Fire: Virtual Reality 20

GN Hearing and Google Announce Partnership to Bring Direct Mobile Streaming from Android Devices to Hearing Aids16.8.2018 16:00Tiedote

GN Hearing and Google have today announced a new technology partnership that will make GN Hearing the first manufacturer to enable a full spectrum of direct audio streaming from Android devices to hearing aids. The expectations are that direct streaming will become available to hearing aid users of the recently launched hearing aids ReSound LiNX Quattro™ and Beltone Amaze™ in a future Android release. “According to the World Health Organization, around 466 million people worldwide have disabling hearing loss. This number is expected to increase to 900 million people by the year 2050. Google is working with GN Hearing to create a new open specification for hearing aid streaming support on future versions of Android devices,” states Seang Chau, Vice President of Engineering at Google. Users will be able to connect and monitor their hearing aids, so they can get the full advantages of their Android devices without using an intermediate device for streaming to their hearing aids. This will

Zurich Expands Global Use of Guidewire InsurancePlatform with Selection of Guidewire Cyence Risk Analytics16.8.2018 15:55Tiedote

Guidewire Software, Inc. (NYSE: GWRE), the provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced that Zurich Insurance Group (Zurich) has selected Guidewire Cyence™ Risk Analytics (Cyence) to leverage the cyber risk knowledge and insights the solution provides to help the company prospect, underwrite, and price risks. Zurich will roll out Cyence globally with an emphasis on enhanced analytics and intelligence for risk selection. Unprecedented technological advances of the 21st century have shifted the nature of risk across the P&C insurance industry. Ever-evolving cyber risks present unique challenges including limited availability of traditional actuarial data needed to model these risks. Cyence combines economic modeling, cybersecurity, machine learning and Internet scale data collection to help risk takers assess the financial impact of cyber risk. “After conducting a thorough search, we found that the capabilities of Guidewire Cyence Risk

Scientist.com Named One of America’s Ten Fastest-Growing Private Companies by Inc. Magazine16.8.2018 15:06Tiedote

Scientist.com, the world’s leading marketplace for outsourced scientific services, today announced that it ranked no. 9 on Inc. magazine’s 2018 list of the 5,000 fastest-growing, privately owned companies in America. Scientist.com ranked no. 2 nationally in the Health category and no. 2 in the state of California. The San Diego-based company builds private marketplaces that connect life science research organizations with a global network of over 2,600 contract research organizations (CROs) and providers of scientific services. “Our mission is to empower and connect scientists worldwide and make it possible to cure all human diseases by 2050,” stated Kevin Lustig, Scientist.com’s CEO and Founder. “On Scientist.com, a single, highly trained scientist can run an entire drug discovery program from concept to clinic from his or her laptop without ever physically entering a laboratory.” The pharmaceutical industry spends about $150B a year on medical research and produces about 25 new medic

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme