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
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.
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).
Office: +32 49-733-2687
Office: +1 215-628-7166
Mobile: +1 267-994-1169
Joseph J. Wolk
Johnson & Johnson
Office: +1 732-524-1142
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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Personalis, Inc. to Present at Advances in Immuno-Oncology Congress UK 201920.5.2019 10:05:00 EEST | Tiedote
Personalis, Inc., a leader in advanced genomics for cancer, today announced that the company will present at Advances in Immuno-Oncology Congress UK 2019 in London on May 21st at 11:00 AM BST. The presentation, entitled “Advancing Precision Oncology Biomarker Discovery with a Multi-dimensional Immunogenomics Platform,” will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT™. In addition to an overview, the presentation will introduce preliminary data from an ongoing study in which this platform is being used to evaluate IO-related biomarkers and potential tumor escape mechanisms in a cohort of melanoma patients treated with anti-PD-1 therapy. ImmunoID NeXT™ is the first platform to provide comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one. This maximizes the
New Study Evaluates Ability of Masimo SpHb® (Noninvasive Hemoglobin) to Estimate Timing for Invasive Measurement to Detect Anemia During Surgery20.5.2019 10:00:00 EEST | Tiedote
Masimo (NASDAQ: MASI) announced today the results of a study published in BMC Anesthesiology in which clinicians at Peking Union Medical College in Beijing evaluated the ability of noninvasive and continuous hemoglobin monitoring with Masimo SpHb® to help clincians estimate when to conduct invasive hemoglobin measurement to detect possible anemia in patients undergoing spine or cytoreductive surgery.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190520005244/en/ Masimo Radical-7® with SpHb® (Photo: Business Wire) Noting that because of the “invasive, time-consuming and intermittent” nature of invasive blood sampling, clincians often forgo these “objective indications” when making transfusion decisions during surgery, Dr. Tang and colleagues sought to determine whether noninvasive, continuous hemoglobin monitoring could aid clinicians in estimating when it might be appropriate to perform an invasive measurement. They enroll
Cleo to Showcase End-to-End Approach to Ecosystem Integration at Gartner AADI in London20.5.2019 10:00:00 EEST | Tiedote
Gartner’s Application Architecture, Development & Integration (AADI) Summit returns to London to provide strategies for solving the pervasive challenges of orchestrating workflows between external B2B and application ecosystems with internal business systems. Cleo, the global leader in ecosystem integration solutions, will be exhibiting in Booth S3 to demonstrate how successful organisations leverage its “outside-in” approach to create seamless end-to-end workflows and help optimize business processes. The Gartner AADI 2019 event, taking place 20-21 May at Park Plaza Westminster, is designed to empower IT and business professionals in transforming their application architecture, agile development, and integration strategies. The event’s focus on application strategies and data processes in the era of the cloud highlights the need for better ways to execute application integration, an inescapable challenge in today’s business landscape. According to the 2019 State of Ecosystem and Integ
Commerzbank Partners with GTC to Further Digitize and Automate its Trade Finance Business20.5.2019 07:00:00 EEST | Tiedote
Commerzbank has entered into a strategic partnership with GlobalTrade Corporation (GTC), a leading Canadian application services provider of innovative multi-bank trade finance solutions. The bank plans to utilise GTC’s @GlobalTrade™ platform to strengthen its digital trade finance product range. As one of Europe’s leading trade finance banks, Commerzbank holds the digitalisation and automation of processes as key priorities. This partnership leverages Commerzbank’s unique network footprint and GTC’s multi-bank technology, coupled with SWIFT connectivity, to meet the trade finance needs of corporate clients across the globe more efficiently and effectively. “We are very pleased to have found a strategic and reliable business partner in the trade finance business in GTC. Together we will provide digital, multi-bank trade finance solutions to our clients as well as an expanded range of trade products,” said Klaus Josef Müller, Head of Trade Finance and Cash Management Product Management
New Exploratory Data from VARSITY, First Head-to-Head Ulcerative Colitis Biologic Study Which Demonstrated Superiority of Vedolizumab to Adalimumab in Clinical Remission at Week 52, Presented at 2019 Digestive Disease Week®20.5.2019 03:16:00 EEST | Tiedote
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced further results from the Phase 3b head-to-head VARSITY study, which demonstrated that the gut-selective biologic vedolizumab (Entyvio®) was superior to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira®) in achieving clinical remission* at week 52 in patients with moderately to severely active ulcerative colitis (UC).1 New exploratory data showed that a greater proportion of patients receiving vedolizumab intravenous (IV) achieved clinical response** at week 14 compared to those treated with adalimumab subcutaneous (SC), 67.1% vs. 45.9% respectively. A separation between the treatment groups was seen as early as week 6, favoring vedolizumab. These results were announced in a Distinguished Abstract Plenary Lecture Presentation at the 2019 Digestive Disease Week® (DDW) annual scientific meeting (May 18-21 in San Diego, CA), one of 18 Takeda sponsored vedolizumab abstracts accep
Age, Gender, Disease Severity Impact Adherence to Long-Term PAP Therapy More Than Previously Thought19.5.2019 22:15:00 EEST | Tiedote
ResMed (NYSE: RMD, ASX: RMD) today revealed several demographic and clinical factors affect adherence to PAP (positive airway pressure) therapy, according to a study it presented at the American Thoracic Society's ATS 2019 International Conference. The study found significant differences in one-year adherence between people of different ages and disease severity levels: Men with sleep apnea are 8.5 percentage points more likely to stay adherent on PAP therapy than women. People over age 60 were 7.3 percentage points more adherent than the entire study cohort (77.7% vs. 70.4%). People with self-reported severe sleep apnea were 78% adherent at the one-year mark, compared to 70.5% of those with self-reported moderate sleep apnea, and 65.2% of those with mild sleep apnea. “Sleep specialists, pulmonologists, and primary care physicians should heed these results and ensure that their younger, female, and more mildly diagnosed patients have the proper supports to stay on therapy,” said Adam B
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