SPRING HOUSE, Pa., Feb. 25, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced 18 company-sponsored abstracts will be presented at the 14th Congress of the European Crohn's and Colitis Organisation (ECCO) taking place in Copenhagen, Denmark from March 6-9. Highlights include six company-sponsored oral or digital oral presentations, including new data from the Phase 3 UNIFI study evaluating the efficacy and safety of STELARA® (ustekinumab) maintenance therapy in patients with moderate to severe ulcerative colitis (UC), which will be presented during the Plenary Session on March 9.
"This year marks the largest showing of data from our inflammatory bowel disease portfolio of products at ECCO, a reflection of our continued leadership and unwavering commitment to addressing unmet needs for people living with IBD," said Scott E. Plevy, M.D., Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC. "We are excited to present new Phase 3 maintenance data for STELARA in ulcerative colitis which are the basis of our pending regulatory applications in the European Union, U.S. and Canada."
A listing of abstracts is provided in the table below. Notable data presentations at ECCO include the following:
New STELARA data in ulcerative colitis
New STELARA data in Crohn's disease
Abstract No. | Title | Date/Time |
Molecular response to ustekinumab in moderate-to-severe ulcerative colitis by serum protein and biopsy gene expression analysis: Results from the UNIFI Phase 3 induction study | Oral presentation Friday, March 8, 2019 8:30 AM - 10:30 AM | |
New-onset autoimmune disorders, primarily psoriasis, in anti-TNF biologic exposed paediatric patients: the DEVELOP experience | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Dose escalation with originator infliximab is more common than standard dosing in paediatric IBD: the DEVELOP experience | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Combination therapy with TNF-inhibitors and immunomodulators are associated with shorter duration to first serious infection: the DEVELOP experience | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Disease severity and intensity of therapy predicts serious adverse events in paediatric ulcerative colitis: the DEVELOP experience | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
General health status in patients with moderate to severe ulcerative colitis receiving ustekinumab: results from the Phase 3 UNIFI induction and maintenance studies | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Ustekinumab therapy induced clinically meaningful improvement and remission as measured by the Inflammatory Bowel Disease Questionnaire: Results from the phase 3 UNIFI induction and maintenance studies | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Efficacy in biologic failure and non-biologic-failure populations in a Phase 3 study of ustekinumab in moderate–severe ulcerative colitis: UNIFI | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Clinical remission by legacy vs. FDA definitions: definition justification and results from UNIFI Study | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Characterisation of patients with delayed response to ustekinumab for Crohn's disease | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Long-term efficacy of ustekinumab with and without concomitant immunosuppressants for Crohn's disease: results from IM-UNITI long-term extension through 2 years | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Efficacy of ustekinumab in Crohn's disease at maintenance Week 56: IM-UNITI study | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Pharmacokinetics and exposure–response relationships of intravenously administered ustekinumab during induction treatment in patients with ulcerative colitis: Results from the UNIFI induction study | Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM | |
Sustained remission in patients with moderate to severe ulcerative colitis: Results from the Phase 3 UNIFI maintenance study | Digital oral presentation Friday, March 8, 2019 5:20 PM - 6:20 PM | |
Effects of ustekinumab induction therapy on endoscopic and histological healing in the UNIFI Phase 3 study in ulcerative colitis | Digital oral presentation Friday, March 8, 2019 5:20 PM - 6:20 PM | |
Efficacy and safety of ustekinumab through Week 16 in patients with moderate-to-severe ulcerative colitis randomised to ustekinumab: results from the UNIFI induction trial | Digital oral presentation Friday, March 8, 2019 5:20 PM - 6:20 PM | |
A colonic gene expression signature predicts non-response to anti-inflammatory therapies in inflammatory bowel disease | Oral presentation Saturday, March 9, 2019 10:50 AM - 12:20 PM | |
Efficacy and safety of ustekinumab as maintenance therapy in ulcerative colitis: Week 44 results from UNIFI | Oral presentation Saturday, March 9, 2019 10:50 AM - 12:20 PM |
About Inflammatory Bowel Diseases
More than five million people worldwide are living with Crohn's disease and ulcerative colitis—collectively known as IBD.1 Crohn's disease most commonly affects the end of the small bowel (the ileum) and the beginning of the colon, but it may affect any part of the gastrointestinal (GI) tract, from the mouth to the anus. Ulcerative colitis is limited to the colon, also called the large intestine. Symptoms of Crohn's disease can vary but may include abdominal cramps and pain, frequent diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn's disease.2 Symptoms of ulcerative colitis can vary but may include looser and more urgent bowel movements, bloody stool, crampy abdominal pain, loss of appetite and fatigue. There is currently no cure for ulcerative colitis.3
About STELARA® (ustekinumab)
STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn's disease who have failed or were intolerant to immunomodulators or corticosteroids; or failed or were intolerant to anti-TNF therapies.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.
Important Safety Information
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:
Serious Infections
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.
Before starting STELARA®, tell your doctor if you:
After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above). STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and interleukin 23 (IL‐23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections.
Cancers
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.
Reversible posterior leukoencephalopathy syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.
Lung Inflammation
Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn't go away during treatment with STELARA®.
Before receiving STELARA®, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
When prescribed STELARA®:
Common side effects of STELARA® include: upper respiratory infections, headache, and tiredness in psoriasis patients; joint pain and nausea in psoriatic arthritis patients; and upper respiratory infections, redness at the injection site, vaginal yeast infections, itching, urinary tract infections, and vomiting in Crohn's disease patients. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.
Please read the Full Prescribing Information, including the Medication Guide for STELARA®, and discuss any questions you have with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal.
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