HORSHAM - The Janssen Pharmaceutical Inc. Companies of Johnson & Johnson announced today that data from nine company-sponsored abstracts will be presented at the 2020 American College of Gastroenterology (ACG) Annual Meeting, being held virtually this year from October 23 - October 28.
Featured among the eight poster presentations and one oral presentation are final five-year data from the IM-UNITI open-label long-term extension (LTE) study evaluating the efficacy and safety of STELARA (ustekinumab) therapy in adult patients with moderately to severely active Crohn's disease, which will be presented via a pre-recorded, on-demand session available to registered attendees.
'While this year's meeting may look different in its virtual setting, our commitment to advancing the science and addressing unmet needs for people living with IBD is unchanged,' said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. 'Patients with a chronic condition like Crohn's disease require long-term treatment, so it is critical to conduct studies like the IM-UNITI long-term extension study to gather important data on durability of treatment response and long-term outcomes. We look forward to sharing findings of this STELARA research with the medical community during this year's congress.'
Other notable presentations at ACG include data from the Phase 3 UNIFI study evaluating the safety and efficacy of STELARA as a maintenance therapy in patients with moderately to severely active ulcerative colitis who previously failed biologic or conventional therapy. Data will be presented from the long-term extension study out to two years, including an abstract showing the effect of the treatment on stool frequency and rectal bleeding.
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 6 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; 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA.
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.
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding STELARA. 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 materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; 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 December 29, 2019, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in the company's most recently filed Quarterly Report on Form 10-Q, 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. None of 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.
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