Pennsylvania-based Janssen Biotech is presenting 15 abstracts at the 2016 Digestive Disease Week (DDW) annual meeting May 21-24 in San Diego, California. Presentations will include data from the Janssen gastroenterology portfolio of injection and infusion biologic therapies, primarily results from the pivotal Phase 3 (IM-UNITI) Stelara (ustekinumab) maintenance therapy study for adults with moderate to severe Crohn’s disease; results of an open-label investigation on safety and efficacy outcomes for Simponi (golimumab) in pediatric patients with ulcerative colitis (UC); and safety data from a cohort of elderly Crohn’s disease patients from the Remicade TREAT registry.
“At Janssen, we are proud of our leadership position in gastroenterology and are pleased to be presenting our breadth of new data at DDW,” said Andrew Greenspan, MD, Janssen vice president of scientific affairs, in a press release. “After more than 20 years focused on inflammatory bowel disease, we understand that significant unmet medical need still exists and are hopeful that our research can potentially lead to novel therapeutics that can change lives for the better.”
Stelara (ustekinumab) is a human interleukin (IL)-12 and IL-23 antagonist, approved in the United States for the treatment of adults with moderate to severe plaque psoriasis who are eligible to receive phototherapy or systemic therapy, and for adults with active psoriatic arthritis alone or in combination with methotrexate (MTX). The drug is being tested as a therapy for Crohn’s disease. Presentations on Stelara include:
- Poster presentation titled “Molecular Response to Ustekinumab in Moderate-to-Severe Crohn’s Disease by Serum Protein Analysis: Results from UNITI-1 Induction, UNITI-2 Induction, and IM-UNITI Maintenance Studies”;
- Poster presentation titled “Pharmacokinetics and Exposure-Response Relationships of Ustekinumab During IV Induction and SC Maintenance Treatment of Patients With Crohn’s Disease With Ustekinumab: Results From the UNITI-1, UNITI-2, and IM-UNITI Studies”;
- Oral presentation titled “A Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Ustekinumab Maintenance Therapy in Moderate-Severe Crohn’s Disease Patients: Results From IM-UNITI”;
- Poster presentation titled “Assessment of Serum C-Reactive Protein, Fecal Lactoferrin, and Fecal Calprotectin in Patients With Moderate-Severely Active Crohns Disease: Results From the IM-UNITI Maintenance Study”;
- Poster presentation titled “Ustekinumab Improves General Health Status and Disease-Specific Health Related Quality of Life of Patients With Moderate to Severe Crohn’s Disease: Results from the UNITI and IM-UNITI Phase 3 Clinical Trials.”
Simponi (golimumab) is a human monoclonal antibody targeting and neutralizing excess TNF-alpha – a protein that when overproduced due to chronic inflammatory diseases might cause inflammation and damage to the bones, cartilage, and tissue. Simponi is approved in 67 countries, including the U.S., for the treatment of adults with moderate to severe rheumatoid arthritis in combination with MTX, and severely active UC, among other conditions. Presentations on Simponi include:
- Poster presentation titled “Population Pharmacokinetic Modeling Analysis of Golimumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis”;
- Poster presentation titled “Pharmacokinetics and Exposure-Response Relationships of Golimumab in Pediatric Patients with Moderate to Severe Ulcerative Colitis: Results From a Multicenter Open Label Study”;
- Poster presentation titled “The Role of the Microbiome in Clinical Response to Golimumab in Ulcerative Colitis”;
- Poster presentation titled “Delayed Response to Golimumab Therapy: UC Patient Characteristics and Long-term Clinical Outcome: Post-Hoc Analyses From the PURSUIT Program”;
- Poster presentation titled “Safety, Efficacy, and Pharmacokinetics of Golimumab in Patients with Moderately to Severely Active Ulcerative Colitis: PURSUIT-SC Long Term Extension”;
- Oral presentation titled “A Multi-Center Open-Label Study Assessing Pharmacokinetics, Efficacy, and Safety of Subcutaneous Golimumab in Pediatric Patients With Moderately-Severely Active Ulcerative Colitis.”
Remicade (infliximab) is a unique anti-TNF-alpha biologic therapy. It is the only therapy that can be administered directly by caregivers in the clinic or office setting. Marketed for more than 22 years, it was the first biologic approved for the treatment of Crohn’s disease. Presentations on Remicade include:
- Poster presentation titled “Risk Factors for Serious Infections in Elderly Patients Receiving Infliximab and Other Crohn’s Disease Therapies: TREAT Registry Data”;
- Oral presentation titled “Risk of Malignancy in Pediatric Inflammatory Bowel Disease: Results From the DEVELOP Registry.”
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