- Data presentations further evaluate HUMIRA® (adalimumab) for the treatment of inflammatory bowel diseases including moderate to severe Crohn’s disease in adult and pediatric patients
- Late-breaking Phase 2 data evaluates risankizumab, an anti-IL-23 monoclonal biologic antibody for the treatment of moderate to severe Crohn’s disease, in collaboration with Boehringer Ingelheim
AbbVie a global biopharmaceutical company, will present 13 abstracts across inflammatory bowel diseases including adult and pediatric Crohn’s disease, and ulcerative colitis at the Digestive Disease Week (DDW) Annual Meeting, May 21-24, 2016, in San Diego. AbbVie and Boehringer Ingelheim will also present late-breaking data on risankizumab, formerly known as BI 655066, an investigational anti-IL-23 monoclonal biologic antibody.
HUMIRA research to be presented during the meeting includes the seven-year interim results from the ongoing PYRAMID post-marketing surveillance safety registry, which is evaluating the safety of HUMIRA in patients with moderate to severe Crohn’s disease. Results of a long-term efficacy and safety analysis of HUMIRA patients with moderate to severe pediatric Crohn’s disease will also be presented.
Phase 2 results evaluating the safety and efficacy of risankizumab in patients with moderate to severe Crohn’s disease will be presented as a late-breaking abstract on May 24. AbbVie and Boehringer Ingelheim entered into a global collaboration agreement in March 2016 to develop and commercialize risankizumab, which is in Phase 2 development for Crohn’s disease, psoriatic arthritis and asthma, and in Phase 3 development for psoriasis.
“AbbVie is committed to continued research in gastroenterology in order to make a significant impact on the lives of patients who face the burden inflammatory bowel diseases can have each day,” said Rob Scott, M.D., vice president, development and chief medical officer. “As leaders in immunology, we are focused on improving care for people living with these serious and chronic diseases.”
HUMIRA is one of the most comprehensively studied biologics available with more than 19 years of clinical trial experience beginning in rheumatoid arthritis1 and is currently being used to treat more than 989,000 patients worldwide, across all indications.2
Inflammatory Bowel Disease (AbbVie-Sponsored) Abstracts
• PYRAMID Registry: An Observational Study of Adalimumab in Crohn’s Disease: Results at Year 7; G. D’Haens, et al.; Presentation Number: Tu1914; Poster Session; Tuesday, May 24, 2016; 9:30 a.m. – 4:00 p.m. PST; Hall C
• Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn’s Disease; W. Faubion, et al.; Presentation Number: Mo1784; Poster Session; Monday, May 23, 2016; 9:30 a.m. – 4:00 p.m. PST; Hall C
• Evaluation of Adalimumab Treatment Effects on Extraintestinal Manifestations in Patients with Moderate to Severe Crohn’s Disease: A Pooled Analysis; E. Louis, et al.; Presentation Number: Mo1791; Poster Session; Monday, May 23, 2016; 9:30 a.m. – 4:00 p.m. PST; Hall C
• Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn’s Disease Aged 10 Years and Younger: Subanalysis of IMAgINE 1; F. Ruemmele, et al.; Presentation Number: Su1918; Poster Session; Sunday, May 22, 2016; 9:30 a.m. – 4:00 p.m. PST; Hall C
• Assessment of IMPACT III Emotional and Social Functioning Domain Scores in Adalimumab-Treated Pediatric Patients with Crohn’s Disease; A. Grant, et al.; Presentation Number: Tu2005; Poster Session; Tuesday, May 24, 2016; 9:30 a.m. – 4:00 p.m. PST; Hall C
• Current Trends in the Quality of Care of Inflammatory Bowel Diseases in the United States; A. Swaminath, et al.; Presentation Number: Mo1864; Poster Session; Monday, May 23, 2016; 9:30 a.m. – 4:00 p.m. PST; Hall C
• Fecal Calprotectin Improves the Predictive Power of Three Practical Indices for Mucosal Healing Among Patients with Crohn’s Disease: Results from PREDICT; W. Sandborn; et al.; Presentation Number: Tu1933; (Poster of Distinction); Tuesday, May 24, 2016; 9:30 a.m. – 4:00 p.m. PST; Hall C
• Impact of Age on Beliefs About and Adherence to Medications in Patients with Inflammatory Bowel Diseases: Results from the ALIGN study; P. Michetti; et al.; Presentation Number: Mo1840; (Poster of Distinction); Monday, May 23, 2016; 9:30 a.m. – 4:00 p.m. PST; Hall C
Risankizumab (AbbVie and Boehringer Ingelheim-Sponsored) Late-Breaking Phase 2 Study
• Efficacy and Safety of Induction Therapy with the Selective IL-23 Inhibitor Risankizumab in Patients with Moderate-to-Severe Crohn’s Disease: Results of a Randomized, Double-blind, Placebo-controlled Phase 2 Study; B. Feagan, et al.; Presentation Number: 812a; Clinical Science Late-Breaking Abstract Plenary;
Risankizumab, formerly BI 655066, selectively blocks IL-23, a key protein involved in inflammation which has been linked to an overactive immune system, and is one of the key drivers of Crohn’s disease, psoriasis and psoriatic arthritis.4
Risankizumab is not approved by regulatory authorities and its safety and efficacy is being investigated.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
1. Burmester GR, Mease P, Dijkmans BA, et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis. 2009;68(12): 1863-9.
2. Data on File ABVRRTI62403.
3. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.
4. Tang C, Chen S, Qian H, Huang W. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012;135(2):112–124.
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