May 19, 2016

AbbVie's Leadership in Gastroenterology Showcased at Digestive Disease Week® with New HUMIRA® (adalimumab) Long-Term, Real-World Research and Promising Anti-IL-23 Antibody Late-Breaking Data

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- 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

NORTH CHICAGO, Ill., May 19, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), 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."

Additional research reviews the impact of age on beliefs about medication and medication adherence and the real-world use of steroids in patients with inflammatory bowel 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

Abstracts of Interest
Abstracts are available here.

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; Tuesday, May 24, 2016; 8:00 a.m.8:15 a.m. PST

About HUMIRA in the U.S.
Uses3

HUMIRA is a prescription medicine used:

  • To reduce the signs and symptoms of:
    • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
    • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
    • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
    • Ankylosing spondylitis (AS) in adults.
    • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
    • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
    • Moderate to severe hidradenitis suppurativa (HS) in adults.
  • In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
  • To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.

Important Safety Information3

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

HUMIRA is given by injection under the skin.

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

Please click here for the Full Prescribing Information and Medication Guide.

About Risankizumab
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.

About AbbVie
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.

Forward-Looking Statements 
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

  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.

 

SOURCE AbbVie

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