May 12, 2015

AbbVie's Commitment to Gastroenterology and Hepatology Showcased at Digestive Disease Week® (DDW) 2015

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- Abstracts presented further evaluate the safety, efficacy of HUMIRA® (adalimumab) in moderate to severe Crohn's disease, pediatric Crohn's disease and ulcerative colitis
- Data examining indirect costs and family burden associated with pediatric Crohn's disease featured in oral presentation
- Research presented further assesses the safety, efficacy of VIEKIRA PAK™ (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets) with or without ribavirin in genotype 1 chronic hepatitis C virus (HCV) infection

NORTH CHICAGO, Ill., May 12, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that 18 abstracts in its gastroenterology and hepatology programs will be presented at Digestive Disease Week® (DDW) 2015, May 16 – 19, in Washington, D.C. The abstracts feature results from studies further evaluating the safety and efficacy of HUMIRA® (adalimumab) and VIEKIRA PAK™ (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets).

"AbbVie remains committed to making a meaningful difference in the lives of patients with serious gastroenterologic and hepatic diseases," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "The depth and breadth of data presented at DDW showcase AbbVie's leadership in these fields, building upon decades of experience and research while deepening our understanding of disease burden and impact."

HUMIRA data being presented include a six-year observational study in patients with moderate to severe Crohn's disease, as well as a post hoc analysis examining durable clinical remission and response in moderate to severe ulcerative colitis. Additionally, AbbVie research analyzing the indirect costs and family burden of pediatric Crohn's disease in the United States will be highlighted in an oral presentation. AbbVie will also present research comparing the patient burden of ulcerative colitis with Crohn's disease, and a study evaluating ulcerative colitis severity.

HUMIRA is one of the most comprehensively studied biologics available and is supported by more than 12 years of physician and patient experience in inflammatory bowel diseases. In the United States, HUMIRA is approved for eight indications, including moderate to severe Crohn's disease in adults, moderate to severe Crohn's disease in children 6 years of age and older and moderate to severe ulcerative colitis in adults.

Data from VIEKIRA PAK's ongoing genotype 1 HCV development program will be presented in both oral and poster sessions throughout the meeting. The studies evaluate safety and efficacy of the regimen, with or without ribavirin, throughout diverse populations seen in clinical practice. Additionally, for the first time, a post hoc analysis of adherence rates from the Phase 3 TURQUOISE-II study in patients with cirrhosis treated with VIEKIRA PAK and ribavirin will be presented.

VIEKIRA PAK was approved in December 2014 in the United States for the treatment of adults with genotype 1 chronic HCV infection, including those who have a certain type of cirrhosis (compensated). 

Selected Abstracts of Interest
Abstracts are available here.

HUMIRA (AbbVie-sponsored) Abstracts of Interest

  • PYRAMID Registry: An Observational Study of Adalimumab in Crohn's Disease: Results at Year 6; G. D'Haens, et al.; Abstract Sa1131; Poster Session; Saturday, May 16, 9:30 a.m.4 p.m. ET; Hall C
  • Durable Clinical Remission and Response in Adalimumab-Treated Patients with Ulcerative Colitis; R. Panaccione, et al,; Abstract Sa1229; Poster Session; Saturday, May 16, 9:30 a.m.4 p.m. ET; Hall C
  • Effect of Adalimumab on Clinical Laboratory Parameters in Pediatric Crohn's Disease Patients from IMAgINE 1; J. Hyams, et al.; Abstract Mo1208; Poster of Distinction; Monday, May 18, 9:30 a.m.4 p.m. ET; Hall C

Inflammatory Bowel Disease (AbbVie-sponsored) Abstracts of Interest

  • The Indirect Costs and Family Burden of Pediatric Crohn's Disease in the United States; S. Kahn, et al.; Abstract 149; Oral Presentation; Saturday, May 16, 2:45 p.m. ET; Room 144
  • Underestimation of Ulcerative Colitis Disease Severity: What Affects the Clinical Assessment? Results from a Case Study Survey; T. Ali, et al.; Abstract Su1239; Poster Session; Sunday, May 17, 9:30 a.m.4 p.m. ET; Hall C
  • Comparison of Ulcerative Colitis With Crohn's Disease From the Perspective of Patient Burden; J. Piercy, et al.; Abstract Tu1256; Poster Session; Tuesday, May 19, 9:30 a.m.4 p.m. ET; Hall C

VIEKIRA PAK (AbbVie-sponsored) Abstracts of Interest

  • Plasma Interferon-?-Inducible Protein 10 (IP-10) and Response to Interferon-Free Direct-Acting Antiviral Therapy in HCV Genotype 1-Infected Patients With and Without Cirrhosis;  Jacobson, et al.; Abstract Tu1024; Poster Session; Tuesday, May 19, 9:30 a.m.4 p.m. ET; Hall C
  • MALACHITE-II: Phase 3b Trial of Ombitasvir/Paritaprevir/r and Dasabuvir + Ribavirin or Telaprevir + Peginterferon/Ribavirin in Peginterferon/Ribavirin Treatment-Experienced Adults With HCV Genotype 1;  Dore, et al.; Abstract Tu1015; Poster Session; Tuesday, May 19, 9:30 a.m.4 p.m. ET; Hall C
  • Rates of Adherence to Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir and Ribavirin in Patients with Cirrhosis: Data from the TURQUOISE-II Study; Pol, et al.; Abstract Tu1019; Poster Session; Tuesday, May 19, 9:30 a.m.4 p.m. ET; Hall C
  • MALACHITE-I: Phase 3b Trial of Ombitasvir/Paritaprevir/r and Dasabuvir +/- Ribavirin or Telaprevir + Peginterferon/Ribavirin in Treatment-Naïve Adults With HCV Genotype 1; Conway, et al., Abstract 1012; Oral Presentation; Tuesday, May 19, 2:15 p.m. ET; Room 206
  • SVR Rates for Multiple Negative Predictors in Genotype 1 Patients Receiving Ombitasvir/Paritaprevir/r, Dasabuvir With or Without Ribavirin for 12 And 24 Weeks: Integrated Analysis of Six Phase 3 Trials; Reau, et al.; Abstract 1013; Oral Presentation; Tuesday, May 19, 2:30 p.m. ET; Room 206
  • Liver Function and Non-Invasive Estimates of Liver Fibrosis 48 Weeks After Treatment With Ombitasvir/Paritaprevir/r, Dasabuvir and Ribavirin in HCV Genotype 1 Patients With Cirrhosis; Flamm, et al.; Abstract 1014; Oral Presentation; Tuesday, May 19, 2:45 p.m. ET; Room 206

About HUMIRA
USE
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 achieve clinical remission in these adults who have also 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.
  • 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 INFORMATION
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, 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.

This is the most important information to know about HUMIRA. For more information, talk with a healthcare provider.

Please see Full Prescribing Information, including Medication Guide.

About VIEKIRA PAK
USE
VIEKIRA PAK™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) is a prescription medicine used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C virus (HCV) infection, including people who have a certain type of cirrhosis (compensated).

VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a healthcare provider before taking VIEKIRA PAK.

IMPORTANT SAFETY INFORMATION

When taking VIEKIRA PAK in combination with ribavirin, people should also read the Medication Guide that comes with ribavirin, especially the important pregnancy information.

What is the most important information to know about VIEKIRA PAK?

VIEKIRA PAK can cause increases in liver function blood test results, especially if people use ethinyl estradiol-containing medicines (such as some birth control products).

  • Ethinyl estradiol-containing medicines (combination birth control pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®) must be stopped before starting treatment with VIEKIRA PAK. If these medicines are used as a method of birth control, another method must be used during treatment with VIEKIRA PAK, and for about 2 weeks after treatment with VIEKIRA PAK ends. A healthcare provider can provide instruction on when to begin taking ethinyl estradiol-containing medicines.
  • A healthcare provider should do blood tests to check liver function during the first 4 weeks of treatment and then as needed.
  • A healthcare provider may tell people to stop taking VIEKIRA PAK if signs or symptoms of liver problems develop. A healthcare provider must be notified right away if any of the following symptoms develop or if they worsen during treatment with VIEKIRA PAK: tiredness, weakness, loss of appetite, nausea, vomiting, yellowing of the skin or eyes, or color changes in stools.

VIEKIRA PAK must not be taken if people:

  • have severe liver problems
  • take any of the following medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) • efavirenz (Sustiva®, Atripla®) • ergot containing medicines including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®, Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines • gemfibrozil (Lopid®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • midazolam (when taken by mouth) • phenytoin (Dilantin®, Phenytek®) • phenobarbital (Luminal®) • pimozide (Orap®) • rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®) when taken for pulmonary artery hypertension (PAH) • simvastatin (Zocor®, Vytorin®, Simcor®) • St. John's wort (Hypericum perforatum) or a product that contains St. John's wort • triazolam (Halcion®)
  • have had a severe skin rash after taking ritonavir (Norvir®)

What should people tell a healthcare provider before taking VIEKIRA PAK?

  • If they have: liver problems other than HCV infection, HIV infection, or any other medical conditions.
  • If they have had a liver transplant. If they take the medicines tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®, Sandimmune®), a healthcare provider should check blood levels, and, if needed, may change the dose of these medicines or how often they are taken, both during and after treatment with VIEKIRA PAK.
  • If they are pregnant or plan to become pregnant or if they are breastfeeding or plan to breastfeed. It is not known if VIEKIRA PAK will harm a person's unborn baby or pass into breast milk. A healthcare provider should be consulted about the best way to feed a baby if taking VIEKIRA PAK. Pregnant females who have both HCV and HIV infection should talk with a healthcare provider about enrolling in the antiretroviral pregnancy registry.
  • About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with VIEKIRA PAK.
    • A new medicine must not be started without telling a healthcare provider. A healthcare provider will provide instruction on whether it is safe to take VIEKIRA PAK with other medicines.
    • When VIEKIRA PAK is finished, a healthcare provider should be consulted on what to do if one of the usual medicines taken was stopped or if the dose changed during VIEKIRA PAK treatment.

What are the common side effects of VIEKIRA PAK?

  • For VIEKIRA PAK used with ribavirin, side effects include tiredness, nausea, itching, skin reactions such as redness or rash, sleep problems, and feeling weak.
  • For VIEKIRA PAK used without ribavirin, side effects include nausea, itching, and sleep problems.

These are not all of the possible side effects of VIEKIRA PAK. A healthcare provider should be notified if there is any side effect that is bothersome or that does not go away.

This is the most important information to know about VIEKIRA PAK. For more information, talk with a healthcare provider.

Please see Full Prescription Information, including Medication Guide.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If people cannot afford their medication, they should contact www.pparx.org for assistance.

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. AbbVie employs more than 26,000 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," in AbbVie's 2014 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.

 

SOURCE AbbVie

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