News Releases

NORTH CHICAGO, Ill., Feb. 25, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present 19 abstracts during the 2019 American Academy of Dermatology (AAD) Annual Meeting, March 1-5, in Washington, D.C., including new data from the psoriasis pivotal trials for risankizumab, an investigational interleukin-23 (IL-23) inhibitor.

Investigators will highlight risankizumab response over time across various psoriasis patient subgroups in the first integrated efficacy analyses of ultIMMa-1 and ultIMMa-2, two replicate trials comparing risankizumab to STELARA® (ustekinumab) or placebo. Additionally, AbbVie will present up to 40 months of safety data for risankizumab, as well as longer-term data from IMMvent, a trial exploring the efficacy of switching to risankizumab versus continued HUMIRA use in moderate to severe psoriasis patients with varying levels of intermediate response to HUMIRA after 16 weeks. 

"We look forward to sharing the latest research from our growing immunology portfolio at AAD, including data on risankizumab that will add to the body of evidence supporting its potential as a future treatment option for patients living with psoriasis," said Marek Honczarenko, M.D., Ph.D., vice president, global immunology development, AbbVie. "The breadth of research we are presenting underscores AbbVie's continued efforts to advance the standard of care and improve treatment expectations for patients living with chronic dermatologic conditions, many of whom still struggle to achieve and maintain their desired treatment goals."

AbbVie will also share results from a Phase 2b trial evaluating upadacitinib, an investigational oral JAK1-selective inhibitor, in patients with moderate to severe atopic dermatitis. Additional presentations on HUMIRA will validate hidradenitis suppurativa patient-reported outcome measures, assess its efficacy in nail psoriasis among patients with and without psoriatic disease and highlight nine-year registry data evaluating its long-term safety and efficacy in patients with psoriasis.

Risankizumab and upadacitinib are not approved, and their safety and efficacy have not been established by regulatory authorities.

Risankizumab Abstracts

• Efficacy and Safety of Continuous Q12W Risankizumab Versus Treatment Withdrawal: Results from the Phase 3 IMMhance Trial. Langley et al. Oral Presentation; Friday, March 1, 2019, 12:00-12:05 p.m. EST
• Efficacy and Safety of Continuous Risankizumab or Switching from Adalimumab to Risankizumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. Reich et al. Oral Presentation; Friday, March 1, 2019, 12:05-12:10 p.m. EST
• Efficacy of Switching to Risankizumab Compared with Continued Adalimumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis. Ryan et al. Oral Presentation; Friday, March 1, 2019, 12:15-12:20 p.m. EST
• Durable Efficacy of Risankizumab Compared with Ustekinumab Across Subgroups of Patients with Moderate-to-Severe Plaque Psoriasis: Integrated Analysis of Two Phase 3 Trials. Foley et al. Oral Presentation; Friday, March 1, 2019, 12:50-12:55 p.m. EST
• Malignancy Rates in Patients with Moderate to Severe Psoriasis During Treatment with Risankizumab: Analysis of Pooled Clinical Trial Data. Reich et al. Oral Presentation; Sunday, March 3, 2019, 1:30-1:35 p.m. EST
• Efficacy and Safety of Risankizumab in Moderate to Severe Plaque Psoriasis: An Integrated Analysis of UltIMMa-1 and UltIMMa-2. Lebwohl et al. Eposter
• Long-term Safety of Risankizumab in Patients with Moderate to Severe Psoriasis: Analysis of Pooled Clinical Trial Data. Leonardi et al. Eposter
• Risankizumab Treatment is Associated with Low and Consistent Infection Rates Over Time in Patients with Moderate to Severe Psoriasis: Analysis of Pooled Clinical Trial Data. Strober et al. Eposter
• Exposure-Response Relationships for Efficacy and Safety of Risankizumab in Patients with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase 2 and 3 Clinical Trials. Khatri et al. Eposter
• Safety and Efficacy Results from the Open Label Extension of a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor in Patients with Active Psoriatic Arthritis. Papp et al. Eposter

HUMIRA Abstracts

• ESPRIT Registry Nine-Year Interim Real-World Safety, Effectiveness, and Patient-Reported Outcomes of Adalimumab for Moderate to Severe Psoriasis. Wu et al. Eposter
• Efficacy of Adalimumab in Nail Psoriasis by History of Psoriatic Arthritis and Overall Safety from Final, Open-Label 26 Weeks of a Phase-3, Randomized, Placebo-Controlled Trial. Elewski et al. Eposter
• Efficacy of Adalimumab in Nail Psoriasis by Baseline Subgroups, and Overall Safety from First 26 Weeks of a Phase-3, Randomized, Placebo-Controlled Trial. Rich et al. Eposter

Upadacitinib Abstract

• Upadacitinib Treatment Withdrawal and Retreatment in Patients with Moderate-to-Severe Atopic Dermatitis from a Phase 2b, Randomized, Controlled Trial. Guttman-Yassky et al. Eposter

HEOR (Health Economic and Outcomes Research) Abstracts

Psoriasis

• Assessing the Impact of Patient Support Programs in Adalimumab-Treated Adults with Psoriasis in Europe. Ryan et al. Oral Presentation; Friday, March 1, 2019, 4:30-4:35 p.m. EST
• Bridging the Gap between Clinical Trials and Real-World Practice: Predicting Psoriasis Area Severity Index Scores (PASI) Based on Body Surface Area (BSA) and Physicians Global Assessment (PGA). Armstrong et al. Oral Presentation; Friday, March 1, 2019, 4:50-4:55 p.m. EST
• Long-Term Safety Profile of Adalimumab versus Ustekinumab in Psoriasis - A Real World Matching-Adjusted Indirect Comparison (MAIC). Wu et al. Oral Presentation; Saturday, March 2, 2019, 12:10-12:15 p.m. EST
• The Comparative Efficacy for Novel Treatments of Moderate to Severe Plaque Psoriasis: A Network Meta-Analysis. Armstrong et al. Oral Presentation; Sunday, March 3, 2019, 2:00-2:05 p.m. EST

Hidradenitis Suppurativa

• Score Interpretation of the Hidradenitis Suppurativa Symptom Assessment (HSSA) and Hidradenitis Suppurativa Impact Assessment (HSIA). Kimball et al. Oral Presentation; Saturday, March 2, 2019, 1:25-1:30 p.m. EST

The 2019 AAD Annual Meeting abstracts are available here.

About Risankizumab
The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Device Agency (PMDA) are currently reviewing risankizumab applications for the treatment of patients with moderate to severe plaque psoriasis. The trade name SKYRIZI™ (risankizumab) has been conditionally accepted by the U.S. FDA and accepted in the European Union. SKYRIZI is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

Risankizumab is an investigational compound that selectively blocks IL-23 by binding to its p19 subunit.¹ IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.² Phase 3 trials of risankizumab in psoriasis, Crohn's disease and psoriatic arthritis are ongoing, and it is also being investigated to treat ulcerative colitis. ^3-7

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally.

About Upadacitinib
Discovered and developed by AbbVie, upadacitinib is an investigational oral, small molecule JAK1-selective inhibitor being studied for moderate to severe rheumatoid arthritis and other immune-mediated diseases.^8,9 Phase 3 trials of upadacitinib in atopic dermatitis, psoriatic arthritis, Crohn's disease, and ulcerative colitis are ongoing and it is also being investigated to treat ankylosing spondylitis.^10-14 Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About HUMIRA in the U.S.
HUMIRA is a prescription medicine used:¹⁵

• 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 certain other medications. 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 in patients 12 years of age and older.
• 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.
• To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults and children 2 years of age and older.

Important Safety Information¹⁵

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, even if their TB test was negative. 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, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they 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. Children should be brought up to date on all vaccines before starting HUMIRA.

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.

You 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 you cannot afford your medication, contact www.pparx.org for assistance.

About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements
Some statements in this news release are, or may be considered, 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 2017 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. Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
2. Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
3. A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on February 7, 2019.
4. A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on February 7, 2019.
5. A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (IMMpact2). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on February 7, 2019.
6. A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065. ClinicalTrials.gov. 2019. https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed on February 7, 2019.
7. A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy. ClinicalTrials.gov. 2019. https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on February 7, 2019.
8. Voss, J, et al; Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. DOI: 10.1002/art.2013.65.issue-s10.
9. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html.   Accessed on February 7, 2019.
10. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on February 7, 2019.
11. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed on February 7, 2019.
12. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1. ClinicalTrials.gov. 2010. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on February 7, 2019.
13. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on February 7, 2019.
14. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on February 7, 2019.
15. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

SOURCE AbbVie