AbbVie Showcases New, Late-Breaking Investigational Data at 2018 American Academy of Dermatology (AAD) Annual Meeting

- Fourteen presentations of HUMIRA® (adalimumab) and pipeline data demonstrate AbbVie's extensive dermatology portfolio and continued commitment to patients living with immune-mediated diseases

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AbbVie

Feb 12, 2018, 08:00 ET

NORTH CHICAGO, Ill., Feb. 12, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced it will present new, late-breaking data across investigational medicines and HUMIRA^® (adalimumab) at the 2018 American Academy of Dermatology (AAD) Annual Meeting (February 16-20, San Diego).

"We continuously seek to improve the care of patients living with chronic dermatologic diseases," said Marek Honczarenko, M.D., Ph.D., vice president, Immunology development, AbbVie. "We believe that delivering the highest quality care starts with the patient. For the first time, we are pleased to present our research from three different targets to address chronic skin conditions in the dermatology community – both through long-term HUMIRA research and new investigational agents risankizumab and upadacitinib."

During the "Late-breaking Research: Clinical Trials" session, AbbVie will present data from ultIMMa-1 and ultIMMA-2, two replicate Phase 3 clinical trials evaluating the safety and efficacy of risankizumab, an investigational IL-23 inhibitor, compared to placebo or STELARA^® (ustekinumab) for the treatment of patients with moderate to severe plaque psoriasis. AbbVie plans to submit risankizumab for the treatment of moderate to severe plaque psoriasis to regulatory authorities in 2018.

In the same session, AbbVie will also share results from a Phase 2b trial of upadacitinib, an investigational oral JAK1-selective inhibitor, evaluating safety and efficacy in patients with moderate to severe atopic dermatitis. Risankizumab and upadacitinib are not approved by regulatory authorities and safety and efficacy have not been established.

Additionally, AbbVie will present HUMIRA data including:

Eight-year interim analyses from the ESPRIT 10-year post-marketing surveillance registry of HUMIRA in patients with moderate to severe chronic plaque psoriasis, which will include real-world effectiveness of skin clearance data.
An analysis of long-term safety and efficacy in patients with fingernail psoriasis.
Patient-reported outcomes from the HUMIRA pivotal studies in hidradenitis suppurativa (HS), and research evaluating HS and surgical outcomes.

HUMIRA is one of the most comprehensively-studied biologics available for immune-mediated inflammatory diseases, and is supported by more than 20 years of clinical trial experience in immunology.¹

Abstracts of Interest

Abstracts are available here.

Risankizumab Abstract

Efficacy and Safety of Risankizumab: Results from Two Double-Blind, Placebo- and Ustekinumab-Controlled, Phase 3 Trials in Moderate-to-Severe Plaque Psoriasis; Abstract #6945; F061 - Late-breaking Research: Clinical Trials; Saturday, February 17; 1:50 p.m. PT

Upadacitinib Abstract

Primary Results from a Phase 2b, Randomized, Placebo-Controlled Trial of Upadacitinib for Patients with Atopic Dermatitis; Abstract #6533; F061 - Late-breaking Research: Clinical Trials; Saturday, February 17; 1:00 p.m. PT

HUMIRA Abstracts
Psoriasis

Eight-Year Interim Results from the ESPRIT 10-Year Postmarketing Surveillance Registry of Adalimumab for Moderate to Severe Psoriasis; Abstract #7442; ePoster Presentation Center 2; Saturday, February 17; 10:50-10:55 a.m. PT
Long-Term Safety and Efficacy of Adalimumab from the Phase 3 Randomized, Placebo-Controlled Trial in Patients with Nail and Skin Psoriasis; Abstract #6901; ePoster Presentation Center 2; Saturday, February 17; 11:40-11:45 a.m. PT
An 8-Year Interim Safety Analysis by Geographic Region of the ESPRIT 10-Year Postmarketing Surveillance Registry of Adalimumab for Moderate to Severe Psoriasis; Abstract #7532; ePoster Presentation Center 1; Saturday, February 17; 4:15-4:20 p.m. PT
Assessing the Impact of Patient Support Programs on Patient Outcomes in Adalimumab-treated Patients with Psoriasis in Europe; Abstract #6451; ePoster Presentation Center 1; Saturday, February 17; 4:25-4:30 p.m. PT
Nail Psoriasis and Psoriatic Arthritis: Assessing the Association Between These Two Manifestations and the Real-world Impact of Biological treatment; Abstract #6454; ePoster Presentation Center 2; Saturday, February 17; 1:00-1:05 p.m. PT

Hidradenitis Suppurativa

Patient-Reported Outcomes Among Patients With Hidradenitis Suppurativa (HS) Experiencing Different Levels of Clinical Response: Integrated Analysis from 2 Clinical Studies; Abstract #7140; ePoster Presentation Center 1; Saturday, February 17; 10:25-10:30 a.m. PT
Effect of Adalimumab Treatment on Metabolic Parameters over 36 Weeks: Integrated Analysis from 2 Phase 3 Studies in Patients with Hidradenitis Suppurativa; Abstract #7099
Assessing the Residual Symptoms and Impacts of Subjects with Hidradenitis Suppurativa After Surgical Intervention; Abstract #6240; ePoster Presentation Center 1; Friday, February 16; 10:20-10:25 a.m. PT
Multiple and More Complex Surgical Procedures for Hidradenitis Suppurativa (HS) are Associated with a Substantial Economic Burden; Abstract #5984; ePoster Presentation Center 1; Friday, February 16; 12:35-12:40 p.m. PT

About Risankizumab
Risankizumab is an investigational compound that selectively blocks IL-23 by binding to its p19 subunit.² IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases.³ Phase 3 trials of risankizumab in psoriasis and Crohn's disease are ongoing, and it is also being investigated to treat psoriatic arthritis.^4,5,6 Future trials are planned to investigate risankizumab in ulcerative colitis.^7,8

ultIMMa-1 and ultIMMa-2 are replicate Phase 3, randomized, double-blind, double-dummy, placebo- and active-controlled studies designed to evaluate the safety and efficacy of risankizumab compared to placebo or ustekinumab in adult patients with moderate to severe plaque psoriasis. The active comparator used for these studies was sourced from the European Union.⁹

Risankizumab is an investigational medicine and is not approved by regulatory authorities. Safety and efficacy have not been established. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of risankizumab globally.

For more information on IL-23 and AbbVie's psoriasis research, please read "Gone Rogue: What Happens When Cells Say the Wrong Thing" and "Seeing Clear: What the Future Holds for Psoriasis" on www.abbvie.com.

About Upadacitinib
Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of immune-mediated disorders.^10,11 Phase 3 trials of upadacitinib in rheumatoid arthritis, psoriatic arthritis and Crohn's disease are ongoing.^12,13,14 Upadacitinib is also being evaluated as a potential treatment for ankylosing spondylitis.¹⁵ AbbVie plans to begin registration-enabling studies in atopic dermatitis, ulcerative colitis and giant cell arteritis this year.^16,17,18

Upadacitinib is an investigational medicine and is not approved by regulatory authorities. Safety and efficacy have not been established.

For more information about JAK inhibitors, please read "What Makes the Immune System Compromise Your Health?" on www.abbvie.com.

About HUMIRA in the U.S.
Uses¹⁹HUMIRA 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 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 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.
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.

Important Safety Information¹⁹HUMIRA 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.

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 70 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 or LinkedIn.

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 2016 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.


¹ Burmester G.R., et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases Ann Rheum Dis. 2009;68:1863–1869.
² Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. NEJM. 2017.
³ Duvallet E, Sererano L, Assier E, et. al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
⁴ Pipeline – Our Science \| AbbVie. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on February 9, 2018.
⁵ A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on February 2, 2018.
⁶ BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. ClinicalTrials.gov.
Available at: https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed on February 2, 2018.
⁷A 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. 2018. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed on February 2, 2018.
⁸ 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. 2018. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on February 2, 2018.
⁹Gordon K, et al. Efficacy and Safety of Risankizumab: Results from Two Double-Blind, Placebo- and Ustekinumab-Controlled, Phase 3 Trials in Moderate-to-Severe Plaque Psoriasis. American Academy of Dermatology. February 2018.
¹⁰ 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
¹¹ Pipeline – Our Science \| AbbVie. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on February 9, 2018.
¹² A Study Comparing ABT-494 to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on February 2, 2018.
¹³ 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. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on February 2, 2018.
¹⁴ A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on February 2, 2018.
¹⁵A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on February 2, 2018.
¹⁶ Phase 2b AD Dose Ranging Study (40wk) N=160. ClinicalTrials.gov. Clinicaltrialsgov. Available at: https://clinicaltrials.gov/ct2/show/NCT02925117. Accessed on February 2, 2018.
¹⁷A 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. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on February 2, 2018.
¹⁸ AbbVie's (ABBV) CEO Richard Gonzalez on Q4 2017 Results - Earnings Call Transcript. Available at: https://seekingalpha.com/article/4140615-abbvies-abbv-ceo-richard-gonzalez-q4-2017-results-earnings-call-transcript. Accessed on February 6, 2018
¹⁹HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.