Welcome!

News Feed Item

AbbVie Initiates New Clinical Trial to Evaluate HUMIRA® (adalimumab) for the Treatment of Fingernail Psoriasis in Patients with Moderate to Severe Chronic Plaque Psoriasis

NORTH CHICAGO, Ill., March 20, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the initiation of a pivotal Phase 3 clinical trial that will evaluate the use of HUMIRA® (adalimumab) as a treatment for fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis, an area of unmet need. Currently there are no approved treatments for fingernail psoriasis.

"Since treatment options are limited, we welcome research that evaluates new options for patients suffering from this disease and are excited to start evaluating adalimumab in this patient population," said Dr. Phoebe Rich, MD, Clinical Adjunct Professor of Dermatology at Oregon Health Science University.

Psoriasis is a non-contagious, chronic immune disease that speeds the growth cycle of skin cells and results in thick, scaly areas of skin. Psoriasis can also affect the fingernails causing pitting, discoloration, loosening and irregular contour of the fingernail.1 Although the prevalence of fingernail psoriasis in those with moderate to severe chronic plaque psoriasis is unknown, about 50% of the 125 million people world-wide with psoriasis have nail involvement.2,3

The 26-week clinical trial is a multinational, double-blind, placebo-controlled study that is expected to enroll 200 patients with moderate to severe chronic plaque psoriasis with fingernail psoriasis. It will be conducted at approximately 32 sites worldwide, including the United Kingdom, Ireland, Germany, Greece, Belgium, France, Australia, Canada, Mexico, and the United States. The primary endpoints for the trial will be evaluated after 26 weeks and are based on advice received from regulatory agencies. The trial will assess the percent of patients who achieve a Physicians Global Assessment of Fingernail Psoriasis (PGA-F) of either "clear" or "minimal" and evaluate the percent of patients who achieve a 75-percent reduction in fingernail psoriasis, as defined by the modified Nail Psoriasis Severity Index (mNAPSI).4,5

"For more than a decade, HUMIRA has served as an important treatment option for patients with chronic inflammatory diseases," said John Medich, Ph.D., vice president, Immunology Clinical Development, AbbVie. "This new clinical trial marks our ongoing commitment to patients living with psoriasis and we look forward to further evaluating the medicine's potential on clinical outcomes in this patient population."

More information on the trial is available at www.clinicaltrials.gov [NCT02016482].4

U.S. Product Information for HUMIRA® (adalimumab)6

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 your bones and joints and may help your ability to perform daily activities.
    • Moderate-to-severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 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 your bones and joints and may help your 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.
  • 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.
  • 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 INFORMATION6

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the 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.

In the European Summary of Product Characteristics, HUMIRA is contraindicated in people who are allergic to adalimumab or any other ingredients of HUMIRA, those who have a severe infection including active TB, or those who have moderate to severe heart failure.7

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

This is not a complete list of the Important Safety Information for HUMIRA.

For additional important safety information, please click here for the Full Prescribing Information and Medication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

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 approximately 25,000 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 2013 Annual Report on Form 10-K/A, 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. Questions and Answers about Psoriasis. National Institute of Arthritis and Musculoskeletal and Skin Diseases Web site. http://www.niams.nih.gov/Health_Info/Psoriasis/default.asp. Accessed March 11, 2014.
  2. Psoriasis Statistics. National Psoriasis Foundation Web site. https://www.psoriasis.org/learn_statistics. Accessed March 11, 2014.
  3. Van Voorhees A, Feldman SR, Koo JYM, et al. The Psoriasis and psoriatic Arthritis Pocket Guide: treatment algorithms and management options. National Psoriasis Foundation Web site. http://www.psoriasis.org/document.doc?id=354. Published 2009. Accessed March 11, 2014.
  4. A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis. US National Institutes of Health Web site. http://www.clinicaltrials.gov/ct2/show/NCT02016482?term=NCT02016482&rank=1. Accessed March 11, 2014.
  5. Data on file, AbbVie Inc.
  6. Humira Injection [package insert]. North Chicago, IL: AbbVie Inc.
  7. HUMIRA [Summary of Product Characteristics], Maidenhead, United Kingdom; AbbVie. September 2013.


 

SOURCE AbbVie

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Today, we have more data to manage than ever. We also have better algorithms that help us access our data faster. Cloud is the driving force behind many of the data warehouse advancements we have enjoyed in recent years. But what are the best practices for storing data in the cloud for machine learning and data science applications?
DXWorldEXPO LLC announced today that ICOHOLDER named "Media Sponsor" of Miami Blockchain Event by FinTechEXPO. ICOHOLDER gives detailed information and help the community to invest in the trusty projects. Miami Blockchain Event by FinTechEXPO has opened its Call for Papers. The two-day event will present 20 top Blockchain experts. All speaking inquiries which covers the following information can be submitted by email to [email protected] Miami Blockchain Event by FinTechEXPOalso offers sp...
DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City and will bring together Cloud Computing, FinTech and Blockchain, Digital Transformation, Big Data, Internet of Things, DevOps, AI, Machine Learning and WebRTC to one location.
Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science" is responsible for guiding the technology strategy within Hitachi Vantara for IoT and Analytics. Bill brings a balanced business-technology approach that focuses on business outcomes to drive data, analytics and technology decisions that underpin an organization's digital transformation strategy.
DevOpsSummit New York 2018, colocated with CloudEXPO | DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City. Digital Transformation (DX) is a major focus with the introduction of DXWorldEXPO within the program. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term.
@DevOpsSummit at Cloud Expo, taking place November 12-13 in New York City, NY, is co-located with 22nd international CloudEXPO | first international DXWorldEXPO and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time t...
Headquartered in Plainsboro, NJ, Synametrics Technologies has provided IT professionals and computer systems developers since 1997. Based on the success of their initial product offerings (WinSQL and DeltaCopy), the company continues to create and hone innovative products that help its customers get more from their computer applications, databases and infrastructure. To date, over one million users around the world have chosen Synametrics solutions to help power their accelerated business or per...
DXWorldEXPO LLC announced today that Kevin Jackson joined the faculty of CloudEXPO's "10-Year Anniversary Event" which will take place on November 11-13, 2018 in New York City. Kevin L. Jackson is a globally recognized cloud computing expert and Founder/Author of the award winning "Cloud Musings" blog. Mr. Jackson has also been recognized as a "Top 100 Cybersecurity Influencer and Brand" by Onalytica (2015), a Huffington Post "Top 100 Cloud Computing Experts on Twitter" (2013) and a "Top 50 C...
Charles Araujo is an industry analyst, internationally recognized authority on the Digital Enterprise and author of The Quantum Age of IT: Why Everything You Know About IT is About to Change. As Principal Analyst with Intellyx, he writes, speaks and advises organizations on how to navigate through this time of disruption. He is also the founder of The Institute for Digital Transformation and a sought after keynote speaker. He has been a regular contributor to both InformationWeek and CIO Insight...
When talking IoT we often focus on the devices, the sensors, the hardware itself. The new smart appliances, the new smart or self-driving cars (which are amalgamations of many ‘things'). When we are looking at the world of IoT, we should take a step back, look at the big picture. What value are these devices providing. IoT is not about the devices, its about the data consumed and generated. The devices are tools, mechanisms, conduits. This paper discusses the considerations when dealing with the...
They say multi-cloud is coming, but organizations are leveraging multiple clouds already. According to a study by 451 Research, only 21% of organizations were using a single cloud. If you've found yourself unprepared for the barrage of cloud services introduced in your organization, you will need to change your approach to engaging with the business and engaging with vendors. Look at technologies that are on the way and work with the internal players involved to have a plan in place when the ine...
Machine learning has taken residence at our cities' cores and now we can finally have "smart cities." Cities are a collection of buildings made to provide the structure and safety necessary for people to function, create and survive. Buildings are a pool of ever-changing performance data from large automated systems such as heating and cooling to the people that live and work within them. Through machine learning, buildings can optimize performance, reduce costs, and improve occupant comfort by ...
Sanjeev Sharma Joins November 11-13, 2018 @DevOpsSummit at @CloudEXPO New York Faculty. Sanjeev Sharma is an internationally known DevOps and Cloud Transformation thought leader, technology executive, and author. Sanjeev's industry experience includes tenures as CTO, Technical Sales leader, and Cloud Architect leader. As an IBM Distinguished Engineer, Sanjeev is recognized at the highest levels of IBM's core of technical leaders.
CI/CD is conceptually straightforward, yet often technically intricate to implement since it requires time and opportunities to develop intimate understanding on not only DevOps processes and operations, but likely product integrations with multiple platforms. This session intends to bridge the gap by offering an intense learning experience while witnessing the processes and operations to build from zero to a simple, yet functional CI/CD pipeline integrated with Jenkins, Github, Docker and Azure...
Digital Transformation is much more than a buzzword. The radical shift to digital mechanisms for almost every process is evident across all industries and verticals. This is often especially true in financial services, where the legacy environment is many times unable to keep up with the rapidly shifting demands of the consumer. The constant pressure to provide complete, omnichannel delivery of customer-facing solutions to meet both regulatory and customer demands is putting enormous pressure on...