SYS-CON MEDIA Authors: Elizabeth White, Ed Featherston, Kevin Benedict, Adrian Bridgwater, Carmen Gonzalez

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
Zerto has announced the general availability of Zerto Virtual Replication 4.0 (ZVR 4.0). The company’s enterprise-class business continuity/disaster recovery (BC/DR) software is the first to protect, replicate, and migrate data between VMware vSphere and Microsoft Hyper-V hypervisors, as well as across private, hybrid and public cloud environments including Amazon Web Services (AWS). ZVR 4.0 also allows channel partners and cloud service providers to expand their offerings to grow revenues by pr...
DevOps approaches within “Unicorns” vary significantly from the reality of DevOps in the enterprise. Most enterprises manage portfolios of heterogeneous applications that are increasingly interconnected, delivered by global teams, at various stages of technology maturity, and are often encumbered by additional compliance and governance obligations. In his session at DevOps Summit, Dalibor Siroky, Director and co-founder at Plutora, will discuss the emerging and evolving experiences of Agile, Co...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading in...
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ...
While Docker continues to be the darling of startups, enterprises and IT innovators around the world, networking continues to be a real mess. Indeed, managing the interaction between Docker containers and networks has always been fraught with complications. Without automation in networking, the vision of running Docker at scale and letting IT run the same apps unchanged on the laptop and in the data center or for any cloud cannot be realized.
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo 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 to wait for long developmen...
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises a...
Why does developer experience matters, what makes for a great developer experience and what is the relationship between developer experience and the broader field of user experience? Software developers are gaining more influence over the purchase decisions of technologies with which they must build on and with which they must integrate. For example, the success of Amazon Web Services, Heroku and MongoDB has been driven primarily by individual software developers choosing to use these tools, ra...
Enterprise IoT is an exciting and chaotic space with a lot of potential to transform how the enterprise resources are managed. In his session at @ThingsExpo, Hari Srinivasan, Sr Product Manager at Cisco, will describe the challenges in enabling mass adoption of IoT, and share perspectives and insights on architectures/standards/protocols that are necessary to build a healthy ecosystem and lay the foundation to for a wide variety of exciting IoT use cases in the years to come.
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
Avnet, Inc. has announced that it ranked No. 4 on the InformationWeek Elite 100 – a list of the top business technology innovators in the U.S. Avnet was recognized for the development of an innovative cloud-based training system that serves as the foundation for Avnet Academy – the company’s education and training organization focused on technical training around top IT vendor technologies. The development of this system allowed Avnet to quickly expand its IT-related training capabilities around...
Docker is becoming very popular--we are seeing every major private and public cloud vendor racing to adopt it. It promises portability and interoperability, and is quickly becoming the currency of the Cloud. In his session at DevOps Summit, Bart Copeland, CEO of ActiveState, discussed why Docker is so important to the future of the cloud, but will also take a step back and show that Docker is actually only one piece of the puzzle. Copeland will outline the bigger picture of where Docker fits a...
This talk focuses on the application of DevOps fundamentals to include network infrastructure. It draws from real deployment case studies on the extension of today's paradigms to address the challenges of the network infrastructures' ability to seamlessly and cohesively integrate into agile workflows. In this session at DevOps Summit, Arista Networks will focus on configuration management using automation with a nod to future work necessary to include telemetry and ephemeral state information....
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
As cloud gives an opportunity to businesses to buy services externally – how is cloud impacting your customers? In his General Session at 15th Cloud Expo, Fabio Gori, Director of Worldwide Cloud Marketing at Cisco, provided answers to big questions: Do you see hybrid cloud as where the world is going? What benefits does it bring? And how does Cisco connect all of these clouds? He also discussed Intercloud and Cisco’s investment on it.