Welcome!

Agile Computing Authors: Liz McMillan, Pat Romanski, Elizabeth White, Lori MacVittie, Charlotte Spencer-Smith

News Feed Item

Abbott Announces First Long-term Patient-reported Health Outcomes Data for Investigational Use of HUMIRA® (Adalimumab) in Patients with Active Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

-In the Phase 3 ABILITY-1 trial, HUMIRA patients experienced a statistically significant improvement in select measures of physical function and health-related quality of life (HRQOL) at 12 weeks

ABBOTT PARK, Ill., Nov. 12, 2012 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the first long-term patient-reported health outcomes data from an open-label analysis of the ongoing, Phase 3 ABILITY-1 trial of HUMIRA® (adalimumab). The study evaluated improvements in physical function and health-related quality of life (HRQOL) after 52 weeks in patients with active non-radiographic axial spondyloarthritis (nr-axSpA). These results are being presented at the American College of Rheumatology Annual Scientific Meeting (ACR) in Washington, D.C.

"There are many adults, especially younger, with nr-axSpA whose disease can be as painful, and have similar adverse impact on the ability to function, as those with more classic ankylosing spondylitis," said Professor Philip Mease, University of Washington and Swedish Medical Center, Seattle, Washington. "This study evaluated adalimumab treatment on reduction of signs and symptoms in nr-axSpA patients and the improvement of important patient-reported outcomes including physical function and health-related quality of life, goals we all want for this often inadequately recognized and treated patient group."

Study Results
An exploratory, post-hoc analysis of data from the open-label extension showed that nr-axSpA patients taking HUMIRA continued to experience improvement in physical function and HRQOL measures at week 52. In both the double-blind and open-label phases of the study, physical function was assessed using the disability index of the Health Assessment Questionnaire for Spondyloarthropathies (HAQ-S). Approximately 62 percent of patients met the minimum important difference (MID) for the HAQ-S of 0.26 at week 52.

The HRQOL was assessed using the Short Form 36 Health Survey (SF-36) score. 77 percent of patients met the MID for SF-36 Physical Component Summary (PCS) score of 3.0 at week 52. Placebo patients who switched to open-label HUMIRA experienced improvements in HRQOL comparable to patients who received HUMIRA through week 52. By week 52, patients in both groups achieved SF-36 scores (42.8 and 44.1, respectively), expressed on a scale of 0-100, where higher scores indicate better health and well-being.

AxSpA can be a debilitating disease most often seen in younger individuals in their most productive time of life, and can go unrecognized for years. AxSpA, which includes ankylosing spondylitis (AS) and nr-axSpA, primarily presents with chronic back pain and stiffness, and can be accompanied by the presence of arthritis, inflammation in the eye and/or gastrointestinal tract. People with nr-axSpA can have similar signs and symptoms as AS – including inflammation that can lead to chronic pain and loss of function – but do not have X-ray evidence of structural damage.

"Patient-reported outcomes data focusing on physical function and health-related quality of life help measure the impact treatment has on patients in their day-to-day life," said John R. Medich, Ph.D., divisional vice president, Immunology Clinical Development, Global Pharmaceutical Research and Development, Abbott. "Because there are currently so few treatment options available to help patients with non-radiographic axSpA, Abbott remains committed to exploring ways HUMIRA can help improve the care and outlook for this patient population."

In the open-label extension, both the investigator and patient knew that patients were receiving HUMIRA. Additionally, open-label extension data may be enriched as patients who remain in the study long-term tend to do better than those who drop out. Physical function and SF-36 PCS were two of nine secondary endpoints evaluated in the double-blind portion of the study, all of which were statistically significant for HUMIRA versus placebo.

Additional results from the double-blind period showed that nr-axSpA patients taking HUMIRA experienced a statistically significantly greater improvement in HAQ-S as compared to placebo (-0.3 versus -0.1 respectively; P=0.025.) at week 12, as well as a statistically significantly greater improvement in SF-36 PCS (5.5 versus 2.0, respectively; p<0.001) at week 12. Patients were then entered into an open-label period, in which all participants (n=179) could receive HUMIRA, and were asked to again complete the health assessment questionnaires at week 52.

In July 2012, the European Commission approved HUMIRA for the treatment of adults with severe nr-axSpA, making it the first biologic and only approved medication available for this disease in Europe. In the U.S., HUMIRA is being investigated for the treatment of nr-axSpA and is not approved for the treatment of spondyloarthritides other than AS and psoriatic arthritis.

About SpA
Spondyloarthritis (SpA) is a group of diseases that share common clinical, radiographic and genetic features. SpA can be categorized according to which part of the body is mainly affected – axial or peripheral. Assessment of SpondyloArthritis International Society (ASAS) developed improved classification criteria for axial and peripheral SpA designed to facilitate identification and classification of people with SpA who share similar symptoms. Criteria for axial SpA incorporate the use of magnetic resonance imaging (MRI), in addition to traditional X-rays, for visualizing sacroiliitis (inflammation of the sacroiliac joint which connects the lower spine and pelvis), one of the hallmarks of axial spondyloarthritis. While worldwide epidemiologic data does not exist for axSpA, studies have shown it is estimated that axSpA affects up to 1 percent of adults in the United States.

About ABILITY-1
ABILITY-1 is the first large, pivotal study to use the ASAS criteria to classify nr-axSpA patients, and to evaluate an anti-tumor necrosis factor medication (anti-TNF) in treating patients with nr-axSpA. It is an ongoing, multi-country, Phase 3 study designed to evaluate the efficacy and safety of HUMIRA in nr-axSpA patients.

Eligible patients were randomized 1:1 to receive either HUMIRA (40 mg every other week, n=91) or placebo (n=94) for 12 weeks. The primary endpoint results from this double-blind, placebo-controlled study showed that a significantly higher percentage of HUMIRA patients, compared to those receiving placebo, achieved ASAS 40 at week 12 (36.3 percent versus 14.9 percent; p<0.001). ASAS 40 is defined as at least a 40 percent improvement from baseline in the Assessment of SpondyloArthritis International Society (ASAS) response criteria.

The double-blind period was followed by the open-label extension phase in which all patients could receive HUMIRA (40 mg every other week) for up to an additional 144 weeks (n=179). During the open-label extension phase of the study, both the investigator and the patient knew that the patient was receiving HUMIRA. Baseline demographics and disease characteristics were comparable between patients who entered the open-label period and those of patients who were initially randomized.

About HUMIRA® (adalimumab)

Uses
HUMIRA (adalimumab) is a prescription used to reduce the signs and symptoms of ankylosing spondylitis in adults.

HUMIRA is used alone or with certain other medicines to reduce the signs and symptoms of psoriatic arthritis in adults. It may prevent further damage to bones and joints and may help with the ability to perform daily activities.

Important Safety Information
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.

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 for the Full Prescribing Information and Medication Guide.

About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

SOURCE Abbott

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.

@ThingsExpo Stories
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
SYS-CON Events announced today that iDevices®, the preeminent brand in the connected home industry, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. iDevices, the preeminent brand in the connected home industry, has a growing line of HomeKit-enabled products available at the largest retailers worldwide. Through the “Designed with iDevices” co-development program and its custom-built IoT Cloud Infrastruc...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry's single source for the cloud. Fusion's advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including clou...
Most people haven’t heard the word, “gamification,” even though they probably, and perhaps unwittingly, participate in it every day. Gamification is “the process of adding games or game-like elements to something (as a task) so as to encourage participation.” Further, gamification is about bringing game mechanics – rules, constructs, processes, and methods – into the real world in an effort to engage people. In his session at @ThingsExpo, Robert Endo, owner and engagement manager of Intrepid D...
Eighty percent of a data scientist’s time is spent gathering and cleaning up data, and 80% of all data is unstructured and almost never analyzed. Cognitive computing, in combination with Big Data, is changing the equation by creating data reservoirs and using natural language processing to enable analysis of unstructured data sources. This is impacting every aspect of the analytics profession from how data is mined (and by whom) to how it is delivered. This is not some futuristic vision: it's ha...
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Learn how IoT, cloud, social networks and last but not least, humans, can be integrated into a seamless integration of cooperative organisms both cybernetic and biological. This has been enabled by recent advances in IoT device capabilities, messaging frameworks, presence and collaboration services, where devices can share information and make independent and human assisted decisions based upon social status from other entities. In his session at @ThingsExpo, Michael Heydt, founder of Seamless...
The IoT's basic concept of collecting data from as many sources possible to drive better decision making, create process innovation and realize additional revenue has been in use at large enterprises with deep pockets for decades. So what has changed? In his session at @ThingsExpo, Prasanna Sivaramakrishnan, Solutions Architect at Red Hat, discussed the impact commodity hardware, ubiquitous connectivity, and innovations in open source software are having on the connected universe of people, thi...