Abbott announces first long-term patient-reported health outcomes data for investigational use of HUMIRA® in patients with active nr-axSpA

Abbott 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.