Abbott Laboratories’s ATLAS Study Shows Significant Reduction In Signs And Symptoms And Improvement In Health-Related Quality Of Life For Ankylosing Spondylitis Patients Taking HUMIRA(R) (Adalimumab)

SAN DIEGO, Nov. 13 /PRNewswire-FirstCall/ -- Results from Abbott’s Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) study show that patients with ankylosing spondylitis (AS), an inflammatory disease of the spine and spinal joints, treated with HUMIRA(R) (adalimumab) had significant reductions in signs and symptoms, including pain and inflammation, and improved health-related quality of life. Phase III ATLAS findings were presented for the first time today at the American College of Rheumatology annual meeting. In October, Abbott submitted a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA as a treatment for AS.

AS is categorized as a spondyloarthritis, the term for a group of closely linked rheumatic diseases that can affect the spine and joints, which can also cause inflammation of the eye, intestine and skin. In its severe form, AS can lead to fusion of the spine, causing extreme physical limitation.

“The results from ATLAS are significant and promising,” said Desiree van der Heijde, M.D., co-lead investigator of ATLAS and Professor of Rheumatology at the Maastricht University, the Netherlands. “In this study, patients treated with HUMIRA achieved statistically and clinically significant improvements in the inflammation and pain symptoms of AS, supporting its potential to battle this debilitating disease.”

ATLAS was a randomized, placebo-controlled, double-blind, Phase III study conducted in the U.S. and Europe. The study involved 315 patients with active AS who had an inadequate response to at least one non-steroidal anti-inflammatory drug (NSAID) or disease modifying anti-rheumatic drug (DMARD). Results were recorded after 12 and 24 weeks of treatment.

Sustained Response Through 24 Weeks of Treatment in More Than Half of Patients

In the ATLAS study, efficacy was assessed using the ASessment in AS (ASAS) International Working Group criteria, which evaluates four primary parameters: function, pain, patient’s global assessment, and inflammation. Scores of ASAS20, ASAS50 and ASAS70 indicate corresponding symptom improvement percentages in at least three of the evaluation parameters with no worsening in the remaining parameter. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), a patient-assessed composite index of disease activity measuring pain, stiffness and fatigue, was also used to measure efficacy. Scores of BASDAI 20, 50 and 70 correspond to percentages of disease activity improvement.

ASAS20, 50 and 70, and BASDAI 50 responses for patients taking HUMIRA 40 mg every other week were significantly better than those on placebo at both week 12 and 24. At week 12, 58 percent of patients taking HUMIRA achieved ASAS20, the study’s primary endpoint, compared to 21 percent on placebo (p<0.001). ASAS20 responses were apparent in some patients as early as two weeks. Roughly one quarter (23 percent) of the patients receiving HUMIRA achieved 70 percent improvement (ASAS70) in their symptoms at 12 weeks, and 24 percent of patients achieved this response at week 24. Additionally, more than 40 percent of patients taking HUMIRA at 12 weeks achieved 50 percent improvement in disease activity including pain, stiffness and fatigue (as measured by BASDAI 50), and 42 percent achieved this response at week 24.

The adverse events were comparable between the HUMIRA and placebo groups. HUMIRA had a safety profile that is expected based on data from HUMIRA treated RA and PsA populations. The most common adverse events included nasopharyngitis and headache.

HUMIRA Patients Achieve Clinically Meaningful Improvements in Quality of Life

ATLAS also evaluated improvement in health-related quality of life (HRQL) in patients with active AS treated with 40 mg of HUMIRA every other week. HRQL was assessed by the Short Form-36 (SF-36) Health Survey, a standard eight-category questionnaire containing Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, and the AS Quality of Life Questionnaire (ASQoL), a validated AS disease-specific HRQL questionnaire.

At 12 weeks, HUMIRA patients reported greater improvement in PCS scores than those on placebo (6.9 versus 1.6, p<0.001). Also, patients on HUMIRA reported statistically significant improvement in the ASQoL score than those on placebo (-3.1 versus -1.0, p<0.001). At 24 weeks, the significantly greater improvements shown in the HUMIRA group were sustained in both PCS and ASQoL scores. Improvements in PCS and ASQoL for HUMIRA patients at both 12 and 24 weeks exceeded the minimum clinically important difference value. No significant change from baseline was seen for MCS scores between HUMIRA and placebo groups.

“Results from ATLAS are extremely encouraging and help to reaffirm the potential of HUMIRA, having shown efficacy in rheumatoid arthritis and psoriatic arthritis and now promise in AS,” says said Alejandro Aruffo, Ph.D., vice president, Global Pharmaceutical Development, Abbott.

About Ankylosing Spondylitis

Ankylosing spondylitis (AS), or arthritis of the spine, is an autoimmune disorder in which a human protein, tumor necrosis factor-alpha (TNF-alpha), has been suggested to play a role. AS belongs to a group of closely linked rheumatic diseases known as spondyloarthritis that can affect the spine and joints, ligaments and tendons and can cause inflammation of the eye, intestine and skin. Other forms of spondyloarthritis include psoriatic arthritis and reactive arthritis. AS is a chronic disease that primarily affects the spine but can also affect other joints and ligaments, potentially resulting in severe joint and back stiffness and deformity over time.

Unlike many other rheumatic conditions, AS affects young adults, mostly men, and commonly begins before the age of 35. AS is difficult to diagnose in its early stages and is the most overlooked cause of persistent back pain in young adults.

Important Safety Information

Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA. Serious infections and sepsis, including fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to infections. Treatment with HUMIRA should not be initiated in patients with active infections. The combination of HUMIRA and anakinra is not recommended.

TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic reactions. Infrequent reports of serious blood disorders have been reported with TNF-blocking agents. More cases of malignancies have been observed among patients receiving TNF blockers, including HUMIRA, compared to control patients in clinical trials. These malignancies, other than lymphoma and non-melanoma skin cancer, were similar in type and number to what would be expected in the general population. There was an approximately four fold higher rate of lymphoma in combined controlled and uncontrolled open label portions of HUMIRA clinical trials. The potential role of TNF-blocking therapy in the development of malignancies is not known.

The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo) were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.

The safety profile for patients with psoriatic arthritis treated with HUMIRA in the clinical trials has been similar to the safety profile seen in patients with RA.

About HUMIRA

HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate (MTX) or other DMARDS (disease-modifying anti-rheumatic drugs).

HUMIRA is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis. HUMIRA can be used alone or in combination with DMARDS.

Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases.

Abbott’s Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases. More information about Abbott Immunology and HUMIRA, including full prescribing information, is available on the Web site http://www.rxabbott.com or in the United States by calling Abbott Medical Information at 1-800-633-9110.

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 60,000 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 http://www.abbott.com .

Abbott

CONTACT: U.S. Media, Liz Shea, +1-847-989-0174, or International Media,Rand Walton, +1-847-938-8848, or Financial Community, John Thomas,+1-847-938-2655, all of Abbott

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