Abbott Laboratories

Abbott Announces Regulatory Submissions for Use of HUMIRA(R) (adalimumab) as First-Line Treatment for Rheumatoid Arthritis

    Abbott Park, Illinois (ots/PRNewswire) -

    - HUMIRA Data Shows Slowed Joint Damage in Pivotal Study

    Abbott (NYSE: ABT) announced it has simultaneously submitted a Type II Variation to the European Medicines Agency (EMEA) and a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) seeking approval to market HUMIRA(R) (adalimumab) for the first-line treatment of moderately to severely active rheumatoid arthritis (RA). Currently, HUMIRA is indicated for the treatment of patients with moderately to severely active RA who have had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs).

    The submission is based on results of the two-year, Phase III PREMIER Study, which found that patients with early RA (RA of less than three years' duration) experienced significant improvement in signs and symptoms while taking HUMIRA in combination with methotrexate (MTX). Results from patients receiving the combination therapy showed:

@@start.t1@@      -- Sixty-two percent of the patients achieved ACR50, one of the study's
          primary endpoints, at one year. ACR50 is a measure used by the
          American College of Rheumatology indicating 50 percent or greater
          improvement in symptoms, including pain, number of swollen joints and
          physical function.
      -- Sixty-one percent of the patients experienced inhibition of
          radiographic progression, as measured by total Sharp score (TSS) - a
          secondary endpoint of the study. TSS assesses bone erosion and
          joint-space narrowing on X-rays.
      -- One out of every two patients achieved remission as defined by DAS
          28<2.6.  DAS 28 (Disease Activity Score 28) measures disease activity
          responses for RA by assessing tender and swollen joint count, general
          health status and an inflammatory marker in the blood.@@end@@

    "In as little as one year, RA can cause measurable joint damage in patients taking traditional DMARDs such as methotrexate," said Alejandro Aruffo, Ph.D., president, Abbott Bioresearch Center and Immunoscience Development Center, Abbott. "While HUMIRA has already provided benefit to more than 83,000 patients worldwide, we are hopeful that once approved as a first-line treatment it could help many more. We are continually investigating new uses for HUMIRA and other treatments and compounds, in keeping with Abbott's commitment to develop innovative medicines and to address major unmet medical needs."

    PREMIER, a two-year, double-blind, controlled study, compared the effectiveness of HUMIRA, MTX and the two drugs combined in treating early RA. Also, it was the first trial of a TNF antagonist (a treatment that targets TNF, a protein implicated in RA) to set ACR50 as a primary endpoint and achieve it.

    Researchers compared ACR50 responses (a measure used by the American College of Rheumatology indicating 50 percent or greater improvement in symptoms, including pain, number of swollen and tender joints and physical function) and radiographic progression in 799 adult patients with recent-onset RA who had not previously used MTX. Patients, separated into three groups, received either HUMIRA (40 mg every other week subcutaneously) combined with MTX (rapidly escalated to 20 mg weekly); MTX alone; or HUMIRA alone.

    Results showed that HUMIRA in combination with MTX significantly improved signs and symptoms of early RA patients. Sixty-two percent of patients receiving the combination therapy achieved the primary endpoint of ACR50 at one year, compared to only 46 percent in the MTX-only group.

    In addition, after two years, one out of every two patients with early RA who received a combination of HUMIRA and methotrexate achieved clinical remission (as defined by DAS 28<2.6) compared to only 25 percent of patients receiving methotrexate alone. DAS 28 (Disease Activity Score 28) measures disease activity responses for RA by assessing tender and swollen joint count, general health status and an inflammatory marker in the blood.

    PREMIER's secondary endpoint, inhibition of radiographic progression, was measured by the change in total Sharp score (TSS). The HUMIRA-MTX combination was significantly more effective at inhibiting radiographic progression with nearly twice as many patients (61 percent) experiencing disease inhibition compared to patients who exhibited disease inhibition with MTX only (34 percent). After two years, patients in the MTX-only group experienced five times the radiographic progression of patients in the HUMIRA-MTX combination group, with TSS increases averaging 10.4 and 1.9, respectively. The differences between the combination group and the MTX group were statistically significant (p<0.001).

    "Early and aggressive treatment can help slow the progression of joint deformity and disability caused by rheumatoid arthritis," said Ferdinand Breedveld, M.D., Leiden University Medical Center, Leiden, the Netherlands and an investigator for the PREMIER trial. "Studies have shown that people who receive early treatment for RA are less likely to experience the type of joint damage that leads to joint replacement."

    About RA

    More than 5 million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of the hands, feet and wrists, and often leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, resulting in eventual destruction of the joints' interior and the surrounding bone.

    More information on RA and current treatment options can be found at .

    Important Safety Information

    Common adverse events (>1/100 and less than or equal to 1/10) at least possibly causally related to HUMIRA include headache, dizziness, respiratory tract and urinary tract infection, nausea, diarrhea, sore throat, herpes simplex, abdominal pain, rash, pruritis and anemia. Injection site pain was reported by >1/10 patients.

    Patients must be monitored closely for infections, including tuberculosis (TB), before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.

    TNF-antagonists, including HUMIRA, have been associated in rare cases with exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Prescribers should exercise caution in considering the use of HUMIRA in patients with pre-existing or recent-onset central nervous system demyelinating disorders.

    HUMIRA should be used with caution in patients with mild heart failure, and is contraindicated in patients with moderate or severe heart failure. HUMIRA must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.

    About HUMIRA

    HUMIRA is the only fully human monoclonal antibody approved by the FDA and EMEA for reducing the signs and symptoms, inhibiting the progression of structural damage and improving physical function in adults with moderately to severely active RA who have had insufficient response to one or more DMARDs. HUMIRA can be used alone or in combination with methotrexate or other DMARDs. HUMIRA offers convenient every-other-week dosing by subcutaneous injection (shot beneath the skin) via a specially designed, pre-filled syringe.

    Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases, including juvenile rheumatoid arthritis (JRA), psoriasis, psoriatic arthritis, Crohn's disease and ankylosing spondylitis. In addition to filing for HUMIRA as a treatment for early RA, Abbott also filed an sBLA in the U.S. and a Marketing Authorization Application (MAA) in the E.U. for HUMIRA for the treatment of psoriatic arthritis.

    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 more than 55,000 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 .

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