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Abbott's PREMIER Study Shows Early Therapy With Humira(R) (adalimumab) and Methotrexate May Affect Long-Term Disease Progression in Patients Battling Rheumatoid Arthritis

VIENNA, AUSTRIA -- June 8, 2005 -- Rheumatoid arthritis (RA) patients whose joint damage was inhibited through a combination therapy of Humira(R) (adalimumab) and methotrexate early in the course of their disease were less likely to experience further damage two years later, according to a new Abbott study.

The PREMIER study found that patients with early RA (less than three years of disease duration) who were treated for six months with a combination of Humira and methotrexate experienced significantly less radiographic progression (joint damage) compared to patients who took methotrexate alone.

The data were presented at the annual congress of the European League Against Rheumatism (EULAR). In addition, PREMIER results also indicate that approximately one in two patients achieved clinical remission (defined as DAS28<2.6).

The Disease Activity Score (DAS) measures disease activity responses in RA by assessing tender and swollen joint count, general health status and an inflammatory marker.

First Six Months of Therapy Critical in Inhibiting Long-Term Progression

One of the PREMIER study's co-primary endpoints was inhibition of radiographic progression, as measured by the change in Total Sharp Score (TSS). TSS assesses bone erosion and joint-space narrowing on X-rays.

Seventy-six percent of patients treated with combination therapy showed no signs of disease progression at six months and of these patients nearly three- quarters (74%) continued to show no progression after 2 years.

In comparison, only 51% of patients taking only methotrexate showed no signs of disease progression at six months and of those patients 61% continued to show no signs of progression at two years.

"The PREMIER data are encouraging because they suggest that early and aggressive treatment may slow or inhibit patients' joint damage," said Ferdinand Breedveld, MD, professor, Department of Rheumatology, University of Leiden, Leiden, Netherlands, and study investigator. "It's estimated that 70% of people with RA experience joint destruction within the first two years. These findings point to the critical need to inhibit disease progression within the first six months of treatment."

The second of the study's co-primary endpoints was ACR 50. This measure, which is used by the American College of Rheumatology, indicates 50% or greater improvement in tender and swollen joint count and other relevant clinical measures.

At 2 years, 59% of the patients on combination therapy achieved ACR 50.

PREMIER is the first RA study to meet ACR 50 as a primary endpoint. The 2-year, double-blind, controlled study, compared the effectiveness of Humira, methotrexate and the combination of the two drugs in treating early RA. A total of 799 patients were separated into three groups. Each group received either the combination therapy of 40 mg Humira every other week with methotrexate, Humira alone or methotrexate alone.

Clinical Remission Achieved with Early Treatment

PREMIER data also show that nearly half (49%) of early RA patients receiving combination therapy achieved clinical remission, as defined by DAS28<2.6. Nearly twice as many patients treated with Humira and methotrexate achieved remission than those taking methotrexate alone. Only 25% of patients taking methotrexate alone achieved a DAS28<2.6 at 2 years.

"The PREMIER study provides data suggesting the rationale for early use of Humira, with the potential to help many patients with early RA achieve inhibition of disease progression and clinical remission," said Rebecca Hoffman, MD, divisional vice president, Immunology Development, Abbott.

In December 2004, Abbott 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 as a first-line treatment of moderately to severely active 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).

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.

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.

Tumor necrosis factor (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.

Physicians should exercise caution when using Humira in patients who have heart failure and monitor them carefully. In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events, including worsening CHF and new onset CHF, have been reported. Cases of worsening CHF have also been reported in patients receiving Humira.

About Humira

Humira is the only fully human monoclonal antibody approved by the EMEA and FDA 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 (a shot beneath the skin) via a specially designed, pre-filled syringe.

To date, Humira has been approved in 57 countries and prescribed to more than 100,000 patients suffering from RA worldwide. Clinical trials are currently underway evaluating the potential of Humira in other autoimmune diseases.


SOURCE: Abbott

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