Abbott Laboratories released Phase III data for the first time from studies of adalimumab, known as D2E7, which is being developed as the first fully human antibody to fight rheumatoid arthritis.

The positive results regarding both safety and efficacy were presented at the annual meeting of the European League Against Rheumatism in Stockholm, Sweden.

Abbott has filed new drug applications with the FDA and with European regulatory authorities for the drug.

"Both European and U.S. regulatory agencies have officially accepted our submission for review," said Cindy Resman, public affairs manager for Abbott Pharmaceuticals, of Abbott Park, Ill.

Resman said since it typically takes about a year for the FDA to review and make decisions on submissions, the company is hoping for a mid-year 2003 approval.

Although data from more than one study were presented, Resman said the "biggest abstract" was one for the Phase III STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis), which the company said was one of the largest controlled safety studies in RA. The study, which included 636 patients, showed that after 24 weeks of therapy, there were no statistically significant differe nces in rates of adverse event between placebo and D2E7 when added to patients' existing treatment. The primary endpoint of the trial was safety, Resman said.

"That is one of the largest safety studies done for an anti-[tumor necrosis factor therapy]," she said.

The safety aspect is important because, since rheumatoid arthritis is an autoimmune disease, patients often experience infections, Abbott's president and chief operation officer of the Pharmaceutical Products Group, Jeff Leiden, said in a prepared statement.

Patients were taking up to four disease-modifying anti-rheumatic drugs when they were randomized to receive subcutaneous doses of either placebo or 40 mg of D2E7 every other week. Abbott said the only adverse reactions exhibited by patients taking D2E7 compared to those taking placebo were injection-site reactions, rash and back pain.

Abbott measured efficacy based on American College of Rheumatology (ACR) criteria, which measures the percentage of improvement in tender and swollen joints, among other things. The company said "significantly more" patients receiving D2E7 experienced an improvement in symptoms compared to those receiving placebo: ACR 20 (20 percent improvement) was 55 percent vs. 36 percent in placebo; ACR 50 was 20 percent vs. 11 percent; and ACR 70 was 15 percent compared to 3 percent with placebo.

In a second Phase III trial of D2E7, patients in the study had very severe rheumatoid arthritis and had failed an average of 3.7 other medications, Resman said. When treated with D2E7, patient responses were rapid, the company said, with 36 percent of patients receiving an ACR 20 response rate by week two.

Other studies are showing that those results can be sustained over the long term, for up to 2.5 years, Resman said.

Another study, Phase II Armada (Anti-TNF Research Study Program of the Monoclonal Antibody D2E7 in Patients with Rheumatoid Arthritis), also showed positive results at one year. After 12 months of therapy, 25.3 percent of patients achieved the ACR 70 response, which is the closest measure indicating remission of symptoms, the company said.

D2E7 was developed as part of a long-term collaboration between Abbott and Cambridge Antibody Technology Group plc, of Melbourn, UK. The collaboration was actually begun with BASF before it was taken over by Abbott in March 2001.

Among the products D2E7 would compete with are Malvern, Pa.-based Centocor Inc.'s Remicade and Seattle-based Immunex Corp.'s Enbrel, both of which are already on the market.

"When you take D2E7, it is virtually indistinguishable from any antibody you would find in your body," Resman said. D2E7 has a potential advantage in that it is administered by injection once every two weeks.