another new drug D2E7

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Research data for D2E7 (adalimumab) shows promise for treating

rheumatoid arthritis

(Posted June 18, 2002)

At the European League Against Rheumatism (EULAR) meeting in Stockholm,

Abbott Laboratories presented data from several studies that it says

contribute to a better understanding of the safety and efficacy profiles

of its investigational medication D2E7 (adalimumab) [pronounced

a-da-lim-yoo-mab], the first fully human monoclonal antibody. D2E7 works

by specifically blocking the activity of tumor necrosis factor alpha

(TNF-alpha), which plays a central role in the inflammation of

autoimmune diseases such as rheumatoid arthritis (RA). According to

Abbott Laboratories, results from Phase III and ongoing clinical trials

of D2E7 show a statistically significant reduction in the signs and

symptoms of RA. The studies also show rapid and sustained positive

clinical responses with D2E7 when administered as a monotherapy or in

combination with methotrexate (MTX) or other multiple disease modifying

anti-rheumatic drugs (DMARDs).

Abbott reports that the results from its Phase III STAR (Safety Trial of

Adalimumab in Rheumatoid Arthritis) trial, one of the largest,

controlled safety studies in RA, show that after 24 weeks of therapy,

there were no statistically significant differences in rates of adverse

events, serious adverse events, infections, or serious infections

between placebo or D2E7 when added to patients' pre-existing

anti-rheumatic therapy. The trial included 636 patients and was designed

to assess safety as a primary endpoint with a protocol that represented

common clinical practice, in which it is common for physicians to

prescribe a combination of DMARDs for patients with RA. Patients in the

study were taking up to four DMARDs when they were randomized to receive

subcutaneous doses of either placebo or 40 mg of D2E7, every-other-week,

in addition to their current DMARDs. The only adverse events that

differed significantly between D2E7 and placebo were injection site

reactions, rash and back pain.

" RA is a progressive disease that can be very debilitating for patients,

which is why the research we are conducting with D2E7 is so exciting, "

said Dr. Schiff, clinical professor of medicine, Rheumatology

Division, University of Colorado School of Medicine and a lead

investigator for D2E7

clinical trials. " The Phase III data for D2E7 offer patients hope for a

potential new option that has demonstrated favorable clinical results

with convenient dosing and administration. "

Effectiveness of D2E7 was also measured in the STAR trial using American

College of Rheumatology (ACR) criteria. ACR 20, ACR 50 and ACR 70

represent the percentage of improvement (20 percent, 50 percent and 70

percent) in tender and swollen joint counts and other relevant clinical

measures.

Overall, significantly more patients receiving D2E7 experienced an

improvement of symptoms with ACR 20, ACR 50 and ACR 70 responses,

compared with patients receiving placebo (55 percent vs. 36 percent, 30

percent vs. 11 percent, and 15 percent vs. 3 percent, respectively). In

this study, D2E7 demonstrated positive clinical results and safety in a

diverse group of patients with RA, many of who required multiple

anti-rheumatic therapies.

" Based on results from our extensive study of D2E7 to date, including

one of the largest safety trials in RA, we are excited about the

potential D2E7 may have in RA, " said Jeff Leiden, M.D., Ph.D., president

and chief operating officer, Pharmaceutical Products Group, and chief

scientific officer, Abbott

Laboratories. " Because RA is an auto-immune disease, patients are more

likely to have infections, and it is critically important for us to

understand the safety profile of D2E7. Based on the number of patients

who have taken D2E7 and the number of studies we've completed, we are

confident in the safety and efficacy profiles, and the convenience D2E7

may offer patients with RA. "

Abbott Laboratories has submitted regulatory applications to the U.S.

Food and Drug Administration (FDA) and the European Agency for the

Evaluation of Medicinal Products (EMEA). The submissions are based on

data from 23 clinical trials involving more than 2,300 RA patients in

North America, Europe and Australia. Research from several other studies

on D2E7 were also presented at EULAR. These included ongoing results

from a Phase II ARMADA Trial in 271 patients; a Phase III trial that

studied D2E7 as a single therapy in 544 patients who had failed

treatment with several other DMARDs; and two open-labelled extension

trials which included 54 and 229 patients, respectively, remaining on

D2E7 therapy for as long as 2.5 years.