ReAct Study Shows Abbott's Humira(R) (Adalimumab) Significantly Reduces Signs and Symptoms in Patients Battling Rheumatoid Arthr
10 Juin 2004 - 3:00PM
PR Newswire (US)
ReAct Study Shows Abbott's Humira(R) (Adalimumab) Significantly
Reduces Signs and Symptoms in Patients Battling Rheumatoid
Arthritis - 'Real-life' Data Collected From 2,000 Patients
Reaffirms Safety and Efficacy of HUMIRA Seen in Pivotal Clinical
Trials - BERLIN, June 10 /PRNewswire-FirstCall/ -- New data about
HUMIRA(R) (adalimumab) from the largest anti-TNF clinical study
ever conducted in Europe, the ReAct trial (Research in Active
Rheumatoid Arthritis), reaffirms the drug's safety and efficacy
seen in pivotal clinical trials. These results along with other key
data about HUMIRA's sustained benefit beyond five years and ability
to inhibit the progression of rheumatoid arthritis (RA) were
presented this week at the European League Against Rheumatism
(EULAR) annual congress in Berlin. Results from the ReAct trial's
first 2,000 patients treated with Abbott Laboratories' HUMIRA
indicate: -- Approximately one in four patients treated with HUMIRA
40 mg every other week, in addition to their existing therapies,
achieved clinical remission within three months. -- The safety
profile of HUMIRA in this trial was consistent with the overall
safety database from pivotal RA HUMIRA trials. -- Forty-two percent
of the patients responded favorably to HUMIRA within two weeks
after the first dose. -- HUMIRA proved effective in RA patients who
had previous experience with other disease modifying anti-rheumatic
drugs (DMARDs). "The data on safety and efficacy from such a large
trial confirm the favorable outcomes seen in the initial HUMIRA
pivotal trials in RA," said G. R. Burmester, M.D., professor of
medicine, Charite Humboldt University, Berlin, Germany. ReAct Data
Show HUMIRA Safe and Effective Treatment in Real-Life Setting In
this open-label study, patients with long-standing moderate to
severe RA were treated with HUMIRA 40 mg every other week in
addition to their existing therapies. The ReAct trial was
considered a "real-life" study because patients met national
treatment guidelines, meaning they represented different stages of
the disease, as well as varying treatment experiences. The trial
also explored the benefits of an "add-on" therapy, in this case
HUMIRA, to the current standard of RA care, which is methotrexate.
Finally, ReAct captured data from a broad patient population
representing individuals from 11 European countries. Other trials
may not be considered real-life because of restrictions in patient
eligibility requirements, as well as patient population size and
diversity. Twenty-four percent of the ReAct patients achieved
clinical remission, DAS28