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New Long-Term HUMIRA(R) (adalimumab) Data Show Up to Seven-Year Efficacy with Combination Treatment for Rheumatoid Arthritis
Date:6/12/2008

patients with moderate to severe RA with inadequate

response to MTX, including assessment of inhibition of radiographic

progression.

* The STAR trial: a Phase III study that evaluated the efficacy and

safety of HUMIRA when added to a standard treatment regimen for RA

in patients with inadequate response.

* DE005: a Phase I study evaluating the safety and efficacy of HUMIRA

in combination with methotrexate in methotrexate partial responders.

* DE037: a Phase I roll-over study that evaluated the safety,

pharmacokinetics and early signs of HUMIRA efficacy among RA

patients in the United States and Japan.

Efficacy

* After six months of therapy, all efficacy measures showed

significant improvements versus baseline.

* At year two, additional improvements were observed in American

College of Rheumatology (ACR) responses. ACR responses represent a

percent improvement in tender joint count, swollen joint count and

other relevant clinical measures.

* Improved response after year one was confirmed by examining

sustained clinical remission (Disease Activity Score (DAS28) of less

than 2.6) for at least three consecutive visits; sustained remission

was achieved in 42 percent of all patients after a mean of 18 +/- 17

months. DAS28 is a composite index that includes variables such as

the number of tender and swollen joints, specific laboratory values

and other measures of disease activity.

Safety

* The treatment exposure-adjusted rate of serious adverse events

(SAEs), and serious infections, declined progressively during seven

years of observation.

* Rates and types of SAEs were consistent with randomized controlled

trials, including the rate of se
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SOURCE Abbott
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