response to MTX, including assessment of inhibition of radiographic
* 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.
* 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.
* 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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