for eMaxHealthSeven-year rheumatoid arthritis (RA) data from open-label extension studies show that treatment with Abbott's HUMIRA (adalimumab) resulted in clinical remission among long-standing RA patients when used in combination with methotrexate (MTX). The percentage of patients achieving clinical remission continued to increase after two or more years of continuous treatment with combination therapy. These data were presented at the European League Against Rheumatism (EULAR) annual meeting in Paris.
The seven-year HUMIRA data are a combined analysis of open-label extensions of the ARMADA, DE019, STAR, DE005 and DE037 trials. The open-label extension period of these studies assessed the measures of efficacy, remission and change over time in the safety profile in patients with long-standing RA treated for up to seven years with 40mg of HUMIRA every other week plus MTX.
"Rheumatoid arthritis is a chronic, progressive disease with no cure and usually requires long-term management for patients, so it is reassuring that HUMIRA has demonstrated up to seven years of efficacy in patients with this disease," said Michael E. Weinblatt, M.D., Brigham and Women's Hospital, Boston, and lead investigator.
Seven-Year Clinical Data Summary
A total of 1,469 patients with a history of RA who had continued on from randomized, controlled HUMIRA trials were treated with HUMIRA and MTX for greater than or equal to 30 days and up to seven years in open-label extension studies. The average length of exposure to treatment was 47 months.
The randomized controlled HUMIRA study included:
*The ARMADA trial: a Phase III study to evaluate efficacy and safety of HUMIRA in patients with moderate to severe RA who had failed at least one disease-modifying anti-rheumatic drug (DMARD).
*DE019: a Phase III study, which evaluated the efficacy and safety of HUMIRA in 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 serious infections. Two patients reported tuberculosis, one after three months and another after 13 months of exposure.
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