Abbott’s Humira has been shown to completely halt the progress of rheumatoid arthritis in a clinical study presented at a meeting of the British Society for Rheumatology.
In the study, called PREMIER, 72% of patients taking Humira (adalimumab) in combination with methotrexate exhibited no further joint damage over the course of two years, compared to 43% of those taking methotrexate alone. Patients taking combination therapy also reported significantly greater improvements in their physical functions and reduction in their level of fatigue than those on single-agent treatment with methotrexate.
Initial one-year data from PREMIER were released in 2004, and Abbott filed for approval to update the labelling of Humira to include the treatment of patients with early rheumatoid arthritis on the strength of the results. The drug was first approved in 2002 to treat patients with moderate to severe disease who had failed treatment with other drugs, and was cleared for early, first-line use in October 2005.
“Early intervention with effective treatments such as adalimumab can make a real difference to disease progression and to the lives of patients living with RA,” commented Dr Ernest Choy, of King’s College London.
Other studies on Humira presented at the BSR meeting included the 6,600-patient ReAct trial, which showed clinically important improvements at 12 weeks in RA patients treated with HUMIRA which were sustained at one-year follow up.
In addition, a retrospective analysis of data from over 2,500 patients from open-label extensions of the Humira pivotal trials demonstrated that the incidence of serious infections in these trials was comparable to that reported for RA patients treated with traditional disease modifying agents (DMARDs).
Humira is currently driving sales growth at Abbott’s pharmaceutical division, posting a 39% hike in turnover to $392 million in the first quarter of 2006.