New data about Humira (adalimumab) from the anti-TNF clinical study, the ReAct trial (Research in Active Rheumatoid Arthritis), reaffirms the drug's safety and efficacy seen in pivotal clinical trials, a company release said.
The safety profile of Humira in this trial was consistent with the overall safety database from pivotal RA Humira trials. Results from the study indicates that 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. Forty-two per cent of the patients responded favorably to Humira within two weeks after the first dose.
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, company claims.
Twenty-four per cent of the ReAct patients achieved clinical remission, DAS28<2.6, at three months, as measured by Disease Activity Scores 28 (DAS28). DAS28 measures disease activity responses for RA by assessing tender and swollen joint counts, general health status and an inflammatory marker.
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 favourable outcomes seen in the initial Humira pivotal trials in RA," said G. R. Burmester, professor of medicine, Charité Humboldt University, Berlin, Germany.
Reports indicates more than 5 million people worldwide suffer from RA, a chronic autoimmune disease that causes pain, swelling and stiffness in the joints of the hands, feet and wrists and often leads to the destruction of joints. Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, often resulting in eventual destruction of the joint's interior and the surrounding bone.
Humira is the first human monoclonal antibody available in Europe for RA, and the first tumour necrosis factor alpha (TNF-a) antagonist approved in Europe with an indication for use with methotrexate or as monotherapy.
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 at the European League Against Rheumatism (EULAR) annual congress in Berlin.