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news.Abbott has simultaneously submitted a supplemental biologics license application with the FDA and a type II variation to the European Medicines Agency, seeking approval to market Humira for the treatment of early rheumatoid arthritis.
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Currently, Humira (adalimumab) is indicated for the treatment of patients with moderately to severely active rheumatoid arthritis (RA) who have had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs).
The submission is based on results of the two-year phase III PREMIER study, which found that patients with early RA (RA of less than three years’ duration) experienced significant improvement in signs and symptoms while taking Humira in combination with methotrexate (MTX).
PREMIER compared the effectiveness of Humira, methotrexate (MTX) and the two drugs combined in treating early RA. PREMIER was the first trial of a TNF antagonist (a treatment that targets TNF, a protein implicated in RA) to use ACR50 as a primary endpoint and achieve it.
Researchers compared ACR50 responses (a measure used by the American College of Rheumatology indicating 50% or greater improvement in symptoms, including pain, number of swollen and tender joints and physical function) and radiographic progression in 799 adult patients with recent-onset RA who had not previously used MTX.
Results showed that Humira in combination with MTX significantly improved signs and symptoms of early RA patients. 62% of patients receiving the combination therapy achieved the primary endpoint of ACR50 at one year, compared to only 46% in the MTX-only group.
In addition, after two years, half of the patients with early RA who received a combination of Humira and methotrexate achieved clinical remission compared to only 25% of patients receiving methotrexate alone.
PREMIER’s secondary endpoint, inhibition of radiographic progression, was measured by the change in total Sharp score (TSS), which assesses bone erosion and joint-space narrowing on X-rays.
The Humira-MTX combination was significantly more effective with nearly twice as many patients (61%) experiencing disease inhibition compared to patients who exhibited disease inhibition with MTX only (34%). After two years, patients in the MTX- only group experienced five times the radiographic progression of patients in the Humira-MTX combination group.
“In as little as one year, RA can cause measurable joint damage in patients taking traditional DMARDs such as methotrexate,” said Dr Alejandro Aruffo, president of Abbott Bioresearch Center and Immunoscience Development Center.
“While Humira has already provided benefit to more than 83,000 patients worldwide, we are hopeful that once approved as a first-line treatment it could help many more. We are continually investigating new uses for Humira and other treatments and compounds.”