News from Arthritis Week of Jan. 19, 2003 / Vol. 3 No. 03

Study: Adalimumab Effective as Add-On Therapy for Rheumatoid Arthritis

The addition of adalimumab to the long-term therapy of methotrexate (MTX) helped rheumatoid arthritis patients achieve significant and rapid improvement over a 24-week period compared to a placebo, according to researchers.

Abbott Laboratories recently received FDA approval to market adalimumab, which is branded as Humira, to treat rheumatoid arthritis. MTX is a common treatment for rheumatoid arthritis.

As reported in the January issue of Arthritis & Rheumatism, study participants received injections of adalimumab or a placebo every other week while continuing to take their long-term stable dosage of MTX.

The drug was deemed to be successful if recipients met the American College of Rheumatology criteria for 20 percent improvement (ACR20) after 24 weeks of treatment. This response was achieved by a significantly greater proportion of patients in the 20-mg, 40-mg, and 80-mg adalimumab plus MTX groups (47.8 percent, 67.2 percent, and 65.8 percent, respectively) than in the placebo plus MTX group (14.5 percent).

Patients achieving 50 percent improvement (ACR50) with the 20-mg, 40-mg, and 80-mg adalimumab dosages were 31.9 percent, 55.2 percent, and 42.5 percent, respectively, compared to 8.1% in the placebo group.

The 40-mg and 80-mg doses of adalimumab were associated with a 70 percent improvement in 26.9 percent and 19.2 percent of the patients, respectively, compared to 4.8 percent in the placebo group.

The researchers reported that the responses to adalimumab were rapid and that the drug was safe and well tolerated.

Other sources: Arthritis & Rheumatism, Vol. 48 Issue 1, 35-45