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Title: Adalimumab (Humira) Shows Efficacy for Ankylosing Spondylitis: Presented at ACR

"Adalimumab (Humira) Shows Efficacy for Ankylosing Spondylitis: Presented at ACR"

By Bruce Sylvester SAN DIEGO, CA -- November 17, 2005 -- Adalimumab (Humira) appears to be effectively treat the signs and symptoms ankylosing spondylitis (AS), according to research presented in a press briefing here on November 14[^th at the American College of Rheumatology Annual Scientific Meeting (ACR).

"Even in long-standing disease we saw our 20% improvement goal reached. This is new and striking," said lead investigator Desiree van der Heijde, professor of rheumatology, Maastricht University, Maastricht, The Netherlands.

Ankylosing spondylitis, an autoimmune disease in which tumor necrosis factor (TNF) attacks spinal joints causing inflammation, occurs mostly in men and affects approximately 1 in every 2,000 people in the US.

Adalimumab, a fully human antitumor necrosis factor alpha monoclonal antibody, is approved for treatment of rheumatoid arthritis.

In this trial, the investigators studied whether the same mode of therapeutic action would be helpful for treatment of patients with AS.

The phase 3 study conducted in the United States and Europe enrolled 315 patients with active AS that had not responded to at least 1 other class of agent. The researchers randomized the subjects to either 40 mg of adalimumab or placebo administered every other week for 24 weeks.

The investigators used 5 assessment tools, designed to calculate clinical response to treatment. The primary endpoint was 20% improvement in signs and symptoms of the disease, measured by the Assessment in Ankylosing Spondylitis (ASAS) criteria after 12 weeks.

The investigators reported that at weeks 12 and 24, twice the proportion of patients on adalimumab compared with placebo achieved the 20% improvement goal, and improvement was observable at 2 weeks in some patients.

Adverse events were comparable in both groups.

"We see emerging here a powerful addition to our treatment choices for patients with AS," Dr. van der Heijde said.

The study was supported by Abbott Laboratories.

[Presentation title: Adalimumab Therapy Results in Significant Reduction of Signs and Symptoms in Subjects With Ankylosing Spondylitis: The ATLAS Trial. Abstract 691]

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