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Adalimumab Demonstrates Long-Term Benefit in Ankylosing Spondylitis: Presented at EULAR

By Jill Stein

PARIS -- June 15, 2008 -- Adalimumab safely decreases symptoms of ankylosing spondylitis (AS), with results maintained for up to 3 years, investigators said on June 14 at EULAR 2008, the Annual Congress of the European League Against Rheumatism.

Desiree van der Heijde, MD, Leiden University Medical Center, Leiden, Netherlands, and associates assessed the effect of adalimumab treatment for up to 3 years on the signs and symptoms of AS in 315 patients who participated in the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS).

According to the study protocol, patients were randomised to treatment with adalimumab 40 mg subcutaneously every other week or placebo through 24 weeks.

Efficacy was measured by the Assessment in SpondyloArthritis, International Society (ASAS) criteria: 20 (ASAS20) response (>=20% improvement in >=3 of 4 domains: patient's global assessment, pain, function, and inflammation without worsening in the 4th domain), ASAS40 (>=40% improvement in 3 of 4 ASAS domains), ASAS5/6 (>=20% improvement in 5 out of 6 domains [the 4 ASAS domains plus C-reactive protein and spinal mobility]), and ASAS partial remission (value <20% in each of the 4 ASAS20 domains). Additional efficacy was measured with a 50% response to the Bath AS Disease Activity Index (BASDAI50). The primary endpoint of the study was the percentage of patients at week 12 who achieved ASAS20.

At weeks 12 and 24, adalimumab-treated patients experienced a statistically significant reduction in signs and symptoms on ASAS20 versus patients assigned to placebo.

At week 24, all patients were switched to open-label adalimumab 40 mg every other week for up to an additional 236 weeks.

Improvement was maintained through 3 years of treatment. After 3 years, 174 patients (74%) achieved ASAS20 and 97 patients (42%) achieved ASAS partial remission.

After 3 years of adalimumab treatment, the 3 most common adverse events were nasopharyngitis (29%), upper respiratory tract infection (21%), and headache (18%).

Overall, the results show that the early benefit with adalimumab treatment in patients with AS was sustained for up to 156 weeks of treatment with no new safety issues observed after 3 years of exposure, Dr. van der Heijde noted.

Funding for the study was provided by Abbott.

[Presentation title: Three Year Safety and Efficacy Results From the Adalimumab (Humira) Trial Evaluating Long-Term Efficacy and Safety in Ankylosing Spondylitis. Abstract Number SAT0273]

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