Adalimumab (Humira) Seen as Safe, Useful in Ankylosing Spondylitis

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Adalimumab Seen Safe, Useful in Ankylosing Spondylitis

Arthritis Rheum 2006;54:2136-2146.

http://www.medscape.com/viewarticle/541120?src=mp

Adalimumab (Humira) significantly reduces pain and inflammation in patients

with active ankylosing spondylitis (AS), according to results of an

international study published in the July issue of Arthritis and Rheumatism.

In the study, 315 AS patients who had an inadequate response or intolerance

to NSAID therapy were randomized to receive a subcutaneous injection of

anti-TNF monoclonal antibody adalimumab (40 mg every other week) or placebo

injection, for 24 weeks.

At week 12, 58.2% of adalimumab-treated patients (121/208) compared with

only 20.6% of placebo-treated patients (22/107) achieved a 20% improvement

in the Assessment in Ankylosing Spondylitis Response Criteria (ASAS20), the

primary endpoint of the study. The difference was highly statistically

significant (p < 0.001).

In fact, " By week 2, after just 1 dose of adalimumab, > 40% of the patients

were ASAS20 responders, " report Dr. C. , Jr., from the University

of California, San Francisco and colleagues.

Unlike previous studies of anti-TNF therapies in AS patients, the current

trial allowed " early-escape open-label " adalimumab treatment for patients

who did not achieve a response up to week 20, the investigators note.

" The ASAS20 response in placebo-treated patients who received early-escape

open-label adalimumab treatment (56.1% at week 24, after 12 weeks of

treatment) was similar to the response in patients initially randomized to

receive adalimumab, " they report.

Significant improvements (p < 0.001) at weeks 12 and 24 were also seen in

two secondary efficacy points -- the ASAS40 response (40% improvement in the

ASAS) and the ASAS5/6, which requires at least 20% improvement in 5 of 6

domains.

At week 24, 44.7% of the adalimumab arm met the ASAS5/6 criteria compared

with only 12.1% of the placebo arm. Similarly, at week 24, 39.4% of

adalimumab-treated patients were ASAS40 responders, compared with only 13.1%

of the placebo-treated patients.

It is noteworthy, according to the team, that patients with radiographic

evidence of total spinal ankylosis benefited from adalimumab, as this group

has been excluded from other clinical trials of anti-TNF therapy.

Adverse events, most of which were mild or moderate in severity, were more

frequent with adalimumab (75.0% versus 59.8% with placebo), " but there was

no statistically significant difference in the incidence of infections, " Dr.

and colleagues report. Infections occurred in 31.7% in the active

treatment arm and 21.5% in the placebo arm.

" Further studies are needed to determine the long-term safety of adalimumab

and the durability of response in patients with AS, " the investigators note.