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Long-term treatment with adalimumab benefits patients with AS

Thursday, October 30 2008 | Comments

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What's This? By David MacDougall

Adalimumab treatment is associated with significant improvements in the signs and symptoms of ankylosing spondylitis (AS), with effectiveness sustained after 3 years of treatment, according to new data.

In the ATLAS trial, 315 patients with AS were randomized to receive 40 mg of adalimumab or placebo every other week for 24 weeks. The primary study endpoint was the proportion of patients at week 12 who achieved a 20% response according to Assessment in Spondyloarthritis International Society criteria (ASAS 20).

At week 12, the proportion of patients who achieved an ASAS 20 response was 58% in the adalimumab group and 21% in the placebo group (P<.001). The significant reduction in disease activity in the adalimumab group relative to the placebo group was maintained at 24 weeks.

A total of 227 patients entered the long-term, open-label, extension period and received >=3 years of adalimumab treatment. Patient assessments during the extension period included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Short Form-36 Health Survey (SF-36), and the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES).

The improvements in ASAS 20, ASAS 40, ASAS 5/6 (>=20% improvement in >=5 of 6 categories including the 4 ASAS domains), ASAS partial remission (a value of <2 on a scale of 1 to 10 in each of the 4 ASAS domains), and MASES achieved at weeks 12 and 24 in the ATLAS trial were sustained through 3 years in the open-label extension trial.

The mean changes in SF-36 Physical Component Summary scores from baseline at week 12, week 24, and 1, 2, and 3 years were 6.93, 7.44, 9.07, 9.96, and 11.47, respectively. The improvements at weeks 12 and 24 were significantly greater than those observed with placebo (P<.001) and were sustained through >=3 years of adalimumab exposure.

The mean changes in Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire scores from baseline at week 12, week 24, and 1, 2, and 3 years were -3.15, -3.58, -4.29, -4.82, and -5.82, respectively. The improvements at weeks 12 and 24 were significantly greater than those observed with placebo (P<.001) and were sustained through >=3 years of adalimumab exposure. The minimum clinically important difference for ASQOL (change of >1.8 points) was achieved by 73% of the patients after 1 year, 76% after 2 years, and 80% after 3 years.

Adverse event rates per 100 patient-years of treatment were similar between the double-blind treatment and long-term extension phases. The most common adverse events after 3 years of adalimumab treatment were nasopharyngitis (29%), upper respiratory tract infection (21%), and headache (18%).

"More than one-half of patients had a sustained reduction in disease activity as measured by BASDAI 50 during long-term adalimumab treatment, and one-third of patients achieved partial remission," the researchers reported. "Adalimumab effectiveness was sustained for up to 3 years of exposure, with no new safety issues during long-term treatment," they concluded. (van der Heijde D, et al. Poster 368.)

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