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Golimumab improves signs, symptoms, physical function among patients with AS, study data show

Wednesday, December 12 2007 | Comments

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What's This? Treatment with golimumab, a new human antibody to tumor necrosis factor, appears to improve the signs and symptoms of ankylosing spondylitis as well as physical function, study data indicate.

Researchers randomized 356 patients with definite AS to receive subcutaneous injections of golimumab in doses of 50 mg or 100 mg or placebo every 4 weeks for 24 weeks. The primary efficacy measure was the proportion of patients who achieved a 20% response according to Assessment in AS (ASAS 20) criteria at week 14. Additionally, the patients who did not achieve at least a 20% improvement in total back pain and morning stiffness at week 16 entered early escape, whereby the patients randomized to placebo were switched to golimumab 50 mg every 4 weeks and those randomized to golimumab 50 mg had their dose increased to 100 mg every 4 weeks until week 24. The patients randomized to golimumab 100 mg who entered early escape continued to receive their assigned treatment until week 24.

The primary endpoint was achieved; specifically, rates of ASAS 20 at week 14 were 59.4% among the patients who received golimumab 50 mg and 60% among those who received golimumab 100 mg compared with 21.8% among those who received placebo (difference vs placebo, P<.001 for both golimumab groups).

Similarly, at 24 weeks, rates of ASAS 20 were 55.8% among the patients who received golimumab 50 mg and 65.7% among those who received golimumab 100 mg, compared with 23.1% among the patients who received placebo (difference vs placebo, P<.001 for both golimumab groups).

Clinical benefit among the golimumab-treated patients was evident as early as week 4 and was maintained throughout the study period, the researchers noted.

In secondary endpoint analysis, rates of ASAS 40 at 14 weeks were 44.9% among the patients who received golimumab 50 mg and 49.3% among those who received golimumab 100 mg, compared with 15.4% of those who received placebo (difference vs placebo, P<.001 for both golimumab groups). Likewise, ASAS 40 rates at 24 weeks were 43.5% among the patients who received golimumab 50 mg and 54.3% among those who received golimumab 100 mg, compared with 15.4% among those who received placebo (difference vs placebo, P<.001 for both golimumab groups).

The golimumab-treated patients had similarly greater rates of ASAS 5/6 response, ASAS partial response, improved Bath AS Disease Activity Index scores, and improved Bath AS Functional Index scores relative to those in the placebo group at weeks 14 and 24 (P=<.002 vs placebo for both golimumab groups for all measures).

The only secondary endpoint that did not reach statistical significance among the golimumab-treated patients compared with placebo was mean change in Bath AS Metrology Index scores from baseline, the authors noted.

There were no deaths in the trial. Adverse events were reported in 79.9% of the golimumab-treated patients (including those who started on placebo and switched to golimumab) compared with 76.6% of the patients in the placebo group. The golimumab-treated patients had increased rates of infections, which were primarily upper-respiratory in nature. Serious adverse events were reported in 5 patients (3.6%) who received golimumab 50 mg, 9 patients (6.4%) who received golimumab 100 mg, and 5 patients (6.5%) who received placebo.

Antibodies to golimumab were detected in 11 patients (4.1%) during the study period, although no patients who were antibody-positive withdrew from the study due to lack of efficacy or safety concerns. However, one patient who was antibody-positive had a mild injection-site reaction of erythema.

"Golimumab improved the signs and symptoms of AS, as well as the physical function of patients with AS, through 24 weeks of treatment," the authors concluded. "There was no major difference in the efficacy or safety of the 2 golimumab dosages." (Braun J, et al. Poster L10/526.)

This information concerns a use that has not been approved by the Food and Drug Administration.

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