Adalimumab improves peripheral arthritis, enthesitis, axial signs, symptoms of AS in patients with long-standing disease treated in real-life practice, researchers report
Wednesday, December 12 2007 | Comments
Adalimumab appears to improve peripheral arthritis and enthesitis as well as axial signs and symptoms in patients with active, long-standing ankylosing spondylitis, according to findings from the RHAPSODY trial.
Researchers conducted a prospective Phase IIIb trial in which 1,250 adult patients with active AS and insufficient responses to at least 1 prior nonsteroidal antiinflammatory drug were administered subcutaneous adalimumab 40 mg every other week on an open-label basis for 12 weeks. Patients were evaluated at weeks 2, 6, and 12 using tender joint counts (TJC) and swollen joint counts (SJC) for patients with symptomatic peripheral arthritis at baseline and using the Maastricht AS Enthesitis Score (MASES) and an additional examination of the fascia plantaris insertion points for patients with symptomatic baseline enthesitis. The study was designed to investigate the effect of adalimumab therapy on peripheral arthritis and on enthesitis in patients with active AS treated within a real-life clinical practice.
Overall, the mean duration of adalimumab therapy was 106 days, and 9.2% of patients discontinued therapy during the study period.
At 12 weeks of therapy, TJC and SJC decreased among patients with peripheral arthritis and at least one swollen joint at baseline (n=281; 23% of total cohort); specifically, mean TJC decreased from 8.1 at baseline to 2.9 at 12 weeks and mean SJC decreased from 3.7 at baseline to 0.8 at 12 weeks.
Additionally, the mean number of inflamed entheses fell from 5.4 at baseline to 2.2 after 12 weeks of adalimumab exposure among patients with at least 1 MASES-scored enthesis (n=667) and from 1.7 to 0.5 among patients with at least 1 enthesis in fascia plantaris (n=173).
Similar rates of response were observed in patients with (n=281) and without (n=969) peripheral arthritis when using ASsessment in AS (ASAS) criteria; specifically, rates of ASAS 20 in these patients were 67% and 71%, respectively; rates of ASAS 40 were 49% and 55%; rates of ASAS 5/6 were 53% and 59%; and rates of ASAS partial remission were 28% and 28%.
Likewise, in patients with (n=686) and without (n=564) enthesitis, rates of ASAS 20 were 70% and 70%, respectively; rates of ASAS 40 were 53% and 54%; rates of ASAS 5/6 were 57% and 59%; and rates of ASAS partial remission were 26% and 30%.
In the trial, the ability of patients to achieve a 50% response according to Bath AS Disease Activity Index (BASDAI) criteria was not affected by either symptomatic arthritis or enthesitis; specifically, rates of BASDAI 50 response were 55% and 58% among patients with and without peripheral arthritis, respectively, and 55% and 60% among patients with and without enthesitis, respectively.
Improvements in C-reactive protein levels from baseline were similarly unaffected by peripheral arthritis or enthesitis status. After 12 weeks of exposure to adalimumab, patients with peripheral arthritis had a mean improvement in CRP level of 31 mg/dL compared with 27.7 mg/dL among those without peripheral arthritis, and patients with enthesitis had a mean improvement of 33.7 mg/dL compared with an improvement of 34.7 mg/dL among those without enthesitis.
"Adalimumab treatment led to clinically important improvements of axial signs and symptoms, peripheral arthritis, and enthesitis in patients with active and long-standing AS in a real-life clinical setting," the authors concluded. (Sieper J, et al. Poster 594.)