VIENNA, Austria-Sustained high disease activity during the early stages of ankylosing spondylitis (AS), despite treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) may be an important prognostic indicator of disease progression, and may suggest a possible earlier role for tumor necrosis factor-alpha (TNF-α), according to results of the ongoing German Spondyloarthritis Inception Cohort (GESPIC) cohort trial, presented here at the Annual European Congress of Rheumatology of the European League Against Rheumatism (EULAR).1

As a result of these findings, "we need treatment trials such as anti-tumor necrosis factor-alpha on patients with early disease at the preradiographic stage," says lead researcher Martin Rudwaleit, MD, rheumatologist at the Medizinische Klinik I, Campus Benjamin Franklin at Charité-Universitätsmedizin Berlin in Berlin, Germany. When asked by CIAOMed whether there is a window of opportunity early in AS in which the disease process can be reset, he says "hopefully," adding that the "treatment trials in patients with early disease in the preradiographic stage will [answer] this important question. [But] we do not know yet."

Sustained AS disease activity may be an important prognostic indicator for disease progression that includes worsening of function, spinal mobility, and sacroiliitis. Very little is known about disease activity over time during the early stages of AS. This recent study sought to assess disease activity in early AS over a 1-year period. To be included in GESPIC, patients needed to have symptoms for less than 10 years. All AS patients fulfilled the modified New York criteria. Disease activity was assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), which, together with other disease parameters, was measured at baseline and every 6 months thereafter.

The analysis included 154 AS patients with a mean age of 36.7 and a mean duration of symptoms of 5.5 years. Overall, 31.8% of all early AS patients had sustained active clinical disease (BASDAI >4) over a period of 1 year. Within this group, 57.1% were taking NSAIDs (96% reporting their efficacy), and more than 20% were intolerant of NSAIDs, usually due to gastrointestinal toxicity.

The mean BASDAI was 3.9 at baseline, 3.6 after 6 months, and 3.6 after 1 year of follow-up. Low-to-moderate disease activity over 1 year (or a BASDAI <4, both at baseline and after 1 year of follow-up) was found in 42.2% of patients, the study found. More than 50% of patients had an elevated C-reactive protein (CRP) of >6 mg/L at baseline and 41.1% had elevated CRP after 1 year. Moreover, 40.1% had a CRP of >10 mg/L at baseline and 28.4% after 1 year of follow-up.

Sixty-two percent of patients with a BASDAI >e;4 at either baseline or after 1 year also had an elevated CRP. Among patients with BASDAI >e;4 at both baseline and 1 year follow-up, CRP was elevated at either time point in 58.5%, and at both time points in 34.1% of patients.

"A substantial proportion of AS patients with early disease prospectively studied in an observational cohort have a sustained high disease activity over a period of 1 year, despite treatment with NSAIDs," Dr. Rudwaleit and colleagues conclude. "These patients are in need of more effective treatment alternatives such as TNF-blocking agents."

The next step with this cohort involves analyzing radiographic progression, outcomes, and parameters predicting outcomes, Dr. Rudwaleit tells CIAOMed.

Reference:

Rudwaleit M, Niewerth M, Listing J, et al. Disease activity over one year in early ankylosing spondylitis in a prospective observational cohort (GESPIC). Presented at: Annual European Congress of Rheumatology of EULAR; June 8-11, 2005; Vienna, Austria. Abstract OP0027.