Clinical and imaging correlates of response to treatment with infliximab in patients with ankylosing spondylitis.

OBJECTIVES

Ankylosing spondylitis (AS) is a chronic disease leading to progressive spinal ankylosis and deformity. The aims of this study were to (1) determine whether infliximab is an effective treatment for AS patients who have failed conventional treatment; (2) identify any baseline clinical variables that can be associated with responsiveness to treatment; and (3) resolve whether the clinical response correlated with changes from baseline inflammatory changes on magnetic resonance imaging (MRI).

METHODS

Twenty-one patients who met the modified New York criteria for AS (M:F 18:3) were enrolled in this open labeled study. The mean age was 37.9+/-7.9 years and mean disease duration was 8.69+/-6.58 years. Patients received infliximab at a dose of 5 mg/kg by intravenous infusion over 2 hours at 0, 2, 6, weeks. Nine functional variables were measured [i.e., Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI) etc.], 6 clinimetrics (chest expansion, finger to floor, etc.), and inflammatory markers in the peripheral blood at baseline and each subsequent visit. Primary response to treatment was defined as a > 20% response in 5/9 functional variables. A subset of 9 consecutive patients was selected for MRI scans before and after infusions.

RESULTS

Eighteen patients were available for assessment at week 14 having received 3 infusions (wks 0, 2, 6). There was > 60% improvement in functional variables, i.e., BASDAI, BASFI, Health Assessment Questionnaire, fatigue, and spinal and total body pain. Clinimetric scores selectively improved, e.g., chest expansion (p < 0.021) by 14 weeks. ESR, CRP and haptoglobin all showed significant improvement at 6 weeks and were maintained to the 14 week assessment point. Imaging studies showed improvement in all patients studied including those with advanced disease. Three patients developed headache during the infusions. Infliximab was effective in all, but degree of response varied. Very good responders were distinguished from good responders by shorter duration of disease and better baseline clinimetric scores.

CONCLUSIONS

Infliximab was an effective treatment for AS in a short term trial. Longterm control of symptoms and potential alteration in clinical course of disease will require longterm assessment.