M. Stone et al., Clinical and imaging correlates of response to treatment with infliximab in patients with ankylosing spondylitis, J RHEUMATOL, 28(7), 2001, pp. 1605-1614
Objectives. Ankylosing spondylitis (AS) is a chronic disease leading to pro
gressive 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 var
iables that can be associated with responsiveness to treatment; and (3) res
olve whether the clinical response correlated with changes from baseline in
flammatory 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 r
eceived infliximab at a dose of 5 mg/kg by intravenous infusion over 2 hour
s 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 ma
rkers in the peripheral blood at baseline and each subsequent visit. Primar
y response to treatment was defined as a > 20% response in 5/9 functional v
ariables. A subset of 9 consecutive patients was selected for MRI scans bef
ore 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 function
al variables, i.e., BASDAI, BASFl, 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 we
ek assessment point. Imaging studies showed improvement in all patients stu
died including those with advanced disease. Three patients developed headac
he during the infusions. Infliximab was effective in all, but degree of res
ponse 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 t
rial. longterm control of symptoms and potential alteration in clinical cou
rse of disease will require longterm assessment.