fetching data ... 
Methods: Patients were randomly assigned in an 8:3 ratio to receive infusions of infliximab 5 mg/kg (n = 201) or placebo (n = 78) at weeks 0, 2, 6, 12, and 18. At week 24, patients in the placebo group crossed over to receive infliximab 5 mg/kg at week 24, 26, 30, and every 6 weeks thereafter through week 96. Starting at week 36, patients randomized to infliximab who had a BASDAI score of at least 3 at two consecutive visits had their dose increased to 7.5 mg/kg through the remainder of the study. Radiographs were taken at baseline and week 102. Radiographs of the lateral cervical and lumbar spine were scored using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) (range 0 to 72). Radiographic changes in the patients who received infliximab for 2 years (ASSERT infliximab group) were compared to patients from the Outcome in AS International Study (OASIS) cohort, a population of consecutive AS patients followed according to a fixed protocol who did not receive anti-TNF therapy. Radiographs of both cohorts of patients were digitized, and the origin of the films was blinded to the readers. Films were scored by two readers who were not aware of the true time order. Mean change in mSASSS between baseline and 2 years was used as the primary endpoint. ANCOVA on the van der Waerden-normalized change scores, with baseline mSASSS as a covariate, was used to test the difference between two groups.
Results: There was no statistically significant difference between the ASSERT infliximab cohort and the entire OASIS cohort in the change from baseline to week 102 in the mSASSS score (Table). The results were similar when the ASSERT infliximab cohort was compared with a cohort of OASIS patients who met the eligibility criteria for the ASSERT study (OASIS matched). Additional sensitivity analyses and adjustment for NSAID use did not influence the results.
Change from baseline to week 102
OASIS
OASIS
ASSERT
in mSASSS score
all
matched
infliximab group
Number of patients in x-ray subset
192
70
201
Number of evaluable patients
165
61
156
Mean (standard deviation)
1.0 (3.2)
1.2 (3.9)
0.9 (2.6)
Median (interquartile range)
0.0 (0.0, 1.3)
0.0 (-0.2, 1.5)
0.0 (-0.5, 1.2)
Range
(-3.1, 25.7)
(-2.3, 25.7)
(-6.6, 12.2)
p value ASSERT vs. OASIS all
0.541
p value ASSERT vs. OASIS matched
0.683
Conclusion: Using an historical database comparison, infliximab therapy in the ASSERT trial did not demonstrate inhibition of radiographic progression in AS over 2 years as measured by change in mSASSS score.