Objective. To evaluate the effect of infliximab on progression of structural damage over 2 years in patients with ankylosing spondylitis (AS).Methods. In the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT), a randomized, double-blind, placebocontrolled trial of the efficacy of infliximab compared with placebo, 279 patients with active AS received either placebo through week 24 and then infliximab 5 mg/kg from week 24 through week 96 (n ‫؍‬ 78) or infliximab 5 mg/kg from baseline through week 96, administered every 6 weeks after a loading dose (n ‫؍‬ 201; these patients were the focus of the radiographic analyses). Radiographic findings in patients from the ASSERT trial were indistinguishable from those in a historical control cohort of patients who had no prior use of anti-tumor necrosis factor agents (from the Outcome in Ankylosing Spondylitis International Study [OASIS] database; n ‫؍‬ 192). Radiographic progression of structural damage from baseline to the 2-year followup was scored using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). All images were scored in one batch.Results. Median changes in the mSASSS from baseline to year 2 were 0.0 for both the OASIS and the ASSERT cohorts (P ‫؍‬ 0.541). Mean changes in the mSASSS were also similar between the OASIS and ASSERT cohorts (mean ؎ SD change over 2 years 1.0 ؎ 3.2 and 0.9 ؎ 2.6, respectively). In addition, results from sensitivity analyses did not show a statistically significant difference in the mSASSS between the OASIS and ASSERT cohorts.Conclusion. AS patients who received infliximab from baseline through week 96 did not show a statistically significant difference in inhibition of structural damage progression at year 2, as assessed using the mSASSS scoring system, when compared with radiographic data from the historical control OASIS cohort. Improvements in clinical outcomes and spinal inflammation have been previously demonstrated with the use of infliximab therapy.

Objective. To assess the minimal clinically important difference (MCID) in joint damage on hand and foot radiographs of patients with early rheumatoid arthritis (RA) as assessed with the Sharp/van der Heijde and Larsen/Scott methods, and to study how the smallest detectable difference (SDD) relates to the MCID for each method.Methods. The judgments of an international panel of experts on the clinical relevance of progression of joint damage as seen on sets of radiographs obtained at 1-year intervals in 4 clinical settings (early versus late RA and mild versus high disease activity) were used as the external criterion, which was compared with the progression scores as determined by the 2 scoring methods. Progression scores with the highest combined sensitivity and specificity for detecting clinically relevant progression represented the MCID. Subsequently, the sensitivity and specificity of the scoring methods were determined when using the SDD as the threshold for relevant progression, and these were compared with the sensitivity and specificity of the MCID.Results. The panel judged changes in joint damage around the level of the SDD (5.0) of the Sharp/van der Heijde method as minimal clinically important, resulting in satisfactory sensitivity (mean 79%) and specificity (mean 84%) for detecting clinically important progression in the 4 clinical settings when using the SDD as the threshold value. The MCID (mean 2.3) of the Larsen/Scott method was much smaller than its SDD (5.8), and the sensitivity for detecting clinically important progression by applying the SDD as threshold was consequently low (mean 51%), accompanied by high specificity (mean 99%).Conclusion. This study suggests that the SDD of the Sharp/van der Heijde method can be used as the MCID, i.e., as the threshold level for individual response criteria. The SDD of the Larsen/Scott method, however, turned out to be too insensitive to use as the threshold for individual clinically relevant change.

Among our selected cohort of patients with early IBP, the prevalence of SpA according to three different criteria sets is high. The ESSG criteria were the most sensitive, followed by the Amor criteria and the Berlin criteria. The modified New York criteria for ankylosing spondylitis appeared to be the most specific. In this cohort, the contribution of MRI and human leucocyte antigen B27 to purely clinical criteria in making a diagnosis of axial SpA was limited.

There is a higher prevalence of vertebral deformities and clinical manifestations of vertebral fractures in patients on Cs than in those not on Cs. Our data indicate that the use of Cs and each 1-mg increase in the current daily Cs dose may increase the risk of development of a vertebral deformity and symptomatic vertebral fracture in patients with RA.

The development of case-specific checklists for SP examinations of physicians' performance has received little attention. To judge the validity of studies of physicians' performances that use SPs, the development processes for the checklists need to be more fully described to enable readers to evaluate the validity and reliability of the studies.