Abstract
ObjectiveThe aim of this study was to compare radiographic progression in patients with ankylosing spondylitis (AS) treated for up to 2 years with secukinumab (MEASURE 1) with a historical cohort of biologic-naïve patients treated with NSAIDs (ENRADAS).MethodsBaseline and 2-year lateral cervical and lumbar spine radiographs were independently evaluated using mSASSS by two readers, who were blinded to the chronology and cohort of the radiographs. The primary endpoint was the proportion of patients with no radiographic progression (mSASSS change ≤ 0 from baseline to year 2). The Primary Analysis Set included patients with baseline (≤ day 30) and post-baseline day 31–743 radiographs. Sensitivity analyses were performed to assess the robustness of the comparison between the two cohorts, as follows: Sensitivity Analysis Set 1 included all patients with baseline (≤ day 30) and year 2 (days 640–819) radiographs; Sensitivity Analysis Set 2 included all patients with baseline and post-baseline (> day 30) radiographs.ResultsA total of 168 patients (84%) from the MEASURE 1 cohort and 69 (57%) from the ENRADAS cohort qualified for the Primary Analysis Set. Over 2 years, the LS (SE) mean change from baseline in mSASSS for the primary analysis was 0.55 (0.139) for MEASURE 1 vs 0.89 (0.216) for ENRADAS (p = 0.1852). Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses. The proportion of patients with no radiographic progression was consistently higher in the MEASURE 1 vs ENRADAS cohort across all cutoffs for no radiographic progression (change in mSASSS from baseline to year 2 of ≤ 0, ≤ 0.5, ≤ 1, and ≤ 2), but the differences were not statistically significant.ConclusionSecukinumab-treated patients demonstrated a numerical, but statistically non-significant, higher proportion of non-progressors and lower change in mSASSS over 2 years versus a cohort of biologic-naïve patients treated with NSAIDs.
Highlights
Ankylosing spondylitis (AS) is a chronic inflammatory disease characterized by inflammation of the sacroiliac joints and the spine that is eventually followed by erosions and new bone formation
Gender, and Modified stoke ankylosing spondylitis spinal score (mSASSS) were comparable across cohorts and analysis sets (Table 1) At baseline, patients had higher mean C-reactive protein (CRP) levels (18.3 vs 8.8), and a lower prevalence of smoking (25.0% vs 44.9%) in the MEASURE 1 vs ENRADAS cohorts, respectively
The mean (SD) number of days between baseline and post-baseline radiographs for the MEASURE 1 and ENRADAS cohorts were 659.6 (170.8) and 695.1 (56.1) days for the Primary Analysis Set, 737.0 (18.3) and 723.5 (29.3) days for Sensitivity Analysis Set 1, and 688.0 (153.4) and 775.9 (135.6) days for Sensitivity Analysis Set 2
Summary
Ankylosing spondylitis (AS) is a chronic inflammatory disease characterized by inflammation of the sacroiliac joints and the spine that is eventually followed by erosions and new bone formation. Irreversible structural damage occurring as a consequence of new bone formation has a negative impact on patients’ spinal mobility and physical function and may adversely impact their quality of life [1, 2]. Next to the reduction of disease activity, reducing structural damage progression is an important goal in the treatment of patients with AS. As it is considered unethical to expose patients with AS to placebo treatment for a 2-year period (reported to be the minimum follow-up to detect radiographic progression in an acceptable number of patients), historically controlled NSAID-treated cohort comparisons have been used [6]. Comparison of anti-TNF agents with historical cohorts of biologic-naïve patients treated with NSAIDs has not shown a significant added benefit in reducing radiographic progression at 2 years [7,8,9]
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