Spine
ANKYLOSING SPONDYLITIS
A total of 280 patients in the pooled secukinumab group and 136 in the placebo-secukinumab group had spine radiographs evaluable for change in mSASSS score (i.e., had values available for both baseline and week 104). At baseline, the mean (SD) mSASSS scores in the secukinumab and placebo-secukinumab groups were 0.68 (2.35) and 0.81 (2.37), respectively. At week 104, the scores were 0.73 (2.49) and 0.88 (2.60) in the secukinumab and placebo-secukinumab groups, respectively. Thus, there was a minimal change over 2 years with a mean (SD) change of 0.04 (0.47) in the secukinumab group and 0.07 (0.36) in the placebo-secukinumab group at week 104.Overall, 97.5% (273 of 280) of patients in the secukinumab group and 97.1% (132 of 136) in the placebo-secukinumab group showed no structural progression over 2 years, when no progression was defined as a change in total mSASSS score ≤ SDC (which was 0.76 at 80% LoA). An increase of > 2 units in the mSASSS total score was observed in 1.1% (3 of 280) of patients in the secukinumab group and 0.7% (1 of 136) in the placebo-secukinumab group. None of the patients had an increase of > 5 (Fig. Cumulative probability of change from baseline to week 104 in mSASSS total score. Groups are presented as randomized (patients who switched to standard of care or from placebo to active treatment are analyzed according to the original treatment assignment at randomization). Green, yellow, and red lines represent the change from baseline in total mSASSS score of 0.76 (SDC), 2, and 5, respectively. SDC, smallest detectable change; mSASSS, modified Stoke Ankylosing Spondylitis Spine ScoreWhen a syndesmophyte scored by at least 1 reader was considered, most of the patients (84.6% [237 of 280] in the secukinumab group and 86.0% [117 of 136] in the placebo-secukinumab group) had no syndesmophytes at baseline. Among these, 1.7% (4 of 237) in the secukinumab group and 3.4% (4 of 117) in the placebo-secukinumab group developed at least 1 new syndesmophyte (at least 1 vertebral corner assigned a score of ≥ 2 by at least 1 reader) over 2 years. On the other hand, among patients reported to have at least 1 syndesmophyte at baseline (15.4% of patients [43 of 280] in the secukinumab group and 14.0% of patients [19 of 136] in the placebo-secukinumab group), a higher proportion of patients, i.e., 20.9% (9 of 43) in the secukinumab group and 36.8% (7 of 19) in the placebo-secukinumab group, had developed at least 1 new syndesmophyte by week 104. Also, irrespective of the treatment group, the majority of patients (79% based on an assessment by a single reader) who had at least 1 syndesmophyte at screening were mNY-negative at baseline (Additional file When the 2-reader agreement was considered, fewer patients had syndesmophytes at baseline (4.6% [13 of 280] in the secukinumab group and 8.8% [12 of 136] in the placebo-secukinumab group), and a lower proportion of these patients developed new syndesmophytes (15.4% [2 of 13] in the secukinumab group and 8.3% [1 of 12] in the placebo-secukinumab group) compared with the single-reader assessment. Among patients without syndesmophytes at baseline, only 1 patient (in the secukinumab group) had developed a syndesmophyte at week 104. Importantly, the proportion of patients who had a syndesmophyte at baseline and were considered mNY-negative was even higher when both evaluations required a 2-reader agreement (88% vs 79% based on single reader assessment) (Additional file 