Zochling J. Steps of symptoms and disease status in ankylosing spondylitis: Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Rabbit polyclonal to TXLNA Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Global Score (BAS\G), Bath Ankylosing Spondylitis Metrology Index (BASMI), Dougados Functional Index (DFI), and Health Assessment Questionnaire for the Spondylarthropathies (HAQ\S). ?0.6; values adjusted for multiple screening; values for BASDAI 50 and SF\36 MCS are unadjusted. Missing data were imputed as nonresponse. 95% CI?=?95% confidence interval; IV?=?intravenous. Improvements in the total BASDAI score were sustained through week 52 (Physique ?(Physique2A2A and Table 3) 21. Furthermore, at week 16, LSM change from baseline in the BASDAI score was greater in patients treated with secukinumab than in those treated with placebo regardless of hsCRP level at baseline. In patients with hsCRP levels 10 mg/liter, LSM??SEM changes from baseline to week 16 were ?1.9??0.2 in those treated with secukinumab IV150 mg and ?2.2??0.2 in those treated with secukinumab IV75 mg versus 0.1??0.4 in those treated with placebo. In patients with hsCRP levels 10 mg/liter, LSM??SEM changes from baseline to week 16 were ?2.9??0.2 in those treated with secukinumab IV150 mg and ?2.5??0.2 in those treated with secukinumab IV75 mg versus 0.5??0.4 in those treated with placebo. These improvements from baseline in BASDAI score were mostly sustained at week 52 in patients treated with secukinumab who experienced hsCRP levels 10 mg/liter (LSM??SEM changes of ?2.5??0.2 with secukinumab IV150 mg and ?2.7??0.2 with secukinumab IV75 mg) and those who had hsCRP levels 10 mg/liter (LSM??SEM changes of ?3.3??0.3 with secukinumab IV150 mg and ?2.8??0.3 with secukinumab IV75 mg). Open in a separate window Physique 2 Mean change from baseline through week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (A), Short Form 36 physical component summary score (B), and Ankylosing Spondylitis Quality of Life questionnaire (C). Least squares mean data are from mixed\effects model repeated steps through week 52. values at week 16 were BM-1074 adjusted for multiple screening. ??=?values for SF\36 MCS were 0.05 for both secukinumab regimens (Determine ?(Figure1).1). Greater ASAS20 and ASAS40 response rates with secukinumab versus placebo 21 were also indicated by the ORs ( 1 for both parameters), which are also shown for comparison (Physique ?(Figure11). Both anti\TNFCnaive patients and those with an inadequate response to anti\TNF showed improvements in SF\36 PCS and ASQoL. For anti\TNFCnaive patients, LSM??SEM changes in SF\36 PCS from baseline to week 16 were 6.9??0.6 in those treated with secukinumab IV150 mg and 6.1??0.7 in those treated with secukinumab IV75 mg versus 1.3??0.7 in those treated with placebo (both em P /em ? ?0.0001). For patients with an inadequate response to anti\TNF brokers, LSM??SEM changes in SF\36 PCS from baseline to week 16 were 3.6??1.2 in those treated with secukinumab IV150 mg and 6.5??1.2 in those treated with secukinumab IV75 mg versus 2.0??1.3 in those treated with placebo ( em P /em ?=?0.35 for secukinumab IV150 mg versus placebo and em P /em ? ?0.05 for secukinumab IV75 mg versus placebo). At week 52, further improvement in SF\36 PCS was observed with secukinumab IV150 mg in patients in both subgroups and with secukinumab IV75 mg in anti\TNFCnaive patients. The mean??SD change from baseline to week 52 was 8.3??7.4 in anti\TNFCnaive patients treated with secukinumab IV150 mg, 7.1??6.2 in anti\TNFCnaive patients treated with secukinumab IV75 mg, 4.9??6.2 in patients with an inadequate response to anti\TNF brokers treated with secukinumab IV150 mg, and 6.8??7.8 in patients with an inadequate response to anti\TNF brokers treated with secukinumab IV75 mg. The LSM??SEM changes from baseline to week 16 in BM-1074 ASQoL in the anti\TNFCnaive subgroup were ?4.4??0.5 in patients treated with secukinumab IV 150 mg and ?3.7??0.5 in patients treated with secukinumab IV75 mg versus ?1.3??0.5 in patients BM-1074 treated with placebo ( em P /em ? ?0.0001 for secukinumab IV150 mg versus placebo and em P /em ? ?0.001 for secukinumab IV75 mg versus placebo). In the subgroup of patients with an inadequate response to anti\TNF, the LSM??SEM changes from baseline to week 16 were ?1.9??0.9 in patients treated with secukinumab IV150 mg and ?4.4??0.9 in patients treated with secukinumab IV75 mg versus ?1.0??0.9 in patients treated with placebo ( em P /em ?=?0.47 for secukinumab IV150 mg versus placebo and em P /em ? ?0.01 for secukinumab IV75 versus placebo). These scores were comparable or improved with both secukinumab regimens at week 52. The mean??SD change from baseline to week 52 was ?5.0??5.3 in anti\TNFCnaive patients treated with secukinumab IV150 mg, ?4.1??4.3 in anti\TNFCnaive patients treated with secukinumab IV75 mg, ?3.4??3.9 in patients with an inadequate response to anti\TNF agents treated with secukinumab IV150 mg, and ?5.7??5.3 in patients with an inadequate response to anti\TNF brokers treated with secukinumab IV75.
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