Table 3. Efficacy outcomes to Week 256.
| N (%) unless otherwise stated | Total (n=296) | ||
| Imputed | OC | ||
| ASDAS-ID (NRI) | Wk 48 | 58 (19.6) | 58/256 (22.7) |
| Wk 256 | 52 (17.6) | 52/173 (30.1) | |
| ASDAS LDA (NRI) | Wk 48 | 146 (49.3) | 146/256 (57.0) |
| Wk 256 | 123 (41.6) | 123/173 (71.1) | |
| ASAS PR (NRI) | Wk 48 | 80 (27.0) | 80/256 (31.3) |
| Wk 256 | 83 (28.0) | 83/201 (41.3) | |
| ASAS20 (NRI) | Wk 48 | 195 (65.9) | 195/256 (76.2) |
| Wk 256 | 171 (57.8) | 171/201 (85.1) | |
| ASAS40 (NRI) | Wk 48 | 153 (51.7) | 153/256 (59.8) |
| Wk 256 | 147 (49.7) | 147/201 (73.1) | |
| ASDAS (MI) mean (SE (MI)/SD (OC)) | BL | 3.9 (0.1) | 3.9 (0.8) |
| Wk 48 | 2.1 (0.1) | 2.0 (0.9) | |
| Wk 256 | 2.1 (0.1) | 1.8 (0.8) | |
| ASDAS-MI (NRI) | Wk 48 | 115 (38.9) | 115/256 (44.9) |
| Wk 256 | 95 (32.1) | 95/173 (54.9) | |
| ASDAS-CII (NRI) | Wk 48 | 200 (67.6) | 200/256 (78.1) |
| Wk 256 | 149 (50.3) | 149/173 (86.1) | |
| BASDAI (MI)Mean (SE (MI)/SD (OC)) | BL | 6.5 (0.1) | 6.5 (1.4) |
| Wk 48 | 3.0 (0.1) | 2.8 (2.0) | |
| Wk 256 | 2.5 (0.2) | 2.2 (1.8) | |
| BASDAI50 (NRI) | Wk 48 | 149 (50.3) | 149/256 (58.2) |
| Wk 256 | 151 (51.0) | 151/201 (75.1) | |
| BASFI (MI) mean (SE (MI)/SD (OC)) | BL | 5.7 (0.1) | 5.7 (2.0) |
| Wk 48 | 3.1 (0.1) | 3.0 (2.2) | |
| Wk 256 | 2.7 (0.1) | 2.5 (2.1) | |
| BASMI (MI) mean (SE (MI)/SD (OC)) | BL | 4.7 (0.1) | 4.7 (1.7) |
| Wk 48 | 3.9 (0.1) | 4.0 (1.8) | |
| Wk 252 | 3.8 (0.1) | 3.9 (1.8) | |
| MASES (MI)* mean (SE (MI)/SD (OC)) | BL | 4.4 (0.2) | 4.4 (3.0) |
| Wk 48 | 0.9 (0.1) | 0.8 (1.7) | |
| Wk 256 | 0.7 (0.1) | 0.6 (1.9) | |
| Resolution of enthesitis (NRI)*† | Wk 48 | 120/194 (61.9) | 120/168 (71.4) |
| Wk 256 | 112/194 (57.7) | 112/132 (84.8) | |
| hs-CRP (MI) geometric mean (median) | BL | 10.7 (12.1) | 10.6 (12.0) |
| Wk 48 | 3.0 (3.6) | 3.1 (3.5) | |
| Wk 256 | 2.7 (3.2) | 2.6 (2.9) | |
| Total spinal pain (MI) mean (SE (MI)/SD (OC)) | BL | 7.1 (0.1) | 7.1 (1.8) |
| Wk 48 | 3.2 (0.1) | 3.0 (2.2) | |
| Wk 256 | 2.7 (0.1) | 2.4 (2.0) | |
| Fatigue (BASDAI Q1) (MI) mean (SE (MI)/SE (OC)) | BL | 6.7 (0.1) | 6.7 (0.1) |
| Wk 48 | 3.6 (0.1) | 3.5 (0.1) | |
| Wk 256 | 2.9 (0.2) | 2.6 (0.2) | |
| Neck, back or hip pain (BASDAI Q2) (MI) mean (SE (MI)/SE (OC)) | BL | 7.5 (0.1) | 7.5 (0.1) |
| Wk 48 | 3.4 (0.1) | 3.3 (0.2) | |
| Wk 256 | 2.8 (0.2) | 2.5 (0.2) | |
| Morning stiffness (mean BASDAI Q5+Q6) (MI) mean (SE (MI)/SE (OC)) | BL | 6.6 (0.1) | 6.6 (0.1) |
| Wk 48 | 2.8 (0.1) | 2.7 (0.1) | |
| Wk 256 | 2.4 (0.2) | 2.1 (0.1) | |
| ASQoL (MI) mean (SE (MI)/SD (OC)) | BL | 8.7 (0.3) | 8.7 (4.3) |
| Wk 48 | 3.7 (0.2) | 3.4 (3.9) | |
| Wk 256 | 3.0 (0.2) | 2.5 (3.3) | |
| SF-36 PCS (MI) mean (SE (MI)/SD (OC)) | BL | 32.3 (0.5) | 32.3 (7.7) |
| Wk 48 | 44.1 (0.5) | 44.6 (8.8) | |
| Wk 256 | 45.8 (0.6) | 46.5 (8.2) | |
| SF-36 MCS (MI) mean (SE (MI)/SD (OC)) | BL | 54.1 (0.5) | 54.1 (8.3) |
| Wk 48 | 56.6 (0.4) | 56.8 (7.0) | |
| Wk 256 | 56.1 (0.5) | 56.8 (6.9) | |
Dose-blind set (Nn=296). For multiple imputation (MI), SE is reported and for observed cases (OC) SD is reported.
Data are reported as imputed (MI, based on the missing at random assumption, or NRI) and OC. For continuous variables, the mean (SE) is reported for MI analyses and the mean (SD) is reported for OC analyses.
Analyses on patients who had MASES>0 at baseline: n=100 in the dose-blind BKZ 160 mg mg group and n=94 in the dose-blind BKZ 320 mg mg group, and n=194 in the DBS total population;
Resolution of enthesitis is defined by MASES=0.
ASAS20/40Assessment of SpondyloArthritis International Society 20/40% responseASAS PRASAS partial remissionASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS-CII, ASDAS clinically important improvement; ASDASID, ASDAS inactive disease; ASDAS-MI, ASDAS major improvement; ASQoL, Ankylosing Spondylitis Quality of Life; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASDAI50, BASDAI 50% response; BASFI, Bath Ankylosing Spondylitis Function Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BL, baseline; hs-CRP, high sensitivity C-reactive protein; LDA, low disease activity; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; NRI, non-responder imputation; SF-36 P/MCSShort-Form 36 physical/component mental summarywk, week