Table 3.
Other efficacy end points up to 48 weeks of bimekizumab treatment (DBS, NRI and MI)
| n (%) | Placebo → | BKZ 16 mg → | BKZ 64 mg → | BKZ 160 mg (n=58) | BKZ 320 mg (n=61) | ||||
| BKZ 160 mg (n=24) | BKZ 320 mg (n=36) | BKZ 160 mg (n=31) | BKZ 320 mg (n=27) | BKZ 160 mg (n=34) | BKZ 320 mg (n=25) | ||||
| ASAS40* | Baseline | – | – | – | – | – | – | – | – |
| Week 12 | 5 (20.8) | 3 (8.3) | 12 (38.7) | 6 (22.2) | 16 (47.1) | 10 (40.0) | 28 (48.3) | 28 (45.9) | |
| Week 48 | 13 (54.2) | 18 (50.0) | 11 (35.5) | 11 (40.7) | 19 (55.9) | 16 (64.0) | 34 (58.6) | 38 (62.3) | |
| ASAS20* | Baseline | – | – | – | – | – | – | – | – |
| Week 12 | 9 (37.5) | 8 (22.2) | 14 (45.2) | 11 (40.7) | 21 (61.8) | 17 (68.0) | 35 (60.3) | 44 (72.1) | |
| Week 48 | 17 (70.8) | 22 (61.1) | 17 (54.8) | 14 (51.9) | 25 (73.5) | 20 (80.0) | 45 (77.6) | 46 (75.4) | |
| ASAS5/6* | Baseline | – | – | – | – | – | – | – | – |
| Week 12 | 2 (8.3) | 2 (5.6) | 10 (32.3) | 8 (29.6) | 19 (55.9) | 11 (44.0) | 32 (55.2) | 33 (54.1) | |
| Week 48 | 15 (62.5) | 16 (44.4) | 13 (41.9) | 13 (48.1) | 21 (61.8) | 20 (80.0) | 37 (63.8) | 40 (65.6) | |
| ASAS-PR* | Baseline | 0 | 0 | 0 | 0 | 0 | 0 | 1.7 | 0 |
| Week 12 | 1 (4.2) | 1 (2.8) | 3 (9.7) | 2 (7.4) | 5 (14.7) | 4 (16.0) | 10 (17.2) | 14 (23.0) | |
| Week 48 | 8 (33.3) | 8 (22.2) | 4 (12.9) | 8 (29.6) | 7 (20.6) | 7 (28.0) | 17 (29.3) | 21 (34.4) | |
| ASDAS-MI† | Baseline | – | – | – | – | – | – | – | – |
| Week 12 | 0 | 0 | 7 (22.6) | 4 (14.8) | 13 (38.2) | 8 (32.0) | 15 (25.9) | 19 (31.1) | |
| Week 48 | 8 (33.3) | 11 (30.6) | 11 (35.5) | 9 (33.3) | 20 (58.8) | 10 (40.0) | 24 (41.4) | 34 (55.7) | |
| ASDAS-ID† | Baseline | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 12 | 0 | 0 | 1 (3.2) | 1 (3.7) | 3 (8.8) | 3 (12.0) | 6 (10.3) | 6 (9.8) | |
| Week 48 | 4 (16.7) | 5 (13.9) | 3 (9.7) | 6 (22.2) | 6 (17.6) | 4 (16.0) | 15 (25.9) | 15 (24.6) | |
| ASDAS-LDA† | Baseline | 0 | 0 | 0 | 0 | 0 | 0 | 1.7 | 0 |
| Week 12 | 3 (12.5) | 5 (13.9) | 6 (19.4) | 3 (11.1) | 10 (29.4) | 9 (36.0) | 16 (27.6) | 20 (32.8) | |
| Week 48 | 9 (37.5) | 16 (44.4) | 10 (32.3) | 7 (25.9) | 13 (38.2) | 8 (32.0) | 17 (29.3) | 23 (37.7) | |
| Mean (SD) | |||||||||
| ASDAS† | Baseline | 3.71 (0.83) | 3.88 (0.93) | 3.96 (0.72) | 3.84 (0.65) | 4.12 (0.80) | 4.18 (0.74) | 3.86 (0.76) | 3.94 (0.74) |
| Change from baseline | Week 12 | −0.31 (0.73) | −0.37 (0.62) | −1.11 (1.07) | −0.85 (1.01) | −1.72 (0.99) | −1.64 (1.21) | −1.40 (0.94) | −1.52 (0.94) |
| Week 48 | −1.70 (0.89) | −1.80 (0.89) | −1.63 (1.05) | −1.61 (0.93) | −2.01 (1.12) | −2.04 (0.95) | −1.78 (0.95) | −2.03 (0.92) | |
| BASDAI 50* | Baseline | – | – | – | – | – | – | – | – |
| Week 12 | 3 (12.5) | 4 (11.1) | 9 (29.0) | 5 (18.5) | 14 (41.2) | 12 (48.0) | 22 (37.9) | 29 (47.5) | |
| Week 48 | 11 (45.8) | 20 (55.6) | 12 (38.7) | 10 (37.0) | 20 (58.8) | 14 (56.0) | 30 (51.7) | 35 (57.4) | |
| Geometric mean (median) | Baseline | 6.2 (6.1) | 9.3 (10.9) | 11.4 (10.7) | 8.1 (9.9) | 14.2 (16.7) | 14.7 (17.6) | 12.0 (16.0) | 10.4 (11.3) |
| hs-CRP† | Week 12 | 9.1 (9.4) | 8.0 (9.4) | 5.6 (5.5) | 3.8 (4.3) | 2.9 (3.0) | 5.3 (6.1) | 3.7 (4.3) | 3.8 (3.5) |
| Week 48 | 2.9 (2.2) | 2.9 (3.0) | 4.0 (5.0) | 3.0 (3.8) | 3.4 (3.5) | 4.1 (3.9) | 3.9 (4.7) | 3.0 (3.6) | |
| BASFI† | Baseline | 5.8 (1.8) | 5.5 (2.2) | 5.8 (1.7) | 5.9 (1.9) | 5.6 (1.8) | 6.2 (1.8) | 5.5 (2.2) | 5.9 (2.0) |
| Change from baseline | Week 12 | −1.0 (2.1) | −0.3 (1.7) | −1.7 (2.0) | −1.1 (2.5) | −1.6 (2.5) | −2.1 (2.3) | −1.7 (1.8) | −2.2 (2.0) |
| Week 48 | −2.9 (2.2) | −2.4 (2.2) | −2.3 (1.5) | −2.5 (2.0) | −2.8 (2.4) | −2.9 (2.4) | −2.5 (2.0) | −2.9 (2.2) | |
| Spinal pain† | Baseline | 6.9 (1.4) | 7.0 (1.9) | 6.8 (2.1) | 7.7 (1.4) | 7.4 (1.5) | 7.4 (1.8) | 6.6 (2.0) | 7.3 (1.5) |
| Change from baseline | Week 12 | −1.5 (1.6) | −0.7 (1.7) | −2.2 (2.4) | −2.2 (2.4) | −3.3 (2.2) | −3.2 (2.7) | −2.6 (2.2) | −3.6 (2.4) |
| Week 48 | −3.7 (2.0) | −3.7 (2.6) | −3.0 (2.9) | −3.8 (2.7) | −4.2 (2.4) | −4.1 (2.2) | −3.8 (2.4) | −4.7 (2.1) | |
| Morning stiffness† | Baseline | 6.9 (1.7) | 6.7 (2.0) | 6.7 (2.0) | 6.4 (1.9) | 6.5 (2.2) | 7.2 (1.7) | 6.5 (1.8) | 6.6 (2.1) |
| Change from baseline | Week 12 | −1.5 (1.7) | −1.1 (1.5) | −2.6 (3.0) | −1.7 (2.8) | −2.9 (2.9) | −3.5 (2.5) | −2.8 (2.0) | −3.4 (2.7) |
| Week 48 | −3.9 (2.2) | −3.6 (2.4) | −3.7 (3.0) | −3.2 (2.3) | −3.9 (2.8) | −4.4 (2.0) | −3.9 (2.2) | −4.4 (2.4) | |
| BASMI† | Baseline | 4.3 (1.6) | 4.5 (1.6) | 4.7 (1.7) | 4.9 (1.8) | 4.5 (1.8) | 4.9 (1.5) | 4.6 (1.8) | 4.8 (1.8) |
| Change from baseline | Week 12 | −0.3 (0.6) | −0.1 (0.8) | −0.5 (1.0) | −0.4 (0.6) | −0.5 (0.8) | −0.4 (0.7) | −0.3 (0.7) | −0.7 (0.7) |
| Week 48 | −0.9 (1.0) | −0.7 (1.0) | −0.7 (1.1) | −0.9 (0.7) | −0.6 (0.7) | −0.9 (0.7) | −0.5 (1.0) | −1.0 (0.9) | |
| Fatigue† | Baseline | 6.4 (1.7) | 6.8 (1.6) | 7.1 (1.6) | 7.1 (1.6) | 6.8 (1.2) | 6.7 (1.5) | 6.4 (1.7) | 6.4 (1.9) |
| Change from baseline | Week 12 | −0.7 (2.5) | −1.0 (1.7) | −1.6 (2.2) | −1.6 (2.3) | −2.4 (2.1) | −2.6 (2.4) | −2.1 (2.2) | −2.1 (2.5) |
| Week 48 | −2.7 (2.2) | −2.8 (2.4) | −2.7 (2.0) | −3.2 (2.7) | −3.5 (2.3) | −3.1 (2.0) | −3.1 (2.1) | −3.3 (2.4) | |
| PGADA† | Baseline | 7.0 (1.5) | 6.9 (1.9) | 7.0 (1.7) | 7.4 (1.3) | 7.4 (1.5) | 7.1 (1.8) | 6.5 (1.8) | 7.1 (1.9) |
| Change from baseline | Week 12 | −1.5 (1.8) | −0.7 (1.6) | −1.9 (2.9) | −2.0 (2.4) | −3.3 (2.3) | −3.2 (2.7) | −2.2 (2.6) | −3.2 (2.2) |
| Week 48 | −3.8 (2.3) | −3.5 (2.7) | −3.3 (3.1) | −3.4 (2.6) | −4.0 (2.4) | −4.0 (2.4) | −3.5 (2.3) | −4.5 (2.3) | |
| MASES‡ | Placebo → | BKZ 16 mg → | BKZ 64 mg → | BKZ 160 mg (n=40) | BKZ 320 mg (n=42) | ||||
| BKZ 160 mg(n=17) | BKZ 320 mg(n=23) | BKZ 160 mg(n=21) | BKZ 320 mg(n=18) | BKZ 160 mg(n=22) | BKZ 320 mg(n=11) | ||||
| Change from baseline | Baseline | 4.1 (3.0) | 5.0 (3.5) | 3.5 (2.4) | 5.9 (3.4) | 4.6 (3.4) | 3.9 (2.5) | 3.8 (2.2) | 4.6 (3.2) |
| Week 12 | −2.5 (2.1) | −2.1 (3.7) | −1.2 (4.1) | −2.0 (3.1) | −2.4 (1.9) | −3.6 (2.2) | −2.5 (2.3) | −2.7 (2.4) | |
| Week 48 | −3.8 (3.1) | −4.4 (3.6) | −2.5 (3.0) | −4.6 (2.8) | −3.1 (2,7) | −3.2 (2.6) | −3.3 (2.2) | −3.4 (3.2) | |
*NRI.
†MI.
‡In patients with enthesitis at baseline.
ASAS, Assessment of SpondyloArthritis international Society; ASAS-PR, ASAS partial remission; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS-ID, ASDAS inactive disease; ASDAS-LDA, ASDAS low disease activity; ASDAS-MI, ASDAS major improvement; BASDAI 50, Bath Ankylosing Spondylitis Disease Activity Index ≥50% improvement; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; BKZ, bimekizumab; DBS, dose-blind set; hs-CRP, high-sensitivity C reactive protein; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MI, multiple imputation; NRI, non-responder imputation; NRS, numerical rating scale; PGADA, patient global assessment of disease activity.