Table 2.
Efficacy outcomes at weeks 52 and 116 during continuous ixekizumab treatment (N=352; NRI and mBOCF)
| All patients N=352 |
Biological DMARD-naïve | TNFi-experienced | ||||||
| r-axSpA N=114 |
nr-axSpA N=104 |
r-axSpA N=134 |
||||||
| Week 52 | Week 116 | Week 52 | Week 116 | Week 52 | Week 116 | Week 52 | Week 116 | |
| Response: n (%) | ||||||||
| ASAS20 | 254 (72.2) | 260 (73.9) | 90 (78.9) | 92 (80.7) | 80 (76.9) | 80 (76.9) | 84 (62.7) | 88 (65.7) |
| ASAS40 | 181 (51.4) | 197 (56.0) | 67 (58.8) | 74 (64.9) | 62 (59.6) | 60 (57.7) | 52 (38.8) | 63 (47.0) |
| ASAS partial remission | 69 (19.6) | 70 (19.9) | 30 (26.3) | 31 (27.2) | 25 (24.0) | 29 (27.9) | 14 (10.4) | 10 (7.5) |
| ASAS 5/6 | 208 (59.1) | 210 (59.7) | 77 (67.5) | 80 (70.2) | 67 (64.4) | 65 (62.5) | 64 (47.8) | 65 (48.5) |
| CRP ≤5 mg/L | 241 (68.5) | 260 (73.9) | 90 (78.9) | 94 (82.5) | 79 (76.0) | 81 (77.9) | 72 (53.7) | 85 (63.4) |
| ASDAS LDA (<2.1) | 163 (46.3) | 165 (46.9) | 67 (58.8) | 65 (57.0) | 56 (53.8) | 55 (52.9) | 40 (29.9) | 45 (33.6) |
| ASDAS ID (<1.3) | 48 (13.6) | 53 (15.1) | 25 (21.9) | 22 (19.3) | 15 (14.4) | 23 (22.1) | 8 (6.0) | 8 (6.0) |
| BASDAI50 | 161 (45.7) | 174 (49.4) | 65 (57.0) | 69 (60.5) | 51 (49.0) | 56 (53.8) | 45 (33.6) | 49 (36.6) |
| ASDAS clinically important improvement (≥1.1 CFB) | 233 (66.2) | 247 (70.2) | 81 (71.1) | 84 (73.7) | 74 (71.2) | 74 (71.2) | 78 (58.2) | 89 (66.4) |
| ASDAS major improvement (≥2.0 CFB) | 122 (34.7) | 130 (36.9) | 45 (39.5) | 48 (42.1) | 37 (35.6) | 41 (39.4) | 40 (29.9) | 41 (30.6) |
| Change from baseline: mean (SD) | ||||||||
| ASDAS | −1.63 (1.04) | −1.70 (1.09) | −1.76 (0.98) | −1.82 (0.99) | −1.71 (1.06) | −1.79 (1.21) | −1.46 (1.06) | −1.54 (1.07) |
| BASDAI | −3.24 (2.18) | −3.39 (2.23) | −3.56 (2.21) | −3.66 (2.18) | −3.52 (2.07) | −3.75 (2.32) | −2.76 (2.16) | −2.88 (2.13) |
| BASDAI inflammation* | −3.52 (2.45) | −3.64 (2.42) | −3.79 (2.47) | −3.84 (2.38) | −3.79 (2.51) | −3.91 (2.56) | −3.09 (2.35) | −3.25 (2.31) |
| CRP (mg/L) | −10.79 (22.30) | −11.15 (22.15) | −9.70 (13.45) | −9.96 (13.36) | −8.70 (16.33) | −8.87 (16.38) | −13.34 (30.67) | −13.94 (30.38) |
| PatGA | −3.3 (2.5) | −3.4 (2.6) | −3.5 (2.4) | −3.6 (2.5) | −3.6 (2.4) | −3.8 (2.9) | −2.9 (2.6) | −3.0 (2.5) |
| BASFI | −2.85 (2.35) | −2.98 (2.37) | −3.06 (2.19) | −3.23 (2.18) | −3.15 (2.60) | −3.31 (2.63) | −2.44 (2.22) | −2.50 (2.24) |
| BASMI | −0.54 (0.93) | −0.59 (0.97) | −0.61 (0.86) | −0.67 (0.90) | −0.59 (0.95) | −0.56 (0.91) | −0.45 (0.97) | −0.53 (1.06) |
| ASAS HI | −3.19 (3.43) | −3.37 (3.84) | −3.20 (3.15) | −3.42 (3.69) | −3.77 (3.68) | −3.95 (3.97) | −2.72 (3.40) | −2.87 (3.81) |
| SF-36 PCS | 8.94 (8.04) | 9.22 (8.58) | 8.89 (7.15) | 9.13 (7.63) | 10.36 (9.08) | 10.61 (10.70) | 7.89 (7.80) | 8.22 (7.32) |
| SF-36 MCS | 4.43 (9.66) | 3.88 (10.44) | 4.02 (9.49) | 3.35 (9.93) | 4.77 (9.44) | 4.26 (10.75) | 4.51 (10.02) | 4.05 (10.67) |
| Spinal pain due to AS | −3.5 (2.5) | −3.7 (2.6) | −4.0 (2.3) | −4.1 (2.4) | −3.6 (2.6) | −3.8 (2.8) | −3.0 (2.5) | −3.1 (2.5) |
| Spinal pain at night due to AS | −3.7 (2.6) | −3.8 (2.6) | −4.0 (2.4) | −4.3 (2.5) | −3.9 (2.7) | −4.0 (2.7) | −3.2 (2.7) | −3.2 (2.5) |
Baseline was defined as week 0 of originating study.
*Mean of BASDAI questions 5 and 6.
AS, ankylosing spondylitis; ASAS, Assessment of Spondyloarthritis International Society; ASAS HI, ASAS Health Index; ASASx, x% improvement of ASAS criteria; ASDAS, Ankylosing Spondylitis Disease Activity Score; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CFB, change from baseline; CRP, C reactive protein; ID, inactive disease; LDA, low disease activity; mBOCF, modified baseline observation carried forward; MCS, Mental Component Summary; nr-axSpA, non-radiographic axSpA; NRI, non-responder imputation; PatGA, Patient Global Assessment of Disease Activity; PCS, Physical Component Summary; r-axSpA, radiographic axSpA; SF-36, 36-item Questionnaire Short-Form Health Survey; TNFi, tumour necrosis factor inhibitor.