Week 16* and 52 efficacy endpoints for PBO and ADA patients rerandomised to ixekizumab at week 16: COAST-V and COAST-W (ETP population: NRI, modified baseline observation carried forward)
| COAST-V (bDMARD-naive) | COAST-W (TNFi-experienced) | |||||
| PBO/IXE (n=86) | ADA/IXE (n=86) | PBO/IXE (n=93) | ||||
| Patients achieving response, n (%) | ||||||
| NRI | Week 16 | Week 52 | Week 16 | Week 52 | Week 16 | Week 52 |
| ASAS40 | 16 (18.6) | 40 (46.5) | 31 (36.0) | 44 (51.2) | 13 (14.0) | 36 (38.7) |
| ASAS20 | 35 (40.7) | 58 (67.4) | 52 (60.5) | 58 (67.4) | 31 (33.3) | 50 (53.8) |
| ASAS partial remission | 7 (8.1) | 16 (18.6) | 13 (15.1) | 18 (20.9) | 1 (1.1) | 9 (9.7) |
| ASDAS clinically important improvement | 20 (23.3) | 55 (64.0) | 48 (55.8) | 55 (64.0) | 18 (19.4) | 49 (52.7) |
| ASDAS major improvement | 4 (4.7) | 27 (31.4) | 21 (24.4) | 28 (32.6) | 4 (4.3) | 25 (26.9) |
| ASDAS<2.1 (low disease activity) | 11 (12.8) | 35 (40.7) | 33 (38.4) | 41 (47.7) | 5 (5.4) | 27 (29.0) |
| ASDAS<1.3 (inactive disease) | 2 (2.3) | 14 (16.3) | 14 (16.3) | 15 (17.4) | 1 (1.1) | 6 (6.5) |
| BASDAI50 | 15 (17.4) | 40 (46.5) | 28 (32.6) | 39 (45.3) | 10 (10.8) | 35 (37.6) |
| Mean change from baseline (SD) | ||||||
| mBOCF† | Week 16 | Week 52 | Week 16 | Week 52 | Week 16 | Week 52 |
| ASDAS | −0.6 (0.8) | −1.6 (1.0) | −1.3 (1.2) | −1.5 (1.1) | −0.2 (1.1) | −1.4 (1.3) |
| BASDAI | −1.5 (1.7) | −2.9 (2.1) | −2.4 (2.3) | −3.0 (2.3) | −1.0 (2.1) | −2.7 (2.6) |
| BASFI | −1.3 (1.8) | −2.4 (2.2) | −2.2 (2.2) | −2.7 (2.3) | −0.7 (2.1) | −2.2 (2.7) |
| SF-36 PCS‡ | 4.2 (6.3) | 7.7 (8.0) | 6.6 (7.2) | 7.7 (8.0) | 1.0 (7.2) | 6.2 (8.7) |
| ASAS Health Index | −1.4 (2.5) | −2.5 (3.3) | −2.4 (3.1) | −2.9 (3.6) | −0.9 (3.2) | −2.4 (3.6) |
| SPARCC MRI spine score§ | −1.1 (5.9) | −8.5 (14.6) | −12.6 (21.4) | −13.9 (21.2) | NA | NA |
| SPARCC MRI sacroiliac joint score¶ | 0.76 (5.4) | −2.7 (6.2) | −2.8 (8.4) | −3.0 (9.0) | NA | NA |
| CRP, mg/L | −1.0 (22.9) | −11.2 (22.3) | −8.4 (17.3) | −9.4 (17.0) | 6.8 (29.9) | −9.7 (25.8 |
*Except for ASAS partial remission (both studies), ASDAS clinically important improvement (both studies), ASDAS major improvement (both studies), ASDAS <1.3 (COAST-W) and BASDAI50 (COAST-W), all week 16 data have been previously reported.10 11
† For patients who discontinued study drug because of an adverse event, the baseline observation was carried forward to the corresponding timepoint for evaluation. For patients discontinuing study drug for any other reason, the last non-missing observation before discontinuation was carried forward to the corresponding time point for evaluation.
‡ SF-36PCS data are reported as t-scores, based on 2009 US general population norms.
§ Observed data only (not assessed after week 16 in COAST-W). COAST-V: week 16, n=81 (PBO/IXE) and n=80 (ADA/IXE); week 52, n=76 (PBO/IXE) and n=76 (ADA/IXE). COAST-W: week 16, n=49 (IXE Q4W) and n=45 (IXE Q2W).
¶ Observed data only (not assessed in COAST-W). COAST-V: week 16, n=81 (PBO/IXE) and n=80 (ADA/IXE); week 52, n=76 (PBO/IXE) and n=76 (ADA/IXE).
ADA, adalimumab; ASAS, Assessment of SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; bDMARD, biological disease-modifying antirheumatic drug; CRP, C reactive protein; ETP, dose double-blind extended treatment period; mBOCF, modified baseline observation carried forward; NA, not applicable; NRI, non-responder imputation;PBO, placebo; SF-36 PCS, Medical Outcomes Study 36-item Short-Form Health Survey Physical Component Score; IXE Q2W, ixekizumab 80 mg every 2 weeks; IXE Q4W, ixekizumab 80 mg every 4 weeks; TNFi, tumour necrosis factor inhibitor.