Week 16 and 52 efficacy endpoints for patients treated continuously with ixekizumab: COAST-V and COAST-W (ITT population: observed data)
| COAST-V (bDMARD-naïve) | COAST-W (TNFi-experienced) | |||||||
| Ixe q4w (N=81) | Ixe q2w (N=83) | Ixe q4w (N=114) | Ixe q2w (N=98) | |||||
| Patients achieving response, n (%) | Week 16 | Week 52 | Week 16 | Week 52 | Week 16 | Week 52 | Week 16 | Week 52 |
| ASAS40 | 39/78 (50.0) | 43/72 (59.7) | 43/81 (53.1) | 42/74 (56.8) | 29/100 (29.0) | 39/88 (44.3) | 30/91 (33.0) | 30/80 (37.5) |
| ASAS20 | 52/78 (66.7) | 53/72 (73.6) | 57/81 (70.4) | 59/74 (79.7) | 55/100 (55.0) | 60/88 (68.2) | 46/91 (50.5) | 47/80 (58.8) |
| ASAS partial remission | 12/78 (15.4) | 22/72 (30.6) | 12/81 (14.8) | 20/74 (27.0) | 7/100 (7.0) | 13/88 (14.8) | 5/91 (5.5) | 8/80 (10.0) |
| ASDAS clinically important improvement | 50/78 (64.1) | 51/72 (70.8) | 50/80 (62.5) | 51/74 (68.9) | 51/100 (51.0) | 53/85 (62.4) | 48/91 (52.7) | 44/78 (56.4) |
| ASDAS major improvement | 24/78 (30.8) | 30/72 (41.7) | 19/80 (23.8) | 29/74 (39.2) | 18/100 (18.0) | 27/85 (31.8) | 21/91 (23.1) | 26/78 (33.3) |
| ASDAS <2.1 (low disease activity) | 35/78 (44.9) | 43/72 (59.7) | 35/80 (43.8) | 43/74 (58.1) | 20/100 (20.0) | 27/85 (31.8) | 16/91 (17.6) | 24/78 (30.8) |
| ASDAS <1.3 (inactive disease) | 13/78 (16.7) | 18/72 (25.0) | 9/80 (11.3) | 16/74 (21.6) | 4/100 (4.0) | 10/85 (11.8) | 5/91 (5.5) | 4/78 (5.1) |
| BASDAI50 | 34/78 (43.6) | 43/72 (59.7) | 36/81 (44.4) | 38/74 (51.4) | 25/100 (25.0) | 31/88 (35.2) | 23/91 (25.3) | 27/80 (33.8) |
| Mean change from baseline (SD) | Week 16 | Week 52 | Week 16 | Week 52 | Week 16 | Week 52 | Week 16 | Week 52 |
| ASDAS | -1.5 (1.1) | -1.8 (1.1) | -1.4 (0.9) | -1.7 (1.0) | -1.2 (1.0) | -1.4 (1.1) | -1.2 (1.1) | -1.5 (1.2) |
| BASDAI | -3.1 (2.4) | -3.6 (2.3) | -2.7 (2.0) | -3.3 (2.3) | -2.3 (2.0) | -2.9 (2.3) | -2.1 (2.4) | -2.8 (2.3) |
| BASFI | -2.5 (2.3) | -3.1 (2.3) | -2.5 (2.2) | -3.1 (2.4) | -1.8 (2.0) | -2.6 (2.5) | -2.1 (2.3) | -2.5 (2.3) |
| SF-36 PCS* | 7.5 (7.7)) | 9.4 (9.0) | 7.5 (6.6) | 9.0 (7.3) | 6.8 (7.4) | 8.0 (8.7) | 6.3 (7.7) | 8.2 (7.8) |
| ASAS Health Index | -2.3 (3.3) | -3.0 (3.2) | -2.9 (3.2) | -3.7 (3.5) | -2.2 (3.1) | -3.0 (3.8) | -1.9 (4.0) | -2.9 (3.7) |
| SPARCC MRI spine score | -8.9 (16.2) | -8.8 (17.3) | -8.7 (16.5) | -8.5 (15.9) | -3.2 (8.3) | NA | -5.1 (11.9) | NA |
| SPARCC MRI sacroiliac joint score | -3.4 (7.6) | -3.3 (8.7) | -4.1 (7.3) | -4.2 (7.5) | NA | NA | NA | NA |
| CRP, mg/L | -7.0 (17.0) | -9.4 (11.1) | -8.2 (15.5) | -10.2 (15.1) | -12.7 (31.7) | -10.9 (33.1) | -11.1 (19.6) | -11.4 (20.5) |
*SF-36 PCS data are reported as t-scores, based on 2009 US general population norms.
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; ITT, intent-to-treat; MBOCF, modified baseline observation carried forward; MRI, magnetic resonance imaging; NA, not applicable; NRI, non-responder imputation; 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; SD, standard deviation; SPARCC, Spondyloarthritis Research Consortium of Canada; TNFi, tumour necrosis factor inhibitor.