IXE Q4W | IXE Q2W | Total IXE | |
---|---|---|---|
Nonprogression at year 2 | |||
Overall population | N = 115 | N = 115 | N = 230 |
Change in total mSASSS < 2 | 102 (88.7) | 104 (90.4) | 206 (89.6) |
Change in total mSASSS ≤ 0 | 86 (74.8) | 88 (76.5) | 174 (75.7) |
Age, ≥ 40 yrs | n = 70 | n = 72 | n = 142 |
Change in total mSASSS < 2 | 60 (85.7) | 63 (87.5) | 123 (86.6) |
Change in total mSASSS ≤ 0 | 49 (70.0) | 49 (68.1) | 98 (69.0) |
Age, < 40 yrs | n = 45 | n = 43 | n = 88 |
Change in total mSASSS < 2 | 42 (93.3) | 41 (95.3) | 83 (94.3) |
Change in total mSASSS ≤ 0 | 37 (82.2) | 39 (90.7) | 76 (86.4) |
Male sex | n = 99 | n = 89 | n = 188 |
Change in total mSASSS < 2 | 86 (86.9) | 78 (87.6) | 164 (87.2) |
Change in total mSASSS ≤ 0 | 71 (71.7) | 65 (73.0) | 136 (72.3) |
Female sex | n = 16 | n = 26 | n = 42 |
Change in total mSASSS < 2 | 16 (100.0) | 26 (100.0) | 42 (100.0) |
Change in total mSASSS ≤ 0 | 15 (93.8) | 23 (88.5) | 38 (90.5) |
Patients with syndesmophytes at baselinea | n = 49 | n = 42 | n = 91 |
Change in total mSASSS < 2 | 39 (79.6) | 34 (81.0) | 73 (80.2) |
Change in total mSASSS ≤ 0 | 30 (61.2) | 27 (64.3) | 57 (62.6) |
Patients without syndesmophytes at baselinea | n = 65 | n = 72 | n = 137 |
Change in total mSASSS < 2 | 62 (95.4) | 70 (97.2) | 132 (96.4) |
Change in total mSASSS ≤ 0 | 55 (84.6) | 61 (84.7) | 116 (84.7) |
HLA-B27 positive at baseline | n = 101 | n = 100 | n = 201 |
Change in total mSASSS < 2 | 88 (87.1) | 89 (89.0) | 177 (88.1) |
Change in total mSASSS ≤ 0 | 74 (73.3) | 74 (74.0) | 148 (73.6) |
HLA-B27 negative at baseline | n = 14 | n = 15 | n = 29 |
Change in total mSASSS < 2 | 14 (100.0) | 15 (100.0) | 29 (100.0) |
Change in total mSASSS ≤ 0 | 12 (85.7) | 14 (93.3) | 26 (89.7) |
Baseline ASDAS (2.1–3.5) | n = 30 | n = 28 | n = 58 |
Change in total mSASSS < 2 | 29 (96.7) | 28 (100.0) | 57 (98.3) |
Change in total mSASSS ≤ 0 | 26 (86.7) | 24 (85.7) | 50 (86.2) |
Baseline ASDAS > 3.5 | n = 85 | n = 87 | n = 172 |
Change in total mSASSS < 2 | 73 (85.9) | 76 (87.4) | 149 (86.6) |
Change in total mSASSS ≤ 0 | 60 (70.6) | 64 (73.6) | 124 (72.1) |
Week 52 MRI in SPARCC spine ≥ 2 | n = 21 | n = 20 | n = 41 |
Change in total mSASSS < 2 | 18 (85.7) | 16 (80.0) | 34 (82.9) |
Change in total mSASSS ≤ 0 | 13 (61.9) | 13 (65.0) | 26 (63.4) |
Week 52 MRI in SPARCC spine < 2 | n = 34 | n = 34 | n = 68 |
Change in total mSASSS < 2 | 33 (97.1) | 32 (94.1) | 65 (95.6) |
Change in total mSASSS ≤ 0 | 31 (91.2) | 28 (82.4) | 59 (86.8) |
Week 16 MRI in SPARCC spine ≥ 2 | n = 35 | n = 40 | n = 75 |
Change in total mSASSS < 2 | 29 (82.9) | 36 (90.0) | 65 (86.7) |
Change in total mSASSS ≤ 0 | 24 (68.6) | 30 (75.0) | 54 (72.0) |
Week 16 MRI in SPARCC spine < 2 | n = 51 | n = 49 | n = 100 |
Change in total mSASSS < 2 | 49 (96.1) | 45 (91.8) | 94 (94.0) |
Change in total mSASSS ≤ 0 | 44 (86.3) | 40 (81.6) | 84 (84.0) |
Patients who normalized CRP at year 2 (≤ 5 mg/L) | n = 83 | n = 87 | n = 170 |
Change in total mSASSS < 2 | 73 (88.0) | 77 (88.5) | 150 (88.2) |
Change in total mSASSS ≤ 0 | 61 (73.5) | 67 (77.0) | 128 (75.3) |
Patients who did not normalize CRP at year 2 (> 5 mg/L) | n = 32 | n = 28 | n = 60 |
Change in total mSASSS < 2 | 29 (90.6) | 27 (96.4) | 56 (93.3) |
Change in total mSASSS ≤ 0 | 25 (78.1) | 21 (75.0) | 46 (76.7) |
No new syndesmophyte at year 2a | |||
Overall population | N = 115 | N = 114 | N = 229 |
107 (93.0) | 111 (97.4) | 218 (95.2) | |
Patients with syndesmophytes at baseline | n = 49 | n = 42 | n = 91 |
43 (87.8) | 39 (92.9) | 82 (90.1) | |
Patients without syndesmophytes at baseline | n = 65 | n = 72 | n = 137 |
63 (96.9) | 72 (100.0) | 135 (98.5) |
↵* Data are N (%) or n (%) for patients treated with IXE for 2 years (108 weeks).
↵a From both of the selected readers at the same location (total IXE: 1 patient had no syndesmophytes at year 2). ASDAS: Ankylosing Spondylitis Disease Activity Score; CRP: C-reactive protein; IXE: ixekizumab; IXE Q2W: 80 mg IXE every 2 weeks; IXE Q4W: 80 mg IXE every 4 weeks; MRI: magnetic resonance imaging; mSASSS: modified Stoke Ankylosing Spondylitis Spinal Score.