Baseline characteristics of patients initiating treatment with SEC or an alternative TNFi after prior exposure to one or more TNFis with available follow-up visit at 1 year for different response analyses
| Parameter | A. Response/tolerance analysis | B. Completer analysis | ||||||
| N=302 | TNFi, n=214 | SEC, n=88 | P value | N=208 | TNFi, n=153 | SEC, n=55 | P value | |
| Male sex, n (%) | 302 | 92 (43.0) | 35 (39.8) | 0.70 | 208 | 73 (47.7) | 20 (36.4) | 0.16 |
| ASAS classification | 302 | 0.97 | 208 | 0.85 | ||||
| Positive, n (%) | 134 (62.6) | 57 (64.8) | 100 (65.4) | 34 (61.8) | ||||
| Negative, n (%) | 45 (21.0) | 18 (20.4) | 28 (18.3) | 12 (21.8) | ||||
| Unknown, n (%) | 35 (16.4) | 13 (14.8) | 25 (16.3) | 9 (16.4) | ||||
| Radiographic sacroiliitis, n (%) | 141 | 75 (76.5) | 37 (86.0) | 0.26 | 104 | 59 (75.6) | 23 (88.5) | 0.27 |
| Age, years | 302 | 44.0 (12.6) | 46.2 (11.5) | 0.17 | 208 | 43.0 (13.0) | 46.3 (12.2) | 0.12 |
| Symptom duration, years | 292 | 13.5 (10.3) | 14.5 (11.6) | 0.54 | 200 | 14.1 (10.9) | 14.2 (11.6) | 0.87 |
| HLA-B27 positive, n (%) | 264 | 108 (58.1) | 43 (55.1) | 0.68 | 180 | 86 (64.7) | 26 (55.3) | 0.30 |
| BASDAI | 218 | 4.7 (2.1) | 5.9 (1.9) | <0.001 | 149 | 4.4 (2.1) | 5.9 (1.9) | <0.001 |
| Physician Global Assessment | 278 | 3.5 (2.0) | 4.3 (2.0) | 0.006 | 191 | 3.4 (2.0) | 4.1 (2.0) | 0.05 |
| Patient Global Assessment | 237 | 3.9 (2.5) | 5.1 (2.6) | 0.002 | 162 | 3.5 (2.4) | 4.5 (2.5) | 0.03 |
| ASDAS | 186 | 2.6 (0.9) | 3.2 (0.9) | <0.001 | 127 | 2.5 (0.9) | 3.3 (0.9) | <0.001 |
| C reactive protein (mg/L); median (IQR) | 244 | 2.0 (0.5; 5.0) | 4.0 (1.6; 5.8) | 0.003 | 171 | 2.0 (0.5; 5.0) | 4.0 (1.4; 5.0) | 0.03 |
| Elevated C reactive protein levels, n (%) | 264 | 53 (28.6) | 26 (32.9) | 0.56 | 183 | 38 (28.4) | 17 (34.7) | 0.47 |
| BASFI | 204 | 2.8 (2.3) | 4.6 (2.5) | <0.001 | 139 | 2.6 (2.2) | 4.8 (2.6) | <0.001 |
| BASMI | 164 | 1.8 (1.6) | 2.5 (1.9) | 0.01 | 115 | 1.8 (1.7) | 2.5 (2.0) | 0.04 |
| EQ-5D | 206 | 63.9 (20.6) | 55.9 (19.7) | 0.006 | 141 | 66.9 (18.8) | 58.6 (16.5) | 0.004 |
| Current peripheral arthritis, n (%) | 280 | 61 (31.0) | 35 (42.2) | 0.07 | 194 | 42 (29.4) | 19 (37.2) | 0.38 |
| No of swollen joints | 274 | 1.0 (2.9) | 1.1 (2.5) | 0.34 | 189 | 0.9 (2.7) | 0.7 (1.6) | 0.60 |
| Current enthesitis, n (%) | 275 | 130 (67.7) | 64 (77.1) | 0.15 | 189 | 91 (65.9) | 37 (72.5) | 0.48 |
| Modified MASES* | 275 | 2.8 (3.4) | 3.7 (3.8) | 0.08 | 189 | 2.3 (2.9) | 3.1 (3.2) | 0.12 |
| Dactylitis ever, n (%) | 298 | 30 (14.2) | 16 (18.4) | 0.38 | 205 | 21 (13.9) | 12 (22.2) | 0.19 |
| Uveitis ever, n (%) | 292 | 31 (15.0) | 8 (9.4) | 0.26 | 200 | 26 (17.7) | 4 (7.5) | 0.11 |
| Inflammatory bowel disease ever, n (%) | 295 | 15 (7.2) | 4 (4.5) | 0.45 | 205 | 12 (8.0) | 1 (1.8) | 0.19 |
| Psoriasis ever, n (%) | 288 | 16 (7.8) | 10 (12.1) | 0.26 | 197 | 10 (6.8) | 6 (11.8) | 0.37 |
| csDMARDs ever, n (%) | 302 | 97 (45.3) | 43 (48.9) | 0.61 | 208 | 67 (43.8) | 28 (50.9) | 0.43 |
| Current csDMARD, n (%) | 302 | 29 (13.6) | 17 (19.3) | 0.22 | 208 | 22 (14.4) | 9 (16.4) | 0.83 |
| Current NSAIDs, n (%) | 262 | 135 (73.8) | 63 (79.8) | 0.35 | 177 | 89 (68.5) | 37 (78.7) | 0.26 |
| Smoker ever, n (%) | 275 | 111 (57.8) | 57 (68.7) | 0.11 | 188 | 84 (61.3) | 33 (64.7) | 0.74 |
| Exercise sessions/week | 138 | 2.9 (2.6) | 3.7 (3.1) | 0.23 | 93 | 3.0 (2.6) | 3.2 (2.7) | 0.76 |
| Body mass index | 173 | 26.6 (5.3) | 27.3 (5.6) | 0.38 | 117 | 26.2 (5.5) | 27.6 (6.0) | 0.23 |
| No of previous bDMARDs used, n (%) | 302 | <0.001 | 208 | <0.001 | ||||
| 1 (second-line treatment) | 133 (62.1) | 20 (22.7) | 96 (62.8) | 13 (23.6) | ||||
| 2 (third-line treatment) | 42 (19.6) | 31 (35.2) | 30 (19.6) | 20 (36.4) | ||||
| ≥3 (>third-line treatment) | 39 (18.3) | 37 (42.1) | 27 (17.6) | 22 (40.0) | ||||
| Reason of discontinuation of previous TNFi | 273 | 0.40 | 181 | 0.07 | ||||
| Ineffectiveness, n (%) | 126 (67.0) | 57 (67.1) | 85 (65.9) | 33 (63.5) | ||||
| Adverse events, n (%) | 31 (16.5) | 19 (22.4) | 19 (14.7) | 15 (28.9) | ||||
| Other, n (%) | 31 (16.6) | 9 (10.6) | 25 (19.4) | 4 (7.7) | ||||
Except where indicated otherwise, values are the mean (SD). A. Population for response/tolerance analysis (patients with available outcome at 1 year, excluding patients having discontinued the bDMARD in the meantime). B. Population for completer analysis (patients still on treatment at outcome assessment).
*Modification refers to the inclusion of the plantar fascia in the count.
ASAS, Assessment in SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; bDMARD, biological disease-modifying antirheumatic drug; CRP, C reactive protein; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; EQ-5D, EuroQol-5 domains; HLA-B27, human leucocyte antigen B27; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; NSAIDs, non-steroidal anti-inflammatory drugs; SEC, secukinumab; TNFi, tumour necrosis factor inhibitor.