Concomitant treatment | cDMARD | MTX | None (cDMARD-naïve or past use at baseline) | ||||||
PBO, n=69 | IXEQ4W, n=68 | IXEQ2W, n=63 | PBO, n=59 | IXEQ4W, n=57 | IXEQ2W, n=53 | PBO, n=37 | IXEQ4W, n=39 | IXEQ2W, n=40 | |
Age (years), mean (SD) | 51.0 (12.5) | 49.1 (10.0) | 49.3 (12.8) | 51.3 (12.8) | 49.9 (10.3) | 50.1 (12.7) | 49.9 (12.1) | 49.1 (10.4) | 50.5 (12.4) |
Male, n (%) | 32 (46.4) | 29 (42.6) | 27 (42.9) | 25 (42.4) | 24 (42.1) | 23 (43.4) | 16 (43.2) | 16 (41.0) | 21 (52.5) |
Weight (kg), mean (SD) | 84.8 (19.7) | 83.5 (19.5) | 81.0 (16.7) | 84.87 (20.1) | 84.58 (20.0) | 81.88 (15.8) | 81.8 (19.6) | 88.9 (28.0) | 82.6 (18.8) |
Time since PsA diagnosis (years), mean (SD) | 6.1 (7.4) | 5.6 (5.8) | 7.4 (7.4) | 6.1 (7.6) | 5.1 (5.3) | 7.8 (7.8) | 6.8 (5.8) | 7.3 (7.3) | 7.0 (9.1) |
Tender joint count (68 joints), mean (SD) | 19.5 (12.8) | 20.6 (13.3) | 21.4 (15.1) | 20.6 (13.4) | 20.5 (13.8) | 21.1 (15.6) | 18.6 (13.4) | 20.3 (14.4) | 21.8 (12.4) |
Swollen joint count (66 joints), mean (SD) | 10.9 (7.7) | 10.8 (7.4) | 11.8 (7.6) | 11.3 (8.1) | 10.8 (7.9) | 11.4 (6.0) | 10.1 (6.4) | 12.6 (9.4) | 12.5 (6.7) |
HAQ-DI total score, mean (SD) | 1.19 (0.60) | 1.25 (0.54) | 1.23 (0.55) | 1.21 (0.60) | 1.21 (0.53) | 1.25 (0.57) | 1.09 (0.62) | 1.22 (0.56) | 1.09 (0.59) |
van der Heijde mTSS, mean (SD) | 18.9 (32.2) | 21.2 (36.9) | 17.3 (32.7) | 17 (28.6) | 21 (38.4) | 19.2 (35.2) | 15.3 (21.6) | 15.7 (23.9) | 11.9 (21.4) |
The study was not designed to test equivalence or non-inferiority of treatment with ixekizumab alone versus treatment with ixekizumab combined with cDMARDs.
cDMARD, conventional disease-modifying antirheumatic drugs; HAQ-DI, Health Assessment Questionnaire-Disability Index; IXEQ2W, 80 mg ixekizumab once every 2 weeks; IXEQ4W, 80 mg ixekizumab once every 4 weeks; mTSS, modified total Sharp score; MTX, methotrexate; n, number of patients; PBO, placebo; PsA, psoriatic arthritis.